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methylprednisolone

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Description

Methylprednisolone: A PREDNISOLONE derivative with similar anti-inflammatory action. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

6alpha-methylprednisolone : The 6alpha-stereoisomer of 6-methylprednisolone. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID6741
CHEMBL ID650
CHEBI ID6888
SCHEMBL ID5084
MeSH IDM0013662

Synonyms (204)

Synonym
MLS002207191
MLS001148159 ,
BRD-K35240538-001-03-1
(6a,11b)-11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione
(6s,8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-17-(2-hydroxyacetyl)-6,10,13-trimethyl-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthren-3-one
MLS000028541 ,
smr000058330
NCI60_001657
(6alpha,11beta)-11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione
PRESTWICK3_000279
nsc19987
medrol
medesone
metrisone
medrate
pregna-1,20-dione, 11,17,21-trihydroxy-6-methyl-, (6.alpha.,11.beta.)-
6.alpha.-methylprednisolone
metilbetasone
moderin
medrone
wyacort
83-43-2
promacortine
mesopren
nsc-19987
metastab
pregna-1,20-dione, 6.alpha.-methyl-11.beta.-17,21-trihydroxy-
pregna-1,20-dione, 11.beta.,17,21-trihydroxy-6.alpha.-methyl-
urbason
dopomedrol
urbasone
noretona
methylprednisolone
besonia
methylprednisolone, 6-alpha
PRESTWICK_622
NCGC00016330-01
metilprednisolona
solomet
methylprednisolon
CHEBI:6888 ,
methylprednisolonum
6alpha-methylprednisolone
11beta,17,21-trihydroxy-6alpha-methylpregna-1,4-diene-3,20-dione
PRESTWICK2_000279
BSPBIO_000158
metysolon
predni n tablinen
delta(sup 1)-6-alpha-methylhydrocortisone
prednol- l
prednisolone, 6alpha-methyl-
pregna-1,4-diene-3,20-dione, 6-alpha-methyl-11-beta-17,21-trihydroxy-
medlone 21
metilprednisolone [dcit]
reactenol
prednisolone, methyl-
methylprednisolonum [inn-latin]
pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6alpha,11beta)-
medrol adt pak
medrol dosepak
pregna-1,4-diene-3,20-dione, 11beta,17,21-trihydroxy-6alpha-methyl-
metipred
metrocort
methyleneprednisolone
artisone-wyeth
hsdb 3127
sieropresol
lemod
summicort;
6-alpha-methylprednisolone
11-beta,17,21-trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione
medixon
suprametil
11beta,17alpha,21-trihydroxy-6alpha-methyl-1,4-pregnadiene-3,20-dione
einecs 201-476-4
esametone
depo-medrol (acetate)
brn 2340300
nirypan
metilprednisolona [inn-spanish]
firmacort
6alpha-methylprednisolone, >=98%
1-dehydro-6alpha-methylhydrocortisone
delta(1)-6alpha-methylhydrocortisone
6alpha-methyl-11beta,17alpha,21-triol-1,4-pregnadiene-3,20-dione
DB00959
D00407
methylprednisolone (jp17/usp/inn)
medrol (tn)
PRESTWICK1_000279
SPBIO_002377
PRESTWICK0_000279
BPBIO1_000174
NCGC00022735-03
6 methylprednisolone
HMS2090B13
M1665
11beta,17alpha,21-trihydroxy-6alpha-methylpregna-1,4-diene-3,20-dione
CHEMBL650
j3.872e ,
HMS1568H20
LMST02030178
HMS2095H20
HMS3259J04
NCGC00255269-01
tox21_302018
dtxsid7023300 ,
cas-83-43-2
dtxcid903300
tox21_110376
HMS2230D16
AKOS015969744
6alpha-methyl-11beta,17alpha,21-trihydroxy-1,4-pregnadiene-3,20-dione
x4w7zr7023 ,
metilprednisolone
ec 201-476-4
4-08-00-03498 (beilstein handbook reference)
summicort
methylprednisolone [usp:inn:ban:jan]
unii-x4w7zr7023
methylprednisolone [usp-rs]
methylprednisolone [green book]
methylprednisolone [mi]
methylprednisolone acetate impurity b [ep impurity]
methylprednisolone component of neo-medrol
methylprednisolone [inn]
neo-medrol component methylprednisolone
methylprednisolone [mart.]
methylprednisolone [ep monograph]
methylprednisolone [jan]
methylprednisolone [hsdb]
6-methyl-prednisolone
methylprednisolone [usp monograph]
methylprednisolone hydrogen succinate impurity a [ep impurity]
methylprednisolone [who-dd]
methylprednisolone [orange book]
methylprednisolone [vandf]
S1733
gtpl7088
CCG-220279
HY-B0260
NC00691
SCHEMBL5084
NCGC00022735-06
tox21_110376_1
KS-1273
11beta,17,21-trihydroxy-6alpha-methyl-1,4-pregnadiene-3,20-dione
VHRSUDSXCMQTMA-PJHHCJLFSA-N
(6s,8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-17-(2-hydroxyacetyl)-6,10,13-trimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3h-cyclopenta[a]phenanthren-3-one
Q-201395
6alpha-methylprednisolone base
11?,17?,21-trihydroxy-6?-methyl-1,4-pregnadiene-3,20-dione
pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6a,11b)-
(6?,11?)-11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione
OPERA_ID_1576
SR-01000003089-2
C16437
sr-01000003089
6alpha-methylprednisolone, vetranal(tm), analytical standard
methylprednisolone, united states pharmacopeia (usp) reference standard
bdbm50103616
methylprednisolone, european pharmacopoeia (ep) reference standard
methylprednisolone for system suitability, european pharmacopoeia (ep) reference standard
methylprednisolone, pharmaceutical secondary standard; certified reference material
methylprednisolone for system suitability a, europepharmacopoeia (ep) reference standard
6-alpha-methylprednisolone 100 microg/ml in acetonitrile
HMS3712H20
methylprednisolone, british pharmacopoeia (bp) reference standard
Q417222
BRD-K35240538-001-11-4
BRD-K35240538-001-26-2
pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6i+/-,11i(2))-
1,4-pregnadien-6alpha-methyl-11beta, 17, 21-triol-3, 20-dione
A855290
methylprednisolone (standard)
CS-0694768
HY-B0260R
EN300-7414014
(1r,3as,3bs,5s,9ar,9bs,10s,11as)-1,10-dihydroxy-1-(2-hydroxyacetyl)-5,9a,11a-trimethyl-1h,2h,3h,3ah,3bh,4h,5h,7h,9ah,9bh,10h,11h,11ah-cyclopenta[a]phenanthren-7-one
metilprednisolona (inn-spanish)
methylpred dp
methylprednisolone (usp-rs)
radilem
methylprednisolone (ep monograph)
solpredone
prednol-l
methylprednisolene tablets
depmedalone
metilbetasone solubile
duralone
veriderm medrol
medrol tablets
methylprednisolonum (inn-latin)
methylprednisolone (usp:inn:ban:jan)
methylprednisolone (mart.)
meprolone
prednilen
caberdelta m
depo moderin
methylprednisolone (usp monograph)
mega-star
predni-m-tablinen
depo-nisolone
methylprednisole

Research Excerpts

Toxicity

Methylprednisolone could significantly decrease postoperative pain score, narcotic consumption. Glucocorticoid-related adverse events were more common following methylprednisols treatment.

ExcerptReferenceRelevance
" Tests of adrenal function suggest that beclomethasone dipropionate at dosages of 400 to 800 mug daily has little or no adverse effect."( Beclomethasone dipropionate inhaler: a review of its pharmacology, therapeutic value and adverse effects. I: Asthma.
Avery, GS; Brogden, RN; Pinder, RM; Sawyer, PR; Speight, TM, 1975
)
0.25
" This suggests that occult vascular lesions may have been present in the allograft which were exacerbated when exposed to the irritant vascular effects of contrast media, producing a mild, reversible toxic nephritis."( Adverse effects of meglumine diatrizoate on renal function in the early post-transplant period.
Etheredge, EE; Hill, G; Light, JA; Perloff, LJ; Spees, EK, 1975
)
0.25
"To determine the frequency of significant adverse effects associated with high-dose intravenous methylprednisolone therapy (HIVMP) given as methylprednisolone 1 g/d for three consecutive days."( A study of adverse effects of high-dose intravenous (pulse) methylprednisolone therapy in patients with rheumatic disease.
Baethge, BA; Goldberg, JW; Lidsky, MD, 1992
)
0.28
"Subjective complaints were elicited via a standardized questionnaire that identified adverse effects through organ system review."( A study of adverse effects of high-dose intravenous (pulse) methylprednisolone therapy in patients with rheumatic disease.
Baethge, BA; Goldberg, JW; Lidsky, MD, 1992
)
0.28
"HIVMP has an acceptably low risk of significant adverse effects."( A study of adverse effects of high-dose intravenous (pulse) methylprednisolone therapy in patients with rheumatic disease.
Baethge, BA; Goldberg, JW; Lidsky, MD, 1992
)
0.28
" The ability to induce "shock protein" synthesis obviously seems to be restricted to toxic drugs."( A cell culture assay for the detection of cardiotoxicity.
Löw-Friedrich, I; Schoeppe, W; von Bredow, F, 1991
)
0.28
" Other features of this adverse drug reaction were unremitting fever, leukocytosis with eosinophilia and atypical lymphocytosis, and proteinuria."( Phenobarbital hepatotoxicity in an 8-month-old infant.
Goldbach, M; Phillips, MJ; Roberts, EA; Spielberg, SP, 1990
)
0.28
" In this study we examined whether steroids could reduce the adverse cardiopulmonary effects of rIL-2."( Steroid pretreatment reduces interleukin-2 toxicity in sheep.
Gunther, RA; Hughes, KS; Jesmok, GJ; Morse, ED, 1990
)
0.28
"A less frequently reported adverse side effect of local steroid injections has been described."( Perilymphatic atrophy of skin. An adverse side effect of intralesional steroid injections.
Kravette, MA, 1986
)
0.27
"5 X 10(-3) M was toxic to all cell lines."( Lymphotoxic activity of methyl prednisolone in vitro--I. Comparative toxicity of methyl prednisolone in human cell lines of B and T origin.
Bell, JB; Hall, JG; Hobbs, SM; Jackson, E; Millar, BC, 1987
)
0.27
"A retrospective analysis of 350 treatment courses using high dose pulsed intravenous methylprednisolone for relapses of multiple sclerosis revealed a low number of adverse effects."( Methylprednisolone therapy in multiple sclerosis: a profile of adverse effects.
Lyons, PR; Newman, PK; Saunders, M, 1988
)
0.27
" The findings suggest that this policy is safe and avoids the potential hazards of long-term CyA."( Conversion from cyclosporin to azathioprine 3 months after renal transplantation--is it safe?
Cassidy, MJ; Irving, E; Jacobson, JE; Pascoe, MD; Swanepoel, CR; van Zyl-Smit, R, 1986
)
0.27
" Thus, toxic effects can be caused by preservatives or inadequate osmolarity of the vehicles alone."( Experimental and clinical observations of the intraocular toxicity of commercial corticosteroid preparations.
Arena, JE; Chandler, D; Hida, T; Machemer, R, 1986
)
0.27
" The LD50 values of THS-201 both in mice and rats were estimated more than 5000 mg/kg at each route, and these are for above larger than those of TA or MPA."( [Study on toxicity of halopredone acetate. (I) Acute toxicity study in mice and rats].
Ichinohe, M; Kaga, M; Okazaki, S; Shinpo, K; Sudo, J; Takeuchi, M; Tanabe, T; Tsuga, T, 1985
)
0.27
"Because previous studies have suggested that some of the toxic effects of oxygen may result from impaired surfactant phospholipid metabolism, we examined the effects of methylprednisolone on the surfactant system in adult mice exposed to greater than 98% O2."( Methylprednisolone increases the toxicity of oxygen in adult mice. Mechanical and biochemical effects on the surfactant system.
Gross, NJ; Smith, DM, 1984
)
0.27
" CPH-only treated rats had severe toxic nephrosis characterised by acute tubular necrosis, and elevated blood urea and creatinine."( Glucocorticoid amelioration of nephrotoxicity: a study of cephaloridine-methylprednisolone interaction in the rat.
Cockburn, A; Everett, DJ; Garcia Conesa, MT; Harvey, PW; Healing, G; Major, IR; McFarlane, M; Olatunde, O; Purdy, KA, 1995
)
0.29
" We conclude that two times 250 mg MPNS administered six hours and one hour before the first administration of OKT3 effectively attenuates adverse reactions following administration of OKT3."( Pretreatment with divided doses of steroids strongly decreases side effects of OKT3.
Bemelman, FJ; Buysmann, S; Schellekens, PT; Surachno, J; ten Berge, IJ; Wilmink, JM, 1994
)
0.29
"Cis-diamminedichloroplatinum (II) (cisplatin) is an effective antitumor drug, but it has an adverse effect of nephrotoxicity."( [Prophylactic effect of methylprednisolone on cisplatin-induced nephrotoxicity].
Koikawa, Y, 1995
)
0.29
" To examine this theory and to investigate the relationship of glucocorticoid metabolism to steroid-induced adverse effects among specific ethnic groups of renal transplant recipients, 9 black and 9 white male patients chronically receiving methylprednisolone were enrolled."( Methylprednisolone pharmacokinetics, cortisol response, and adverse effects in black and white renal transplant recipients.
Biocevich, DM; Reed, K; Singh, JP; Tornatore, KM; Tousley, K; Venuto, RC, 1995
)
0.29
" The outcome variables were: duration of hospitalization, percent of predicted peak expiratory flow rates recorded at 12-hour intervals, number of albuterol treatments required, and adverse effects."( Aminophylline therapy does not improve outcome and increases adverse effects in children hospitalized with acute asthmatic exacerbations.
Bonagura, VR; Strauss, RE; Valacer, DJ; Wertheim, DL, 1994
)
0.29
" In the Am group, 6 of the 14 patients who entered the study experienced significant adverse effects consisting of nausea, emesis, headache, abdominal pain, and palpitations."( Aminophylline therapy does not improve outcome and increases adverse effects in children hospitalized with acute asthmatic exacerbations.
Bonagura, VR; Strauss, RE; Valacer, DJ; Wertheim, DL, 1994
)
0.29
"There is no benefit and considerable risk of adverse effects associated with the use of Am in hospitalized asthmatic children."( Aminophylline therapy does not improve outcome and increases adverse effects in children hospitalized with acute asthmatic exacerbations.
Bonagura, VR; Strauss, RE; Valacer, DJ; Wertheim, DL, 1994
)
0.29
"Cis-diamminedichloroplatinum (II) (cisplatin) is a very effective antitumor drug, but It has an adverse effect of nephrotoxicity."( [Prophylactic effect of methylprednisolone on cisplatin-induced nephrotoxicity in rats].
Koikawa, Y; Kumazawa, J; Ueda, T; Uozumi, J; Yasumasu, T, 1993
)
0.29
"Acute encephalopathy is a recognized toxic effect of Cyclosporin A (CsA) in organ transplantation recipients."( Case report: cyclosporin A-induced neurotoxicity.
Almeida-Pinto, J; Lopes, G; Monteiro, L; Rocha, J; Rocha, N, 1993
)
0.29
"TAO is safe and may be a reasonable treatment alternative in a limited trial for patients who are unable to tolerate tapering of their glucocorticoid dosage."( Efficacy and safety of low-dose troleandomycin therapy in children with severe, steroid-requiring asthma.
Brenner, AM; Hill, MR; Iklé, DN; Kamada, AK; Szefler, SJ, 1993
)
0.29
"The main side effect of alpha-CD3-IT, vascular leak syndrome, was entirely prevented by adjunctive immunosuppressive therapy."( Tolerability and side effects of anti-CD3-immunotoxin in preclinical testing in kidney and pancreatic islet transplant recipients.
Cartner, S; Contreras, JL; Eckhoff, DE; Frenette, L; Neville, DM; Robbin, ML; Thomas, FT; Thomas, JM, 1999
)
0.3
"8%), adverse effects persisted."( Treatment of tacrolimus-related adverse effects by conversion to cyclosporine in liver transplant recipients.
Emre, S; Fishbein, TM; Genyk, Y; Guy, SR; Miller, CM; Schluger, LK; Schwartz, ME; Sheiner, PA, 2000
)
0.31
"Systemic toxic effects may develop as a result of topical and local use of ophthalmic corticosteroid preparations in susceptible patients."( Systemic toxicity of topical and periocular corticosteroid therapy in an 11-year-old male with posterior uveitis.
Cheng, L; Freeman, WR; Levi, L; Ozerdem, U; Scher, C; Song, MK, 2000
)
0.31
" The long-term effectiveness and side-effect profiles of pulse immunosuppressive regimens warrant further study."( Combination therapy with pulse cyclophosphamide plus pulse methylprednisolone improves long-term renal outcome without adding toxicity in patients with lupus nephritis.
Austin, HA; Balow, JE; Boumpas, DT; Collins, L; Crane, M; Danning, CL; Gourley, MF; Illei, GG; Klippel, JH; Kuroiwa, T; Steinberg, AD; Vaughan, EM; Yarboro, CH, 2001
)
0.31
"Rates of treatment failure (defined as need for supplemental immunosuppressive therapy or doubling of serum creatinine concentration, or death) and adverse events."( Combination therapy with pulse cyclophosphamide plus pulse methylprednisolone improves long-term renal outcome without adding toxicity in patients with lupus nephritis.
Austin, HA; Balow, JE; Boumpas, DT; Collins, L; Crane, M; Danning, CL; Gourley, MF; Illei, GG; Klippel, JH; Kuroiwa, T; Steinberg, AD; Vaughan, EM; Yarboro, CH, 2001
)
0.31
" Combination therapy and cyclophosphamide therapy alone did not differ statistically in terms of effectiveness or adverse events."( Combination therapy with pulse cyclophosphamide plus pulse methylprednisolone improves long-term renal outcome without adding toxicity in patients with lupus nephritis.
Austin, HA; Balow, JE; Boumpas, DT; Collins, L; Crane, M; Danning, CL; Gourley, MF; Illei, GG; Klippel, JH; Kuroiwa, T; Steinberg, AD; Vaughan, EM; Yarboro, CH, 2001
)
0.31
" The combination of pulse cyclophosphamide and methylprednisolone appears to provide additional benefit over pulse cyclophosphamide alone and does not confer additional risk for adverse events."( Combination therapy with pulse cyclophosphamide plus pulse methylprednisolone improves long-term renal outcome without adding toxicity in patients with lupus nephritis.
Austin, HA; Balow, JE; Boumpas, DT; Collins, L; Crane, M; Danning, CL; Gourley, MF; Illei, GG; Klippel, JH; Kuroiwa, T; Steinberg, AD; Vaughan, EM; Yarboro, CH, 2001
)
0.31
" LFM-A13 was not toxic to mice when administered systemically at dose levels ranging from 10 to 80 mg/kg."( In vivo pharmacokinetic features, toxicity profile, and chemosensitizing activity of alpha-cyano-beta-hydroxy-beta- methyl-N-(2,5-dibromophenyl)propenamide (LFM-A13), a novel antileukemic agent targeting Bruton's tyrosine kinase.
Carpenter, R; Cetkovic-Cvrlje, M; Chen, CL; Chen, H; Lisowski, E; Uckun, FM; Vassilev, A; Waurzyniak, B; Zheng, Y, 2002
)
0.31
"A major thrust of transplantation research is to find more effective and less broadly toxic immunosuppressive agents."( Long-term safety, tolerability and efficacy of daclizumab (Zenapax) in a two-dose regimen in liver transplant recipients.
Koch, M; Kuse, ER; Light, S; Nashan, B; Niemeyer, G, 2002
)
0.31
" None of the three adverse events reported were considered to be related to treatment."( A randomized, controlled study of the safety and efficacy of topical corticosteroid treatments of sunburn in healthy volunteers.
Duteil, L; Lorenz, B; Ortonne, JP; Queille-Roussel, C; Thieroff-Ekerdt, R, 2002
)
0.31
" Adverse events were more frequently observed in infliximab-treated patients, but only gold-treated patients discontinued treatment because adverse events (2 patients due to proteinuria, 2 patients due to mucocutaneous changes and one patient due to leucopenia)."( [Analysis of efficacy and safety of multiple intravenous infusion of anti-tumor necrosis factor-alpha monoclonal antibody (Remicade) combined with methotrexate compared with sodium aurothiomalate and intramuscular depot methylprednisolone in rheumatoid ar
Chlebicki, A; Głowska, A; Szechiński, J; Wiland, P, 2002
)
0.31
" In this series, intralesional steroid proved to be a safe effective treatment."( Capillary haemangioma of the eyelids and orbit: a clinical review of the safety and efficacy of intralesional steroid.
Byrne, SA; Lanigan, B; O'Keefe, M, 2003
)
0.32
" Adverse events were also evaluated."( Comparison of the efficacy and safety of combinations of metopimazine or ondansetron with methylprednisolone in the prevention of delayed emesis in patients receiving chemotherapy.
Bloch, J; Delgado, A; Khayat, D; Meric, JB; Rixe, O, 2005
)
0.33
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32
" An objective causality assessment revealed that the adverse reaction was possibly related to ibuprofen."( Optic neuritis with visual field defect--possible Ibuprofen-related toxicity.
Gabel, VP; Gamulescu, MA; Schalke, B; Schuierer, G, 2006
)
0.33
" Although idiopathic optic neuritis cannot be completely ruled out, the absence of other risk factors and additional findings plus the improvement after discontinuation of the drug speak for isolated toxic optic neuritis of the right eye."( Optic neuritis with visual field defect--possible Ibuprofen-related toxicity.
Gabel, VP; Gamulescu, MA; Schalke, B; Schuierer, G, 2006
)
0.33
"The aim of this study was to evaluate the long-term adverse effect (AE) profile of azathioprine (AZA) plus methylprednisolone combined immunosuppressive treatment in myasthenia gravis (MG) in a larger patient cohort."( Safety of long-term combined immunosuppressive treatment in myasthenia gravis--analysis of adverse effects of 163 patients.
Fornadi, L; Komoly, S; Lovas, G; Rozsa, C; Szabo, G, 2006
)
0.33
" Drug-related adverse events were only observed in the tacrolimus group."( Efficacy and safety of methylprednisolone aceponate ointment 0.1% compared to tacrolimus 0.03% in children and adolescents with an acute flare of severe atopic dermatitis.
Arcangeli, F; Belloni-Fortina, A; Bieber, T; Fölster-Holst, R; Städtler, G; Vick, K; Worm, M, 2007
)
0.34
" All adverse effects were self-limiting."( Side effects of postoperative administration of methylprednisolone and gentamicin into the posterior sub-Tenon's space.
Mercieca, F; Mercieca, K, 2007
)
0.34
"Celiac plexus neurolysis and block are considered safe but provide limited pain relief."( Initial evaluation of the efficacy and safety of endoscopic ultrasound-guided direct Ganglia neurolysis and block.
Chari, ST; Clain, JE; de la Mora, JG; Gleeson, FC; Levy, MJ; Pearson, RK; Pelaez, MC; Petersen, BT; Rajan, E; Topazian, MD; Vege, SS; Wang, KK; Wiersema, MJ, 2008
)
0.35
" There were no differences in the number and type of adverse events."( A double-blind placebo controlled trial of etanercept in patients with giant cell arteritis and corticosteroid side effects.
Belzunegui, J; Bonilla, G; Carreño, L; Figueroa, M; López-Longo, J; Martínez-Taboada, VM; Mola, EM; Rodríguez-Valverde, V, 2008
)
0.35
"IFN-alpha2a is efficient and safe for the long-term management of severe uveitis associated with Behçet disease."( Long-term efficacy and safety of low-dose interferon alpha2a therapy in severe uveitis associated with Behçet disease.
Bodaghi, B; Cassoux, N; Fardeau, C; Gendron, G; Gueudry, J; Lehoang, P; Piette, JC; Terrada, C; Wechsler, B, 2008
)
0.35
"No meaningful difference occurred between siplizumab and placebo groups in the incidence or severity of adverse events or laboratory test results."( Safety profile and clinical outcomes in a phase I, placebo-controlled study of siplizumab in acute graft-versus-host disease.
Adkins, D; Ratanatharathorn, V; White, B; Yang, H, 2009
)
0.35
"Liver toxicity, although not mentioned among the possible adverse effects of corticosteroids, has been occasionally reported in literature."( Hepatotoxicity after high-dose methylprednisolone for demyelinating disease.
Banfi, P; Bono, G; Cosentino, M; Loraschi, A; Mauri, M; Sessa, F,
)
0.13
" We did not find any difference in treatment-emergent adverse events between the ITM and placebo group."( Efficacy and safety of a single intrathecal methylprednisolone bolus in chronic complex regional pain syndrome.
Ferrari, MD; Marinus, J; Munts, AG; Teepe-Twiss, IM; van der Plas, AA; van Hilten, JJ, 2010
)
0.36
"Combining intra-articular corticosteroid and anti-TNF agent has proved to be safe in our cohort of patients."( Efficacy and safety of combining intra-articular methylprednisolone and anti-TNF agent to achieve prolonged remission in patients with recurrent inflammatory monoarthritis.
Haroon, M; O'Gradaigh, D, 2010
)
0.36
"The adverse effects and risks associated with intracarotid propofol injection during Wada testing were retrospectively compared in two groups of patients with (n = 75) and without (n = 58) intravenous methylprednisolone administered before intracarotid propofol injection."( Intravenous methylprednisolone reduces the risk of propofol-induced adverse effects during Wada testing.
Hashimoto, N; Kikuchi, T; Matsumoto, A; Mikuni, N; Miyamoto, S; Yamada, S; Yokoyama, Y, 2010
)
0.36
" MPA has an optimized efficacy/safety profile with minimal local or systemic adverse effects."( Balancing efficacy and safety in the management of atopic dermatitis: the role of methylprednisolone aceponate.
Luger, TA, 2011
)
0.37
" On follow-up for the second epidural at 1 to 2 months, VAS scores and any reports of adverse side effects were obtained by pain clinic nursing staff who were blinded to the type of corticosteroid used."( Efficacy and safety of lumbar epidural dexamethasone versus methylprednisolone in the treatment of lumbar radiculopathy: a comparison of soluble versus particulate steroids.
Brown, J; Kim, D,
)
0.13
" They are mostly presented in the group of mood stabilizers and antiepileptic drugs, particularly the carbamazepine and lamotrigine, and can be manifested through the Stevens Johnson syndrome, Toxic Epidermal Necrolysis (TEN)/Lyell's syndrome with about 30% lethality."( Exanthema medicamentosum as a side effect of promazine.
Cvitanović, MZ; Hlevnjak, I; Lasić, D; Uglešić, B; Višić, V, 2011
)
0.37
" Its safety has been debated after reports of adverse events."( Safety assessment and pharmacokinetics of intrathecal methylprednisolone acetate in dogs.
Grafe, MR; Kalkman, CJ; Meulenhoff, PC; Rijsdijk, M; Steinauer, J; van Wijck, AJ; Yaksh, TL, 2012
)
0.38
"Other than a brief motor block, no adverse clinical event occurred in any animal."( Safety assessment and pharmacokinetics of intrathecal methylprednisolone acetate in dogs.
Grafe, MR; Kalkman, CJ; Meulenhoff, PC; Rijsdijk, M; Steinauer, J; van Wijck, AJ; Yaksh, TL, 2012
)
0.38
" The WOMAC scale was applied at 4 weeks and adverse events were recorded."( Safety and efficacy of methylprednisolone infiltration in anserine syndrome treatment.
Esquivel-Valerio, JA; Galarza-Delgado, DÁ; Garza-Elizondo, MA; Negrete-López, R; Vega-Morales, D,
)
0.13
" The incidence of adverse events did not show any differences either."( Safety and efficacy of methylprednisolone infiltration in anserine syndrome treatment.
Esquivel-Valerio, JA; Galarza-Delgado, DÁ; Garza-Elizondo, MA; Negrete-López, R; Vega-Morales, D,
)
0.13
" Adverse events were recorded at each visit."( Efficacy and safety of three different cumulative doses of intravenous methylprednisolone for moderate to severe and active Graves' orbitopathy.
Azzolini, C; Baldeschi, L; Bartalena, L; Bernard, M; Boboridis, KG; Boschi, A; Bournaud, C; Currò, N; Daumerie, C; Krassas, GE; Marcocci, C; Mourits, MP; Nardi, M; Salvi, M; Sassi, L; Soeters, MR; Stahl, M; Veronesi, G; von Arx, G; Wiersinga, W, 2012
)
0.38
" Major adverse events were slightly more frequent using the highest dose but occurred also using the lowest dose."( Efficacy and safety of three different cumulative doses of intravenous methylprednisolone for moderate to severe and active Graves' orbitopathy.
Azzolini, C; Baldeschi, L; Bartalena, L; Bernard, M; Boboridis, KG; Boschi, A; Bournaud, C; Currò, N; Daumerie, C; Krassas, GE; Marcocci, C; Mourits, MP; Nardi, M; Salvi, M; Sassi, L; Soeters, MR; Stahl, M; Veronesi, G; von Arx, G; Wiersinga, W, 2012
)
0.38
" By repeated physical and laboratory examinations and history taking, patients were assessed for adverse effects that would be related to pulse therapy before, within, and 3 months after the treatment."( Short-term safety of pulse steroid therapy in multiple sclerosis relapses.
Alinaghian, M; Ashtari, F; Fatehi, F; Norouzi, R; Salari, M; Shaygannejad, V,
)
0.13
"6%) developed minor adverse effects of which the most common were palpitation, flashing, dyspepsia, insomnia, and virulent taste."( Short-term safety of pulse steroid therapy in multiple sclerosis relapses.
Alinaghian, M; Ashtari, F; Fatehi, F; Norouzi, R; Salari, M; Shaygannejad, V,
)
0.13
"This study approved that high-dose intravenous methylprednisolone is a safe treatment in MS attacks and the short-term adverse effects were mostly minor and transient."( Short-term safety of pulse steroid therapy in multiple sclerosis relapses.
Alinaghian, M; Ashtari, F; Fatehi, F; Norouzi, R; Salari, M; Shaygannejad, V,
)
0.13
"MP infusion therapy in combination with CsA-based immunosuppression could be safe and effective in treating recurrent FSGS after kidney transplantation."( Combination of pulse methylprednisolone infusions with cyclosporine-based immunosuppression is safe and effective to treat recurrent focal segmental glomerulosclerosis after pediatric kidney transplantation.
Aikawa, A; Asanuma, H; Hamasaki, Y; Hataya, H; Honda, M; Ishikura, K; Muramatsu, M; Satou, H; Shishido, S,
)
0.13
" GCS treatment is significantly higher than oral glucocorticoid (oral GCS) therapy and is associated with fewer adverse events."( Is high dose intravenous methylprednisolone pulse therapy in patients with Graves' orbitopathy safe?
Ambroziak, U; Bednarczuk, T; Główczyńska, R; Kahaly, G; Kryczka, A; Miśkiewicz, P; Opolski, G; Rutkowska, B, 2014
)
0.4
" Frequency, severity and characterization of adverse events (AE) were prospectively analyzed."( Prospectively recorded and MedDRA-coded safety data of intravenous methylprednisolone therapy in Graves' orbitopathy.
Kahaly, GJ; Kampmann, E; Kolbe, E; Krämer, I; Riedl, M, 2015
)
0.42
" AEs judged as at least possibly related to drug treatment were graded as side effect (SE)."( Prospectively recorded and MedDRA-coded safety data of intravenous methylprednisolone therapy in Graves' orbitopathy.
Kahaly, GJ; Kampmann, E; Kolbe, E; Krämer, I; Riedl, M, 2015
)
0.42
" Adverse effects were more frequent among HD recipients (MD=43%, HD=66%, p=0."( Effectiveness and safety of medium-dose prednisone in giant cell arteritis: a retrospective cohort study of 103 patients.
Les, I; Martínez-Berriotxoa, A; Pijoán, JI; Rodríguez-Álvarez, R; Ruiz-Irastorza, G,
)
0.13
"MD prednisone regimen may be an effective and safe alternative to HD prednisone regimen in GCA."( Effectiveness and safety of medium-dose prednisone in giant cell arteritis: a retrospective cohort study of 103 patients.
Les, I; Martínez-Berriotxoa, A; Pijoán, JI; Rodríguez-Álvarez, R; Ruiz-Irastorza, G,
)
0.13
" Safety was monitored estimating the frequency of adverse events (AEs) and controlling vital functions and laboratory indicators."( [Efficacy and safety of intravenous methylprednisolone in the treatment of patients with active ankylosing spondylitis: results of a 12-week, prospective, open-label, pilot (METALL) study].
Gaydukova, IZ; Poddubnyi, DA; Rebrov, AP, 2015
)
0.42
"Pulse therapy with MP 500 mg is safe and effective in the short-term treatment of patients with active AS who have achieved no benefits of NSAIDs."( [Efficacy and safety of intravenous methylprednisolone in the treatment of patients with active ankylosing spondylitis: results of a 12-week, prospective, open-label, pilot (METALL) study].
Gaydukova, IZ; Poddubnyi, DA; Rebrov, AP, 2015
)
0.42
"We describe a case of a patient from Far North Queensland, Australia, with life-threatening hepatotoxicity caused by ipilimumab induced immune-related adverse events (irAEs)."( Resolution of ipilimumab induced severe hepatotoxicity with triple immunosuppressants therapy.
Ahmed, T; Black, J; Pandey, R; Shah, B, 2015
)
0.42
" Although human islets are prone to direct toxic effect of tacrolimus and sirolimus, we found no additive effects of the drug combination."( Treatment with Tacrolimus and Sirolimus Reveals No Additional Adverse Effects on Human Islets In Vitro Compared to Each Drug Alone but They Are Reduced by Adding Glucocorticoids.
Bergan, S; Foss, A; Kloster-Jensen, K; Korsgren, O; Sahraoui, A; Scholz, H; Vethe, NT, 2016
)
0.43
" Overall, our data indicate that high-dose CS treatment for neurological diseases is relatively safe with respect to psychiatric complications."( Psychiatric side effects of acute high-dose corticosteroid therapy in neurological conditions.
Benninger, F; Fireman, L; Lotan, I; Steiner, I; Weizman, A, 2016
)
0.43
"After LT, an immunosuppressive regimen without steroids could be a safe and feasible treatment for HBVrelated HCC patients, thus resulting in the reduction of HBV recurrence."( Efficacy and Safety of a Steroid-Free Immunosuppressive Regimen after Liver Transplantation for Hepatocellular Carcinoma.
Shen, Y; Wang, C; Wang, W; Wei, Q; Wu, J; Xie, H; Xu, X; Zhang, M; Zheng, S; Zhou, L; Zhuang, L; Zhuang, R, 2016
)
0.43
"Safety was evaluated based on occurrence of adverse events."( A Clinical Trial Comparing the Safety and Efficacy of Topical Tacrolimus versus Methylprednisolone in Ocular Graft-versus-Host Disease.
Abud, TB; Amparo, F; Ciolino, JB; Dana, R; Di Zazzo, A; Dohlman, TH; Hamrah, P; Saboo, US, 2016
)
0.43
" Changes in ophthalmic parameters after treatment and frequencies of adverse effects due to GCs of the 2 groups were compared."( Overall safety and efficacy of high-dose and low-dose intravenous glucocorticoid therapy in patients with moderate-to-severe active Graves' ophthalmopathy.
Fushimi, Y; Inagaki, N; Kanamoto, N; Miura, M; Nakao, K; Okada, T; Sone, M; Tanaka-Mizuno, S; Togashi, K; Ueda-Sakane, Y; Yasoda, A; Yasuno, S, 2016
)
0.43
"In a prospective multi-center observational study, we evaluated the frequency, severity, and impact on activities of daily living (ADL) of adverse effects (AEs) of high-dose intravenous methylprednisolone (IVMP) in relapsing remitting multiple sclerosis (MS) patients with a relapse."( Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment: a prospective web-based multi-center study in multiple sclerosis patients with a relapse.
Boringa, J; Gaillard, P; Gladdines, W; Heerings, M; Hoogervorst, E; Jongen, PJ; Linssen, WH; Lönnqvist, F; Sinnige, LG; Stavrakaki, I; van der Kruijk, R; van Munster, E; Verhagen, WI; Verheul, F; Visser, LH; Voet, B, 2016
)
0.43
" Response to therapy, duration of clinical remission, serology of the response, and adverse effects of rituximab were evaluated."( Efficacy and safety of rituximab therapy in patients with pemphigus vulgaris: first report from Turkey.
Akman Karakaş, A; Alpsoy, E; Bilgiç Temel, A; Bozkurt, S; Dicle, Ö; Erat, A; Ergün, E; Eskiocak, AH; Koç, S; Nazlım, B; Özkesici, B; Uğurlu, N; Uzun, S; Yılmaz, E, 2016
)
0.43
"Rituximab is a beneficial and relatively safe adjuvant treatment for PV that facilitates prolonged clinical remission and has a significant steroid-sparing effect."( Efficacy and safety of rituximab therapy in patients with pemphigus vulgaris: first report from Turkey.
Akman Karakaş, A; Alpsoy, E; Bilgiç Temel, A; Bozkurt, S; Dicle, Ö; Erat, A; Ergün, E; Eskiocak, AH; Koç, S; Nazlım, B; Özkesici, B; Uğurlu, N; Uzun, S; Yılmaz, E, 2016
)
0.43
"Short episodes of corticosteroids seem to be safe in HBV carriers, even in the presence of DMARDs, but lamivudine prophylaxis should be considered for patients exposed to biologicals or cyclophosphamide."( Safety of Corticosteroid Treatment in Rheumatologic Patients With Markers of Hepatitis B Viral Infection: Pilot Evaluation Study.
Balbir-Gurman, A; Braun, M; Braun-Moscovici, Y; Markovits, D; Nahir, MA; Saadi, T, 2016
)
0.43
" An effective and safe alternative induction regimen is needed."( Efficacy and safety of rituximab in comparison with common induction therapies in pediatric active lupus nephritis.
Babu, BG; Basu, B; Roy, B, 2017
)
0.46
" In comparison with few minor adverse events in the other two cohorts, several serious adverse events occurred in the CYC group."( Efficacy and safety of rituximab in comparison with common induction therapies in pediatric active lupus nephritis.
Babu, BG; Basu, B; Roy, B, 2017
)
0.46
" In this retrospective, observational cohort study, we compared time to any adverse event (primary outcome); serious or nonserious events; partial and complete remission of the nephrotic syndrome; and a composite of doubling of serum creatinine, ESRD, or death between 100 Rtx-treated patients and 103 patients who received daily St-Cp We monitored patients with standardized protocols and adjusted for baseline characteristics by Cox regression."( Safety of Rituximab Compared with Steroids and Cyclophosphamide for Idiopathic Membranous Nephropathy.
Chianca, A; Hofstra, JM; Perna, A; Remuzzi, G; Ruggenenti, P; Ruggiero, B; van den Brand, JAJG; Wetzels, JFM, 2017
)
0.46
"Nephrotoxicity is a well-known side effect of platinum-based chemotherapy."( Incidence and prognostic significance of nephrotoxicity in patients receiving eshap as salvage therapy for lymphoma.
Batlle, M; Feliu, E; Ferra, C; Garcia, O; Ibarra, G; Lopez, D; Moreno, M; Pineda, A; Ribera, JM; Sancho, JM; Sorigue, M; Tapia, G; Vives, S, 2017
)
0.46
" Very few diseases are known to produce such high levels of GFAP, indicating a toxic effect on astrocytes."( Heroin-induced acute myelopathy with extreme high levels of CSF glial fibrillar acidic protein indicating a toxic effect on astrocytes.
Herrman, L; Hietala, MA; Sveinsson, O, 2017
)
0.46
"To assess the efficacy of viscosupplementation (hyaluronic acid [HA]) on the pain and disability caused by hip osteoarthritis, and to determine the occurrence of adverse events."( Viscosupplementation for Hip Osteoarthritis: A Systematic Review and Meta-Analysis of the Efficacy on Pain and Disability, and the Occurrence of Adverse Events.
Buehler, AM; Daud Amadera, JE; Leite, VF, 2018
)
0.48
"69), and high evidence that it is not superior in adverse events (risk ratio [RR]=1."( Viscosupplementation for Hip Osteoarthritis: A Systematic Review and Meta-Analysis of the Efficacy on Pain and Disability, and the Occurrence of Adverse Events.
Buehler, AM; Daud Amadera, JE; Leite, VF, 2018
)
0.48
" Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention."( Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis.
Buvanendran, A; Choi, D; Davis, T; DePalma, M; Desai, M; Gupta, A; Hunter, C; Kapural, L; Lindley, D; Loudermilk, E; Patel, N; Soloman, M, 2018
)
0.48
" There were no procedure-related serious adverse events."( Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis.
Buvanendran, A; Choi, D; Davis, T; DePalma, M; Desai, M; Gupta, A; Hunter, C; Kapural, L; Lindley, D; Loudermilk, E; Patel, N; Soloman, M, 2018
)
0.48
"Our strategy for refractory Kawasaki disease was safe and effective in preventing CAA."( The Clinical Utility and Safety of a New Strategy for the Treatment of Refractory Kawasaki Disease.
Ebato, T; Fujimoto, M; Ishii, M; Kitagawa, A; Ogata, S; Ogihara, Y; Takanashi, M, 2017
)
0.46
"Corticosteroids (CSs), used to treat rheumatoid arthritis (RA), confer a risk of adverse events (AEs)."( Safety and efficacy of alternate-day corticosteroid treatment as adjunctive therapy for rheumatoid arthritis: a comparative study.
Kishimoto, M; Ohde, S; Okada, M; Suda, M; Tsuda, T, 2018
)
0.48
" Variables studied: age, sex, MTP cumulative doses, duration of treatment, therapeutic response and adverse effects."( [Methylprednisolone for the treatment of Immune-mediates Diseases flares. Relationship between doses, effectiveness and safety. A pilot study].
Danza Galdo, Á, 2017
)
0.46
" The mean dose in patients with adverse effects was 4,4 (SD 1,8) grams, and in cases without adverse effects was 3,2 (SD 1,6) grams (p<0,05)."( [Methylprednisolone for the treatment of Immune-mediates Diseases flares. Relationship between doses, effectiveness and safety. A pilot study].
Danza Galdo, Á, 2017
)
0.46
" However, an association between higher doses of MTP and adverse effects was observed."( [Methylprednisolone for the treatment of Immune-mediates Diseases flares. Relationship between doses, effectiveness and safety. A pilot study].
Danza Galdo, Á, 2017
)
0.46
" Outcomes were number of responders to treatment, remission rate of treatment responders, overall probability of 5-year remission, and the occurrence of adverse events."( Corticosteroids in chronic inflammatory demyelinating polyneuropathy : A retrospective, multicentre study, comparing efficacy and safety of daily prednisolone, pulsed dexamethasone, and pulsed intravenous methylprednisolone.
Basta, I; Doneddu, PE; Eftimov, F; Gallia, F; Nikolic, A; Nobile-Orazio, E; Peric, S; van Lieverloo, GGA; van Schaik, IN; Verhamme, C; Wieske, L, 2018
)
0.48
" Adverse events leading to a change in treatment occurred in ten patients (8%)."( Corticosteroids in chronic inflammatory demyelinating polyneuropathy : A retrospective, multicentre study, comparing efficacy and safety of daily prednisolone, pulsed dexamethasone, and pulsed intravenous methylprednisolone.
Basta, I; Doneddu, PE; Eftimov, F; Gallia, F; Nikolic, A; Nobile-Orazio, E; Peric, S; van Lieverloo, GGA; van Schaik, IN; Verhamme, C; Wieske, L, 2018
)
0.48
" The recently published European Group on Graves Orbitopathy guidelines re-evaluated the recommended doses of intravenous methylprednisolone (ivMP) in response to the potential for adverse effects."( RETROSPECTIVE ANALYSIS OF PATIENTS WITH GRAVES ORBITOPATHY TREATED BY PULSES OF METHYLPREDNISOLONE, WITH A FOCUS ON ADVERSE EVENTS.
Cibickova, L; Frysak, Z; Karasek, D; Karhanova, M; Kovarova, D; Schovanek, J, 2018
)
0.48
" Adverse events were reported using Version 4 of Common Terminology Criteria for Adverse Events."( RETROSPECTIVE ANALYSIS OF PATIENTS WITH GRAVES ORBITOPATHY TREATED BY PULSES OF METHYLPREDNISOLONE, WITH A FOCUS ON ADVERSE EVENTS.
Cibickova, L; Frysak, Z; Karasek, D; Karhanova, M; Kovarova, D; Schovanek, J, 2018
)
0.48
"Ninety-two percent of patients who started the treatment were able to finish it; 5% did not finish the study due to adverse events, and 3% did not finish the treatment protocol because of noncompliance."( RETROSPECTIVE ANALYSIS OF PATIENTS WITH GRAVES ORBITOPATHY TREATED BY PULSES OF METHYLPREDNISOLONE, WITH A FOCUS ON ADVERSE EVENTS.
Cibickova, L; Frysak, Z; Karasek, D; Karhanova, M; Kovarova, D; Schovanek, J, 2018
)
0.48
"High-dose ivMP for active, moderate to severe, and sight-threatening GO, when applied cautiously in carefully selected and monitored patients, is generally safe during the treatment period."( RETROSPECTIVE ANALYSIS OF PATIENTS WITH GRAVES ORBITOPATHY TREATED BY PULSES OF METHYLPREDNISOLONE, WITH A FOCUS ON ADVERSE EVENTS.
Cibickova, L; Frysak, Z; Karasek, D; Karhanova, M; Kovarova, D; Schovanek, J, 2018
)
0.48
"AE = adverse effect; CAS = clinical activity score; CTCAE = Common Terminology Criteria for Adverse Events; DM = diabetes mellitus; EUGOGO = European Group on Graves Orbitopathy; GC = glucocorticoid; GO = Graves orbitopathy; ivMP = intravenous methylprednisolone."( RETROSPECTIVE ANALYSIS OF PATIENTS WITH GRAVES ORBITOPATHY TREATED BY PULSES OF METHYLPREDNISOLONE, WITH A FOCUS ON ADVERSE EVENTS.
Cibickova, L; Frysak, Z; Karasek, D; Karhanova, M; Kovarova, D; Schovanek, J, 2018
)
0.48
" Eight patients complained of adverse effects from steroid therapy such as heartburn, insomnia, weight gain, and myalgia."( Efficacy and Safety of Low-to-Moderate Dose Oral Corticosteroid Treatment in Ocular Myasthenia Gravis.
Kim, US; Lee, YG, 2018
)
0.48
" The secondary outcomes include adverse effects (gastrointestinal events and pruritus) and postoperative complications (deep venous thrombosis, pulmonary embolism and infection); (5) Study design: RCTs."( The efficacy and safety of methylprednisolone for pain control after total knee arthroplasty: A meta-analysis of randomized controlled trials.
Gao, Z; Liu, J; Shen, S, 2018
)
0.48
"Methylprednisolone could significantly decrease postoperative pain score, narcotic consumption and opioid-related adverse effects after TKA."( The efficacy and safety of methylprednisolone for pain control after total knee arthroplasty: A meta-analysis of randomized controlled trials.
Gao, Z; Liu, J; Shen, S, 2018
)
0.48
" A dysregulated activation of T-cells directed to normal tissues stands as the main mechanism of immune-related adverse events (irAE)."( Long-term adverse event: inflammatory orbitopathy induced by pembrolizumab in a patient with metastatic melanoma.
Aubin, F; Beaudoin, MA; Borg, C; Borot, S; Cattin, F; Gauthier, AS; Nardin, C; Puzenat, E; Schillo, F, 2019
)
0.51
" Although their conventional adverse effects including hyperglycemia, hypertension, hyperlipidemia, and osteoporosis are well-recognized and managed, steroid-induced cardiac arrhythmias are known to a lesser extent."( Dose-dependent bradycardia as a rare side effect of corticosteroids: a case report and review of the literature.
Bodakçi, E; Korkmaz, C; Üsküdar Cansu, D, 2018
)
0.48
"Overall, adjunctive systemic corticosteroids therapy was effective and safe for patients with severe CAP."( Efficacy and safety of adjunctive corticosteroids therapy for patients with severe community-acquired pneumonia: A systematic review and meta-analysis.
Guo, J; Huang, J; Huang, W; Li, H; Zhang, T, 2019
)
0.51
" Ublituximab proved to be safe in all 5 NMOSD subjects, with no serious adverse events recorded."( A pilot safety study of ublituximab, a monoclonal antibody against CD20, in acute relapses of neuromyelitis optica spectrum disorder.
Levy, M; Mealy, MA, 2019
)
0.51
"Ublituximab is a safe add-on therapy for NMOSD patients presenting with acute transverse myelitis and optic neuritis."( A pilot safety study of ublituximab, a monoclonal antibody against CD20, in acute relapses of neuromyelitis optica spectrum disorder.
Levy, M; Mealy, MA, 2019
)
0.51
"This study provides Class IV evidence that for patients with NMOSD with acute transverse myelitis or optic neuritis, ublituximab is safe and may improve neurological outcome."( A pilot safety study of ublituximab, a monoclonal antibody against CD20, in acute relapses of neuromyelitis optica spectrum disorder.
Levy, M; Mealy, MA, 2019
)
0.51
" Drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare yet severe adverse drug-induced reaction characterized by exfoliative dermatitis and maculopapular rash, lymphadenopathy, fever, eosinophilia, leukocytosis, and myriad internal organ involvement."( A rare and severe cutaneous adverse effect of telaprevir: drug rash with eosinophilia and systemic symptoms.
Bahali, AG; Biyik Ozkaya, D; Cengiz, FP; Emiroglu, N; Onsun, N; Su, O, 2019
)
0.51
" We evaluated adverse events of an acute treatment in NMOSD patients in a university-based hospital during January 2009 and December 2017."( Retrospective study of the adverse events of the treatment for an acute attack of neuromyelitis optica spectrum disorder.
Prayoonwiwat, N; Siritho, S; Veerachit-O-Larn, T, 2020
)
0.56
"We conclude that high-dose methylprednisolone is effective in the treatment of SMPP without increasing the incidence of adverse reactions."( Meta-analysis of the Clinical Efficacy and Safety of High- and Low-dose Methylprednisolone in the Treatment of Children With Severe Mycoplasma Pneumoniae Pneumonia.
Deng, ZZ; Sun, LL; Wang, CJ; Ye, C; Zhou, YL; Zuo, SR, 2020
)
0.56
"The most effective and safe treatment protocol for Graves' orbitopathy (GO) needs to be further assessed."( Comparison of efficacy and safety of parenteral versus parenteral and oral glucocorticoid therapy in Graves' orbitopathy.
Ciric, J; Knezevic, M; Lalic, T; Miletic, M; Nedeljkovic Beleslin, B; Savic, S; Stankovic, B; Stojanovic, M; Stojkovic, M; Zarkovic, M, 2020
)
0.56
" The efficacy outcomes included a cessation of epileptic spasms (as per caregiver reporting) and resolution of hypsarrhythmia on electroencephalogram; safety outcome was the frequency of various adverse effects."( Safety, Feasibility and Effectiveness of Pulse Methylprednisolone Therapy in Comparison with Intramuscular Adrenocorticotropic Hormone in Children with West Syndrome.
Gupta, A; Madaan, P; Rajpurohit, M; Sahu, JK; Singhi, P, 2021
)
0.62
" The survival time, cause of death, adverse events, liver function, and HBV DNA replication were analyzed."( The efficacy and safety of methylprednisolone in hepatitis B virus-related acute-on-chronic liver failure: a prospective multi-center clinical trial.
Duan, ZH; He, WP; Jia, L; Li, J; Liu, HX; Meng, QH; Ren, MX; Wang, XM; Xing, HC; Xue, R; Zhao, J; Zhu, Y, 2020
)
0.56
"MP therapy is an effective and safe clinical strategy in HBV-ACLF, increasing the 6-month survival rate."( The efficacy and safety of methylprednisolone in hepatitis B virus-related acute-on-chronic liver failure: a prospective multi-center clinical trial.
Duan, ZH; He, WP; Jia, L; Li, J; Liu, HX; Meng, QH; Ren, MX; Wang, XM; Xing, HC; Xue, R; Zhao, J; Zhu, Y, 2020
)
0.56
" The incidence of adverse events was assessed using the same questionnaire."( Efficacy and safety of oral prednisolone tapering following intravenous methyl prednisolone in patients with multiple sclerosis relapses: A randomized, double-blind, placebo-controlled trial.
Baghbanian, SM; Bazi, A; Ghazaeian, M; Hendoiee, N; Saeedi, M, 2021
)
0.62
"MP group than the TG group experienced adverse events."( Efficacy and safety of tripterygium glycosides for active moderate to severe Graves' ophthalmopathy: a randomised, observer-masked, single-centre trial.
Liu, J; Lu, B; Shao, J; Wang, J; Ye, X; Zhao, H, 2021
)
0.62
" The primary adverse reaction was infection."( Efficacy and Safety of Long-Term Corticosteroid Monotherapy in 26 Cases of Nephrotic Syndrome with Biopsy-Proven Membranous Nephropathy Induced by Seronegative Hepatitis B Virus-Associated Glomerulonephritis.
Chen, S; Han, H; Liu, J; Yang, D; Yang, X; Zhang, X; Zhang, Y, 2021
)
0.62
"The long-term middle-dose corticosteroid therapy without antiviral drugs is effective and safe for membranous sn HBV-GN patients."( Efficacy and Safety of Long-Term Corticosteroid Monotherapy in 26 Cases of Nephrotic Syndrome with Biopsy-Proven Membranous Nephropathy Induced by Seronegative Hepatitis B Virus-Associated Glomerulonephritis.
Chen, S; Han, H; Liu, J; Yang, D; Yang, X; Zhang, X; Zhang, Y, 2021
)
0.62
" We did not observe any severe adverse events relating to the IVMP procedures."( Efficacy and safety of i.v. methylprednisolone pulse therapy for vitiligo: A retrospective study of 58 therapy experiences for 33 vitiligo patients.
Aiba, S; Hatchome, N; Kimura, Y; Sasaki, R; Tsuchiyama, K; Wada-Irimada, M; Watabe, A; Yamasaki, K, 2021
)
0.62
" However, the benefits and adverse effects of methylprednisolone have not been well assessed in patients with ARDS."( Efficacy and safety of methylprednisolone against acute respiratory distress syndrome: A systematic review and meta-analysis.
Chen, M; Chen, Q; Cheng, L; Dai, L; Geng, Y; Lu, J; Lv, H; Wang, X, 2021
)
0.62
"10; I2 = 0%) in patients with ARDS, but it was not associated with increased rates of adverse events (OR = 0."( Efficacy and safety of methylprednisolone against acute respiratory distress syndrome: A systematic review and meta-analysis.
Chen, M; Chen, Q; Cheng, L; Dai, L; Geng, Y; Lu, J; Lv, H; Wang, X, 2021
)
0.62
"This systematic review and meta-analysis demonstrated that Methylprednisolone is safe against ARDS."( Efficacy and safety of methylprednisolone against acute respiratory distress syndrome: A systematic review and meta-analysis.
Chen, M; Chen, Q; Cheng, L; Dai, L; Geng, Y; Lu, J; Lv, H; Wang, X, 2021
)
0.62
"TCZ combined with mPSL pulse therapy improved the survival rate without significant adverse events in critical HD and non-HD patients with COVID-19 by strongly suppressing systemic hyperinflammation."( Clinical efficacy and safety of combination therapy of tocilizumab and steroid pulse therapy for critical COVID-19 in HD patients.
Fujii, K; Itoh, K; Kikuchi, T; Kondo, Y; Ryuzaki, M; Sekine, K; Toda, M; Yoshifuji, A, 2022
)
0.72
" Mpz and Hc seem safe as a rescue therapy in terms of adverse outcomes for established BPD in which lung and brain tissue is already impaired."( Glucocorticoids in a Neonatal Hyperoxic Lung Injury Model: Pulmonary and Neurotoxic effects.
Büyüktiryaki, M; Çakır, E; Çakır, U; Koyuncu, İ; Özer Bekmez, B; Tayman, C; Türkmenoğlu, TT, 2022
)
0.72
" During study, adverse events of the treatments were recorded."( Comparing efficacy and safety of tocilizumab and methylprednisolone in the treatment of patients with severe COVID-19.
Abbasian, L; Alizade, F; Azadbakhsh Kanaf Gorabi, M; Ghaderkhani, S; Ghiasvand, F; Hasannezhad, M; Jafari, S; Khalili, H; Nakhostin, M; Rahmani, H; Salahshour, F; Salehi, M; Toroghi, N, 2022
)
0.72
" Other adverse events were comparable among patients in the groups."( Comparing efficacy and safety of tocilizumab and methylprednisolone in the treatment of patients with severe COVID-19.
Abbasian, L; Alizade, F; Azadbakhsh Kanaf Gorabi, M; Ghaderkhani, S; Ghiasvand, F; Hasannezhad, M; Jafari, S; Khalili, H; Nakhostin, M; Rahmani, H; Salahshour, F; Salehi, M; Toroghi, N, 2022
)
0.72
"Pituitary immune-related adverse events induced by programmed cell death protein 1 inhibitors in advanced lung cancer patients: A report of 3 cases SUMMARY Programmed cell death protein 1 (PD-1) and its ligand 1 (PD-L1) have been widely used in lung cancer treatment, but their immune-related adverse events (irAEs) require intensive attention."( [Pituitary immune-related adverse events induced by programmed cell death protein 1 inhibitors in advanced lung cancer patients: A report of 3 cases].
Cao, BS; Gu, YC; Liu, Y; Xie, C, 2022
)
0.72
"Routine systemic therapy for bullous pemphigoid (BP) has been challenged due to the inevitably adverse effects."( Dupilumab combined with low-dose systemic steroid therapy improves efficacy and safety for bullous pemphigoid.
Chen, S; Chen, Z; Gao, H; He, S; Hu, Y; Liu, S; Luo, X; Ma, L; Tang, C; Tang, L; Wang, L; Xu, Y; Yang, F; Yang, J; Zhang, Z; Zhao, Y, 2022
)
0.72
" Overall, corticosteroids reduced inflammatory complications after 3MS and did not show any serious adverse effects."( Comparative efficacy and safety of different corticosteroids to reduce inflammatory complications after mandibular third molar surgery: a systematic review and network meta-analysis.
Canellas, JVDS; Ritto, FG; Tiwana, P, 2022
)
0.72
" The two groups did not differ in severe adverse events."( Efficacy and safety of methylprednisolone pulse followed by oral prednisone vs. oral prednisone alone in sarcoidosis tubulointerstitial nephritis: a randomized, open-label, controlled clinical trial.
Audard, V; Boffa, JJ; Cez, A; Daugas, E; Delahousse, M; Guerrot, D; Hanrotel, C; Krastinova, E; Mahevas, M; Pillebout, E; Rousseau, A; Valeyre, D; Verhelst, D, 2023
)
0.91
" We extracted data on trials and patient characteristics, and the following primary outcomes: all-cause mortality (ACM), and treatment-emergent adverse events (TEAEs)."( Comparative efficacy and safety of pharmacological interventions for severe COVID-19 patients: An updated network meta-analysis of 48 randomized controlled trials.
Chen, J; Cheng, Q; Fang, Z; Jia, Q; Zhao, G, 2022
)
0.72
" We found that most medications were safe in treating severe COVID-19."( Comparative efficacy and safety of pharmacological interventions for severe COVID-19 patients: An updated network meta-analysis of 48 randomized controlled trials.
Chen, J; Cheng, Q; Fang, Z; Jia, Q; Zhao, G, 2022
)
0.72
" Moreover, no significant adverse events were observed, compared to placebo or standard support therapy."( Safety and efficacy of corticosteroids in ARDS patients: a systematic review and meta-analysis of RCT data.
Chang, X; Dang, H; Fu, Y; Li, S; Liu, C, 2022
)
0.72
"Budesonide-MMX is a topically active corticosteroid degraded by cytochrome-P450 enzymes, resulting in favorable side-effect profile."( Possible genetical predictors of efficacy and safety of budesonide-MMX in patients with mild-to-moderate ulcerative colitis, and safety comparison with methylprednisolone.
Bacsur, P; Bálint, A; Bor, R; Fábián, A; Farkas, K; Keresztes, C; Mangó, K; Milassin, Á; Molnár, T; Monostory, K; Pigniczki, D; Resál, T; Rutka, M; Szántó, K; Szepes, Z,
)
0.13
" Glucocorticoid-related adverse events were more common following methylprednisolone treatment (47."( Possible genetical predictors of efficacy and safety of budesonide-MMX in patients with mild-to-moderate ulcerative colitis, and safety comparison with methylprednisolone.
Bacsur, P; Bálint, A; Bor, R; Fábián, A; Farkas, K; Keresztes, C; Mangó, K; Milassin, Á; Molnár, T; Monostory, K; Pigniczki, D; Resál, T; Rutka, M; Szántó, K; Szepes, Z,
)
0.13
" No adverse event associated with dupilumab was recorded."( The efficacy and safety of dupilumab combined with methylprednisolone in the treatment of bullous pemphigoid in China.
Qi, W; Rushan, X, 2023
)
0.91
" Clinicoserological features, initial response, relapse during follow-ups, cumulative doses of glucocorticoids, and adverse effects of glucocorticoids were compared for the IV and oral steroid groups."( Efficacy and safety of intravenous glucocorticoid therapy for IgG4-related ophthalmic disease.
Choi, YA; Kim, GJ; Sa, HS; Yang, MK, 2023
)
0.91
"Recent advances in immune-checkpoint inhibitors (ICIs) have highlighted the need for effective management of immune-related adverse events (irAEs)."( Systematic surveillance of immune-related adverse events in clinical practice and impact of subsequent steroid medication on survival outcomes.
Egashira, N; Hata, K; Hirota, T; Ieiri, I; Matsuda, K; Matsukane, R; Minami, H; Nakao, S; Suetsugu, K; Watanabe, H, 2023
)
0.91
" In terms of safety endpoints, the total adverse event rates (AEs), leucopenia, gastrointestinal (GI) AEs, skin diseases, and liver dysfunction of the "IGU+MP" group and the "HCQ+MP" group were comparable."( Efficacy and safety of iguratimod combined with methylprednisolone for primary Sjögren's syndrome: a meta-analysis and trial sequential analysis.
Hu, G; Xu, Q; Yang, XY; Yin, S; You, H; Yu, YF, 2023
)
0.91
" IGU combined with MP does not increase the risk of adverse events, which means that IGU combined with MP may be a safe and effective strategy for the treatment of pSS and has value for further research exploration."( Efficacy and safety of iguratimod combined with methylprednisolone for primary Sjögren's syndrome: a meta-analysis and trial sequential analysis.
Hu, G; Xu, Q; Yang, XY; Yin, S; You, H; Yu, YF, 2023
)
0.91
" ​In this case series the authors describe three pediatric patients with this side effect in the setting of severe macrophage activation syndrome (MAS) in KD and sJIA."( Anakinra and hepatotoxicity in pediatric rheumatology: a case series.
Aguiar, F; Azevedo, AC; Brito, I; Ganhão, S; Martins, FR; Rodrigues, M, 2023
)
0.91
" Exclusion of sepsis / toxic shock syndrome warranted introduction of IV methylprednisolone and immunoglobulin (IG IV), with partial response."( Anakinra and hepatotoxicity in pediatric rheumatology: a case series.
Aguiar, F; Azevedo, AC; Brito, I; Ganhão, S; Martins, FR; Rodrigues, M, 2023
)
0.91
" Notably, no serious adverse effects were observed in the study."( Long-term efficacy and safety of dupilumab for severe bullous pemphigoid: A prospective cohort study.
Ding, Y; Gao, Y; Huang, D; Jiang, Y; Kong, L; Shi, Y; Yu, Y; Zhang, Y, 2023
)
0.91
" The statistical analysis revealed no significant differences in adverse events."( Efficacy and safety of corticosteroid therapy in patients with cardiac arrest: A meta-analysis of randomized controlled trials.
Li, DZ; Liu, C; Zhang, Y; Zhou, FC; Zhou, FW, 2024
)
1.44

Pharmacokinetics

Methylprednisolone (MPL) given to adrenalectomized (ADX) rats. Mean elimination half-life increased from 2.5 to 3%. 50% inhibitory concentration values were also similar to those derived from pharmacodynamic models.

ExcerptReferenceRelevance
" After intravenous infusion, methylprednisolone hemisuccinate was rapidly converted to methylprednisolone with a half-life of about 20 min."( Pharmacokinetics of high-dose methylprednisolone in children.
Ito, S; Ito, Y; Kusunoki, Y; Oka, T; Okuno, A; Yoshioka, H, 1992
)
0.28
" Indeed, test doses of cyclosporin followed by series of blood samples and the calculation of individual pharmacokinetic parameters are needed to assure successful immunosuppression right from the start."( Optimisation of immunosuppressive therapy using pharmacokinetic principles.
Grevel, J, 1992
)
0.28
" The 50% inhibitory concentration values for methylprednisolone derived from pharmacodynamic models were also similar, indicating no difference in intrinsic responsiveness."( Pharmacokinetics and pharmacodynamics of methylprednisolone when administered at 8 am versus 4 pm.
Fisher, LE; Jusko, WJ; Ludwig, EA; Middleton, E; Sloan, RR; Wald, JA, 1992
)
0.28
" Blood samples were collected and assayed for MP by HPLC for pharmacokinetic analysis."( Two-compartment basophil cell trafficking model for methylprednisolone pharmacodynamics.
Chen, HY; Jusko, WJ; Salazar, DE; Wald, JA, 1991
)
0.28
" Pharmacodynamic models were applied for these immediate effects of methylprednisolone based on the premise that receptor interactions of steroids are followed by rapid suppression of the circadian rhythm of cortisol and recirculation of basophils and helper T cells, which persist until inhibitory concentrations (IC50) of methylprednisolone disappear."( Pharmacokinetics and pharmacodynamics of methylprednisolone in obesity.
Camara, DS; Dunn, TE; Jusko, WJ; Ludwig, EA; Slaughter, RL, 1991
)
0.28
" To ascertain which pharmacokinetic properties of these drugs explain this difference, we gave methylprednisolone and prednisolone, 5 mg/kg intravenous bolus, to 23 adult rabbits."( Methylprednisolone achieves greater concentrations in the lung than prednisolone. A pharmacokinetic analysis.
Bloedow, DC; Greos, LS; Hill, MR; Irvin, CG; Larsen, GL; Szefler, SJ; Vichyanond, P, 1991
)
0.28
" Forty different pharmacodynamic parameters were followed for 1 week."( Pharmacodynamics of methylprednisolone phosphate after single intravenous administration to healthy volunteers.
Barth, J; Derendorf, H; Krieg, M; Möllmann, C; Möllmann, H; Röthig, HJ; Tunn, S, 1991
)
0.28
" The pharmacokinetic values of the two drugs in patients having cardiopulmonary bypass were compared to those in younger, healthy subjects."( Pharmacokinetics of methylprednisolone sodium succinate and methylprednisolone in patients undergoing cardiopulmonary bypass.
Beam, TR; Jungbluth, GL; Jusko, WJ; Kong, AN; Pasko, MT, 1990
)
0.28
" A pharmacodynamic model for basophil cell distribution to and from an extravascular compartment describes the effects of MP after both regimens."( Steroid dose sparing: pharmacodynamic responses to single versus divided doses of methylprednisolone in man.
Jusko, WJ; Ludwig, EA; Middleton, E; Reiss, WG; Slaughter, RL, 1990
)
0.28
" After the development of a data base of pharmacokinetic parameters, we examined glucocorticoid pharmacokinetics in 54 patients between 2 and 70 years of age using 70 pharmacokinetic studies after administration of intravenous methylprednisolone (n = 25), oral methylprednisolone (n = 15), intravenous prednisolone (n = 18), and oral prednisone (n = 12)."( Monitoring glucocorticoid therapy: a pharmacokinetic approach.
Ball, BD; Bartoszek, M; Brenner, AM; Hill, MR; Szefler, SJ, 1990
)
0.28
" The same parasitic burden provoked only a slight decrease in the elimination half-life of methylprednisolone alcohol when its hemisuccinate ester was administered."( Comparative incidence of experimental fascioliasis on corticosteroid pharmacokinetics in sheep.
Alvinerie, M; Galtier, P; Houin, G; Toutain, PL; Tufenkji, AE, 1989
)
0.28
" The presented methods are simple, rapid, specific, sensitive, reproducible, and economical for the pharmacokinetic study of these steroids."( Two chromatographic methods for the determination of corticosteroids in human biological fluids: pharmacokinetic applications.
al-Habet, SM; Rogers, HJ, 1989
)
0.28
"A pharmacokinetic investigation of administered corticosteroids was conducted in a 16-year-old girl with cystic fibrosis (CF)."( Rapid methylprednisolone clearance in a patient with cystic fibrosis.
Farrell, PM; Green, CG; Jusko, WJ; Kraus, CK; Lemanske, RF, 1988
)
0.27
"499 L/h/kg and its half-life was 15."( Pharmacokinetics of methylprednisolone succinate, methylprednisolone, and lidocaine in the normal dog and during hemorrhagic shock.
Alvinerie, M; Autefage, A; Oukessou, M; Toutain, PL, 1987
)
0.27
" To compare clinical and pharmacokinetic variables of methylprednisolone and oral prednisolone in patients with RA, a controlled crossover study was carried out."( Comparison of methylprednisolone (1 g i.v.) with prednisolone (1 g orally) in rheumatoid arthritis: a pharmacokinetic and clinical study.
Boutagy, J; Brooks, PM; Cosh, D; Donovan, S; McCredie, M; Needs, CJ; Smith, M, 1988
)
0.27
"The absolute bioavailability and pharmacokinetic parameters of two methylprednisolone formulations (methylprednisolone sodium succinate and methylprednisolone acetate) were determined in five dogs."( Pharmacokinetics of methylprednisolone, methylprednisolone sodium succinate, and methylprednisolone acetate in dogs.
Alvinerie, M; Fayolle, PM; Koritz, GD; Toutain, PL, 1986
)
0.27
"The pharmacokinetic properties of cyclosporine and mainly its absorption and hepatic elimination can vary in each patient in relation to the subject's individual characteristics (inter-subject variability), as well as in an individual patient during his treatment because of clinical episodes or drug interactions (intra-subject variabilities)."( [Pharmacokinetics and metabolism of cyclosporin; drug interactions].
Kiechel, JR; Lavene, D; Le Bigot, JF, 1987
)
0.27
" A physiologic pharmacodynamic model was developed to describe changes in circulating lymphocytes as a function of both endogenous cortisol and methylprednisolone concentrations."( Pharmacodynamic model for joint exogenous and endogenous corticosteroid suppression of lymphocyte trafficking.
Anné, S; Jusko, WJ; Ludwig, EA; Middleton, E; Milad, MA, 1994
)
0.29
"Due to the short pharmacokinetic half-life of its active metabolite, pharmacodynamic effects of deflazacort are of shorter duration than those of methylprednisolone and prednisolone."( Pharmacokinetic/pharmacodynamic evaluation of deflazacort in comparison to methylprednisolone and prednisolone.
Barth, J; Derendorf, H; Hochhaus, G; Möllmann, H; Rohatagi, S, 1995
)
0.29
" Rabbits are a good animal model for pharmacokinetic studies of these drugs."( Pharmacokinetic and pharmacodynamic effects of coadministration of methylprednisolone and tacrolimus in rabbits.
Chow, FS; Jusko, WJ; Piekoszewski, W, 1994
)
0.29
" A 24-hour pharmacokinetic evaluation was conducted in a sub-group of African-American and Caucasian patients after intravenous administration of methylprednisolone."( Post-transplant diabetes mellitus and methylprednisolone pharmacokinetics in African-American and Caucasian renal transplant recipients.
Biocevich, DM; Gray, V; Murray, BM; Reed, KA; Singh, JP; Tornatore, KM; Tousley, K; Venuto, RC, 1995
)
0.29
" The serum samples were analyzed for methylprednisolone with high-performance liquid chromatography (HPLC) and pharmacokinetic parametes were generated."( Pharmacokinetics of methylprednisolone during acute renal allograft rejection.
Reed, K; Tornatore, KM; Venuto, RC; Walshe, JJ, 1995
)
0.29
"Rejection crises after kidney transplantation could be associated with individual variability of pharmacokinetic parameters of steroids."( Pharmacokinetics of methylprednisolone and rejection episodes in kidney transplant patients.
Hemmen, T; Keller, F; Offermann, G; Schöneshöfer, M; Schwarz, A, 1995
)
0.29
"Serum methylprednisolone concentrations were determined by HPLC and were used to generate the pharmacokinetic parameters of the drug."( Repeated assessment of methylprednisolone pharmacokinetics during chronic immunosuppression in renal transplant recipients.
Reed, KA; Tornatore, KM; Venuto, RC, 1995
)
0.29
" The net response (area under the curve) and inhibitory concentrations (IC50) of methylprednisolone for each pharmacodynamic parameter were similar in both groups."( Methylprednisolone pharmacokinetics and pharmacodynamics in chronic renal failure.
Jusko, WJ; Kohli, RK; Lew, KH; Ludwig, EA; Milad, MA, 1995
)
0.29
" No dependence on time was apparent for any prodrug pharmacokinetic parameter."( Pilot study of the pharmacokinetics of methylprednisolone after single and multiple intravenous doses of methylprednisolone sodium succinate and methylprednisolone suleptanate to healthy volunteers.
Della-Coletta, AA; Ferry, JJ; VanderLugt, JT; Weber, DJ, 1994
)
0.29
" Standard pharmacokinetic parameters for methylprednisolone were determined and cortisol responses were characterized by total cortisol area under the concentration curve (AUC), return cortisol AUC, and cortisol suppression half-life."( Methylprednisolone pharmacokinetics, cortisol response, and adverse effects in black and white renal transplant recipients.
Biocevich, DM; Reed, K; Singh, JP; Tornatore, KM; Tousley, K; Venuto, RC, 1995
)
0.29
"A randomized, parallel pharmacokinetic trial."( Pharmacokinetics of methylprednisolone in elderly and young healthy males.
Davis, PJ; Logue, G; Tornatore, KM; Venuto, RC, 1994
)
0.29
" Serum methylprednisolone concentrations were determined by high performance liquid chromatography and utilized to determine the pharmacokinetic parameters."( Pharmacokinetics of methylprednisolone in elderly and young healthy males.
Davis, PJ; Logue, G; Tornatore, KM; Venuto, RC, 1994
)
0.29
" This pharmacokinetic alteration seen in healthy elderly subjects may contribute to the increased incidence of adverse effects from chronic glucocorticoid therapy that has been observed among elderly patients."( Pharmacokinetics of methylprednisolone in elderly and young healthy males.
Davis, PJ; Logue, G; Tornatore, KM; Venuto, RC, 1994
)
0.29
"Four basic models for characterizing indirect pharmacodynamic responses after drug administration have been developed and compared."( Comparison of four basic models of indirect pharmacodynamic responses.
Dayneka, NL; Garg, V; Jusko, WJ, 1993
)
0.29
"To examine the pharmacodynamic patterns of cortisol and pharmacokinetic values of long-term methylprednisolone in renal transplant recipients."( Cortisol pharmacodynamic response to long-term methylprednisolone in renal transplant recipients.
Reed, K; Tornatore, KM; Venuto, RC; Walshe, JJ,
)
0.13
"Twenty-four-hour pharmacokinetic and pharmacodynamic evaluation of patients who participated in a glucocorticoid-monitoring program."( Cortisol pharmacodynamic response to long-term methylprednisolone in renal transplant recipients.
Reed, K; Tornatore, KM; Venuto, RC; Walshe, JJ,
)
0.13
"The pharmacodynamic response of cortisol in renal transplant recipients may be associated in part with long-term steroid exposure."( Cortisol pharmacodynamic response to long-term methylprednisolone in renal transplant recipients.
Reed, K; Tornatore, KM; Venuto, RC; Walshe, JJ,
)
0.13
"Comprehensive pharmacokinetic evaluations of patients who participated in our glucocorticoid-monitoring program."( Racial differences in the pharmacokinetics of methylprednisolone in black and white renal transplant recipients.
Reed, KA; Tornatore, KM; Venuto, RC,
)
0.13
"Serum methylprednisolone concentrations were determined by HPLC and were used to generate pharmacokinetic parameters for this drug."( Comparative methylprednisolone pharmacokinetics in renal transplant patients receiving double- or triple-drug immunosuppression.
Holdsworth, MT; Reed, KA; Tornatore, KM; Venuto, RC; Walshe, JJ, 1993
)
0.29
" Therefore, the pharmacokinetic variability noted in this study may have important clinical implications regarding the development of chronic toxicity (e."( Comparative methylprednisolone pharmacokinetics in renal transplant patients receiving double- or triple-drug immunosuppression.
Holdsworth, MT; Reed, KA; Tornatore, KM; Venuto, RC; Walshe, JJ, 1993
)
0.29
" Twenty-two different pharmacodynamic parameters were followed as a function of time for 48 hours."( Receptor-based pharmacokinetic-pharmacodynamic analysis of corticosteroids.
Barth, J; Derendorf, H; Hochhaus, G; Krieg, M; Möllmann, C; Möllmann, H; Tunn, S, 1993
)
0.29
" Pharmacodynamic parameters measured were plasma cortisol, whole blood histamine (reflecting basophils), and blood helper T lymphocytes."( Oral contraceptive effects on methylprednisolone pharmacokinetics and pharmacodynamics.
Ferry, JJ; Jusko, WJ; Lew, KH; Ludwig, EA; Middleton, E; Slayter, KL, 1996
)
0.29
"447 L/hr/kg), resulting in a longer elimination half-life (2."( Oral contraceptive effects on methylprednisolone pharmacokinetics and pharmacodynamics.
Ferry, JJ; Jusko, WJ; Lew, KH; Ludwig, EA; Middleton, E; Slayter, KL, 1996
)
0.29
" This slower clearance rate contributed to a longer elimination half-life for methylprednisolone (2."( Oral contraceptive effects on methylprednisolone pharmacokinetics and pharmacodynamics.
Ferry, JJ; Jusko, WJ; Lew, KH; Ludwig, EA; Middleton, E; Slayter, KL, 1996
)
0.29
" Dose-dependent changes in pharmacokinetic parameters were observed for both free and liposomal drug."( Liposomal methylprednisolone in rats: dose-proportionality and chronic-dose pharmacokinetics/pharmacodynamics.
Jusko, WJ; Mishina, EV, 1996
)
0.29
" Pharmacodynamic parameters were obtained by fitting seven differential equations in a piecewise fashion."( Third-generation model for corticosteroid pharmacodynamics: roles of glucocorticoid receptor mRNA and tyrosine aminotransferase mRNA in rat liver.
Almon, RR; DuBois, DC; Jusko, WJ; Sun, YN; Xu, ZX, 1995
)
0.29
" The objectives of this study were to compare the effect of methylprednisolone on cortisol patterns in elderly and young healthy men, to define the relationship between pharmacokinetic parameters of methylprednisolone and pharmacodynamics of cortisol in the elderly and young men."( Cortisol pharmacodynamics after methylprednisolone administration in young and elderly males.
Davis, PJ; Logue, G; Tornatore, KM; Venuto, RC, 1997
)
0.3
"Ninety volunteers were included in the pharmacokinetic analysis."( A comparative population pharmacokinetic analysis for methylprednisolone following multiple dosing of two prodrugs in patients with acute asthma.
Daley-Yates, PT; Parker, TJ; Wood, SA, 1997
)
0.3
" Based on individual Bayesian estimates, the exposure of patients to MP was marginally lower for MP suleptanate although the parameter estimates were not significantly different for half-life (2."( A comparative population pharmacokinetic analysis for methylprednisolone following multiple dosing of two prodrugs in patients with acute asthma.
Daley-Yates, PT; Parker, TJ; Wood, SA, 1997
)
0.3
"The aim of this study was to establish whether pharmacokinetic differences between two pro-drugs of methylprednisolone (MP) are likely to be of clinical significance."( Pharmacokinetic and pharmacodynamic assessment of bioavailability for two prodrugs of methylprednisolone.
Brooks, CD; Daley-Yates, PT; Gregory, AJ, 1997
)
0.3
" Bioequivalence was assessed by conventional pharmacokinetic analysis, by measuring pharmacodynamic responses plus a novel approach using pharmacokinetic/pharmacodynamic modeling."( Pharmacokinetic and pharmacodynamic assessment of bioavailability for two prodrugs of methylprednisolone.
Brooks, CD; Daley-Yates, PT; Gregory, AJ, 1997
)
0.3
"The MP Cmax was less for MP suleptanate due to a longer absorption halflife of the prodrug from the intramuscular injection site."( Pharmacokinetic and pharmacodynamic assessment of bioavailability for two prodrugs of methylprednisolone.
Brooks, CD; Daley-Yates, PT; Gregory, AJ, 1997
)
0.3
" The use of both pharmacokinetic and pharmacodynamic response data together gives greater confidence in the conclusions compared with those based only on conventional pharmacokinetic bioequivalence analysis."( Pharmacokinetic and pharmacodynamic assessment of bioavailability for two prodrugs of methylprednisolone.
Brooks, CD; Daley-Yates, PT; Gregory, AJ, 1997
)
0.3
" Due to the complicated pharmacokinetic properties of prednisolone, it is extremely difficult to determine the dose needed to obtain a desired target concentration."( Pharmacokinetics of methylprednisolone and prednisolone after single and multiple oral administration.
Barth, J; Derendorf, H; Hochhaus, G; Möllmann, C; Möllmann, H; Rohatagi, S; Soldner, A, 1997
)
0.3
" Pharmacodynamic monitoring has been investigated by us and other investigators on primarily five immunosuppressive drugs: cyclosporine (CsA), mycophenolate mofetil (MMF), rapamycin (RAPA), azathioprine (AZA), and methylprednisolone (MP)."( The monitoring of immunosuppressive drugs: a pharmacodynamic approach.
Aspeslet, LJ; Yatscoff, RW, 1998
)
0.3
" Pharmacodynamic parameters were obtained by fitting seven differential equations piecewise using the maximum likelihood method in the ADAPT II program."( Fourth-generation model for corticosteroid pharmacodynamics: a model for methylprednisolone effects on receptor/gene-mediated glucocorticoid receptor down-regulation and tyrosine aminotransferase induction in rat liver.
Almon, RR; DuBois, DC; Jusko, WJ; Sun, YN, 1998
)
0.3
"In the present study, we established cochlear fluid pharmacokinetic profiles of hydrocortisone, methylprednisolone, and dexamethasone in the guinea pig following oral, intravenous, and topical (intratympanic) administration."( Corticosteroid pharmacokinetics in the inner ear fluids: an animal study followed by clinical application.
Freeman, DJ; Parnes, LS; Sun, AH, 1999
)
0.3
" Indirect Pharmacodynamic Response Model I (Model A) where the complex in the nucleus decreases the transcription rate of GR mRNA better described GR mRNA/GR down-regulation."( Dose-dependence and repeated-dose studies for receptor/gene-mediated pharmacodynamics of methylprednisolone on glucocorticoid receptor down-regulation and tyrosine aminotransferase induction in rat liver.
Almon, RR; DuBois, DC; Jusko, WJ; Pyszczynski, NA; Sun, YN, 1998
)
0.3
" Preliminary pharmacokinetic data were obtained from one patient who showed illustrative plasma concentration-time curves and renal excretion-time profiles after a short-lasting infusion (0."( High-performance liquid chromatography analysis, preliminary pharmacokinetics, metabolism and renal excretion of methylprednisolone with its C6 and C20 hydroxy metabolites in multiple sclerosis patients receiving high-dose pulse therapy.
Jongen, PJ; Lagerwerf, AJ; Verwey-van Wissen, CP; Vree, TB, 1999
)
0.3
" infusion of 5FU in patients with advanced solid tumors to determine the maximum tolerated dose, the recommended dose for Phase II studies, and the safety and pharmacokinetic profiles of this combination."( A phase I and pharmacokinetic study of docetaxel administered in combination with continuous intravenous infusion of 5-fluorouracil in patients with advanced solid tumors.
Bartholomeus, S; Bleiberg, H; Brassinne, C; Cazenave, I; de Valeriola, D; Hennebert, P; Kerger, J; Kusenda, Z; Lefresne-Soulas, F; Piccart, M; Selleslags, J; Van Den Neste, E; Wythouck, H, 2000
)
0.31
" This phase I study was performed to determine the maximum tolerated dose (MTD) and side-effects of the combination, and to establish whether there is any pharmacokinetic interaction between the two compounds."( A phase I and pharmacokinetic study of the combination of capecitabine and docetaxel in patients with advanced solid tumours.
Gordon, RJ; Osterwalder, B; Planting, AS; Pronk, LC; Reigner, B; Sparreboom, A; Twelves, C; Vasey, P; Verweij, J, 2000
)
0.31
" Both PKS and CAPCIL failed to predict theophylline serum levels based exclusively on population pharmacokinetic parameters."( Theophylline pharmacokinetics with concomitant steroid and gold therapy.
Almeida, AM; Caramona, MM; Falcão, AC; Rocha, MJ, 2000
)
0.31
" Plasma cortisol concentrations were determined as a pharmacodynamic index."( Effect of itraconazole on the pharmacokinetics of prednisolone and methylprednisolone and cortisol secretion in healthy subjects.
Archer, VC; Chosidow, O; Diquet, B; Lebrun-Vignes, B; Levron, JC; Puech, AJ; Warot, D, 2001
)
0.31
" The pharmacokinetic interaction between methylprednisolone and itraconazole is probably related to inhibition of hepatic CYP3A4 activity by itraconazole."( Effect of itraconazole on the pharmacokinetics of prednisolone and methylprednisolone and cortisol secretion in healthy subjects.
Archer, VC; Chosidow, O; Diquet, B; Lebrun-Vignes, B; Levron, JC; Puech, AJ; Warot, D, 2001
)
0.31
"Although the elimination half-life of most glucocorticoids is short, they are usually administered once daily, or even on alternate days."( Pharmacokinetics and pharmacodynamics of methylprednisolone after one bolus dose compared with two dose fractions.
Boehm, BO; Czock, D; Keller, F; Mertz, A; Uhl, A; Zellner, D, 2002
)
0.31
"There were no significant differences in methylprednisolone half-life (2."( Pharmacokinetics and pharmacodynamics of methylprednisolone after one bolus dose compared with two dose fractions.
Boehm, BO; Czock, D; Keller, F; Mertz, A; Uhl, A; Zellner, D, 2002
)
0.31
" These patterns are consistent with and rationalized by pharmacodynamic expectations based on earlier models."( Pharmacodynamics and pharmacogenomics of diverse receptor-mediated effects of methylprednisolone in rats using microarray analysis.
Almon, RR; Brandenburg, EH; DuBois, DC; Jusko, WJ; Shi, W; Straubinger, RM; Zhang, S, 2002
)
0.31
" Pharmacodynamic factors were assessed by plasma cortisol and T-helper and T-suppressor lymphocytes by means of extended indirect response models."( Pharmacokinetic and pharmacodynamic interactions between diltiazem and methylprednisolone in healthy volunteers.
Blum, RA; Booker, BM; Jusko, WJ; Lates, CD; Magee, MH, 2002
)
0.31
"8 L/h), resulting in a longer half-life (2."( Pharmacokinetic and pharmacodynamic interactions between diltiazem and methylprednisolone in healthy volunteers.
Blum, RA; Booker, BM; Jusko, WJ; Lates, CD; Magee, MH, 2002
)
0.31
"Controlled-delivery diltiazem, 180 mg, significantly increased methylprednisolone AUC and half-life and reduced clearance, lending to greater systemic exposure to the steroid."( Pharmacokinetic and pharmacodynamic interactions between diltiazem and methylprednisolone in healthy volunteers.
Blum, RA; Booker, BM; Jusko, WJ; Lates, CD; Magee, MH, 2002
)
0.31
"We demonstrated that pharmacokinetic interaction occurs between steroids and tacrolimus in renal transplant patients."( Pharmacokinetic interaction between corticosteroids and tacrolimus after renal transplantation.
Anglicheau, D; Beaune, P; Cassinat, B; Flamant, M; Legendre, C; Martinez, F; Schlageter, MH; Thervet, E, 2003
)
0.32
" The coadministration of daclizumab did not result in a pharmacokinetic interaction with MPA, the active metabolite of MMF."( Pharmacokinetics of daclizumab and mycophenolate mofetil with cyclosporine and steroids in renal transplantation.
Bumgardner, G; Gaston, RS; Kirkman, RL; Light, S; Nieforth, K; Patel, IH; Pescovitz, MD; Vincenti, F, 2003
)
0.32
" A comparison is also presented between several methods based on animal pharmacokinetic data, using the same set of proprietary compounds, and it lends further support for the use of this method, as opposed to methods that require the gathering of pharmacokinetic data in laboratory animals."( Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
Gao, F; Lombardo, F; Obach, RS; Shalaeva, MY, 2004
)
0.32
" The study objectives were (a) to compare the pharmacokinetics of methylprednisolone in premenopausal renal transplant recipients with previously studied male counterparts and (b) to describe the pharmacodynamic response of the hypothalamic-pituitary-adrenal axis during chronic steroid therapy."( Pharmacokinetics and pharmacodynamic response of methylprednisolone in premenopausal renal transplant recipients.
Farooqui, M; Gilliland-Johnson, KK; Reed, KA; Tornatore, KM; Venuto, RC, 2004
)
0.32
" Concentration-time data of MPHS and MP were analyzed using population pharmacokinetic analysis with NONMEM software."( Population pharmacokinetics of methylprednisolone in accident victims with spinal cord injury.
Balbach, S; Barth, J; Derendorf, H; Madabushi, R; Möllenhoff, G; Möllmann, H; Nagaraja, NV; Schumann, R; Winkler, J, 2004
)
0.32
" Pharmacokinetic and pharmacodynamic parameter values were similar on 2 occasions during the consumption of a low-carbohydrate diet and a Weight Watchers diet, indicating that the decreased clearance was unlikely attributable to a change in diet composition."( Reduced methylprednisolone clearance causing prolonged pharmacodynamics in a healthy subject was not associated with CYP3A5*3 allele or a change in diet composition.
Calis, KA; Goldstein, JA; Hon, YY; Jann, MW; Jusko, WJ; Lee, SJ; Salaita, CG; Spratlin, VE, 2006
)
0.33
" To demonstrate the potential value of the model, methylprednisolone distribution in the cochlea was calculated for two clinically relevant application protocols using pharmacokinetic parameters derived from a prior one-dimensional (1D) model."( Cochlear pharmacokinetics with local inner ear drug delivery using a three-dimensional finite-element computer model.
Plontke, SK; Salt, AN; Siedow, N; Wegener, R; Zenner, HP, 2007
)
0.34
" Finally, theoretical assumptions about the potential pharmacokinetic changes of glucocorticoids in pregnancy and their application to clinical settings are discussed."( Pharmacokinetics of corticosteroids during pregnancy.
Ghulmiyyah, LM; Hankins, GD; Pacheco, LD; Snodgrass, WR, 2007
)
0.34
") dosing for use in pharmacodynamic studies."( Pharmacokinetics of methylprednisolone after intravenous and intramuscular administration in rats.
Almon, RR; DuBois, DC; Hazra, A; Jusko, WJ; Pyszczynski, N, 2007
)
0.34
" An integrated pharmacodynamic (PD) model with inhibition of lymphocyte trafficking from tissue to blood by both MPL and CS and induction of cell apoptosis by MPL reasonably captured this lymphocytopenia."( Pharmacokinetic/pharmacodynamic modeling of corticosterone suppression and lymphocytopenia by methylprednisolone in rats.
Almon, RR; DuBois, DC; Jusko, WJ; Yao, Z, 2008
)
0.35
" AUCs of OP and IVMP were determined by the trapezoid method; pharmacokinetic parameters were obtained using noncompartmental and compartmental analysis."( Pharmacokinetic study of oral prednisolone compared with intravenous methylprednisolone in patients with juvenile dermatomyositis.
Daru, JA; Gursahaney, A; Ngai, KL; Pachman, LM; Rouster-Stevens, KA, 2008
)
0.35
" Mean peak concentration was higher for IVMP (34."( Pharmacokinetic study of oral prednisolone compared with intravenous methylprednisolone in patients with juvenile dermatomyositis.
Daru, JA; Gursahaney, A; Ngai, KL; Pachman, LM; Rouster-Stevens, KA, 2008
)
0.35
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
"A physiologic pharmacodynamic model was developed to jointly describe the effects of methylprednisolone (MPL) on adrenal suppression and glycemic control in normal rats."( Pharmacodynamics of glucose regulation by methylprednisolone. II. normal rats.
Jin, JY; Jusko, WJ, 2009
)
0.35
" The large pharmacokinetic (PK) and pharmacodynamic (PD) variability and narrow therapeutic range of MPA provide a potential for therapeutic drug monitoring."( Mycophenolate pharmacokinetics and pharmacodynamics in belatacept treated renal allograft recipients - a pilot study.
Bergan, S; Bremer, S; Holdaas, H; Jørgensen, PF; Midtvedt, K; Rootwelt, H; Stenstrøm, J; Vethe, NT, 2009
)
0.35
" Prodrug and drug concentrations were quantitated using HPLC, and noncompartmental pharmacokinetic parameters were estimated."( Plasma pharmacokinetics and tissue disposition of novel dextran-methylprednisolone conjugates with peptide linkers in rats.
Agarwal, HK; Mehvar, R; Parang, K; Penugonda, S, 2010
)
0.36
"5 hours (C1/2) and 2 hours (C2), providing a total of 114 pharmacokinetic profiles at various periods from 3 days to 6 months posttransplantation (D3, D7, D14, M1, M3, and M6)."( Pharmacokinetics of mycophenolic acid in living donor liver transplantation.
Choi, GS; Joh, JW; Jung, H; Kim, JM; Kim, SJ; Kwon, CH; Lee, SK; Lee, ST; Lee, SY; Moon, JI; Shin, M, 2010
)
0.36
" Of 114 pharmacokinetic profiles, 40 (35%) AUC and 7 (6."( Pharmacokinetics of mycophenolic acid in living donor liver transplantation.
Choi, GS; Joh, JW; Jung, H; Kim, JM; Kim, SJ; Kwon, CH; Lee, SK; Lee, ST; Lee, SY; Moon, JI; Shin, M, 2010
)
0.36
" This multiple-dose, randomized, crossover, open-label study evaluated and compared pharmacodynamic outcomes in subjects who received ACTH analog (80 U subcutaneously) or IVMP (1 g) daily for 5 days."( Pharmacodynamics and tolerability of repository corticotropin injection in healthy human subjects: A comparison with intravenous methylprednisolone.
Becker, PM; Bell, S; Challenger, R; Decker, D; Hammock, V; Lal, R; Nyberg, M; Young, D, 2016
)
0.43
" This regimen was associated with durable donor engraftment and relatively low rates of regimen related toxicity (RRT); future alemtuzumab pharmacokinetic studies may improve outcomes, by allowing targeted alemtuzumab clearance to reduce graft rejection and promote more rapid immune reconstitution."( Unrelated donor hematopoietic stem cell transplantation for the treatment of non-malignant genetic diseases: An alemtuzumab based regimen is associated with cure of clinical disease; earlier clearance of alemtuzumab may be associated with graft rejection.
Abdel-Azim, H; Crooks, GM; Kapoor, N; Khazal, S; Kohn, DB; Mahadeo, KM; Shah, AJ; Zhao, Q, 2015
)
0.42
" An in-depth functional analysis was performed using rich pharmacodynamic (temporal-based) proteomic data measured over 66h in rat liver following a single dose of methylprednisolone (MPL)."( Functional proteomic analysis of corticosteroid pharmacodynamics in rat liver: Relationship to hepatic stress, signaling, energy regulation, and drug metabolism.
Almon, RR; Ayyar, VS; DuBois, DC; Jusko, WJ; Qu, J; Sukumaran, S, 2017
)
0.46
" These studies characterize GILZ as a pharmacodynamic marker of corticosteroid actions in several tissues."( Mechanistic Multi-Tissue Modeling of Glucocorticoid-Induced Leucine Zipper Regulation: Integrating Circadian Gene Expression with Receptor-Mediated Corticosteroid Pharmacodynamics.
Almon, RR; Ayyar, VS; DuBois, DC; Jusko, WJ, 2017
)
0.46
"A multiscale pharmacodynamic model was developed to characterize the receptor-mediated, transcriptomic, and proteomic determinants of corticosteroid (CS) effects on clinically relevant hepatic processes following a single dose of methylprednisolone (MPL) given to adrenalectomized (ADX) rats."( Receptor/gene/protein-mediated signaling connects methylprednisolone exposure to metabolic and immune-related pharmacodynamic actions in liver.
Almon, RR; Ayyar, VS; DuBois, DC; Jusko, WJ; Qu, J; Sukumaran, S, 2018
)
0.48
" SIGNIFICANCE STATEMENT: Mechanisms relating to sex-based pharmacodynamic variability in genomic responses to corticosteroids have been unclear."( Modeling Corticosteroid Pharmacokinetics and Pharmacodynamics, Part III: Estrous Cycle and Estrogen Receptor-Dependent Antagonism of Glucocorticoid-Induced Leucine Zipper (GILZ) Enhancement by Corticosteroids.
Almon, RR; Ayyar, VS; DuBois, DC; Jusko, WJ, 2019
)
0.51
"The plasma and tissue binding properties of two corticosteroids, dexamethasone (DEX) and methylprednisolone (MPL), were assessed in the rat in anticipation of developing physiologically based pharmacokinetic and pharmacokinetic/pharmacodynamic models."( Modeling Corticosteroid Pharmacokinetics and Pharmacodynamics, Part I: Determination and Prediction of Dexamethasone and Methylprednisolone Tissue Binding in the Rat.
Almon, RR; Ayyar, VS; DuBois, DC; Jusko, WJ; Song, D, 2019
)
0.51
"The aim of this study was to identify factors affecting blood concentrations of voriconazole following letermovir coadministration using population pharmacokinetic (PPK) analysis in allogeneic hematopoietic stem cell transplant (allo-HSCT) recipients."( Effects of Letermovir and/or Methylprednisolone Coadministration on Voriconazole Pharmacokinetics in Hematopoietic Stem Cell Transplantation: A Population Pharmacokinetic Study.
Akashi, K; Egashira, N; Fukumoto, J; Hirota, T; Ieiri, I; Matsukane, R; Miyamoto, T; Mori, Y; Muraki, S; Suetsugu, K, 2021
)
0.62
"The aims of this study were to evaluate and compare the pharmacokinetic profiles and bioequivalence of two tablet formulations of methylprednisolone (test formulation: Zhejiang Xianju Pharmaceutical Co."( Pharmacokinetics and bioequivalence of two methylprednisolone tablet formulations in healthy Chinese subjects under fasting and fed conditions.
Fan, L; Gan, C; Huang, Q; Mai, G; Qiu, D; Shen, Z; Shentu, J; Xiao, X; Yang, Y; Zhang, P, 2023
)
0.91

Compound-Compound Interactions

This study was aimed to evaluate the clinical efficacy of flap transplantation combined with vacuum sealing drainage in the treatment of ulcer wound of patients with pyoderma gangrenosum (PG)

ExcerptReferenceRelevance
" Also, large doses of cyclophosphamide and methylprednisolone as pretreatment did not cause any detrimental effect to the allograft kidney when used in combination with cryoprecipitated plasma and pulsatile perfusion."( Immunological donor pretreatment in combination with pulsatile preservation in cadaveric renal transplantation.
Holley, KE; Khan, AU; Leary, FJ; Woods, JE; Zincke, H, 1978
)
0.26
"Peptichemio, a new oncolytic drug with alkylating and antimetabolic properties was employed in combination with vincristine and 6-methylprednisolone (PVP) for the treatment of diffuse non-Hodgkin's lymphomas (NHL), stages III and IV."( Peptichemio: A new oncolytic drug in combination with vincristine and prednisolone in the treatment of non-Hodgkin lymphomas.
Bacigalupo, A; Carella, AM; Damasio, EE; Fusco, FA; Giordano, D; Marmont, AM; Rossi, E; Santini, G, 1977
)
0.26
"Two well-documented cases of bilateral retinal artery and choriocapillaris occlusions with blindness following head and neck soft-tissue injection with methylprednisolone acetate in combination with lidocaine, epinephrine, or penicillin are reported."( Bilateral retinal artery and choriocapillaris occlusion following the injection of long-acting corticosteroid suspensions in combination with other drugs: I. Clinical studies.
Havener, WH; McGrew, RN; Wilson, RS, 1978
)
0.26
"An experimental dog model was used to reproduce the clinical picture of bilateral arteriole and choriocapillaris occlusion from a unilateral intracarotid injection of long-acting corticosteroids combined with other drugs including lidocaine, epinephrine, and penicillin."( Bilateral retinal artery and choriocapillaris occlusion following the injection of long-acting corticosteroid suspensions in combination with other drugs: II. Animal experimental studies.
McGrew, RN; White, HJ; Wilson, RS, 1978
)
0.26
"Inhibition of renal vasoconstriction during hyperacute rejection by phenoxybenzamine or methylprednisolone combined with either the antiplatelet agent pyridinolcarbamate or heparin was evaluted in primates."( Successful short-term modification of hyperacute renal allograft rejection in the primate. Intrarenal effects of phenoxybenzamine and methylprednisolone combined with heparin.
Busch, GJ; Colman, RW; Hollenberg, NK; Martins, AC; Moretz, RC; Wilson, RE, 1976
)
0.26
" We have, therefore, carried out a multicenter, double-blind randomized trial comparing a combination of high-dose metoclopramide (MTC) (1 mg/kg x 4) and methylprednisolone (P) (treatment A) with a shorter but higher single-dose schedule of metoclopramide (3 mg/kg x 2) combined with dexamethasone (DEX) and diphenhydramine (DIP) to prevent extrapyramidal reactions (treatment B)."( Protection from nausea and vomiting in cisplatin-treated patients: high-dose metoclopramide combined with methylprednisolone versus metoclopramide combined with dexamethasone and diphenhydramine: a study of the Italian Oncology Group for Clinical Research
Basurto, C; Bracarda, S; Di Costanzo, F; Donati, D; Malacarne, P; Monici, L; Patoia, L; Picciafuoco, M; Roila, F; Tonato, M, 1989
)
0.28
"Nausea and vomiting are reported in approximately 60% of neoplastic patients treated with doxorubicin used alone at doses greater than or equal to 50 mg/m2 or in combination with other noncisplatin antiblastic agents."( A double-blind trial comparing antiemetic efficacy and toxicity of metoclopramide versus methylprednisolone versus domperidone in patients receiving doxorubicin chemotherapy alone or in combination with other antiblastic agents.
Ballatori, E; Basurto, C; Bracarda, S; Del Favero, A; Roila, F; Tonato, M, 1988
)
0.27
"The authors provided evidence of a positive effect of combined therapy (plasmapheresis in combination with pulse-therapy) on a course of cryoglobulinemic glomerulonephritis and ulcerative-necrotic vasculitis in patients with Sjögren's disease (SD)."( [A positive effect of combined therapy (plasmapheresis in combination with pulse therapy) on the course of cryoglobulinemic glomerulonephritis and ulcerative-necrotic vasculitis in patients with Sjögren's disease].
Chiklikchi, AS; Kirtava, ZZ; Mach, ES; Solov'ev, SK; Vasil'ev, VI, 1987
)
0.27
"We designed a multicenter, double-blind randomized study to determine the safety and antiemetic effectiveness of intravenous (IV) methylprednisolone (P) combined with high-dose IV metoclopramide (MTC) v MTC alone in 200 untreated cancer patients receiving cisplatin chemotherapy."( Antiemetic activity of high doses of metoclopramide combined with methylprednisolone versus metoclopramide alone in cisplatin-treated cancer patients: a randomized double-blind trial of the Italian Oncology Group for Clinical Research.
Ballatori, E; Basurto, C; Bella, M; DiCostanzo, F; Donati, D; Morsia, D; Passalacqua, R; Roila, F; Tognoni, G; Tonato, M, 1987
)
0.27
" In conclusion, the present study indicates that both orbital cobalt irradiation combined with systemic methylprednisolone treatment and systemic methylprednisolone therapy alone are valuable methods of treatment for Graves' ophthalmopathy, but the combined therapy proved to be more effective."( Orbital cobalt irradiation combined with systemic corticosteroids for Graves' ophthalmopathy: comparison with systemic corticosteroids alone.
Andreani, D; Bartalena, L; Baschieri, L; Cavallacci, G; Chiovato, L; Laddaga, M; Lepri, G; Marcocci, C; Pinchera, A, 1983
)
0.27
" To further assess its effectiveness, we studied the effects of natural human interferon-alpha (nIFN alpha), alone and in combination with 6-methyl-prednisolone (PDN), in a prospective, randomized, controlled trial in patients with symptomatic MC."( Natural interferon-alpha versus its combination with 6-methyl-prednisolone in the therapy of type II mixed cryoglobulinemia: a long-term, randomized, controlled study.
Cornacchiulo, V; Dammacco, F; Han, JH; Iacobelli, AR; Lauletta, G; Rizzi, R; Sansonno, D; Shyamala, V, 1994
)
0.29
" Pharmacokinetic studies did not show any significant difference in clearance of FK506 when administered alone or in combination with methylprednisolone or MTX."( Tacrolimus (FK506) alone or in combination with methotrexate or methylprednisolone for the prevention of acute graft-versus-host disease after marrow transplantation from HLA-matched siblings: a single-center study.
Anasetti, C; Appelbaum, FR; Doney, K; Etzioni, R; Furlong, T; Gooley, T; Martin, P; Nash, RA; Slattery, J; Storb, R, 1995
)
0.29
"In treatment of GO, 24 Gy of radiation is a more effective dose than 10 Gy when combined with systemic corticosteroids."( Graves ophthalmopathy: MR evaluation of 10-Gy versus 24-Gy irradiation combined with systemic corticosteroids.
Futami, S; Hoshi, H; Jinnouchi, S; Morita, M; Murakami, N; Nagamachi, S; Nakahara, H; Noguchi, S; Ohnishi, T; Tamaru, M, 1995
)
0.29
"We enrolled 11 patients with secondary progressive MS in a randomized single-masked cross-over study of plasma exchange (PE) in combination with azathioprine 2 mg/kg."( Plasma exchange combined with azathioprine in multiple sclerosis using serial gadolinium-enhanced MRI to monitor disease activity: a randomized single-masked cross-over pilot study.
Christiansen, P; Jensen, CV; Nordenbo, A; Ravnborg, M; Schreiber, K; Szpirt, W; Sørensen, PS; Wanscher, B, 1996
)
0.29
"In experiment A, craniectomy was performed in combination with durotomy, diuretic administration, methylprednisolone sodium succinate administration, and hyperventilation, and effect of these manipulations on ICP was determined."( Effect of craniectomy/durotomy alone and in combination with hyperventilation, diuretics, and corticosteroids on intracranial pressure in clinically normal dogs.
Bagley, RS; Gavin, PR; Greene, SA; Harrington, ML; Keegan, RD; Moore, MP; Pluhar, GE, 1996
)
0.29
" Thirteen patients were treated with an intravenous pulse of methylprednisolone, and fifteen with methylprednisolone combined with cyclophosphamide."( Intravenous cyclophosphamide combined with methylprednisolone in the treatment of severe refractory rheumatoid arthritis: the effect on lymphocytes.
Lacki, JK; Leszczynski, P; Mackiewicz, SH,
)
0.13
"In this selected group of patients with multiple sclerosis with very active disease, mitoxantrone combined with methylprednisolone was effective in improving both clinical and MRI indices of disease activity over a period of six months whereas methylprednisolone alone was not."( Therapeutic effect of mitoxantrone combined with methylprednisolone in multiple sclerosis: a randomised multicentre study of active disease using MRI and clinical criteria.
Berry, I; Brochet, B; Cabanis, E; Clanet, M; Confavreux, C; Edan, G; Froment, JC; Gandon, JM; Iba-Zizen, MT; Lai, HM; Lubetzki, C; Lyon-Caen, O; Miller, D; Moseley, I; Rolland, Y; Sabouraud, O, 1997
)
0.3
" The preventive effect of azathioprine alone and its combination with methylprednisolone on chronic cerebral vasospasm was studied."( [Azathioprine and its combination with methylprednisolone: preventive effect on chronic cerebral vasospasm].
Liu, B; Wang, Z; Wu, J, 1996
)
0.29
" Pathological examination showed that azathioprine alone and its combination with methylprednisolone obviously reduced the damage to the BA wall."( [Azathioprine and its combination with methylprednisolone: preventive effect on chronic cerebral vasospasm].
Liu, B; Wang, Z; Wu, J, 1996
)
0.29
"The calcium channel blocker diltiazem is often included in post-transplant regimens in combination with other immunosuppressive drugs such as cyclosporin A (CyA)."( The modulatory effect of diltiazem on human in vitro alloreactivity when used alone or in combination with cyclosporin A and/or methylprednisolone.
D'Ambrosio, A; Quintieri, F; Segoloni, G, 1997
)
0.3
"The prevention of nausea, vomiting and appetite loss induced by remission induction chemotherapy for acute myeloid leukemia was compared by randomization between granisetron alone and combination with granisetron plus methylprednisolone."( [Efficacy of combination with granisetron and methylprednisolone for nausea, vomiting and appetite loss in remission induction chemotherapy of acute myeloid leukemia--a randomized comparative trial between granisetron alone and granisetron plus methylpred
Hirota, K; Kikuchi, H; Nakayama, T; Nasu, M; Ohno, E; Ohtuka, E; Ono, K; Saburi, Y; Uchida, I; Uno, N, 1999
)
0.3
" In the groups receiving GH and GH combined with IGF-I, urinary hydroxyproline excretion increased more when compared with methylprednisolone alone (P<0."( Effects of IGF-I combined with GH on glucocorticoid-induced changes of bone and connective tissue turnover in man.
Berneis, K; Keller, U; Kraenzlin, M; Oehri, M, 1999
)
0.3
"The possible pharmacokinetic interaction between the new immunosuppressive mycophenolate mofetil (MMF) and tacrolimus (TAC), respectively, was assessed by comparing routinely estimated mycophenolic acid (MPA) plasma trough levels of 15 consecutive renal transplant patients receiving MMF in combination with methylprednisolone (MEP) and cyclosporin A (CSA, 10 patients) or in combination with MEP and tacrolimus (TAC, 5 patients)."( Drug interaction between mycophenolate mofetil and tacrolimus detectable within therapeutic mycophenolic acid monitoring in renal transplant patients.
Eismann, R; Hübner, GI; Sziegoleit, W, 1999
)
0.3
" The pharmacokinetics of docetaxel are not influenced by combination with ifosfamide, regardless of the drug sequence, but ifosfamide pharmacokinetics are changed by docetaxel, depending on the sequence of administration."( Pharmacokinetics of ifosfamide are changed by combination with docetaxel: results of a phase I pharmacologic study.
Bruno, R; De Bruijn, E; Highley, M; Locci-Tonelli, D; Pronk, L; Schrijvers, D; Van Oosterom, AT; Verweij, J, 2000
)
0.31
" Eighty-six patients were treated in combination with high-dose or pulsed corticosteroids and irradiation."( Clinical outcomes of orbital irradiation combined with or without systemic high-dose or pulsed corticosteroids for Graves' ophthalmopathy.
Abe, M; Fukada, S; Hagiwara, M; Hirota, S; Hishikawa, Y; Kono, M; Takada, Y; Tsujino, K, 2000
)
0.31
"Orbital irradiation combined with high-dose or pulsed corticosteroids is an effective treatment for moderate to severe GO, especially in cases with major manifestations of soft-tissue signs, extraocular muscle impairment, or sight loss."( Clinical outcomes of orbital irradiation combined with or without systemic high-dose or pulsed corticosteroids for Graves' ophthalmopathy.
Abe, M; Fukada, S; Hagiwara, M; Hirota, S; Hishikawa, Y; Kono, M; Takada, Y; Tsujino, K, 2000
)
0.31
"1, 1, 5 and 10 mg/ml), phenylbutazone (1000 microgram/ml) and acetylsalicylic acid (25, 250, 2500 microgram/ml) alone, and combined with 10 mg/ml of ofloxacin on the respiratory burst."( [Effect of anti-inflammatory drugs, alone and combined with ofloxacin, on the respiratory burst of human polymorphonuclear leukocytes].
Cabrera, E; Cantón, E; Martínez, P; Orero, A; Velert, MM, 2001
)
0.31
" Both clinical symptoms and MRI findings of these cases significantly improved in response to cyclosporin A (CsA) combined with methylprednisolone (mPSL) pulse therapy."( [Therapeutic effect of cyclosporin A combined with methylprednisolone pulse therapy on hemophagocytic syndrome with the central nervous system involvement].
Otake, M; Takayanagi, M; Yamamoto, K, 2002
)
0.31
"Cyclosporine (INN: ciclosporin) A or tacrolimus have been used mostly in combination with azathioprine as primary immunosuppression after lung transplantation."( Cyclosporine A versus tacrolimus in combination with mycophenolate mofetil and steroids as primary immunosuppression after lung transplantation: one-year results of a 2-center prospective randomized trial.
Birsan, T; Deviatko, E; Klepetko, W; Reichart, B; Reichenspurner, H; Treede, H; Zuckermann, A, 2003
)
0.32
"This 2-center, prospective randomized study showed high immunosuppressive potency of both cyclosporine A and tacrolimus in combination with mycophenolate mofetil."( Cyclosporine A versus tacrolimus in combination with mycophenolate mofetil and steroids as primary immunosuppression after lung transplantation: one-year results of a 2-center prospective randomized trial.
Birsan, T; Deviatko, E; Klepetko, W; Reichart, B; Reichenspurner, H; Treede, H; Zuckermann, A, 2003
)
0.32
" We evaluated the efficacy of methylprednisolone and urokinase pulse therapy combined with cyclophosphamide for patients with HSPN of at least grade IVb."( Efficacy of methylprednisolone and urokinase pulse therapy combined with or without cyclophosphamide in severe Henoch-Schoenlein nephritis: a clinical and histopathological study.
Kawasaki, Y; Suzuki, H; Suzuki, J, 2004
)
0.32
" Of them, 20 (Group A) were treated with methylprednisolone and urokinase pulse therapy, and 17 (Group B) were treated with methylprednisolone and urokinase pulse therapy combined with cyclophophamide."( Efficacy of methylprednisolone and urokinase pulse therapy combined with or without cyclophosphamide in severe Henoch-Schoenlein nephritis: a clinical and histopathological study.
Kawasaki, Y; Suzuki, H; Suzuki, J, 2004
)
0.32
"Our study suggests that methylprednisolone and urokinase pulse therapy combined with cyclophosphamide is useful for patients with severe HSPN."( Efficacy of methylprednisolone and urokinase pulse therapy combined with or without cyclophosphamide in severe Henoch-Schoenlein nephritis: a clinical and histopathological study.
Kawasaki, Y; Suzuki, H; Suzuki, J, 2004
)
0.32
"To evaluate the efficacy of prednisolone, warfarin, and dipyridamole therapy combined with mizoribine (PWDM) in the treatment of diffuse immunoglobulin A (IgA) nephropathy in comparison with prednisolone, warfarin, and dipyridamole therapy without mizoribine (PWD) and with methylprednisolone pulse therapy (PWD pulse)."( Efficacy of multidrug therapy combined with mizoribine in children with diffuse IgA nephropathy in comparison with multidrug therapy without mizoribine and with methylprednisolone pulse therapy.
Hosoya, M; Isome, M; Kawasaki, Y; Nozawa, R; Onishi, N; Suzuki, H; Suzuki, J; Takahashi, A,
)
0.13
" He was diagnosed as having acute respiratory distress syndrome due to severe pneumonia, and was treated with pulse methylprednisolone and sivelestat sodium in combination with intravenous erythromycin and ciprofloxacin."( [A case of Legionella pneumonia complicated with acute respiratory distress syndrome treated with methylprednisolone and sivelestat sodium in combination with intravenous erythromycin and ciprofloxacin].
Arinobu, Y; Himeji, D; Kikuchi, I; Kojima, T; Oguma, A; Ueda, A, 2004
)
0.32
"An assessment of complications during systemic corticosteroid therapy combined with orbital radiotherapy in patients with thyroid eye disease."( [Complications during systemic corticosteroid therapy combined with orbital radiotherapy in patients with graves orbitopathy].
Kaźmierczyk-Puchalska, A; Krzyzanowska-Swiniarska, B; Kulig, G; Pilarska, K, 2004
)
0.32
" In the present study, the authors conducted a randomized controlled trial to compare the success of treatment between surgery and aspiration combined with methylprednisolone acetate injection plus wrist immobilization."( Randomized controlled trial between surgery and aspiration combined with methylprednisolone acetate injection plus wrist immobilization in the treatment of dorsal carpal ganglion.
Limpaphayom, N; Wilairatana, V, 2004
)
0.32
"To evaluate the efficacy of pulsed high-dose corticosteroids combined with orally administered low-dose methotrexate therapy in patients with severe localized scleroderma (LS)."( Pulsed high-dose corticosteroids combined with low-dose methotrexate in severe localized scleroderma.
Altmeyer, P; Breuckmann, F; Freitag, M; Gambichler, T; Hoffmann, K; Kreuter, A; Rotterdam, S; Stuecker, M, 2005
)
0.33
" Interventions Oral methotrexate (15 mg/wk) combined with pulsed intravenous methylprednisolone (1000 mg for 3 days monthly) for at least 6 months."( Pulsed high-dose corticosteroids combined with low-dose methotrexate in severe localized scleroderma.
Altmeyer, P; Breuckmann, F; Freitag, M; Gambichler, T; Hoffmann, K; Kreuter, A; Rotterdam, S; Stuecker, M, 2005
)
0.33
"These data suggest that pulsed high-dose corticosteroids combined with orally administered low-dose methotrexate therapy is beneficial and safe in the treatment of patients with LS."( Pulsed high-dose corticosteroids combined with low-dose methotrexate in severe localized scleroderma.
Altmeyer, P; Breuckmann, F; Freitag, M; Gambichler, T; Hoffmann, K; Kreuter, A; Rotterdam, S; Stuecker, M, 2005
)
0.33
" We conducted a phase II trial of sirolimus combined with tacrolimus and methylprednisolone in patients with steroid-resistant cGVHD."( Sirolimus in combination with tacrolimus and corticosteroids for the treatment of resistant chronic graft-versus-host disease.
Andersson, B; Champlin, R; Couriel, DR; de Lima, MJ; Donato, M; Escalón, MP; Ghosh, S; Giralt, S; Hicks, K; Hosing, C; Hsu, Y; Ippoliti, C; Khouri, IF; Neumann, J; Saliba, R, 2005
)
0.33
"We report a case of IgA nephropathy with tuberculous pleurisy that was treated with steroid pulse therapy combined with tonsillectomy."( [Steroid pulse therapy combined with tonsillectomy in a patient with IgA nephropathy complicated with tuberculous pleurisy].
Koike, K; Okuda, S; Sugawara, K; Takeda, K; Tamaki, K; Wakasugi, D, 2005
)
0.33
"Tacrolimus (TAC) combined with mycophenolate mofetil (MMF) has been suggested to play a critical role in the reversal of C4d-positive acute humoral rejection (AHR) in renal transplantation, but the efficacy of using only TAC-MMF without immunoadsorption or plasmapheresis has not been investigated."( Tacrolimus combined with mycophenolate mofetil can effectively reverse C4d-positive steroid-resistant acute rejection in Chinese renal allograft recipients.
Chen, H; Chen, J; Ji, S; Li, LS; Liu, ZH; Sun, Q; Yin, G, 2006
)
0.33
"To compare the effects of methotrexate (MTX), alone or in combination with intravenous (IV) methylprednisolone (MP) or infliximab, on magnetic resonance imaging (MRI)-detected synovitis, bone edema, and erosive changes in patients with early rheumatoid arthritis (RA)."( Treatment of early rheumatoid arthritis: a randomized magnetic resonance imaging study comparing the effects of methotrexate alone, methotrexate in combination with infliximab, and methotrexate in combination with intravenous pulse methylprednisolone.
Corluy, L; Depresseux, G; Durez, P; Houssiau, FA; Lauwerys, BR; Luyten, FP; Malghem, J; Nzeusseu Toukap, A; Verschueren, P; Westhovens, R, 2007
)
0.34
" Conclusion Methylprednisolone combined with lipopolysaccharide can induce typical rabbit model for early avascular necrosis of femoral head."( [Experimental study on avascular necrosis of femoral head induced by methylprednisolone combined with lipopolysaccharide in rabbits].
Chai, Y; Li, X; Ma, H; Zeng, B, 2008
)
0.35
"We compared the short-term results of anti-inflammatory drugs alone or in combination with local injection of a corticosteroid and anesthetic mixture in the treatment of tennis elbow."( [Short-term results of treatment of tennis elbow with anti-inflammatory drugs alone or in combination with local injection of a corticosteroid and anesthetic mixture].
Aksakalli, E; Gülcan, E; Kilinçoğlu, V; Ozkan, K; Toker, S,
)
0.13
" The patients were randomized to oral and topical anti-inflammatory drugs alone (group 1, n=10) or combined with a single local injection of a corticosteroid and anesthetic mixture (group 2, n=11)."( [Short-term results of treatment of tennis elbow with anti-inflammatory drugs alone or in combination with local injection of a corticosteroid and anesthetic mixture].
Aksakalli, E; Gülcan, E; Kilinçoğlu, V; Ozkan, K; Toker, S,
)
0.13
" Fourteen patients were treated with three cycles of rituximab (375 mg/m(2) weekly for 4 weeks) in combination with HDMP (1 gm/m(2) daily for 5 days)."( Rituximab in combination with high-dose methylprednisolone for the treatment of fludarabine refractory high-risk chronic lymphocytic leukemia.
Bole, J; Castro, JE; Kipps, TJ; Rassenti, L; Sandoval-Sus, JD, 2008
)
0.35
" 60 MM patients including 19 de novo patients, out of them 14 patients received the treatment using regimen of bortezomib in combination with thalidomide (BT), 5 patients received bortezomib-methylprednisolone regimen (BMP)."( [Bortezomib combined with other drugs for treating 60 cases of multiple myeloma].
Chen, SL; Hu, Y; Li, X; Zhang, JJ; Zhong, YP, 2009
)
0.35
"To investigate the efficiency and safety of two-dose steroid combined with two-dose daclizumab and tacrolimus (FK506) regimen in liver transplant recipients."( [Two-dose steroid combined with two-dose daclizumab and tacrolimus regimen in liver transplant recipients].
He, XS; Hu, AB; Huang, JF; Ju, WQ; Ma, Y; Tai, Q; Tan, YL; Wang, DP; Wu, LW; Zhu, XF, 2009
)
0.35
"Two-dose steroid combined with two-dose daclizumab and tacrolimus would be a safe and efficient immunosuppression strategy without increase the acute rejection rate hazard, that could reduce post-transplant infection and other complications from side-effect of long-term usage of steroid."( [Two-dose steroid combined with two-dose daclizumab and tacrolimus regimen in liver transplant recipients].
He, XS; Hu, AB; Huang, JF; Ju, WQ; Ma, Y; Tai, Q; Tan, YL; Wang, DP; Wu, LW; Zhu, XF, 2009
)
0.35
"In this prospective, randomized, open-label, single-center study, we compared the efficacy and safety of two anti-interleukin-2 receptor monoclonal antibodies combined with triple immunosuppression."( Basiliximab versus daclizumab combined with triple immunosuppression in deceased donor renal transplantation: a prospective, randomized study.
Arnol, M; Bren, AF; Kandus, A; Kmetec, A; Oblak, M; Omahen, K; Vidan-Jeras, B, 2010
)
0.36
"Basiliximab or daclizumab combined with triple therapy was an efficient and a safe immunosuppression strategy, demonstrated with low incidence of acute rejections, excellent graft function, high survival rates, and acceptable adverse event profile in adult recipients within the 1st year after deceased donor renal transplantation."( Basiliximab versus daclizumab combined with triple immunosuppression in deceased donor renal transplantation: a prospective, randomized study.
Arnol, M; Bren, AF; Kandus, A; Kmetec, A; Oblak, M; Omahen, K; Vidan-Jeras, B, 2010
)
0.36
"The effectiveness of steroid pulse therapy combined with tonsillectomy (ST) has been shown in immunoglobulin A nephropathy (IgAN) patients with moderate or severe urinary abnormalities."( Clinical effectiveness of steroid pulse therapy combined with tonsillectomy in patients with immunoglobulin A nephropathy presenting glomerular haematuria and minimal proteinuria.
Fukuhara, S; Gillespie, B; Hayashino, Y; Hotta, O; Ieiri, N; Kawaguchi, T; Miyazaki, M; Taguma, Y; Yamazaki, S, 2010
)
0.36
"In 2001, we designed a multicentre, double-blind, randomised, parallel-group trial, termed the methylprednisolone in combination with interferon beta-1a for relapsing-remitting multiple sclerosis (MECOMBIN) study."( Methylprednisolone in combination with interferon beta-1a for relapsing-remitting multiple sclerosis (MECOMBIN study): a multicentre, double-blind, randomised, placebo-controlled, parallel-group trial.
Andersson, M; Bartholomé, E; Beer, K; Celius, EG; Constantinescu, CS; Elovaara, I; Garde, E; Jongen, PJ; Ravnborg, M; Sperling, B; Sørensen, PS, 2010
)
0.36
"Monthly pulses of methylprednisolone in combination with interferon beta-1a do not seem to affect disability progression any more than interferon beta-1a treatment alone."( Methylprednisolone in combination with interferon beta-1a for relapsing-remitting multiple sclerosis (MECOMBIN study): a multicentre, double-blind, randomised, placebo-controlled, parallel-group trial.
Andersson, M; Bartholomé, E; Beer, K; Celius, EG; Constantinescu, CS; Elovaara, I; Garde, E; Jongen, PJ; Ravnborg, M; Sperling, B; Sørensen, PS, 2010
)
0.36
" We concluded that orbital MR imaging combined with CAS could improve the sensitivity of detection of active disease and the prediction of the response to ivGC."( Orbital magnetic resonance imaging combined with clinical activity score can improve the sensitivity of detection of disease activity and prediction of response to immunosuppressive therapy for Graves' ophthalmopathy.
Murakami, T; Nakashima, A; Noguchi, H; Noguchi, S; Noguchi, Y; Ohyabu, Y; Tachibana, S, 2010
)
0.36
" To reduce the total dose of steroids, we have been using mizoribine (MZR) in combination with tonsillectomy-steroid pulse therapy since 2004."( Methylprednisolone pulse therapy combined with mizoribine following tonsillectomy for immunoglobulin A nephropathy: clinical remission rate, steroid sparing effect, and maintenance of renal function.
Fujino, T; Hirama, A; Iino, Y; Kaneko, T; Katayama, Y; Ueda, K; Utsumi, K, 2011
)
0.37
"The aim of this study was to explore the clinical effect and toxicity of bortezomib combined with methylprednisolone in treatment of relapsed or refractory multiple myeloma (MM)."( [Effects of bortezomib combined with methylprednisolone in treatment of 33 cases of relapsed or refractory multiple myeloma].
An, N; Chen, SL; Hu, Y; Li, X; Zhang, JJ; Zhong, YP, 2011
)
0.37
" Some immunosuppressive drugs also interact with one another: cyclosporine raises the level of mTOR inhibitors and lowers the level of mycophenolate."( [Drug interactions and immunosuppression in organ transplant recipients].
Amundsen, R; Asberg, A; Bergan, S; Midtvedt, K; Vethe, NT, 2011
)
0.37
"We previously reported the efficacy of extensive eradication of infectious foci in oral and ENT lesions, combined with tonsillectomy plus methylprednisolone (MP) pulse therapy, for curing pediatric Henoch-Schönlein purpura (HSP) and HSP nephritis."( Impact of periodontal treatment in combination with tonsillectomy plus methylprednisolone pulse therapy and angiotensin blockade for pediatric IgA nephropathy.
Chiba, Y; Homma, R; Inoue, CN; Ishidoya, M; Matsutani, S; Nagasaka, T, 2012
)
0.38
"To compare the efficacy and safety of a low dose (LD) methotrexate (MTX) in combination with a LD methylprednisolone(MP) or standard dose(SD) MP in the treatment of acute graft-versus-host disease (aGVHD)."( [Comparison study on treatment of acute graft-versus-host disease with low-dose methotrexate in combination with low-dose methylprednisolone or standard-dose methylprednisolone].
Chen, H; Chen, YH; Han, W; Huang, XJ; Liu, DH; Liu, KY; Wang, J; Wang, Y; Xu, LP, 2011
)
0.37
" The UGI combined with shoulder exercises in the treatment of subacromial adhesive bursitis is effective to ensure a more frequent complete pain relief in the medium term."( Effectiveness of ultrasound-guided injections combined with shoulder exercises in the treatment of subacromial adhesive bursitis.
Benedetti, MG; Fusaro, I; Galletti, S; Gasparre, G; Volini, S, 2012
)
0.38
"Tonsillectomy combined with steroid pulse therapy achieved higher RR after 1 year of treatment, compared with steroid pulse monotherapy in patients with IgAN."( Comparison between steroid pulse therapy alone and in combination with tonsillectomy for IgA nephropathy.
Moriyama, T; Nitta, K; Ochi, A; Takei, T; Uchida, K, 2013
)
0.39
"To study the effectiveness of mycophenolate mofetil (MMF) as first-line therapy combined with systemic corticosteroids in acute uveitis associated with Vogt-Koyanagi-Harada (VKH) disease."( The outcomes of mycophenolate mofetil therapy combined with systemic corticosteroids in acute uveitis associated with Vogt-Koyanagi-Harada disease.
Abu El-Asrar, AM; Al-Mezaine, HS; Al-Muammar, AM; Hemachandran, S; Kangave, D, 2012
)
0.38
"To investigate the effect of prostaglandins E1 combined with Xuebijing injection on the expression of transforming growth factor-β₁ (TGF-β₁) and tumor necrosis factor-α (TNF-α) in rats with acute pulmonary interstitial fibrosis."( [Effect of prostaglandin E1 combined with Xuebijing injection on transforming growth factor-β₁ in rats with pulmonary interstitial fibrosis].
Li, ZJ; Zhang, WX, 2012
)
0.38
"Prostaglandin E1 combined with Xuebijing injection may significantly inhibit TGF-β₁ expression in the lung tissue of rats with acute pulmonary interstitial fibrosis, which reduces alveolar inflammatory response."( [Effect of prostaglandin E1 combined with Xuebijing injection on transforming growth factor-β₁ in rats with pulmonary interstitial fibrosis].
Li, ZJ; Zhang, WX, 2012
)
0.38
"The possibility to prevent acute spinal cord injury (ASCI) by selective infliximab combined with methylprednisolone (MP) was assessed in experimental ASCI."( Effect of infliximab combined with methylprednisolone on expressions of NF-κB, TRADD, and FADD in rat acute spinal cord injury.
Chengke, L; Hao, Z; Penghui, Z; Ping, W; Wei, P; Weiwei, L; Xiaoyang, P; Xiyang, W; Zhengquan, X, 2013
)
0.39
"To investigate the effects of infliximab, MP, and the combination of these 2 agents on expressions of NF-κB (nuclear factor Kappa B), TRADD (tumor necrosis factor receptor associated death domain), and FADD (fas associated death domain) in a rat model of acute spinal cord injury (ASCI), and to confirm the therapeutic efficacy and possible mechanism of infliximab combined with MP in the treatment of ASCI."( Effect of infliximab combined with methylprednisolone on expressions of NF-κB, TRADD, and FADD in rat acute spinal cord injury.
Chengke, L; Hao, Z; Penghui, Z; Ping, W; Wei, P; Weiwei, L; Xiaoyang, P; Xiyang, W; Zhengquan, X, 2013
)
0.39
" Moreover, infliximab combined with MP exhibited the more powerful ability to this amelioration."( Effect of infliximab combined with methylprednisolone on expressions of NF-κB, TRADD, and FADD in rat acute spinal cord injury.
Chengke, L; Hao, Z; Penghui, Z; Ping, W; Wei, P; Weiwei, L; Xiaoyang, P; Xiyang, W; Zhengquan, X, 2013
)
0.39
"Infliximab combined with methylprednisolone may be an effective treatment for the recovery of ASCI."( Effect of infliximab combined with methylprednisolone on expressions of NF-κB, TRADD, and FADD in rat acute spinal cord injury.
Chengke, L; Hao, Z; Penghui, Z; Ping, W; Wei, P; Weiwei, L; Xiaoyang, P; Xiyang, W; Zhengquan, X, 2013
)
0.39
"To study the anatomical outcome of rhegmatogenous retinal detachment combined with choroidal detachment after pars plana vitrectomy with periocular/intravitreal injection of steroids."( Vitrectomy combined with periocular/intravitreal injection of steroids for rhegmatogenous retinal detachment associated with choroidal detachment.
Bi, C; Chen, F; Wang, H; Wang, N; Wei, Y; Yang, X; Zu, Z, 2014
)
0.4
"Seventy-seven eyes that have rhegmatogenous retinal detachment combined with choroidal detachment were treated by pars plana vitrectomy with oral prednisolone (Group A) or periocular/intravitreal injection of steroids (Group B) and then divided into 5 subgroups according to different intraocular tamponade agents; Group A1: oral steroids and silicone oil, Group A2: oral steroids and C(3)F(8), Group B1: periocular/intravitreal steroid injections and silicone oil, Group B2: periocular steroid injection and silicone oil, and Group B3: periocular steroid injection and C(3)F(8)."( Vitrectomy combined with periocular/intravitreal injection of steroids for rhegmatogenous retinal detachment associated with choroidal detachment.
Bi, C; Chen, F; Wang, H; Wang, N; Wei, Y; Yang, X; Zu, Z, 2014
)
0.4
"For the treatment of rhegmatogenous retinal detachment combined with choroidal detachment, pars plana vitrectomy with periocular/intravitreal corticosteroids was comparable in reattachment rate to pars plana vitrectomy with systemic steroids, suggesting an acceptable alternative for patients with this condition who cannot tolerate systemic steroids."( Vitrectomy combined with periocular/intravitreal injection of steroids for rhegmatogenous retinal detachment associated with choroidal detachment.
Bi, C; Chen, F; Wang, H; Wang, N; Wei, Y; Yang, X; Zu, Z, 2014
)
0.4
" This study evaluated the efficacy and safety of alefacept compared with placebo when combined with tacrolimus, mycophenolate mofetil and corticosteroids in de novo renal transplant recipients."( Alefacept combined with tacrolimus, mycophenolate mofetil and steroids in de novo kidney transplantation: a randomized controlled trial.
Charpentier, B; First, R; Franks, B; Glyda, M; Hettich, F; Holman, JM; Houbiers, JG; Rigotti, P; Rostaing, L, 2013
)
0.39
" Elevated serum tumor necrosis factor-α, interferon-γ, and IL-12 levels returned to normal 10 days after initiating plasma exchange combined with leukocytapheresis, with a reduction in white blood cell count."( Successful remission induced by plasma exchange combined with leukocytapheresis against refractory systemic juvenile idiopathic arthritis.
Abe, J; Fujimaru, T; Ito, S; Kamei, K; Miyazono, A; Ogura, M; Sato, M, 2014
)
0.4
" In our current treatment protocol, the total steroid dose has been significantly reduced through the use of the immunosuppressant mizoribine in combination with tonsillectomy-steroid pulse therapy for the treatment of active IgA nephropathy in patients with renal impairment."( Efficacy of steroid pulse therapy in combination with mizoribine following tonsillectomy for immunoglobulin A nephropathy in renally impaired patients.
Iino, Y; Kaneko, T; Katayama, Y; Shimizu, A; Tsuruoka, S, 2013
)
0.39
" One week later, intravenous methylprednisolone pulse therapy (500 mg/day) was administered for 3 days, followed by oral prednisolone in combination with mizoribine (100 to 150 mg/day)."( Efficacy of steroid pulse therapy in combination with mizoribine following tonsillectomy for immunoglobulin A nephropathy in renally impaired patients.
Iino, Y; Kaneko, T; Katayama, Y; Shimizu, A; Tsuruoka, S, 2013
)
0.39
"Steroid pulse therapy in combination with mizoribine following tonsillectomy is effective in improving urinary findings and preserving renal function in the treatment of IgA nephropathy, which remained active in patients with renal impairment (estimated glomerular filtration rate ≥20 and <60 mL/min/1."( Efficacy of steroid pulse therapy in combination with mizoribine following tonsillectomy for immunoglobulin A nephropathy in renally impaired patients.
Iino, Y; Kaneko, T; Katayama, Y; Shimizu, A; Tsuruoka, S, 2013
)
0.39
" We treated SRNS patients resistant to CIs and MPT with additional rituximab combined with MPT and immunosuppressive agents."( Rituximab treatment combined with methylprednisolone pulse therapy and immunosuppressants for childhood steroid-resistant nephrotic syndrome.
Fujimaru, T; Iijima, K; Ito, S; Kaito, H; Kamei, K; Nakayama, M; Ogura, M; Okada, M; Sato, M, 2014
)
0.4
"Additional rituximab combined with conventional MPT and immunosuppressive agents is a promising option for overcoming refractory SRNS."( Rituximab treatment combined with methylprednisolone pulse therapy and immunosuppressants for childhood steroid-resistant nephrotic syndrome.
Fujimaru, T; Iijima, K; Ito, S; Kaito, H; Kamei, K; Nakayama, M; Ogura, M; Okada, M; Sato, M, 2014
)
0.4
"Patients with biopsy-proven IgAN, proteinuria and low serum creatinine were randomly allocated to receive tonsillectomy combined with steroid pulses (Group A; n = 33) or steroid pulses alone (Group B; n = 39)."( A multicenter randomized controlled trial of tonsillectomy combined with steroid pulse therapy in patients with immunoglobulin A nephropathy.
Fujimoto, S; Furusu, A; Hamaguchi, A; Hirano, K; Horikoshi, S; Imai, H; Imasawa, T; Ishii, T; Kanozawa, K; Kasai, K; Kawamura, T; Kimura, K; Matsuo, S; Matsushima, M; Miura, N; Miyazaki, Y; Ogura, M; Okamoto, H; Okonogi, H; Shibata, T; Shirai, S; Soma, J; Suzuki, Y; Tomino, Y; Ueda, H; Utsunomiya, Y; Wada, A; Yamaji, I; Yasuda, T; Yokoo, T; Yoshimura, M, 2014
)
0.4
"The results indicate tonsillectomy combined with steroid pulse therapy has no beneficial effect over steroid pulses alone to attenuate hematuria and to increase the incidence of clinical remission."( A multicenter randomized controlled trial of tonsillectomy combined with steroid pulse therapy in patients with immunoglobulin A nephropathy.
Fujimoto, S; Furusu, A; Hamaguchi, A; Hirano, K; Horikoshi, S; Imai, H; Imasawa, T; Ishii, T; Kanozawa, K; Kasai, K; Kawamura, T; Kimura, K; Matsuo, S; Matsushima, M; Miura, N; Miyazaki, Y; Ogura, M; Okamoto, H; Okonogi, H; Shibata, T; Shirai, S; Soma, J; Suzuki, Y; Tomino, Y; Ueda, H; Utsunomiya, Y; Wada, A; Yamaji, I; Yasuda, T; Yokoo, T; Yoshimura, M, 2014
)
0.4
"The aim of this study was to investigate the effects of two different treatment regimes in patients with IgA nephropathy (IgAN): steroids alone and in combination with a medium dose of cyclosporine A (CsA)."( Comparison of glucocorticoids alone and combined with cyclosporine a in patients with IgA nephropathy: a prospective randomized controlled trial.
Ding, X; Fang, Y; Ji, J; Liu, C; Liu, H; Xu, X; Yuan, M; Zhang, X, 2014
)
0.4
"The objective is to explore the clinical curative effects of methylprednisolone combined with MTX and DXM intrathecal injection in treating neuropsychiatric systemic lupus erythematosus (NPSLE) and its effects on autoantibody level and anti-N-methyl-D-aspartate receptor subtype NR2a/2b antibody (anti-NR2 antibody) level."( Impact analysis of autoantibody level and NR2 antibody level in neuropsychiatric SLE treated by methylprednisolone combined with MTX and DXM intrathecal injection.
Fu, B; Lei, H; Wang, J; Zhang, J; Zhao, Y; Zhu, G, 2014
)
0.4
" The aim of this study was to investigate the therapeutic efficacy of the usage of aminoguanidine (AG), in myocardial damage occurring after BCT, alone and in combination with methylprednisolone (MP)."( Cardioprotective effect of aminoguanidine in combination with steroid therapy after blunt chest trauma.
Akdemir, HU; Alacam, H; Demir, F; Duran, L; Gacar, A; Guvenc, T; Guzel, A; Karadeniz, C; Murat, N; Ozdemir, S, 2014
)
0.4
"To study the effects of a Gold Belt (GB, a traditional Chinese herbal medicine) combined with methyl-prednisolone (MP) on the motor function and brain-derived neurotrophic factor (BDNF) expression in rats with contusive spinal cord injury (SCI)."( [Effect of Gold Belt combined with methylprednisolone on motor function and brain-derived neurotrophic factor expression in rats following traumatic spinal cord injury].
Li, C; Wang, T; Xu, Z, 2015
)
0.42
"GB combined with MP produces better therapeutic effects for treating SCI than GB or MP used alone, and such effects are probably related with enhanced BDNF expression in the spinal cord."( [Effect of Gold Belt combined with methylprednisolone on motor function and brain-derived neurotrophic factor expression in rats following traumatic spinal cord injury].
Li, C; Wang, T; Xu, Z, 2015
)
0.42
"This paper aims to make an analysis of the effects of ganglioside (GM) combined with methylprednisolone (MP) in early acute spinal injury."( Clinical study of ganglioside (GM) combined with methylprednisolone (MP) for early acute spinal injury.
Li, Y; Sun, Y; Xu, D; Yang, L, 2015
)
0.42
"The efficacy of double-filtration plasmapheresis (DFPP), combined with methylprednisolone, to treat diffuse proliferative lupus nephritis (LN) was studied."( Therapeutic effect of double-filtration plasmapheresis combined with methylprednisolone to treat diffuse proliferative lupus nephritis.
Chen, X; Gao, Y; Li, M; Qiu, Q; Wang, Y; Wei, R; Zhang, L; Zhang, X, 2016
)
0.43
" The patients in the treatment group were first treated with DFPP combined with methylprednisolone (0."( Therapeutic effect of double-filtration plasmapheresis combined with methylprednisolone to treat diffuse proliferative lupus nephritis.
Chen, X; Gao, Y; Li, M; Qiu, Q; Wang, Y; Wei, R; Zhang, L; Zhang, X, 2016
)
0.43
"Appropriate application of DFPP combined with glucocorticoid therapy could accelerate the remission of diffuse proliferative LN, reduce overall glucocorticoid dosage, prevent recurrence, and maintain C3 level in a higher level."( Therapeutic effect of double-filtration plasmapheresis combined with methylprednisolone to treat diffuse proliferative lupus nephritis.
Chen, X; Gao, Y; Li, M; Qiu, Q; Wang, Y; Wei, R; Zhang, L; Zhang, X, 2016
)
0.43
"We evaluated the clinical efficacy and side effect of oral methylprednisolone (MPD) mini-pulse therapy combined with narrow-band UVB (NBUVB) for adults with non-segmental vitiligo retrospectively."( A Retrospective Study of Methylprednisolone Mini-Pulse Therapy Combined with Narrow-Band UVB in Non-Segmental Vitiligo.
Chu, H; Kim, DS; Kim, M; Lee, H; Lee, J; Oh, SH, 2016
)
0.43
"Oral MPD mini-pulse therapy combined with NBUVB appears effective in arresting vitiligo progression and rapidly inducing repigmentation with minimal side effects."( A Retrospective Study of Methylprednisolone Mini-Pulse Therapy Combined with Narrow-Band UVB in Non-Segmental Vitiligo.
Chu, H; Kim, DS; Kim, M; Lee, H; Lee, J; Oh, SH, 2016
)
0.43
" Treatment protocols were a single-course steroid pulse combined with mizoribine during a period from August 2006 to June 2010 (Group A; n = 34) and a three-course steroid pulse during a period from July 2010 to March 2013 (Group B; n = 32)."( Comparison of immunosuppressive therapies for IgA nephropathy after tonsillectomy: three-course versus one-course steroid pulse combined with mizoribine.
Arai, M; Hirama, A; Ikeda, M; Kaneko, T; Morita, M; Shimizu, A; Tsuruoka, S; Watanabe, Y, 2015
)
0.42
"Single-course steroid pulse therapy combined with mizoribine was considered to have a protective effect on the renal function in IgA nephropathy, especially accompanying renal dysfunction."( Comparison of immunosuppressive therapies for IgA nephropathy after tonsillectomy: three-course versus one-course steroid pulse combined with mizoribine.
Arai, M; Hirama, A; Ikeda, M; Kaneko, T; Morita, M; Shimizu, A; Tsuruoka, S; Watanabe, Y, 2015
)
0.42
" This study was performed to compare two treatment regimens, steroid-pulse therapy or combined with mizoribine (MZR) in progressive IgAN."( Comparison of steroid-pulse therapy and combined with mizoribine in IgA nephropathy: a randomized controlled trial.
Hirakata, H; Hirakawa, M; Katafuchi, R; Kitazono, T; Masutani, K; Mitsuiki, K; Tsuchimoto, A; Tsuruya, K; Yamada, T, 2016
)
0.43
"Study design was a prospective randomized controlled trial of 40 patients with moderate to severe glomerular injuries who were randomly administered either pulse methylprednisolone followed by a 25-month course of oral prednisolone (P group, n = 20) or in combination with MZR (150 mg/day for 24 months, M + P group, n = 20)."( Comparison of steroid-pulse therapy and combined with mizoribine in IgA nephropathy: a randomized controlled trial.
Hirakata, H; Hirakawa, M; Katafuchi, R; Kitazono, T; Masutani, K; Mitsuiki, K; Tsuchimoto, A; Tsuruya, K; Yamada, T, 2016
)
0.43
" We could not find the additional effect of MZR in combination with steroid-pulses in this small-scale controlled trial."( Comparison of steroid-pulse therapy and combined with mizoribine in IgA nephropathy: a randomized controlled trial.
Hirakata, H; Hirakawa, M; Katafuchi, R; Kitazono, T; Masutani, K; Mitsuiki, K; Tsuchimoto, A; Tsuruya, K; Yamada, T, 2016
)
0.43
"MSC combined with budesonide, almeterol and azithromycin has been confirmed to be generally safe and can reduce the dose of glucocorticoid in treatment of BOS after HSCT."( [Mesenchymal Stem Cells Combined with Budesonide, Almeterol and Azithromycin for the Treatment of Bronchiolitis Obliterans Syndrome after Hematopoietic Stem Cell Transplantation].
Cao, XP; Ding, L; Guo, ZK; Han, DM; Liu, J; Wang, HX; Wang, ZD; Xue, M; Yan, HM; Zheng, XL; Zhu, L, 2016
)
0.43
" The efficacy of tonsillectomy combined with steroid pulse (SP) administration (TSP) for clinical remission of IgAN has been reported."( Comparison of methods of steroid administration combined with tonsillectomy for IgA nephropathy patients.
Aoyagi, R; Goto, S; Hosojima, M; Kaneko, Y; Kondo, D; Narita, I; Takata, T; Watanabe, H; Yamamoto, S; Yamazaki, H, 2017
)
0.46
"We retrospectively compared clinical remission in IgAN patients treated with tonsillectomy combined with two different steroid administration methods: (1) three courses of SP therapy and oral prednisolone administered on alternate days (group 3A; n = 25); and (2) one course of SP therapy and oral prednisolone administered on consecutive days (group 1C; n = 22)."( Comparison of methods of steroid administration combined with tonsillectomy for IgA nephropathy patients.
Aoyagi, R; Goto, S; Hosojima, M; Kaneko, Y; Kondo, D; Narita, I; Takata, T; Watanabe, H; Yamamoto, S; Yamazaki, H, 2017
)
0.46
" Low-dose indomethacin combined with methylprednisolone may be a new choice for AFOP treatment."( Methylprednisolone combined with low-dose indomethacin treating acute fibrinous and organizing pneumonia after a surgical resection of rectal adenocarcinoma: a case report and literature review.
Bian, LJ; Chen, M; Chen, QK; Huang, LJ; Jiang, SP; Lin, XL; Tang, TT; Zhou, CX, 2016
)
0.43
"To discuss the effects glucocorticoid combined with gamma globulins in the treatment of children with myasthenia gravis and its effects on immune globulin and complement of children."( Effect of glucocorticoid combined with gamma globulin in treatment of children with myasthenia gravis and its effects on immune globulin and complement of children.
An, Q; Deng, XQ; Huang, XX; Wang, MG; Yao, D, 2016
)
0.43
"To evaluate the effectiveness and safety of mycophenolate mofetil (MMF) as first-line therapy combined with systemic corticosteroids in initial-onset acute uveitis associated with Vogt-Koyanagi-Harada (VKH) disease."( Mycophenolate mofetil combined with systemic corticosteroids prevents progression to chronic recurrent inflammation and development of 'sunset glow fundus' in initial-onset acute uveitis associated with Vogt-Koyanagi-Harada disease.
Abu El-Asrar, AM; Al-Muammar, A; Dosari, M; Gikandi, PW; Hemachandran, S, 2017
)
0.46
"Use of MMF as first-line therapy combined with systemic corticosteroids in patients with initial-onset acute VKH disease prevents progression to chronic recurrent granulomatous inflammation and development of 'sunset glow fundus'."( Mycophenolate mofetil combined with systemic corticosteroids prevents progression to chronic recurrent inflammation and development of 'sunset glow fundus' in initial-onset acute uveitis associated with Vogt-Koyanagi-Harada disease.
Abu El-Asrar, AM; Al-Muammar, A; Dosari, M; Gikandi, PW; Hemachandran, S, 2017
)
0.46
"To investigate the clinical efficacy and safety of intravenous injection of low-dose versus high-dose gamma globulin combined with glucocorticoid pulse therapy in the treatment of children with moderate/severe acute Guillain-Barré syndrome (GBS)."( [Clinical efficacy of different doses of gamma globulin combined with glucocorticoid in treatment of moderate/severe acute Guillain-Barré syndrome in children: a comparative analysis].
Li, Y; Li, Z; Ma, XY; Ma, YP; Wang, XJ; Ye, JJ, 2016
)
0.43
"4 g/(kg · d) gamma globulin respectively combined with methylprednisolone."( [Clinical efficacy of different doses of gamma globulin combined with glucocorticoid in treatment of moderate/severe acute Guillain-Barré syndrome in children: a comparative analysis].
Li, Y; Li, Z; Ma, XY; Ma, YP; Wang, XJ; Ye, JJ, 2016
)
0.43
"Low-dose versus high-dose gamma globulin combined with methylprednisolone pulse therapy have comparable clinical efficacy and safety in the treatment of children with moderate/severe acute GBS."( [Clinical efficacy of different doses of gamma globulin combined with glucocorticoid in treatment of moderate/severe acute Guillain-Barré syndrome in children: a comparative analysis].
Li, Y; Li, Z; Ma, XY; Ma, YP; Wang, XJ; Ye, JJ, 2016
)
0.43
" The aim of this study was to investigate the efficacy and safety of bortezomib combined with glucocorticoids in refractory lupus patients."( The short-term efficacy of bortezomib combined with glucocorticoids for the treatment of refractory lupus nephritis.
Hou, J; Hu, W; Huang, L; Huang, X; Liu, Z; Zhang, H; Zhou, M, 2017
)
0.46
" The objective of this study was to characterize the potential drug-drug interactions (DDIs) between voriconazole and glucocorticoids using physiologically based pharmacokinetic (PBPK) models."( Assessment of drug-drug interactions between voriconazole and glucocorticoids.
Chen, L; Li, M; Li, N; Qi, F; Zhu, L, 2018
)
0.48
"In this study we compared the anatomic and functional outcomes of two steroid treatments on rhegmatogenous retinal detachment (RRD) combined with choroidal detachment (CD), namely treatment with oral prednisolone (1 mg/kg daily) for 3-7 days before vitrectomy or a single periocular injection of methylprednisolone (40 mg) 1-3 days before vitrectomy."( The effect of single periocular injection of methylprednisolone and drainage of suprachoroidal fluid in the treatment of rhegmatogenous retinal detachment combined with choroidal detachment.
Chen, H; Chen, X; Wang, X; Wei, Y; Zhou, R, 2019
)
0.51
" Seventy five eyes with RRD combined with CD were divided into 2 groups based on the two different treatment regimens as above."( The effect of single periocular injection of methylprednisolone and drainage of suprachoroidal fluid in the treatment of rhegmatogenous retinal detachment combined with choroidal detachment.
Chen, H; Chen, X; Wang, X; Wei, Y; Zhou, R, 2019
)
0.51
"For RRD combined with CD, eyes treated with a single periocular injection of methylprednisolone (40 mg, 1-3 days before pars plana vitrectomy) combined with the drainage of suprachoroidal fluids during the surgery had similar anatomic and functional outcomes compared to the eyes treated with oral prednisolone for 3-7 days before vitrectomy."( The effect of single periocular injection of methylprednisolone and drainage of suprachoroidal fluid in the treatment of rhegmatogenous retinal detachment combined with choroidal detachment.
Chen, H; Chen, X; Wang, X; Wei, Y; Zhou, R, 2019
)
0.51
"To study the effect of the leukotriene receptor agonist montelukast combined with methylprednisolone on inflammatory response and peripheral blood lymphocyte subset content in children with mycoplasma pneumonia."( Effect of montelukast combined with methylprednisolone for the treatment of mycoplasma pneumonia.
Ding, X; Ji, W; Liang, Y; Wu, H; Zhao, D, 2019
)
0.51
"Montelukast combined with methylprednisolone for the treatment of mycoplasma pneumonia can inhibit inflammatory responses and regulate levels of Th1/Th2 and Th17/Treg cells."( Effect of montelukast combined with methylprednisolone for the treatment of mycoplasma pneumonia.
Ding, X; Ji, W; Liang, Y; Wu, H; Zhao, D, 2019
)
0.51
" As a conservative therapy for SLE-associated AAC, corticosteroid therapy combined with azathioprine might be beneficial."( Systemic Lupus Erythematosus-associated Acute Acalculous Cholecystitis Successfully Treated by a Corticosteroid Combined with Azathioprine.
Fujiyama, S; Kudo, N; Shimomura, T; Suzushima, H; Takaoka, H, 2019
)
0.51
" We analyzed the efficacy of tonsillectomy combined with steroid pulse therapy (TSP)."( The impact of tonsillectomy combined with steroid pulse therapy in patients with advanced IgA nephropathy and impaired renal function.
Kamiyama, T; Karasawa, K; Kumon, S; Moriyama, T; Nitta, K, 2020
)
0.56
"To determine the curative effect of gamma globulin combined with methylprednisolone sodium succinate on paediatric patients with severe hand-foot-mouth disease and analyse its influence on cardio-pulmonary functions."( Effectiveness of gamma globulin combined with methylprednisolone sodium succinate in severe hand foot mouth disease - Baoding Children's Hospital, China.
Jie, C; Li-Po, H; Yu, Z; Yuan-da, Z, 2020
)
0.56
" Those in the test group accepted gamma globulin combined with methylprednisolone sodium succinate."( Effectiveness of gamma globulin combined with methylprednisolone sodium succinate in severe hand foot mouth disease - Baoding Children's Hospital, China.
Jie, C; Li-Po, H; Yu, Z; Yuan-da, Z, 2020
)
0.56
"Curative effect of gamma globulin combined with methylprednisolone sodium succinate on paediatric patients showed significance and this treatment could be effectively improve clinical symptoms and cardio-pulmonary functions of paediatric patients."( Effectiveness of gamma globulin combined with methylprednisolone sodium succinate in severe hand foot mouth disease - Baoding Children's Hospital, China.
Jie, C; Li-Po, H; Yu, Z; Yuan-da, Z, 2020
)
0.56
" We analyzed the effects of roflumilast combined with ESHAP (etoposide, cisplatin, methylprednisolone, and cytarabine) chemotherapy in experimental and clinical settings."( Role of Roflumilast Combined with ESHAP Chemotherapy in Relapsed/Refractory Patients with Diffuse Large B-Cell Lymphoma.
Chung, JS; Kim, DY; Kim, SW; Nam, J; Shin, HJ, 2022
)
0.72
"We found that roflumilast is efficient when combined with other chemotherapy drugs, especially cytarabine."( Role of Roflumilast Combined with ESHAP Chemotherapy in Relapsed/Refractory Patients with Diffuse Large B-Cell Lymphoma.
Chung, JS; Kim, DY; Kim, SW; Nam, J; Shin, HJ, 2022
)
0.72
"We found that roflumilast, when combined with ESHAP chemotherapy, for relapsed/refractory DLBCL was clinically active and well tolerated."( Role of Roflumilast Combined with ESHAP Chemotherapy in Relapsed/Refractory Patients with Diffuse Large B-Cell Lymphoma.
Chung, JS; Kim, DY; Kim, SW; Nam, J; Shin, HJ, 2022
)
0.72
" IA combined with methylprednisolone to induce and alleviate the disease effectively, and cyclophosphamide (0."( Diffuse alveolar hemorrhage in a patient with anti-neutrophil cytoplasm antibody-associated vasculitis successfully treated with immunoadsorption combined with methylprednisolone.
Jin, S; Luo, J; Wang, D; Wu, M; Zhang, W, 2022
)
0.72
" Recently, tonsillectomy combined with corticosteroid pulse (TSP) has been shown to be effective for achieving clinical remission and favorable renal outcome in patients with IgAN."( Comparison of administration of single- and triple-course steroid pulse therapy combined with tonsillectomy for immunoglobulin A nephropathy.
Atsumi, T; Fukasawa, Y; Iwasaki, S; Kaneshima, N; Maoka, T; Matsuoka, N; Nakagaki, T; Nakazawa, D; Nishimoto, N; Nishio, S; Tsuji, T; Watanabe-Kusunoki, K; Yamamoto, J; Yamamoto, R, 2021
)
0.62
" According to the successful applications of dupilumab in BP cases reported, therefore, we investigate the real-life efficacy and safety of dupilumab combined with low-dose oral steroid for BP."( Dupilumab combined with low-dose systemic steroid therapy improves efficacy and safety for bullous pemphigoid.
Chen, S; Chen, Z; Gao, H; He, S; Hu, Y; Liu, S; Luo, X; Ma, L; Tang, C; Tang, L; Wang, L; Xu, Y; Yang, F; Yang, J; Zhang, Z; Zhao, Y, 2022
)
0.72
" This case report indicated that remdesivir might interact with cytochrome P450 3A4 substrates, such as tacrolimus and everolimus, and elevate their blood concentrations under high inflammatory conditions."( Drug-drug interaction between remdesivir and immunosuppressant agents in a kidney transplant recipient.
Hirai, T; Inoue, T; Iwamoto, T; Mizuta, A; Nishikawa, K; Sasaki, T, 2022
)
0.72
"Diabetic kidney disease (DKD) combined with Membranous Nephropathy (MN) was observed in some patients with the increasing of Diabetic patients."( Retrospective analysis of leflunomide and low-dose methylprednisolone for the treatment of diabetic nephropathy combined with membranous nephropathy.
Cui, S; Li, P; Li, Q; Li, W; Shang, S; Wang, C; Wang, W, 2022
)
0.72
"This study was aimed to evaluate the clinical efficacy of flap transplantation combined with vacuum sealing drainage and methylprednisolone and cyclosporine in the treatment of ulcer wound of patients with pyoderma gangrenosum (PG)."( Clinical efficacy of flap transplantation combined with vacuum sealing drainage and methylprednisolone and cyclosporine in the treatment of pyoderma gangrenosum.
Feng, Z; Hao, Y; He, J; Li, C; Zhao, Z, 2023
)
0.91
" We aimed to evaluate the effect of methylprednisolone added to ultrasound-guided peripheral nerve blocks (PNBs) combined with multimodal analgesia including intravenous dexamethasone for prolonged analgesia after early discharge."( Effect of Adding Perineural Methylprednisolone to Peripheral Nerve Blocks Combined With Intravenous Dexamethasone for Prolonged Postdischarge Analgesia After Fast-track Total Knee Arthroplasty: A Randomized Controlled Trial.
Akaravinek, P; Kampitak, W; Limsakul, K; Ngarmukos, S; Tanavalee, A; Tanavalee, C, 2023
)
0.91
" There are rare reports regarding the treatment of systemic lupus erythematosus (SLE) combined with CSC."( A case report of systemic lupus erythematosus combined with central serous chorioretinopathy treated with glucocorticoids.
Ku, M; Rao, Q; Wan, Q, 2023
)
0.91
"We access the safety and efficacy of methylprednisolone combined with dupilumab in treating the bullous pemphigoid."( The efficacy and safety of dupilumab combined with methylprednisolone in the treatment of bullous pemphigoid in China.
Qi, W; Rushan, X, 2023
)
0.91
"We studied the neuroprotective effect of local application of methylprednisolone in combination with a block copolymer after contusion spinal cord injury in rats."( Morphofunctional Changes in the Spinal Cord of Rats after Contusion Injury with Local Delivery of Methylprednisolone in Combination with a Copolymer.
Baltin, ME; Baltina, TV; Chernova, ON; Sabirova, DE; Sachenkov, OA, 2023
)
0.91
"Clinical studies of IGU combined with MP for pSS were searched through eight databases."( Efficacy and safety of iguratimod combined with methylprednisolone for primary Sjögren's syndrome: a meta-analysis and trial sequential analysis.
Hu, G; Xu, Q; Yang, XY; Yin, S; You, H; Yu, YF, 2023
)
0.91
"IGU combined with MP effectively attenuates autoimmune responses (IgG, IgM, IgA), reduces clinical symptoms and disease activity (ESR, PLT, ESSPRI, ESSDAI), and improves the exocrine gland functional status (SIT) in patients with pSS."( Efficacy and safety of iguratimod combined with methylprednisolone for primary Sjögren's syndrome: a meta-analysis and trial sequential analysis.
Hu, G; Xu, Q; Yang, XY; Yin, S; You, H; Yu, YF, 2023
)
0.91
"In this study, the clinical effect of lamivudine combined with leflunomide and methylprednisolone in the treatment of hepatitis B virus-associated glomerulonephritis (HBV-GN) and their influence on renal function indexes was explored."( Clinical Effect of Lamivudine Combined with Leflunomide and Methylprednisolone Tablets in the Treatment of Hepatitis B Virus-Associated Glomerulonephritis and Its Influence on Renal Function Indicators.
Jiang, F; Liu, H; Xing, X; Zhang, M; Zheng, K; Zhou, C, 2023
)
0.91
"Lamivudine combined with methylprednisolone and leflunomide treatment is conducive to clearing Hepatitis B virus (HBV) and improving renal function."( Clinical Effect of Lamivudine Combined with Leflunomide and Methylprednisolone Tablets in the Treatment of Hepatitis B Virus-Associated Glomerulonephritis and Its Influence on Renal Function Indicators.
Jiang, F; Liu, H; Xing, X; Zhang, M; Zheng, K; Zhou, C, 2023
)
0.91

Bioavailability

The aim of the study was to determine the oral bioavailability of high dose methylprednisolone and to establish whether this is a feasible and more convenient route of administration. The study found that when 80 mg was also taken by mouth, the relative bio availability of the tablets was 99%.

ExcerptReferenceRelevance
" The median value of bioavailability (relative to oral dose) of methylprednisolone acetate based on unchanged methylprednisolone plasma levels was 14."( Rectal and oral absorption of methylprednisolone acetate.
Albert, KS; Garg, DC; Sakmar, E; Wagner, JG; Weidler, DJ, 1979
)
0.26
"The variability and relative bioavailability of methylprednisolone tablets were evaluated utilizing a double Latin square crossover design in which each of 20 subjects was given four of five treatments."( Double Latin square study to determine variability and relative bioavailability of methylprednisolone.
Albert, KS; Brown, SW; Chen, TT; DeSante, KA; DiSanto, AR; Stewart, RD, 1979
)
0.26
"This presentation has attempted to provide a brief view of the importance of bioavailability and bioequivalence to those physicians who use corticosteroids."( Corticosteroids and bioavailability.
Stubbs, SS, 1975
)
0.25
" This method was successfully implemented for the analysis of specimens generated from a single-dose bioavailability and safety study for a new formulation of Depo-Medrol sterile aqueous suspension."( Validation of the simultaneous determination of methylprednisolone and methylprednisolone acetate in human plasma by high-performance liquid chromatography.
Addison, TE; Brisson, J; Hopkins, NK; Wagner, CM, 1992
)
0.28
" The relative oral bioavailability of the sterol was 69."( High dose oral methylprednisolone in patients with rheumatoid arthritis: pharmacokinetics and clinical response.
Ahern, MJ; Cosh, DG; Hayball, PJ; Roberts-Thomson, PJ; Schultz, DW, 1992
)
0.28
" Although the effects of precipitate formation on drug bioavailability and toxicity have not been fully determined, until such information is available, the use of combinations of drugs that remain in solution during administration is recommended."( The solubility of antibiotic and corticosteroid combinations.
Lee, BL; Matoba, AY; Osato, MS; Robinson, NM, 1992
)
0.28
" We studied the immunosuppressive properties of new, synthetic, prostaglandin E1 (PGE1) methyl ester analogs (misoprostol, enisoprost) with oral bioavailability using an allogeneic in vitro immunoassay."( The immunosuppressive properties of new oral prostaglandin E1 analogs.
Dumble, LJ; Maddux, MS; Moran, M; Pollak, R; Wiederkehr, JC, 1990
)
0.28
" Oral bioavailability was essentially 100 percent, ruling out impaired absorption."( Rapid methylprednisolone clearance in a patient with cystic fibrosis.
Farrell, PM; Green, CG; Jusko, WJ; Kraus, CK; Lemanske, RF, 1988
)
0.27
"The absolute bioavailability and pharmacokinetic parameters of two methylprednisolone formulations (methylprednisolone sodium succinate and methylprednisolone acetate) were determined in five dogs."( Pharmacokinetics of methylprednisolone, methylprednisolone sodium succinate, and methylprednisolone acetate in dogs.
Alvinerie, M; Fayolle, PM; Koritz, GD; Toutain, PL, 1986
)
0.27
" Bioavailability of prednisolone after the oral administration of prednisone and methylprednisolone ranged from 86% to 104% during anticonvulsant therapy."( Prednisolone and methylprednisolone kinetics in children receiving anticonvulsant therapy.
Bartoszek, M; Brenner, AM; Szefler, SJ, 1987
)
0.27
" When methylprednisolone (80 mg) was also taken by mouth, the relative bioavailability of the tablets was 99%."( Kinetics of methylprednisolone and its hemisuccinate ester.
Derendorf, H; Möllmann, H; Rehder, J; Rohdewald, P; Schmidt, EW, 1985
)
0.27
" In vivo pharmacokinetic studies in rhesus monkeys were also conducted to compare the bioconversion rates and overall bioavailability of several solution-stable prodrugs with the 21-succinate ester."( Strategies in the design of solution-stable, water-soluble prodrugs III: influence of the pro-moiety on the bioconversion of 21-esters of corticosteroids.
Anderson, BD; Conradi, RA; Forbes, AD; Spilman, CH, 1985
)
0.27
" Assessment of methylprednisolone disposition following oral and intravenous doses revealed no effect of cimetidine on the bioavailability (74 to 81 percent absorption) or plasma clearance (22 to 24 liters per hour) of the steroid."( Cimetidine-methylprednisolone-theophylline metabolic interaction.
Ebling, WF; Gardner, MJ; Green, AW; Jusko, WJ, 1984
)
0.27
"This study was conducted to evaluate the influence of route of administration upon the bioavailability and pharmacokinetics of methylprednisolone sodium succinate."( Influence of route of administration on the pharmacokinetics of methylprednisolone.
Albert, KS; Antal, EJ; Gillespie, WR; Wright, CE, 1983
)
0.27
"This was a single-blind, single-dose, randomized crossover study to determine the absolute bioavailability of Medrol, a new high dose (100 mg) methylprednisolone tablet product, by comparing it with 100 mg methylprednisolone from an intravenous formulation, Solu-Medrol."( Absolute bioavailability of a new high dose methylprednisolone tablet formulation.
Groenewoud, G; Hundt, HK; Luus, HG; Müller, FO; Schall, R, 1994
)
0.29
" The aim of the study was to determine the oral bioavailability of high dose methylprednisolone and to establish whether this is a feasible and more convenient route of administration."( Pharmacokinetics of high dose methylprednisolone and use in hematological malignancies.
Graham, MA; McElwain, TJ; Newell, DR; Patel, PM; Selby, PJ; Viner, C,
)
0.13
" In addition the differences in the pharmacokinetics for the prodrugs resulted in only a small difference in the relative bioavailability of MP for MP suleptanate (0."( A comparative population pharmacokinetic analysis for methylprednisolone following multiple dosing of two prodrugs in patients with acute asthma.
Daley-Yates, PT; Parker, TJ; Wood, SA, 1997
)
0.3
" The bioavailability of MP was equivalent when based on AUC with a MP suleptanate median 108% of the MP succinate value (90% CI: 102-114%)."( Pharmacokinetic and pharmacodynamic assessment of bioavailability for two prodrugs of methylprednisolone.
Brooks, CD; Daley-Yates, PT; Gregory, AJ, 1997
)
0.3
" These complications could be reduced by techniques that increase the spinal bioavailability of intravenously administered methylprednisolone while simultaneously decreasing plasma bioavailability."( Spinal cord bioavailability of methylprednisolone after intravenous and intrathecal administration: the role of P-glycoprotein.
Bernards, CM; Koszdin, KL; Shen, DD, 2000
)
0.31
" In addition, wild-type mice and P-glycoprotein knockout mice were used to determine the role of P-glycoprotein in limiting spinal bioavailability of methylprednisolone."( Spinal cord bioavailability of methylprednisolone after intravenous and intrathecal administration: the role of P-glycoprotein.
Bernards, CM; Koszdin, KL; Shen, DD, 2000
)
0.31
"These pig studies demonstrate that the spinal cord bioavailability of methylprednisolone is poor after intravenous administration."( Spinal cord bioavailability of methylprednisolone after intravenous and intrathecal administration: the role of P-glycoprotein.
Bernards, CM; Koszdin, KL; Shen, DD, 2000
)
0.31
"The quantitative structure-bioavailability relationship of 232 structurally diverse drugs was studied to evaluate the feasibility of constructing a predictive model for the human oral bioavailability of prospective new medicinal agents."( QSAR model for drug human oral bioavailability.
Topliss, JG; Yoshida, F, 2000
)
0.31
"The significance of intestinal P-glycoprotein (P-gp) in determining the oral bioavailability of tacrolimus has been still controversial."( Limited interaction between tacrolimus and P-glycoprotein in the rat small intestine.
Achiwa, K; Aungst, BJ; Kobayashi, M; Oda, M; Saikachi, Y; Saitoh, H; Tadano, K; Takahashi, Y; Yamaguchi, M; Yuhki, Y, 2006
)
0.33
" The pharmacokinetics of MPL showed bi-exponential disposition with two first-order absorption components from the injection site and bioavailability was 21%."( Modeling receptor/gene-mediated effects of corticosteroids on hepatic tyrosine aminotransferase dynamics in rats: dual regulation by endogenous and exogenous corticosteroids.
Almon, RR; DuBois, DC; Hazra, A; Jusko, WJ; Pyszczynski, N, 2007
)
0.34
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."( Hologram QSAR model for the prediction of human oral bioavailability.
Andricopulo, AD; Moda, TL; Montanari, CA, 2007
)
0.34
"To investigate the effect of PEO-PPO-PEO polymeric micelles (PM) formulation on the bioavailability of methylprednisolone (MP), a treatment of spinal cord injury (SCI), to the blood and spinal cord (SC) of rabbits."( Bioavailability effect of methylprednisolone by polymeric micelles.
Chang, SF; Chen, CL; Hsu, CY; Lee, D; Lee, YH; Liaw, J; Lin, SJ; Yang, LY, 2008
)
0.35
"Patients with juvenile DM and ERL loss may have decreased bioavailability of OP compared with IVMP."( Pharmacokinetic study of oral prednisolone compared with intravenous methylprednisolone in patients with juvenile dermatomyositis.
Daru, JA; Gursahaney, A; Ngai, KL; Pachman, LM; Rouster-Stevens, KA, 2008
)
0.35
"We included 13 patients with MS with NAbs and a low IFN-beta bioavailability detected by the MxA-mRNA response in a descriptive, non-randomized trial."( Treatment with azathioprine and cyclic methylprednisolone has little or no effect on bioactivity in anti-interferon beta antibody-positive patients with multiple sclerosis.
Bendtzen, K; Christensen, O; Hesse, D; Jensen, PE; Ravnborg, M; Sørensen, PS; Tovey, MG, 2009
)
0.35
"The intestinal absorption rate constant of methylprednisolone (MP) evaluated by the loop method increased significantly with increasingly higher concentrations of the drug up to 500 microM in a nonlinear fashion but did not increase further at higher concentrations."( Nonlinear absorption of methylprednisolone by absorptive and secretory transporters.
Fujinaga, I; Hayashi, M; Tomita, M; Watanabe, A; Yamakawa, T, 2010
)
0.36
" Analysis of dose-adjusted exposure parameters showed significant increases in AUC and Cmin after SL administration confirming a better bioavailability of the SL route compared with oral route."( Sublingual administration improves systemic exposure of tacrolimus in kidney transplant recipients: comparison with oral administration.
Apicella, L; Balletta, MM; Capone, D; Carrano, R; Federico, S; Mosca, T; Nappi, R; Russo, L; Sabbatini, M; Santangelo, M; Tarantino, G, 2016
)
0.43
"Risedronate sodium is a bisphosphonate derivative having very low bioavailability when administered through the oral route."( Improvement of bone microarchitecture in methylprednisolone induced rat model of osteoporosis by using thiolated chitosan-based risedronate mucoadhesive film.
Anbu, J; Azamthulla, M; Banala, VT; Mukherjee, D; Ramachandra, SG; Srinivasan, B, 2018
)
0.48
"Olmesartan medoxomil (OLM) is an antihypertensive drug with low oral bioavailability due to extensive first-pass metabolism."( Use of transethosomes for enhancing the transdermal delivery of olmesartan medoxomil: in vitro, ex vivo, and in vivo evaluation.
Abdelbary, AA; Albash, R; El-Nabarawi, MA; Refai, H, 2019
)
0.51
"We review prior and current literature on the use of MP treatment for ASCI patients with a discussion of novel drug delivery systems that have demonstrated the potential to improve MP's bioavailability at the site of injury while minimizing systemic side effects."( Updated Review: The Steroid Controversy for Management of Spinal Cord Injury.
Bowles, DR; Canseco, JA; DiMaria, SL; Karamian, BA; Leibensperger, MR; Markowitz, MP; Semenza, NC; Smith, ML; Vaccaro, AR, 2021
)
0.62

Dosage Studied

All the 7 patients recovered. High dose methylprednisolone (kg/30 mg) was administered by intravenous infusion in the 8th, 16th and 24th hours after injury. The results of pulmonary function tests, Asthma Control Test (ACT) and Asthma Health Questionnaire (AHQ)-33 were compared in patients pre- and post-treatment with omalizumab.

ExcerptRelevanceReference
" As the results indicated 400 mug a day to have the most pronounced effect on nasal symptoms, this dosage is recommended for children as well as adults suffering from summer hay fever."( Beclomethasone dipropionate aerosol treatment of hay fever. A dose-response investigation.
Andersen, JB; Halberg, P; Mygind, N, 1975
)
0.25
" In the first case rapidly progressive glomerulonephritis with 100% crescents was arrested and followed by improvement of renal function from a creatinine clearance of 5 ml/min to 30 ml/min; in the second case multiple lung granulomata of 8 months' standing, unresponsive to oral steroids, disappeared 8 days after treatment with high dosage intravenous methylprednisolone."( Methylprednisolone pulse therapy in the treatment of polyarteritis nodosa.
Lee, HA; Neild, GH, 1977
)
0.26
"This study was designed to determine the effect of methylprednisolone on the profile of hepatic oxygen supply and selected blood parameters in fasted, male rats administered an LD85 dosage of E coli endotoxin intraperitoneally."( The effect of methylprednisolone on hepatic oxygen supply and plasma lactate and glucose in endotoxemia.
Casey, JP; Rink, RD; Short, BL, 1979
)
0.26
"Long-term glucocorticoid dosing directly enhances a facilitatory function of cat soleus motor nerve terminals."( Effects of a single methylprednisolone dose on a facilitatory response of mammalian motor nerve.
Baker, T; Hall, ED; Riker, WF, 1977
)
0.26
" Since increased cardiac output was associated with increased stroke volume and left ventricular stroke work index, but without an increase in preload (PWP) or a decrease in afterload (MABP), methylprednisolone(MP), in pharmacologic dosage appears to have a positive inotropic effect on the myocardium of trauma patients during resuscitation."( Evaluation of glucocorticoids during resuscitation of injured patients.
Dutton, RE; Newell, JC; Powers, SR; Rhodes, GR; Scovill, WA; Shah, DM, 1979
)
0.26
" The failure to demonstrate any beneficial effect and the slight increased mortality and morbidity associated with the bolus methylprednisolone dosage makes this therapy unjustifiable."( High dose (bolus) intravenous methylprednisolone at the time of kidney homotransplantation.
Fox, PS; Kauffman, HM; Sampson, D; Stawicki, AT, 1977
)
0.26
" Methylprednisolone in an early pharmacologic dosage is effective in fulminant instances of fat embolism that occur in spite of adequate respiratory care and the proper treatment of fractures."( Corticosteroids in patients with a high risk of fat embolism syndrome.
Alho, A; Eerola, P; Hämäläinen, M; Koskinen, M; Saikku, K, 1978
)
0.26
" ALG in the dosage used did not show any beneficial effects and varying degrees of rejection occurred in the majority of these unmatched animal pairs."( Segmental pancreatic transplantation in pigs.
Kyriakides, GK; Miller, J; Nuttall, FQ, 1979
)
0.26
" Endotoxin in a dosage of 3,000 microgram was not lethal for nonmedicated control animals."( Endotoxin toxicity in rats with 6-sulfanilamidoindazole arthritis.
Hiramoto, RN; Miller, ML; Samuelson, CO; Ward, JR, 1979
)
0.26
" Our data suggest that for optimal graft and patient survival the dosage of steroids should be less than 150 mg/day of methylprednisolone on days 1-3, less than 50 mg/day of prednisone on days 4-21, less than 30 mg/day on days 22-30, and less than 20 mg/day between one mo and one yr."( Steroid treatment for routine immunosuppression in cadaver renal transplantation. A survey of hospitals.
Gonzalez, FM; Kodlin, D; Kumar, P; Leech, SH,
)
0.13
" These results suggest a significant cumulative effect in reducing infarct size over that achieved with one agent alone; however, further studies are needed to determine the appropriate dosage and temporal factors."( Reduction of experimental myocardial infarct size by combined treatment with methylprednisolone sodium succinate and betahistine hydrochloride.
Joyce, LD; Lillehei, RC; Mauer, HG; Smith, JM, 1978
)
0.26
"While corticosteroids in standard neurosurgical dosage do not appear to influence recovery from severe head injury or elevated intracranial pressure (ICP), some reports claim that a much higher dose is effective."( Failure of high-dose steroid therapy to influence intracranial pressure in patients with severe head injury.
Becker, DP; Gudeman, SK; Miller, JD, 1979
)
0.26
" The most likely effect of high dosage steroids is reduction of cerebral oedema."( Use of high dose corticosteroids in patients with inoperable brain tumours.
Glass, P; Goodgold, A; LeBrun, Y; Lieberman, A; Lux, W; Ransohoff, J; Wise, A, 1977
)
0.26
" Topical steroid in the dosage used does not potentiate infection in standard burn wound sepsis models."( Prevention of dermal ischemia after thermal injury.
Eriksson, E; Kucan, JO; Paik, KI; Robson, MC, 1978
)
0.26
" The special feature of this treatment involved a high dosage (96 mg."( New method of treatment of immune infertility.
Davis, P; Harlin, B; Shulman, S, 1978
)
0.26
" in the same dosage in combination with heparin 5000 U/day."( Treatment of acute allograft rejection with high doses of corticosteroids.
Alarcon-Zurita, A; Ladefoged, J, 1976
)
0.26
" Allergic nasal symptoms were disabling in many patients when the oral dosage of corticosteroids was tapered."( Beclomethasone dipropionate aerosol in the treatment of steroid-dependent asthma. A 12-week double-blind study comparing beclomethasone dipropionate and a vehicle aerosol.
Harvey, LL; Kass, I; Nair, SV, 1976
)
0.26
" The significant dialysance of methylprednisolone may require adjustment of dosage in certain clinical situations when hemodialysis is necessary for patients receiving the steroid."( Effect of hemodialysis on methylprednisolone plasma levels.
Letteri, JM; Sherlock, JE, 1977
)
0.26
" Injections of hydrocortisone sodium succinate 10 mg twice daily (but not at the reduced dosage of 5 mg twice daily) or methyprenisolone acetate 5 mg twice daily beginning 30 min before the first challenge and continued to the time of killing reduced the extent and intensity of vasculitis in both the treated groups and showed less alveolar septal thickening in the hydrocortisone treated group and less alveolar consolidation in the methylprednisolone treated group compared to the pulmonary lesions in the rabbits which were sensitized and then subjected to OA aerosol challenges, but received no treatment."( A study of the effects of systemic administration of adrenal glucocorticoids in an experimental model of hypersensitivity pneumonitis.
Dill, J; Ghose, T; Landrigan, P, 1977
)
0.26
" The method was applied to samples of one subject's plasma containing methylprednisolone and endogenous hydrocortisone after oral dosing with multiple doses of methylprednisolone."( Determination of methylprednisolone and hydrocortisone in plasma using high pressure liquid chromatography.
Ayres, JW; Garg, DC; Wagner, JG, 1977
)
0.26
"On the basis of curves illustrating the effects of dosage on experimental animals, it was shown that glucocorticoids inhibit as well as stimulate lecithin synthesis in the fetal lung."( [Experimental investigations in regard to the optimal stimulation of lecithin synthesis in the fetal lung via glucocorticoids (author's transl)].
Gerner, R; Halberstadt, E, 1976
)
0.26
"In a controlled study, a 1-week course of a moderate dosage of corticosteroids given to ragweed-sensitive subjects was associated with a statistically significant decrease in blood eosinophi, levels and tissue esosinophil, but not mast cell, responses to ragweed antibody levels or gross whealing responses to antigen or compound 48/80."( Histologic studies of human skin test responses to ragweed and compound 48/80. II. Effects of corticosteroid therapy.
Slott, RI; Zeweiman, B, 1975
)
0.25
" A persistent fall of the IgG globulins was noted in the first ten days after renal allograft with the immunosuppressive regimen of an initial gramme of methylprednisolon and high dosage of azothioprine."( [Immunglobulin levels after kidney transplantation and during rejection crisis (author's transl)].
Leithner, C; Oppolzer, R; Pinggera, W; Schieler, K; Singer, F; Stummvoll, H; Wolf, A, 1975
)
0.25
" To assess the role of glucocorticoids given in pharmacologic dosage in the early treatment of patients with acute myocardial infarction, serial serum creatine phosphokinase (CPK) were obtained every 1-2 hours in 39 consecutive patients admitted with acute myocardial infarction."( Effect of methylprednisolone on predicted myocardial infarction size in man.
Brandon, J; Gulotta, S; Maley, T; Morrison, J; Pyros, I; Reduto, L; Victa, C,
)
0.13
" On the maximum dosage of desiccated thyroid, the patient developed mild weight loss associated with an increased appetite; there was no other sign or symptom of hyperthyroidism."( Nerve regeneration and thyroid hormone treatment.
McQuarrie, IG, 1975
)
0.25
"Beclomethasone dipropionate, a new corticosteroid for inhalation in the form of a pressurised aerosol with a daily dosage of 300-400/mug, has been given to 130 adult asthmatics."( [Beclomethasonedipropionate for corticoid inhalation therapy in bronchial asthma].
Debelić, M; Virchow, C, 1975
)
0.25
" The increase in renal resistance is generally irreversible (three or four cases) under conditions of high MP dosage (2."( Effect of high doses of methylprednisolone on the isolated, perfused canine kidney.
Banowsky, LH; Braun, WE; Dvorak, KJ; Magnusson, MO; Stowe, NT, 1976
)
0.26
" We conclude that IVGG plus methylprednisolone can be given safely at monthly intervals for a prolonged period but in the dosage administered did not prevent exacerbations in 80% of patients with progressive multiple sclerosis."( Intravenous gamma globulin in progressive MS.
Bansil, S; Bielory, L; Cook, SD; Dowling, PC; Jotkowitz, A; Mehta, PD; Oleske, J; Rohowsky-Kochan, C; Troiano, R, 1992
)
0.28
" Three of five patients developed flare of aGVHD during reduction of the corticosteroid dosage and died with aGVHD and infection."( High-dose methylprednisolone therapy for acute graft-versus-host disease associated with matched unrelated donor bone marrow transplantation.
Coyle, K; Felker, D; Myers, L; Oblon, DJ, 1992
)
0.28
" Psychiatric symptoms usually resolve with dosage reduction or controlled withdrawal of glucocorticoids, but antipsychotic medication may be indicated if symptoms are severe or prolonged."( Adverse psychiatric effects of systemic glucocorticoid therapy.
Klein, JF, 1992
)
0.28
" In this study we examined the dose-response effect and the effect of delayed treatment with MP in an established rat model of retinal photic injury."( Therapeutic parameters of methylprednisolone treatment for retinal photic injury in a rat model.
Lam, TT; Rosner, M; Tso, MO, 1992
)
0.28
" Among the many pharmacological agents presently in use, only prednisone (or methylprednisolone) and cyclosporin require dosage individualisation."( Optimisation of immunosuppressive therapy using pharmacokinetic principles.
Grevel, J, 1992
)
0.28
" This pharmacodynamic model allows flexibility for characterizing any type of steroid dosing regimen and is relevant in describing complex response data for corticosteroid immunosuppressive effects in man."( Pharmacoimmunodynamics of methylprednisolone: trafficking of helper T lymphocytes.
Fisher, LE; Jusko, WJ; Ludwig, EA, 1992
)
0.28
") dosage formulation of methylprednisolone, as the sodium hemisuccinate salt (Solu Medrol, Upjohn) was administered both parenterally and orally (pulse steroid therapy) on separate occasions, to eight elderly (mean 65 y) patients with active rheumatoid arthritis."( High dose oral methylprednisolone in patients with rheumatoid arthritis: pharmacokinetics and clinical response.
Ahern, MJ; Cosh, DG; Hayball, PJ; Roberts-Thomson, PJ; Schultz, DW, 1992
)
0.28
" Regimen B, employing a lower dosage of metoclopramide and steroids and using a more simple schedule of administration should be the preferred treatment."( Antiemetic activity of two different high doses and schedules of metoclopramide in dacarbazine-treated cancer patients.
Basurto, C; Boschetti, E; Bracarda, S; Del Favero, A; Lupattelli, M; Picciafuoco, M; Roila, F; Sassi, M; Tonato, M, 1992
)
0.28
" Antirheumatic therapy therefore requires strict adherence to the prescribed indications and careful selection of the specific drug type and dosage regimen."( [Glucocorticoids].
Hayashi, T, 1992
)
0.28
" Prednisone was used in 17 cases, high dosage of methylprednisolone in 8 (in one case twice), azathioprine in 11 and cyclophosphamide in 10."( Immunosuppressive treatment for juvenile myasthenia gravis.
Badurska, B; Ryniewicz, B; Strugalska, H, 1992
)
0.28
" These results suggest the usefulness of boluses of methylprednisolone in exacerbations of Still's disease, avoiding the disadvantages of high dosage daily corticosteroids."( [Treatment of Still's disease with bolus methylprednisolone. Retrospective study of 7 patients].
Bisagni-Faure, A; Job-Deslandre, C; Menkès, CJ, 1992
)
0.28
" There has been no recurrence of pain after stepwise reduction over one year of the steroid dosage until its discontinuation."( [Giant-cell arteritis limited to the femoral arteries].
Baumann, G; Bogner, J; Haschka, C; Spengel, FA; Stautner-Brückmann, C, 1992
)
0.28
" The patients were randomly assigned to receive either alternating one-month courses of methylprednisolone and then chlorambucil for a total of six months (group 1) or methylprednisolone alone for six months at the same cumulative dosage (group 2)."( Methylprednisolone plus chlorambucil as compared with methylprednisolone alone for the treatment of idiopathic membranous nephropathy. The Italian Idiopathic Membranous Nephropathy Treatment Study Group.
Cesana, B; Passerini, P; Ponticelli, C; Zucchelli, P, 1992
)
0.28
" In this regard a low dosage of methylprednisolone is equally effective as the most often recommended high dose."( Methylprednisolone prophylaxis protects against endotoxin-induced death in rabbits.
Hoiting, BH; Jansen, NJ; van Oeveren, W; Wildevuur, CR, 1991
)
0.28
"A 24-hour intensive intravenous dosing regimen with the glucocorticoid steroid methylprednisolone has recently been shown to be effective in enhancing neurological recovery in spinal cord-injured patients when initiated within 8 hours after injury."( The neuroprotective pharmacology of methylprednisolone.
Hall, ED, 1992
)
0.28
" We conducted a randomized, double-blinded, 7 arm clinical trial to: (1) identify the presence of a dose-response for complete protection from emesis, and (2) compare batanopride with a standard antiemetic, methylprednisolone if a dose-response was found not to exist."( A randomized, double-blinded study comparing six doses of batanopride (BMY-25801) with methylprednisolone in patients receiving moderately emetogenic chemotherapy.
Findlay, B; Kaizer, L; Laberge, F; Latreille, J; Lofters, WS; Osoba, D; Pater, J; Rusthoven, J; Warr, D; Wilson, K, 1991
)
0.28
" None of the previous studies with the usual dosage of steroids or ACTH has proven that this therapy is beneficial."( [Effect of prednisolone on the course of optic neuritis. Results of a double-blind study].
Aulhorn, E; Diener, HC; Minder, C; Pfluger, D; Trauzettel-Klosinski, S, 1991
)
0.28
" All had failed previous attempts to reduce their dosage of steroids."( Use of troleandomycin as a steroid-sparing agent in both asthma and chronic obstructive pulmonary disease.
Cash, M; Shivaram, U, 1991
)
0.28
" However, methylprednisolone should be administered on the basis of ideal body weight, and the dosing interval should be potentially lengthened because of decreased methylprednisolone clearance in obesity."( Pharmacokinetics and pharmacodynamics of methylprednisolone in obesity.
Camara, DS; Dunn, TE; Jusko, WJ; Ludwig, EA; Slaughter, RL, 1991
)
0.28
" Baseline daily steroid dosage requirements decreased from 15."( Benefits and complications of troleandomycin (TAO) in young children with steroid-dependent asthma.
Flotte, TR; Loughlin, GM, 1991
)
0.28
" Although the combination of CSA and MP in this dosing schedule was active in preventing acute GVHD, nephrotoxicity remained a problem, and outcome was limited by the inability to achieve the target CSA trough concentration in a substantial proportion of patients."( Cyclosporine and methylprednisolone after allogeneic marrow transplantation: association between low cyclosporine concentration and risk of acute graft-versus-host disease.
Bloom, EJ; Przepiorka, D; Rosenfeld, CS; Schwinghammer, TL; Shadduck, RK; Shapiro, S; Venkataramanan, R, 1991
)
0.28
" In vivo studies included iv and oral dosing of 10 or 50 mg/kg of MP in both forms, while liver perfusion involved initial perfusate concentrations of 5 and 25 micrograms/mL of either compound."( Disposition of methylprednisolone and its sodium succinate prodrug in vivo and in perfused liver of rats: nonlinear and sequential first-pass elimination.
Jusko, WJ; Kong, AN, 1991
)
0.28
" bolus doses are required to achieve this effect, but the biphasic dose-response curve limits the dose size to approximately 30 mg/kg."( Inhibition of lipid peroxidation in CNS trauma.
Hall, ED, 1991
)
0.28
" The corticosteroid dosage administered at the time CyA therapy was initiated was variable and was continued following CyA therapy."( Long-term cyclosporine A treatment of steroid-resistant and steroid-dependent nephrotic syndrome.
Cohen, AH; Fine, RN; Kamil, ES; Melocoton, TL, 1991
)
0.28
" The method of a local step-by-step intrapulmonary administration of GCS made it possible to increase the treatment efficacy by bringing down the GCS dosage required to maintain++ remission and excluding complications caused during intrapulmonary injection of drugs to patients with corticoid dependent bronchial asthma."( [Treatment of patients with corticoid-dependent bronchial asthma by step-by-step intra-pulmonary administration of glucocorticoids].
Nikitin, AV; Omeliusik, VV, 1990
)
0.28
" Thus, time of initiation, dosage and duration of treatment may differentially affect the course of EAE."( Development of experimental allergic encephalomyelitis during steroid administration. Outcome of neurological immune-mediated disorders under immunosuppressive therapy.
Abramsky, O; Brenner, T; Mizrachi-Kol, R; Steiner, I, 1991
)
0.28
"9 years (min 33, max 93) were given intranasal sCT at the dosage regimen of 200 IU/day/6 months."( [Use of salmon calcitonin nasal spray in the prevention of corticosteroid-induced osteoporosis in bullous diseases].
Cappio, F; Caputo, R; Colombo, MD, 1990
)
0.28
"A study of the dose-response effects of naloxone and methylprednisolone after rat ventral spinal cord injury is presented."( Dose-dependent effects of naloxone and methylprednisolone in the ventral compression model of spinal cord injury.
Beal, JA; Benzel, EC; Hoffpauir, GM; Kesterson, L; Lancon, JA; Thomas, MM, 1990
)
0.28
" Dose-response and time-course considerations make it unlikely that these effects are mediated via the glucocorticoid receptor, a concept further supported by the ability of sex steroids to work similar effects."( Steroids decrease granulocyte membrane fluidity, while phorbol ester increases membrane fluidity. Studies using electron paramagnetic resonance.
Hammerschmidt, DE; Jacob, HS; Knabe, AC; Lamche, HR; Silberstein, PT; Thomas, DD, 1990
)
0.28
" One patient receiving methylprednisolone had a relapse of symptoms when the dosage was tapered, but symptoms again remitted when the dosage was increased to 32 mg/d."( The beneficial effect of methylprednisolone in acute vestibular vertigo.
Adour, KK; Ariyasu, L; Byl, FM; Sprague, MS, 1990
)
0.28
" Height standard deviation scores positively improved in males but not in females, as prednisone dosage was decreased."( Growth in children following kidney transplantation.
Capen, RC; Carter, RL; Fennell, RS; Howard, RJ; Iravani, A; Moles, M; Pfaff, W; Richard, GA; Walker, RD, 1990
)
0.28
" This technique can be used to individualize glucocorticoid dosing regimens."( Monitoring glucocorticoid therapy: a pharmacokinetic approach.
Ball, BD; Bartoszek, M; Brenner, AM; Hill, MR; Szefler, SJ, 1990
)
0.28
" The mechanism of action and therapeutic usefulness of high dosage steroids in tumoral obstructive pathology is discussed."( [The value of high dose steroid therapy in obstructive uropathy caused by a tumor].
Bello, I; Díaz-González, R; Gutierres-Millet, V; Hernández, E; Moreno, F; Rodicio, JL; Rodríguez, A,
)
0.13
" The regimen consisted of dosing patients with two applications of the two drugs every day for 4 weeks."( [Alclometasone dipropionate (Legederm) for the treatment of steroid-sensitive dermatoses in the elderly].
Criante, P; Giacchetti, A; Mambelli, V; Marchesi, E; Morresi, A; Mozzicafreddo, G; Simonacci, M; Sisti, S, 1990
)
0.28
" We conclude that methylprednisolone, when administered at the dosage used in previous studies of adult humans and animals, does not affect the response of the pulmonary vascular bed to hypoxia in newborn lambs."( The effect of methylprednisolone on hypoxic pulmonary vasoconstriction in the newborn late-gestation lamb.
Alpan, G; Clyman, RI, 1990
)
0.28
" Different from the regimen for immunosuppressive treatment after organ transplantation, the dosage of cyclosporine was set not according to whole-blood levels but individualized to variations in serum transaminases."( [Successful treatment of primary biliary cirrhosis with cyclosporin].
Lie, TS; Preissinger, H, 1990
)
0.28
" Our results show that MP at the dosage of 30 mg/kg does not affect complement-mediated granulocytopenia in any important way."( Complement activated leucopenia during hemodialysis: effect of pulse methyl-prednisolone.
Catalano, C; Enia, G; Maggiore, Q; Misefari, V; Mundo, N; Salnitro, F; Tetta, C, 1990
)
0.28
" ALG dosage modifications were made in order to maintain peripheral CD3+ cells between 10 and 20%."( Antilymphoblast globulin, cyclosporine, and steroids in cadaveric renal transplantation.
Alsina, J; Andres, E; Castelao, AM; Diaz, C; Gil-Vernet, S; Griño, JM; Mestre, M; Sabate, I; Sabater, R; Seron, D, 1990
)
0.28
" A new protocol avoids these adverse effects by a rapid reduction in the dose of MP to alternating administrations and low TAO dosage (250 mg)."( [Experiences with a combination therapy of methylprednisolone and troleandomycin in severe bronchial asthma requiring high-dose corticoids].
Haack, D; Hauser, F; Menz, G; Rothe, T; Schmitt, M; Schmitz, M; Virchow, C, 1990
)
0.28
" Anti-rejection therapy consisted of methylprednisolone 10 mg/kg/day iv for 5 days and an increase of oral cyclosporine dosage to 25 mg/kg/day."( Percutaneous fine needle aspiration biopsy of canine pancreas allograft provides diagnosis of treatable rejection.
Allen, RD; Allwright, SJ; Deane, SA; Earl, MJ; Ekberg, H; Greenberg, ML; Hawthorne, WJ; Little, JM; Stewart, GJ; Williamson, P, 1989
)
0.28
" The toxicity of high dose IVIG was minimal, but the cost is high, search for an optimal dosage is warranted."( Improvement of histological and immunological change in steroid and immunosuppressive drug-resistant lupus nephritis by high-dose intravenous gamma globulin.
Chiang, H; Hsu, HC; Lin, CY, 1989
)
0.28
" Research work on high dosage cyclophosphamide and total lymphoid irradiation is still too limited."( Multiple sclerosis. II. A critical assessment of immunotherapy.
Bergamini, L; Durelli, L,
)
0.13
" She went into hematological remission 6 weeks following 40 mg/day treatment with prednisolone, but the anemia relapsed frequently when the dosage was lessened."( [Chronic T-cell lymphoproliferative disorder associated with pure red cell aplasia].
Akihama, T; Chubachi, A; Endo, Y; Kuwayama, A; Miura, A; Yoshida, K, 1989
)
0.28
" Moreover, they seem to correlate with the dosage applied."( Psychiatric disorders associated with corticosteroid therapy.
Kostić, VS; Lević, Z, 1989
)
0.28
" Reduced dosage of steroids is feasible and safe, and a decrease in steroid-related side effects can be achieved without jeopardizing the graft."( Pulsed steroids for treatment of cardiac rejection after transplantation. What dosage is necessary?
Haverich, A; Heublein, B; Wahlers, T, 1989
)
0.28
" The steroid dosage given was significantly lower in the second group."( Low-dose cyclosporin A therapy in cadaver renal transplantation in children.
Bonzel, KE; Gretz, N; Mehls, O; Möhring, K; Müller-Wiefel, DE; Pomer, S; Ruder, H; Schaefer, F; Schärer, K; Strehlau, J, 1989
)
0.28
" All patients had previously received the same chemotherapy with metoclopramide in conventional dosage and experienced severe emesis."( Methylprednisolone and chlorpromazine in patients receiving cancer chemotherapy: a prospective non-randomized study.
Ben-Baruch, N; Biran, S; Brufman, G; Gera, C; Gez, E; Kaufman, B; Sulkes, A; Yitzhaki, N, 1989
)
0.28
" Therapeutic lessons learned from this experience involve (1) selection of monoclonal antibodies over methylprednisolone for rejection control, (2) return of drained bile to the gastrointestinal tract, and (3) careful cyclosporine level and dosage monitoring."( Significance of asymptomatic biliary tract disease in heart transplant recipients.
Attum, AA; Barbie, RN; DeWeese, BM; Girardet, RE; Lansing, AM; Lusk, RA; Masri, ZH; Rosenbloom, P; Yared, SF,
)
0.13
" In a prospective randomized multicenter trial, 123 patients undergoing acute rejection of cadaveric renal transplants were treated either with OKT3 daily for a mean of 14 days, with concomitant lowering of the dosage of other immunosuppressive drugs (63 patients), or with conventional high-dose steroids (60 patients)."( A randomized clinical trial of OKT3 monoclonal antibody for acute rejection of cadaveric renal transplants.
, 1985
)
0.27
" Dosing with the free alcohol or ester produces identical disposition curves for methylprednisolone."( Methylprednisolone disposition in rabbits. Analysis, prodrug conversion, reversible metabolism, and comparison with man.
Ebling, WF; Jusko, WJ; Szefler, SJ,
)
0.13
" The response was characterized by dose-response and kinetics investigations."( The proliferative T-lymphocyte response to streptokinase.
Bruserud, O; Jørgensen, PF; Sollid, L, 1986
)
0.27
" One may hope that this dosage of mechlorethamine will not be gonadotoxic."( [Value of chlormethine in children with corticoid-dependent or partially corticoid-sensitive nephrosis, in steroid poisoning].
Loirat, C; Macher, MA; Maisin, A; Mathieu, H; Pillion, G,
)
0.13
" This demonstrated that at the dosage levels used in this study, MPSS was an effective antioxidant."( Iron-induced lipid peroxidation in spinal cord: protection with mannitol and methylprednisolone.
Anderson, DK; Means, ED, 1985
)
0.27
" The ability of intensive dosing with the glucocorticoid steroid methylprednisolone to beneficially affect post-traumatic ischemia and to promote chronic neurologic recovery in spinal cord injured animals has been correlated not with its glucocorticoid activity, but rather with the ability to inhibit post-traumatic spinal lipid peroxidation."( New pharmacological treatment of acute spinal cord trauma.
Braughler, JM; Hall, ED; McCall, JM, 1988
)
0.27
" Contrary to the majority of similar reported cases, no decompression operation was performed, because the neurological signs had not progressed and the clinical findings in fact quickly regressed once the steroid dosage had been reduced and they showed a clear dependence on the amount of steroid administered."( [Epidural lipomatosis as a complication of a long-term glucocorticoid therapy].
Bischoff, C, 1988
)
0.27
" The corticosteroid dosage and the serum testosterone level were inversely related (r = -0."( Reduction of serum testosterone levels during chronic glucocorticoid therapy.
Chipps, BE; MacAdams, MR; White, RH, 1986
)
0.27
" The same protective effect was obtained with lower cyclophosphamide dosage (15 mg/kg on day 0 and then 2 mg/kg per day)."( Effect of methylprednisolone and cyclophosphamide in mercury-induced autoimmune glomerulonephritis.
Bariety, J; Belair, MF; Druet, P; Mandet, C; Pasquier, R; Pelletier, L; Vial, MC, 1987
)
0.27
" In its classic form the disease is monitored by adjusting the steroid dosage with the erythrocyte sed rate (ESR)."( Giant cell arteritis.
Ishak, AW; Mitchell, PC; Persak, GC; Warwick, S, 1988
)
0.27
" No dose-response relationship was observed."( Methylprednisolone for the control of CMF-induced emesis.
Bruzzi, P; Campora, E; Chiara, S; Lionetto, R; Rosso, R, 1987
)
0.27
" In group II, cyclosporine was started only after the procedure at a lower dosage and was complemented by azathioprine, which was used for the first postoperative week."( Cardiac transplantation: improved quality of survival with a modified immunosuppressive protocol.
Bahnson, HT; Griffith, BP; Hardesty, RL; Kormos, RL; Thompson, ME; Trento, A, 1987
)
0.27
"8%) the oral prednisolone dosage was increased, from a mean of 10."( [Management of rejection following heart transplantation using oral steroid medication].
Fieguth, HJ; Frimpong, K; Haverich, A; Herrmann, G; Jurmann, M; Kemnitz, J; Schäfers, HJ; Wahlers, T, 1987
)
0.27
" dose, while initially supportive, lost its effect during the later stages of the experiment, indicating a sharp biphasic dose-response relationship for the effect of methylprednisolone on caudate blood flow after subarachnoid hemorrhage."( Attenuation of progressive brain hypoperfusion following experimental subarachnoid hemorrhage by large intravenous doses of methylprednisolone.
Hall, ED; Travis, MA, 1988
)
0.27
" Careful tailoring of dosage is important to avoid adrenal atrophy and signs of adrenocortical hypofunction."( Corticosteroids for rheumatic disease. 1. Physiology, pharmacology, and therapeutic strategies.
Jamieson, T, 1986
)
0.27
" Each patient improved considerably and in each case the dosage of conventional immunosuppression was reduced."( PUVA therapy for drug-resistant graft-versus-host disease.
Atkinson, K; Biggs, J; Ryman, W; Weller, P, 1986
)
0.27
" Since its inception, cyclosporine loading dosage has been reduced between 20 to 50 percent."( Therapeutic immunosuppression in cardiac transplantation.
O'Connell, JB; Robinson, JA,
)
0.13
"22 mg/kg by the fourth month being also administered at the same dosage during the fifth and the sixth month."( Cyclosporin A in nephrotic syndrome of childhood--a 14 month experience.
Capodicasa, G; De Santo, NG; Giordano, C; Nuzzi, F,
)
0.13
" A further trial is necessary to determine the optimal dosage and scheduling of the available agents."( [Randomized crossover trial of the antiemetic effects obtained with metoclopramide and droperidol versus those obtained with metoclopramide, droperidol and methylprednisolone in patients receiving cis-platinum chemotherapy].
Fujii, M; Kiura, K; Okabe, K; Tamai, M; Toki, H, 1986
)
0.27
" These effects were mitigated at a lower dosage especially by the addition of cefoxitin and deoxycortone."( An attempt to develop a model to study the effects of intrathecal steroids.
Rosen, M; Swai, EA, 1986
)
0.27
" In vitro, the dose-response curves to MP were examined in pretransplant PHA cultures."( The impact of high lymphocyte sensitivity to glucocorticoids on kidney graft survival in patients treated with azathioprine and cyclosporine.
Ladefoged, J; Langhoff, E, 1987
)
0.27
"We report a young woman with systemic lupus erythematosus complicated by pseudotumor cerebri which resolved with high dosage corticosteroid therapy."( Dural sinus thrombosis: a mechanism for pseudotumor cerebri in systemic lupus erythematosus.
Goodwin, JA; Levinson, DJ; Parnass, SM; Patel, DV; Reinhard, JD, 1987
)
0.27
" It may lead to erroneous conclusions concerning patient compliance, unwarranted increases in salicylate dosage and resultant toxicity, and delay of appropriate therapeutic maneuvers."( Transient fall in serum salicylate levels following intraarticular injection of steroid in patients with rheumatoid arthritis.
Baer, PA; Ikeman, RL; Shore, A, 1987
)
0.27
" The intensive 48-hour dosing regimen was designed to maintain therapeutic tissue levels of MP and consisted of an initial 30 mg/kg intravenous bolus of MP; 2 and 6 hours later additional 15 mg/kg MP doses were administered by intravenous bolus."( Evaluation of an intensive methylprednisolone sodium succinate dosing regimen in experimental spinal cord injury.
Anderson, DK; Braughler, JM; Hall, ED; Means, ED; Waters, TR, 1987
)
0.27
" Serum methylprednisolone levels rose rapidly, giving a dose-response curve similar to that after an intramuscular injection in humans."( The systemic and local effects of an intramedullary injection of methylprednisolone acetate in growing rabbits.
Aronson, DD; Colville, MR; Crissman, JD; Prcevski, P,
)
0.13
" The initial dosage was maintained for 1 or 2 weeks in each group, tailing off with a period of several weeks of oral prednisolone."( High-dose intravenous corticosteroids in the treatment of multiple sclerosis.
Hamaguchi, K; Ohno, R; Sowa, K; Tanaka, H; Watanabe, Y, 1987
)
0.27
"9% NaCl, at the rate of 10 cc/min, for a dosage of 30 mg/kg."( The morphological changes of the pancreas in hypovolemic shock and the effect of pretreatment with steroids.
Barzilai, A; Dreiling, DA; Medina, JA; Ryback, BJ; Toth, L, 1987
)
0.27
" It is effective in many disorders, and these are documented, together with the dosage ranges which can be used."( Stosstherapy: a fresh look at some principles of therapy--especially chemotherapy.
Keipert, JA, 1986
)
0.27
" Applying the same dosage we now investigated whether there is a similar effect of a short-term application of prednisolone in mesenchymal and parenchymal organs of young adult and presenile rats of the same strain (Chbb: THOM/SPF) analyzing the physiological cell regeneration (DNA concentration) as well as functional parameters of the glycosaminoglycan metabolism (e."( [Age-related changes in cell content (DNA) and glycosaminoglycan-degrading enzymes (beta-glucuronidase, beta-N-acetylglucosaminidase of connective tissue and parenchymal organs of the rat caused by 6-methylprednisolone (enzyme induction, adaptation, accel
Lindner, J; Nüssgen, A; Schmiegelow, P; Schönrock, P,
)
0.13
"The deleterious effects of corticosteroids (CS) on bone are well known, but probably differ depending on duration and dosage of CS therapy."( Bone metabolism during methylprednisolone pulse therapy in rheumatoid arthritis.
Bijlsma, JW; Duursma, SA; Huber-Bruning, O, 1986
)
0.27
" Subsequently, patients received weekly injections of MP on a reducing dosage regime to a maintenance dose of 125 mg IV weekly."( Methylprednisolone pulse therapy in severe anterior uveitis.
Wakefield, D, 1985
)
0.27
" Recipients were also given pulse doses of methylprednisolone (100 mg/kg) and azathioprine (3 mg/kg) once a week, the dosage schedule being gradually reduced and azathioprine discontinued as recipients became long-term survivors (greater than 60 days)."( Orthotopic cardiac xenografting in the newborn goat.
Bailey, LL; Jang, J; Johnson, W; Jolley, WB, 1985
)
0.27
" Methylprednisolone seemed to be effective in the cases administrated in the dosage of 10, 15 mg/kg/day."( [A study of the optimum dose of a glucocorticoid, methylprednisolone sodium succinate, before and after neurosurgical major operations--relationship between beta-glucuronidase level and post operative brain edema].
Niizuma, H; Shirane, R; Suzuki, J, 1985
)
0.27
" In the face of increased levels, the dosage is reduced in order to prevent CsA-induced nephrotoxicity."( Effect of renal allograft dysfunction upon cyclosporine trough levels in host blood.
Anaise, D; Arnold, AN; Rapaport, FT; Waltzer, WC; Weinstein, SW, 1985
)
0.27
" Ten animals received the same dosage of methylprednisolone beginning 2 h after the start of endotoxin infusion."( Prophylactic and delayed treatment with high-dose methylprednisolone in a porcine model of early ARDS induced by endotoxaemia.
Borg, T; Gerdin, B; Modig, J, 1985
)
0.27
"Of nineteen patients with RPCGN who responded promptly to initial treatment with PMP or PX, and who were subsequently maintained on oral immunosuppression with prednisolone (reducing dosage from 30mg/day) and azathioprine/cyclophosphamide (1-3 mg/kg/day), five showed progressive loss of renal function within one year of responding to treatment."( Follow-up prednisolone dosage in rapidly progressive crescentic glomerulonephritis successfully treated with pulse methylprednisolone or plasma exchange.
Bone, JM; Stevens, ME, 1985
)
0.27
" They contend that in view of their poor clinical record, it is unlikely that increasing the steroid dose or changing the dosing regimen will improve clinical efficacy, since steroids have already failed at what may be considered huge doses by glucocorticoid standards."( Current application of "high-dose" steroid therapy for CNS injury. A pharmacological perspective.
Braughler, JM; Hall, ED, 1985
)
0.27
"The effect of methylprednisolone (MP) of high dosage on not only surfactant lipids but also other phospholipid components of adult rat lungs was studied."( Alteration in phospholipid content of lung of adult rats treated with methylprednisolone of high doses.
Ichikawa, I; Kikkawa, Y, 1985
)
0.27
" The side effects of antihistamines are minor, and the dosage of corticosteroid used and length of time it is given are small enough to avoid major side effects."( Chronic urticaria. Possible causes, suggested treatment alternatives.
Kaplan, AP, 1983
)
0.27
" Azathioprine or corticosteroid dosage intake on the day of the test did not influence the level of graft recipient NKCA."( Decrease in natural killer cell activity in kidney allograft recipients.
Fauconnier, B; Hegaret, A; Moreau, JF; Soulillou, JP; Ythier, A,
)
0.13
" After pentobarbital anesthesia, intra-arterial pressure and dose-response curves to AII were determined, before and after SQ14225 (d-3-mercapto-2-methylpropranoyl-l-proline) (1 mg/kg iv)."( Effect of converting enzyme inhibition on glucocorticoid hypertension in the rat.
Elijovich, F; Krakoff, LR, 1980
)
0.26
" The data suggest that, in order to be of therapeutic value in the treatment of acute spinal cord trauma, early intervention with high-dose intravenous methylprednisolone (30 to 40 mg/kg) is necessary, followed by intravenous maintenance dosing of 15 to 20 mg/kg every 2 to 3 hours."( Correlation of methylprednisolone levels in cat spinal cord with its effects on (Na+ + K+)-ATPase, lipid peroxidation, and alpha motor neuron function.
Braughler, JM; Hall, ED, 1982
)
0.26
" We conclude from these results (1) that previously the dosage of CyA administered at this centre was probably too high, and (2) early adjustment of dose levels on the basis of blood concentrations and with low-dose prednisone cover appears to be safe and effective, but requires further verification."( Cyclosporin A used alone or in combination with low-dose steroids in cadaveric renal transplantation.
Brünisholz, M; Brunner, F; Follath, F; Harder, F; Landmann, J; Lörtscher, R; Mihatsch, M; Thiel, G; Wenk, M, 1983
)
0.27
" This randomized double-blind study describes the effect of various dosing regimens of naloxone and MPSS upon hemodynamics and plasma catecholamines in patients with septic shock (n = 57)."( Naloxone and methylprednisolone sodium succinate enhance sympathomedullary discharge in patients with septic shock.
Hughes, GS, 1984
)
0.27
" In fact, over a certain dosage range of MP an increased number of suppressor cells appeared to be generated."( Opposing effects of methylprednisolone on in vitro alloantigen-induced cytotoxic and suppressor lymphocytes in man.
Hirschberg, H; Hirschberg, T; Pfeffer, P; Randazzo, B, 1980
)
0.26
" All patients were evaluated from the standpoint of clinical response to thymectomy, and the number and dosage of anti-myasthenic drugs required after operation."( Cervical thymectomy in the treatment of myasthenia gravis.
Donnelly, RJ; Fabri, B; Florence, AM; Hayward, M; Laquaglia, MP, 1984
)
0.27
" Metoclopramide and methylprednisolone, at the dosage and schedule used, were well tolerated and moderately active in preventing nausea and vomiting induced by cis-platin; their use in combination could further improve these results."( Comparison of methylprednisolone and metoclopramide in the prophylactic treatment of cis-platin-induced nausea and vomiting.
Bertetto, O; Calciati, A; Ciuffreda, L; Clerico, M; Donadio, M; Ferrati, P; Giaccone, G; Musella, R, 1984
)
0.27
" The optimal routes of administration, dosage, dosage interval, and other factors are unknown."( Intermediate-dose intramuscular methylprednisolone acetate in the treatment of rheumatic disease.
Kovarsky, J, 1983
)
0.27
" CT measurements on the first day without medication, continued with an initial dosage of 1000 mg Urbason, followed by 3 X 40 mg daily during the second to the fifth day, and finally on the seventh day after the steroid was stopped."( [Influence of alpha-methyl-prednisolone on perifocal brain edema--CT observations in ten patients with circumscribed supratentorial brain tumours].
Lerch, KD; von Wild, K, 1983
)
0.27
" The other group received the same dosage of ADR but also MP 20 mg/kg subcutaneously 3 hr before, with ADR and 3 hr after ADR."( Prevention of adriamycin (ADR)-induced cardiotoxicity in rats using methylprednisolone (MP).
Dasmahapatra, KS; Karakousis, CP; Perez-Brett, R; Rao, U; Vezeridis, M, 1984
)
0.27
"By measuring airway resistance (Raw) as an index of response, dose-response curves to aerosolized carbachol were constructed in 10 patients suffering from grass pollen allergy."( Seasonal increase of carbachol airway responsiveness in patients allergic to grass pollen. Reversal by corticosteroids.
Badier, M; Orehek, J; Sotomayor, H; Vervloet, D, 1984
)
0.27
" Cutting down the dosage to half resulted in an improvement of the one-year patient survival by 16 per cent (from 63 to 79 per cent and the one-year graft survival by 10 percent (from 46 to 56 per cent)."( Effect on patient and graft survival of reducing the methylprednisolone dose after renal transplantation.
Kuhlbäck, B, 1981
)
0.26
"Steroids are commonly used in the treatment of acute spinal cord injury patients although a review of the literature fails to define a consistent regimen for administration with regard to optimal preparation or dosage or schedule."( A comparative study of steroid therapy in acute experimental spinal cord injury.
Green, BA; Kahn, T; Klose, KJ, 1980
)
0.26
" Oral prednisolone in the dosage described is as effective as about 10 times that dose of intravenous methylprednisolone; it is much cheaper and is viewed as less unpleasant by patients."( Comparison of high-dose intravenous methylprednisolone with low-dose oral prednisolone in acute renal allograft rejection in children.
Bewick, M; Chantler, C; Haycock, G; Orta-Sibu, N, 1982
)
0.26
" The use of high glucocorticoid doses, early therapy initiation, and rigorous maintenance dosing is discussed."( Lactate and pyruvate metabolism in injured cat spinal cord before and after a single large intravenous dose of methylprednisolone.
Braughler, JM; Hall, ED, 1983
)
0.27
" The administration of pharmacological doses of glucocorticoids increased the dosage of 1,25(OH)2D3 needed to maintain a normal serum calcium level 7- to 10-fold in 2 patients whose renal grafts failed to function, but there was no decrease in sensitivity to 1,25(OH)2D3 in 1 patient whose renal graft functioned normally."( Interactions between treatment with 1,25(OH)2D3 and glucocorticoids in uremic patients after kidney transplantation.
Coburn, JW; Siemsen, AW; Sugihara, JG; Wong, EG, 1980
)
0.26
" The findings suggest that the development of steroid diabetes can serve as a warning signal for excessive dosage of corticosteroids, and help to identify patients that are particularly sensitive to immunosuppressive therapy with large doses of steroids."( Steroid diabetes--a sign of overtreatment with steroids in the renal graft recipient?
Groth, CG; Gunnarsson, R; Lundgren, G; Magnusson, G; Ost, L, 1980
)
0.26
" It seems that a rather moderate dosage of methylprednisolone allows us to prolong and repeat the courses according to individual needs, and this may be the main reason for the significantly improved graft function at one year."( Steroids and rejection treatment in the Gothenburg transplant programme.
Brynger, H; Gelin, LE, 1980
)
0.26
"On the basis of 15-years' experience with the allogeneic transplantation of the kidney, the authors present recommendations, concerning the dosage of azathioprine and prednisone (methylprednisolone) during the schematic immunosuppression."( Schematic and controlled immunosupression after renal allotransplantation.
Jirka, J; Kaslík, J; Kaslíková, J; Kocandrle, V, 1981
)
0.26
" For all dosage strengths of methylprednisolone sodium succinate studied, these data indicate that solutions can be made stable for at least 12 hours by selecting the appropriate volume of diluent."( Stability of methylprednisolone sodium succinate in small volumes of 5% dextrose and 0.9% sodium chloride injections.
Nail, SL; Puchala, AH; Townsend, RJ, 1981
)
0.26
" The dose-response curve for prednisolone plateaued at high doses."( Influence of prednisolone on ethanol-induced gastric injury in the rat.
Derelanko, MJ; Long, JF, 1982
)
0.26
" The results reported in this paper have shown that glucocorticoid dosing produces numerous effects on motor neuron excitability and impulse generation and conduction."( Glucocorticoid effects on the electrical properties of spinal motor neurons.
Hall, ED, 1982
)
0.26
" The limited variability of the pharmacokinetics of methylprednisolone suggests that tissue sensitivity may be a more important indicator of drug dosage needs in nephrotic syndrome."( Disposition of pulse dose methylprednisolone in adult and paediatric patients with the nephrotic syndrome.
Appiani, AC; Assael, BM; Banfi, G; Edefonti, A; Jusko, WJ, 1982
)
0.26
" By 12 hours, plasma zinc concentrations had decreased below control levels and the extent and duration of the depression depended on the dosage of the steroid administered."( Influence of synthetic corticosteroids on plasma zinc and copper levels in humans.
Czerwinski, AW; Lindeman, RD; Yunice, AA,
)
0.13
" The recommended dosage of Solu-Medrol would appear to be 20 mg and not less."( A 3 1/2-year experience with double-lumen implants in breast surgery.
Braun, H; Ellenberg, AH, 1980
)
0.26
" Methylprednisolone exhibited a dose-response effect in reducing LDH leakage in cultures, which were subsequently deprived of oxygen and glucose for 4 hr."( Reduction of cell injury in hypoxic cultures of rat myocardial cells by methylprednisolone.
Acosta, D; Li, CP; Puckett, M, 1980
)
0.26
" However, dosage of both methylprednisolone and dexamethasone could be increased to a level at which damage by oxygen was reduced to 50% of nuclei compared with 90% damaged in cells unprotected by steroids."( Protective effect of steroids on cultured cells damaged by high concentrations of oxygen.
Hulands, GH; Sturrock, JE, 1980
)
0.26
" Using the cat spinal cord compression model (180g x 5 min at L3; Na pentobarbitol anesthesia), we examined whether 30 min postinjury dosing with MP (30 mg/kg IV) could attenuate spinal tissue eicosanoid levels measured by enzyme immunoassay at 1 h (Experiment 1)."( Lack of effect of postinjury treatment with methylprednisolone or tirilazad mesylate on the increase in eicosanoid levels in the acutely injured cat spinal cord.
Hall, ED; Sun, FF; Taylor, BM; Yonkers, PA, 1995
)
0.29
" The initial heavy proteinuria promptly decreased after the prednisolone dosage was increased and disappeared 4 weeks later."( Minimal-change nephrotic syndrome associated with systemic lupus erythematosus.
Haramoto, T; Makino, H; Ogura, T; Ota, Z; Shikata, K, 1995
)
0.29
" These results show: 1) possible synergism exists between methylprednisolone and bFGF, such that combinations of these drugs significantly enhance neurological recovery, 2) bFGF exhibits a dose-response effect in function but not in capillary density, and 3) heated, inactivated bFGF is not therapeutically effective."( Synergistic effect of basic fibroblast growth factor and methylprednisolone on neurological function after experimental spinal cord injury.
Achanta, K; Baffour, R; Berman, J; Friedmann, P; Garb, JL; Kaufman, J; Rhee, S, 1995
)
0.29
" Cyclosporine in a dosage of 10 mg/kg per day can effectively suppress the immune response after transplantation of vascularized tracheal allografts."( Experimental tracheal allograft revascularization and transplantation.
Delaere, PR; Feenstra, L; Hermans, R; Liu, ZY; Sciot, R, 1995
)
0.29
" Corticosteroid dosage was then reduced according to clinical improvement."( Long-term corticosteroid and dipyridamole treatment of membranoproliferative glomerulonephritis type I in children.
Matsutani, H; Niimura, F; Takeda, A, 1995
)
0.29
"A dose of CBG to yield 95% binding with 1000 ng/ml of prednisolone in vitro in rat plasma or saline was administered before dosing 2 mg/kg of prednisolone hemisuccinate or methylprednisolone intravenously."( Effect of corticosteroid binding globulin on the pharmacokinetics of prednisolone in rats.
Almon, RR; Jusko, WJ; Ko, HC, 1995
)
0.29
" The absolute bioavailability of the tablet product was 82%, which is in agreement with published data for other oral dosage forms of methylprednisolone."( Absolute bioavailability of a new high dose methylprednisolone tablet formulation.
Groenewoud, G; Hundt, HK; Luus, HG; Müller, FO; Schall, R, 1994
)
0.29
"The effect of a liposomal formulation of methylprednisolone (MPL) on the inhibition of lymphocyte proliferation in spleen cells was investigated following IV dosing in rats."( Inhibition of rat splenocyte proliferation with methylprednisolone: in vivo effect of liposomal formulation.
Jusko, WJ; Mishina, EV, 1994
)
0.29
"To investigate the efficacy of intravenous methylprednisolone pulse therapy on Graves' ophthalmopathy (GO), fifteen patients with severe GO were treated with large dose intravenous methylprednisolone (at a daily dosage of 1 g for 3 successive days)."( Intravenous methylprednisolone pulse therapy for Graves' ophthalmopathy.
Hiromatsu, Y; Kaise, N; Kojima, K; Kuroki, T; Nishida, H; Nishimura, H; Nonaka, K; Sato, M; Tanaka, K, 1993
)
0.29
"Liposomal methylprednisolone (L-MPL) applied in monotherapy prolonged cardiac allograft survival in rats in comparison with the same dosage regimen of drug in solution (Solu-Medrol)."( Effect of liposomal methylprednisolone on heart allograft survival and immune function in rats.
Binder, J; Jusko, WJ; Kupiec-Weglinski, JW; Mishina, EV, 1994
)
0.29
" Initial methylprednisolone (MP) treatment helps to implement task, optimal dosage is, however, a yet unresolved problem."( [The importance of administration of a series of methylprednisolone minipulses in the treatment of active rheumatoid arthritis].
Hrncír, Z, 1994
)
0.29
" Dose-response evaluation of MPSS determined more effective doses."( Modeling of acute spinal cord injury in the rat: neuroprotection and enhanced recovery with methylprednisolone, U-74006F and YM-14673.
Beattie, MS; Behrmann, DL; Bresnahan, JC, 1994
)
0.29
" These findings suggest a more individualized dosing method may be necessary to optimize the immunosuppressive effect of glucocorticoids and minimize clinical toxicity."( Cortisol pharmacodynamic response to long-term methylprednisolone in renal transplant recipients.
Reed, K; Tornatore, KM; Venuto, RC; Walshe, JJ,
)
0.13
"8) and less total dosage (34 +/- 16 mg compared with 70 +/- 34 mg; mean difference, -36 mg; CI, -60."( Does aminophylline benefit adults admitted to the hospital for an acute exacerbation of asthma?
Aull, L; Harman, E; Hendeles, L; Huang, D; O'Brien, RG; Reents, S; Shieh, G; Visser, J, 1993
)
0.29
" Incorporating the differences may allow for more individualized dosing and more efficacious use of the agent in this patient population."( Racial differences in the pharmacokinetics of methylprednisolone in black and white renal transplant recipients.
Reed, KA; Tornatore, KM; Venuto, RC,
)
0.13
" Although the alpha phase kinetics of both dosage forms were similar, L-MPL showed a substantially slower elimination phase than did free drug."( Enhancement of tissue delivery and receptor occupancy of methylprednisolone in rats by a liposomal formulation.
Jusko, WJ; Mishina, EV; Pyszczynski, NA; Straubinger, RM, 1993
)
0.29
" The delayed dosing was associated with improved graft survival and no increase in the frequency of rejection episodes."( Is there an optimal time for the first cyclosporin dose in renal transplantation?
Fenn, N; Griffin, PJ; Krishnan, H; Moore, RH; Salaman, JR, 1993
)
0.29
"The mean daily methylprednisolone dosage was 19 +/- 19 mg in the double-drug group and 9 +/- 2 mg in the triple-drug group."( Comparative methylprednisolone pharmacokinetics in renal transplant patients receiving double- or triple-drug immunosuppression.
Holdsworth, MT; Reed, KA; Tornatore, KM; Venuto, RC; Walshe, JJ, 1993
)
0.29
" Typically, methylprednisolone is prescribed according to a standardized dosing protocol that assumes minimal interpatient variation."( Comparative methylprednisolone pharmacokinetics in renal transplant patients receiving double- or triple-drug immunosuppression.
Holdsworth, MT; Reed, KA; Tornatore, KM; Venuto, RC; Walshe, JJ, 1993
)
0.29
" The experimental group received a standard dosage of oral postoperative corticosteroids."( Arthroscopy of the knee. Ten-day pain profiles and corticosteroids.
Highgenboten, CL; Jackson, AW; Meske, NB,
)
0.13
" We conclude that, in multidrug therapies, the continuation of corticosteroid at conventional dosage beyond the first course does not improve response rate or survival time in multiple myeloma."( Corticosteroid is not beneficial in multiple-drug combination chemotherapy for multiple myeloma. Finnish Leukaemia Group.
Ala-Harja, K; Almqvist, A; Elonen, E; Hallman, H; Hänninen, A; Ilvonen, M; Isomaa, B; Järvenpää, E; Jouppila, J; Palva, IP, 1993
)
0.29
" ATG dosage was adjusted on a daily basis to keep the absolute T lymphocyte count under 50 cells/microliters."( Administration of ATG according to the absolute T lymphocyte count during therapy for steroid-resistant rejection.
Clark, KR; Forsythe, JL; Lennard, TW; Proud, G; Shenton, BK; Taylor, RM, 1993
)
0.29
" The vast majority of patients in both groups achieved alternate-day dosing (29 of 30 on TAO and 23 of 27 on placebo in the first year)."( A double-blind study of troleandomycin and methylprednisolone in asthmatic subjects who require daily corticosteroids.
Bucher, BL; Buchmeier, AD; Corsello, PR; Hamilos, DL; Levesque, NV; Nelson, HS, 1993
)
0.29
"The purpose of this study was to determine the effects of two dosage regimens of dexamethasone on the serum cortisol levels of a group of patients undergoing major maxillofacial surgical procedures."( Dosage effects of pulsed steroid therapy on serum cortisol levels in oral and maxillofacial surgery patients.
Butler, RC; Finstuen, K; Vorono, AA, 1993
)
0.29
"This experiment was undertaken for three purposes: (1) to determine a dose-response curve of acute steroid inhibition of wound contraction in the rat; (2) to confirm the results of our preliminary study that platelet-derived growth factor (PDGF) enhanced wound contraction in acutely steroid impaired rats; and (3) to examine the histology of the PDGF-treated wounds."( Platelet-derived growth factor and wound contraction in the rat.
Bubak, PJ; Engrav, LH; Karr, BP; Pavlin, EG; Sprugel, KH, 1995
)
0.29
" For initial evaluation and follow-up, MRI and US yielded reliable results in comparison to plain films and CT, thus helping to reduce the radiation dosage in children."( Localized Langerhans cell histiocytosis of bone: treatment and follow- up in children.
Libicher, M; Roeren, T; Tröger, J, 1995
)
0.29
"The purpose of this study was to examine the relationship of cumulative steroid dosage and duration of therapy with osteoporosis."( Osteoporosis in steroid-dependent asthma.
Gordon, EH; Hahn, TJ; Klaustermeyer, WB; Villareal, MS, 1996
)
0.29
" The clinical utilization of methylprednisolone during the early post-transplant period is based upon standardized dosing protocols that do not consider factors which may influence the pharmacokinetics of this drug during the post-transplant period."( Methylprednisolone and cortisol metabolism during the early post-renal transplant period.
Reed, KA; Tornatore, KM; Venuto, RC, 1995
)
0.29
" Since there was no activity of the mixed connective tissue disease the methylprednisolone dosage was reduced and the administration of azathioprine was ceased."( [Chronic recurrent subileus due to Strongyloides stercoralis infection under immunosuppressive therapy].
Back, W; Birck, R; Braun, C; Gottstein, T; Gretz, N; Manegold, BC; Rohmeiss, P; Strauch, M, 1996
)
0.29
" The remaining patients (group A, n = 10) were given diclofenac in a dosage of 150 mg per day for three days then 75 mg per day for three days."( Corticosteroid therapy for the treatment of acute attacks of crystal-induced arthritis: an effective alternative to nonsteroidal antiinflammatory drugs.
Gabay, C; Vischer, TL; Werlen, D, 1996
)
0.29
" GC mini pulses are effective on early clinical and biological parameters of inflammation and requires a lower cumulative daily dosage than conventional oral GC treatment."( 6-methylprednisolone 'mini-pulses': a new modality of glucocorticoid treatment in systemic onset juvenile chronic arthritis.
Borrone, C; Buoncompagni, A; Gattorno, M; Picco, P; Pistoia, V, 1996
)
0.29
"0 mg x kg-1 of methylprednisolone (6 alpha methylprednisolone 21-acetate) by intramuscular injection 6 hours before and every 48 hours after irradiation; (3) an untreated control group (C); and (4) a methylprednisolone control group (S), which received the same dosage of methylprednisolone as the RS group."( [Suppression by methylprednisolone of the expression of LFA-1 by alveolar macrophages in irradiated rat lungs].
Katoh, H; Kawana, A; Ohta, Y; Shioya, S; Tsuji, C, 1996
)
0.29
" Methotrexate was given weekly for 8 weeks beginning at the conclusion of OKT3 therapy (postoperative days 8 to 16), and dosed according to white blood cell count."( Methotrexate for rejection prophylaxis after heart transplantation.
Ensley, RD; Olsen, SL; Renlund, DG; Taylor, DO,
)
0.13
" MP dosage based on BMI may be a reasonable alternative to a fixed-dose regimen with the advantage of limiting steroid exposure and the consequent side-effects."( Treatment of renal allograft acute rejection with methylprednisolone: effect of fixed dose versus dose per body mass index.
Carson, RW; Douzdjian, V; Fisch, JC; Gugliuzza, KK; Rice, JC, 1996
)
0.29
" 2) Eight week treatment with the selected dosing regimen (n = 6) of the steroid and histomorphometry including strut analysis measured the development of a characteristic osteopenia which can be described briefly as "uncut but thinning" of trabecular bone structure, and which was prevented by salmon calcitonin (0."( Glucocorticoid-induced osteopenia in rats: histomorphometrical and microarchitectural characterization and calcitonin effect.
Hoshino, T; Koida, M; Nakamuta, H; Nitta, T, 1996
)
0.29
"Using standard lymphocyte culture techniques, the concentration of prednisolone (P) and methylprednisolone (MP) required to cause 50% inhibition (IC50) of the proliferative response to phytohemagglutinin (PHA) was determined from dose-response curves."( Differential glucocorticoid responsiveness of dialysis patients' lymphocytes.
Briggs, WA; Burdick, JF; Choi, MJ; Gao, ZH; Gimenez, LF; Scheel, PJ,
)
0.13
" From the dose-response curves, the concentration of steroid required to cause 50% inhibition (IC50) of the PHA-induced proliferative response was determined."( Lymphocyte responsiveness to glucocorticoids, cyclosporine, or both.
Briggs, WA; Burdick, JF; Choi, MJ; Gao, ZH; Gimenez, LF; Scheel, PJ, 1996
)
0.29
" Dosing according to area under the serum MP time vs."( Methylprednisolone exposure, rather than dose, predicts adrenal suppression and growth inhibition in children with liver and renal transplants.
Holmberg, C; Hoppu, K; Laine, J; Neuvonen, PJ; Sarna, S, 1997
)
0.3
" Dosage was reduced gradually to 10 mg daily over 4 weeks."( Therapeutic responses to corticosteroids in Graves' ophthalmopathy.
Chang, TC; Hsiao, YL; Huang, KM; Kao, SC; Lu, CP; Tzeng, SS, 1996
)
0.29
" However, the optimal dosage of HDMP and its role in maintenance therapy should be determined in future, randomized studies."( High-dose methylprednisolone for children with acute lymphoblastic leukemia and unfavorable presenting features.
Atahan, L; Gümrük, F; Gürgey, A; Hiçsönmez, G; Ozsoylu, S; Tuncer, MA; Yetgin, S; Zamani, PV, 1997
)
0.3
"continuous intravenous infusion of cyclosporine at dosage of 2 mg/kg/day is a highly effective and safe therapy that may avoid or defer colectomy to eligible conditions."( [Treatment of acute a steroid-resistant ulcerative colitis with continuous venous infusion of cyclosporine].
Casà, A; Cottone, M; Oliva, L; Orlando, A; Rosselli, M, 1996
)
0.29
" The optimal dosage and route of corticosteroid treatment for GCA with visual loss remain elusive and warrant a treatment trial."( Progressive visual loss from giant cell arteritis despite high-dose intravenous methylprednisolone.
Cornblath, WT; Eggenberger, ER, 1997
)
0.3
"It was concluded that for the multiple dosage regimen used in patients with acute asthma the systemic exposure to MP following dosing with MP suleptanate is similar to that arising from MP succinate."( A comparative population pharmacokinetic analysis for methylprednisolone following multiple dosing of two prodrugs in patients with acute asthma.
Daley-Yates, PT; Parker, TJ; Wood, SA, 1997
)
0.3
" However, a dose-response effect was seen only in the DFZ group."( In vitro improvement of chlorambucil-induced cytotoxicity by deflazacort and 6-methylprednisolone in B-cell chronic lymphocytic leukaemia.
Brugiatelli, M; Callea, I; Cartisano, G; Dattola, A; Irrera, G; Morabito, F; Rodinò, A, 1997
)
0.3
" The initial dose of 1 mg/kg body weight was reduced by 20 mg each every 2 weeks, until a maintenance dosage of 8-12 mg/day was achieved."( [Immunosuppressive therapy for effective suppression of life threatening ventricular tachyarrhythmias in chronic myocarditis].
Ganschow, US; Hennersdorf, M; Klein, RM; Kühl, U; Perings, C; Schannwell, CM; Schultheiss, HP; Strauer, BE; Vester, EG, 1997
)
0.3
" Combined azathioprine methylprednisolone has produces better effects when only lower dosage is used."( [Azathioprine and its combination with methylprednisolone: preventive effect on chronic cerebral vasospasm].
Liu, B; Wang, Z; Wu, J, 1996
)
0.29
" Three patients were treated with intravenous acyclovir with concomitant reduction of steroid dosage and recovered completely."( Management of varicella infection during the course of inflammatory bowel disease.
Balasubramanian, S; Giannadaki, E; Greenstein, AJ; Manousos, ON; Mouzas, IA; Sachar, DB, 1997
)
0.3
" If varicella infection occurs, prompt diagnosis and treatment with acyclovir and concomitant reduction in immunosuppressive therapy (reduction in steroid dosage and discontinuation of azathioprine) should be initiated immediately to limit viremia and avoid fatal complications."( Management of varicella infection during the course of inflammatory bowel disease.
Balasubramanian, S; Giannadaki, E; Greenstein, AJ; Manousos, ON; Mouzas, IA; Sachar, DB, 1997
)
0.3
" As the steroid dosage was reduced, bone mass improved."( Effects of inflammation and treatment on bone turnover and bone mass in polymyalgia rheumatica.
Corrigall, V; Dasgupta, B; Dolan, AL; Li, F; Mackintosh, C; Moniz, C; Panayi, GS; Todd, P, 1997
)
0.3
" The slope and the shape of the dose-response curve of DEX were similar irrespective of either the input stimuli or the output cytokines; half-maximal inhibition was observed at 10(-8) mol/L, and nearly complete abolishment was observed at 10(-7) mol/L."( Glucocorticoids inhibit chemokine generation by human eosinophils.
Hirai, K; Izumi, S; Kasahara, T; Matsushima, K; Misaki, Y; Miyamasu, M; Morita, Y; Nakamura, H; Takaishi, T, 1998
)
0.3
" The study design required dosing with less tacrolimus (mean mg/day +/- SEM), which was achieved at 1 week (23."( Tacrolimus (FK506) and mycophenolate mofetil combination therapy versus tacrolimus in adult liver transplantation.
Bynon, JS; Contreras, JL; Eckhoff, DE; Frenette, LR; Hudson, SL; McGuire, BM, 1998
)
0.3
" Over 20 years, we have simply observed our patients clinically after diagnosis, and only used aggressive therapy with steroids in high dosage and azathioprine for 21 patients with progressive renal failure."( 'Progressive' versus 'indolent' idiopathic membranous glomerulonephritis.
Bone, JM; Rustom, R; Williams, PS, 1997
)
0.3
"The higher dosage of IVMP has a more powerful and prolonged action in maintaining blood-brain barrier integrity after a clinical relapse."( Randomized trial comparing two different high doses of methylprednisolone in MS: a clinical and MRI study.
Aguglia, U; Bono, F; Fera, F; Gambardella, A; Oliveri, RL; Pardatscher, K; Quattrone, A; Russo, C; Sibilia, G; Valentino, P; Zappia, M, 1998
)
0.3
"A postal questionnaire covering the use of corticosteroids for acute multiple sclerosis relapse and chronic progressive multiple sclerosis with regard to frequency of use, type of corticosteroid, and dosage regime was sent to all members of the Association of British Neurologists with a United Kingdom address."( Use of corticosteroids in multiple sclerosis by consultant neurologists in the United Kingdom.
Luscombe, DK; Tremlett, HL; Wiles, CM, 1998
)
0.3
" Throughout the dosing interval, enzyme activity parallels that of drug concentrations."( The monitoring of immunosuppressive drugs: a pharmacodynamic approach.
Aspeslet, LJ; Yatscoff, RW, 1998
)
0.3
" The dosage of tacrolimus (D), the trough blood concentrations (C), and the evolution of the ratio (D/C) were followed up for 2 years after transplantation in 50 adult patients (38 men, 12 women) undergoing liver allograft transplantation."( Therapeutic drug monitoring of tacrolimus in liver transplantation, phase III FK506 multicenter Spanish Study Group: a two-year follow-up.
Andres, I; Andreu, H; Bilbao, I; Brunet, M; Corbella, J; Lopez, R; Margarit, C; Pou, L; Rimola, A, 1998
)
0.3
"Mesalamine in microgranular formulation seems to be equally as effective as a standard dosage of steroids in the treatment of the mild to moderate form of Crohn's ileitis."( Mesalamine in the treatment of mild to moderate active Crohn's ileitis: results of a randomized, multicenter trial.
Annese, V; Bianchi Porro, G; Cerutti, R; Cottone, M; Franzè, A; Pallone, F; Prantera, C, 1999
)
0.3
" Down-regulation of GR mRNA and GR density were observed: GR mRNA level declined to 45-50% of the baseline in 8-10 hr, and slowly returned to predose level in about 3 days; GR density fell to 0 soon after dosing and returned to the baseline in two phases."( Fourth-generation model for corticosteroid pharmacodynamics: a model for methylprednisolone effects on receptor/gene-mediated glucocorticoid receptor down-regulation and tyrosine aminotransferase induction in rat liver.
Almon, RR; DuBois, DC; Jusko, WJ; Sun, YN, 1998
)
0.3
" Standardized dosage tables for high-dose methylprednisolone were developed for prescribers, nurses, and pharmacists."( Standardized dosing tables to reduce errors involving high-dose methylprednisolone for acute spinal cord injury.
Lesar, TS, 1994
)
0.29
" Corticosteroid dosing involves six phases: (1) initial high doses to control inflammation; (2) tapering to a maintenance dose that will continue to suppress the inflammation but lessen the risk of corticosteroid toxic reactions; (3) continuing to receive the maintenance dose until a decision to taper off corticosteroids is made; (4) tapering off corticosteroid therapy; (5) observation for relapse; and (6) treatment if relapse occurs."( An approach to the treatment of pulmonary sarcoidosis with corticosteroids: the six phases of treatment.
Judson, MA, 1999
)
0.3
"The administration of one single weekly dose of methotrexate 10 mg in adults and 15 in one pediatric patient allowed for a decrease of approximately 50% in the glucocorticosteroid dosage in this group of patients with corticosteroid-dependent bronchial asthma with no relevant adverse reactions during therapy."( [Efficiency of methotrexate in the treatment of cortico-dependent asthmatic patients].
Bosque García, M; Comet Monte, R; Domingo Ribas, C; Montón Soler, C; Morón Besolí, A, 1999
)
0.3
" There was no dose-response to intraperitoneal MP (up to 12 mg/kg) for nociceptive thresholds to heat (Peltier) or mechanical (analgesy-meter and von Frey fibers) stimuli in normal rats."( Methylprednisolone prevents the development of autotomy and neuropathic edema in rats, but has no effect on nociceptive thresholds.
Castellote, JM; Kingery, WS; Maze, M, 1999
)
0.3
" Except for the angiotensin-converting enzyme inhibitor, these medications were not effective in terms of allowing a reduction in the high dosage of steroid, which in turn threatened progressive osteoporosis and lumbar vertebrae fracture."( Effect of pituitary microsurgery on acromegaly complicated nephrotic syndrome with focal segmental glomerulosclerosis: report of a rare clinical case.
Akikusa, B; Hasegawa, S; Iesato, K; Murotani, N; Saeki, N; Shimada, T; Wakashin, M; Yamamoto, S; Yoshida, H, 1999
)
0.3
" There was no indication that the dosage or timing of corticosteroid treatment or the timing of surgery was associated with an increased probability of visual improvement."( The treatment of traumatic optic neuropathy: the International Optic Nerve Trauma Study.
Beck, RW; Joseph, MP; Kraker, R; Levin, LA; Seiff, S, 1999
)
0.3
" Steroid therapy can be considered in the treatment of children with refractory late ARDS but larger prospective studies are needed to define indications, timing, dosing and safety of this mode of treatment in children."( Corticosteroid rescue in late paediatric acute respiratory distress syndrome.
Goh, AY; Roziah, M; Sekaran, D, 1999
)
0.3
"We investigated the bronchodilator dose-response to nebulized albuterol and the dose of albuterol which produces maximal bronchodilation in the acutely ill, hospitalized asthmatic."( Dose-response characteristics of nebulized albuterol in the treatment of acutely ill, hospitalized asthmatics.
Brennan, K; Ciccolella, DE; Criner, GJ; Kelsen, SG, 1999
)
0.3
" In examined cases the antithyroid dosage was medium high (mean 40 mg/die)."( [Methimazole-induced aplastic anemia].
Bolognesi, S; Castiglioni, MG; Mechelli, S; Siuti, E; Stefanelli, A, 1999
)
0.3
" However, when the dosage was tapered, BOOP recurred."( [Successful treatment of steroid-resistant bronchiolitis obliterans-organizing pneumonia with orally administered cyclosporin and pirfenidone].
Arai, Y; Isogane, N; Ito, K; Ogawa, C; Otomo, M; Sano, Y; Sekiya, T; Suzuki, N; To, Y, 2000
)
0.31
" Depending on the intensity of allergen exposure, complaints now occur in February/March only, requiring updating of the therapy in respect of dosage and number of drugs used."( [Two out-of-the-ordinary (?) case reports an asthmatic disease].
Hausen, T, 2000
)
0.31
" The clinical responses of the patients to treatment, including alterations in muscle strength, muscle enzyme levels and corticosteroid dosage as well as the development of side-effects, were recorded."( Efficacy of early treatment of severe juvenile dermatomyositis with intravenous methylprednisolone and methotrexate.
Al-Mayouf, S; Al-Mazyed, A; Bahabri, S, 2000
)
0.31
" This consists of Plasmapheresis associated with pharmacological therapy so that dosage of immunosuppressors can be reduced and consequently also the side effects of the pharmacological therapy."( [Plasmapheresis combined with pharmacology in the treatment of lupus nephritis: a new therapeutic protocol].
Bauco, B; Bisciglia, MF; Bonello, M; Bosco, M; De Paola, A; Maresca, L; Russo, GE; Tedaldi, M; Vitaliano, E,
)
0.13
" The dosage of methylprednisolone recommended by the NASCIS 3 is the highest dose of steroids ever being used during a 2-day period for any clinical condition."( High-dose methylprednisolone may do more harm for spinal cord injury.
Campagnolo, D; Kirshblum, S; Qian, T, 2000
)
0.31
" In severe ophthalmopathy steroids are effective in more than 60% of patients [1, 3], but to be effective high dosage is necessary [1, 4-6]."( [Treatment of Grave's ophthalmopathy with high doses of corticosteroids].
Cirić, J; Drezgić, M; Gligorović, M; Nesović, M; Pepenezić, Z; Randjelović, G; Stojanović, M; Trbojević, B; Zarković, M,
)
0.13
" Corticosteroid therapy with methylprednisolone at low dosage (0."( A case of vesiculo-bullous Darier's disease associated with bipolar psychiatric disorder.
Amato, L; Caproni, M; Fabbri, P; Gallerani, I; Mei, S; Palleschi, GM; Perrella, E, 2000
)
0.31
" In the multiple regression test, a linear coincidence was observed between apo A1, apo B and prednisone cumulative dosage after the 1st month, TG and cyclosporine in the 6th month and LDL and cyclosporine in the 12th month after transplantation."( Does immunosuppressive regimen influence the lipid disturbances in kidney recipients?
Kisielnicka, E; Kortas, B; Lysiak-Szydłowska, W; Rutkowski, B; Wróblewska, M; Zdrojewski, Z,
)
0.13
" However, it is important to monitor serum SRL levels to determine the optimal dosing regimen."( A calcineurin inhibitor-sparing regimen with sirolimus, mycophenolate mofetil, and anti-CD25 mAb provides effective immunosuppression in kidney transplant recipients with delayed or impaired graft function.
Ascher, NL; Chang, GJ; Freise, CE; Hirose, R; Mahanty, HD; Roberts, JP; Stock, PG; Vincenti, F, 2000
)
0.31
"A physiologic pharmacodynamic model was developed to jointly characterize the effects of corticosteroid treatment on adrenal suppression and T-helper cell trafficking during single and multiple dosing in asthmatic patients."( Modeling interactions between adrenal suppression and T-helper lymphocyte trafficking during multiple dosing of methylprednisolone.
Chow, FS; Jusko, WJ; Sharma, A, 1999
)
0.3
" In conclusion, the systemic corticosteroids are effective in 36% of patients, independent of dosage and pharmacological agents and duration of the therapy."( Management of cutaneous hemangiomas: a retrospective analysis of 1109 cases and comparison of conventional dose prednisolone with high-dose methylprednisolone therapy.
Akyüz, C; Büyükpamukçu, M; Kutluk, MT; Yariş, N,
)
0.13
"5 mg/kg q6h for 3 days, and group 2 was administered the same dosage of MP for the first 3 days, after which it was tapered and terminated on the tenth day."( Systemic glucocorticoids in severe exacerbations of COPD.
Aytemur, ZA; Cirit, M; Sayiner, A; Unsal, I, 2001
)
0.31
" Despite this, the pharmacokinetics of prednisolone have never been fully characterized in these patients, and consequently dosing remains empirical."( Simultaneous determination of plasma prednisolone, prednisone, and cortisol levels by high-performance liquid chromatography.
Akhlaghi, F; Holt, DW; Lee, T; Majid, O; Trull, A, 2001
)
0.31
" Five patients who treated with steroids at the onset of neurological symptoms showed clinical improvement, regardless of their age, sex, the pathology and stage of breast cancer, or the total dosage of chemotherapeutic agents."( 5-fluorouracil-induced leukoencephalopathy in patients with breast cancer.
Cho, KH; Choi, SM; Kim, BC; Kim, MK; Lee, SH; Yang, YS, 2001
)
0.31
"Targeted topical steroid administration avoids the significant systemic side effects of oral steroids and may offer more effective dosing than simple transtympanic injection of medicine."( Targeted topical steroid therapy in sudden sensorineural hearing loss.
Hoffer, ME; Jackson, RL; Kopke, RD; O'Leary, MJ; Wester, D, 2001
)
0.31
" In order to obtain a corticosteroid-sparing effect, new studies are necessary to evaluate a reduced initial dosage of corticosteroids."( [Horton's disease in elderly patients aged over 75: clinical course, complications of corticotherapy. Comparative study of 164 patients. Towards a reduced initial dose].
Barrier, JH; Chevalet, P; de Wazières, B; Duhamel, E; el Kouri, D; Glémarec, J; Hamidou, M; Jégo, P; Maugars, Y; Planchon, B; Rodat, O, 2001
)
0.31
"Eleven nondiabetic patients with worsening LSRPN were treated - ten with infusions of IV MP (1 gm/wk) for 8 to 16 weeks and one with an equivalent dosage of oral prednisone."( Methylprednisolone may improve lumbosacral radiculoplexus neuropathy.
Dyck, PJ; Norell, JE, 2001
)
0.31
" Cyclosporin A dosage and trough levels were not significantly different before and after steroid withdrawal."( Risk of steroid withdrawal in pediatric renal transplant patients with suspected steroid toxicity.
Förster, B; Jeck, N; Klaus, G; Konrad, M; Soergel, M, 2001
)
0.31
" Combined use of azathioprine with methylprednisolone allows lower dosage and less complication compared with a single agent, and results in a better outcome."( Azathioprine and methylprednisolone: prevention of chronic cerebral vasospasm in dogs.
Liu, B; Sun, Y; Wang, C; Wu, J; Wu, Z, 2000
)
0.31
"8 months), total used dosage of steroids (G1= 20, G2= 28, G3= 16 grams) and time of drug use (G1= 20, G2= 26, G3= 14."( [A comparative study of therapeutic complications in Systemic Lupus Erythematosus and in idiopathic glomerulopathy].
Almeida, DB; Balbi, AL; Barbosa, RA; Lima, MC,
)
0.13
"Randomised trials comparing different routes of administration and dosage schemes of corticosteroid or adrenocorticotrophic hormone therapy versus a control group where no therapy considered effective for this condition was administered, unless it was also given in a similar way to the experimental group."( Corticosteroids for Bell's palsy (idiopathic facial paralysis).
Alvarez, G; Alvarez, MI; Ferreira, J; Salinas, RA, 2002
)
0.31
" Complications due to treatment included: duodenal ulcer in one patient that responded to medical treatment, and transient elevation in serum creatinine levels in three patients, which returned to normal after decrease in dosage or cessation of oral CSA."( Combined intravenous pulse methylprednisolone and oral cyclosporine A in the treatment of corneal graft rejection: 5-year experience.
Cheng, LL; Lam, DS; Leung, AT; Rao, SK; Wong, AK; Young, AL, 2002
)
0.31
" The dosage of steroids was tapered in 3 out of 4 CyA-responsive cases without re-exacerbation."( Usefulness of cyclosporine A on rapidly progressive interstitial pneumonia in dermatomyositis.
Inase, N; Miyake, S; Miyasaka, N; Miyazaki, Y; Ohtani, Y; Sawada, M; Takano, S; Yoshizawa, Y, 2002
)
0.31
"008) with the divided dosage regimen than after the single dose (8422 +/- 2163 vs."( Pharmacokinetics and pharmacodynamics of methylprednisolone after one bolus dose compared with two dose fractions.
Boehm, BO; Czock, D; Keller, F; Mertz, A; Uhl, A; Zellner, D, 2002
)
0.31
" High dose methylprednisolone (kg/30 mg) was administered by intravenous infusion in the 8th, 16th and 24th hours after injury followed by infusion of the same dosage every 6 hours for 24 hours."( Efficacy of methylprednisolone in acute experimental cauda equina injury.
Alptekin, M; Bakir, K; Erkutlu, I; Gök, A; Uk, C; Yilmaz, M, 2002
)
0.31
" bolus dose of methylprednisolone (MPL) in male adrenalectomized rats, and confirmed using data from other acute dosage regimens."( Fifth-generation model for corticosteroid pharmacodynamics: application to steady-state receptor down-regulation and enzyme induction patterns during seven-day continuous infusion of methylprednisolone in rats.
Almon, RR; DuBois, DC; Jusko, WJ; Pyszczynski, NA; Ramakrishnan, R, 2002
)
0.31
" The NASCIS III dosing regimen is the most commonly prescribed steroid protocol."( Why do you prescribe methylprednisolone for acute spinal cord injury? A Canadian perspective and a position statement.
Hurlbert, RJ; Moulton, R, 2002
)
0.31
"Observational study on the timing and correct dosage of methylprednisolone."( Failure to administer methylprednisolone for acute traumatic spinal cord injury-a prospective audit of 100 patients from a regional spinal injuries unit.
Casey, AT; Middleton, F; Molloy, S, 2002
)
0.31
"Intravenous methylprednisolone at the dosage and duration used in this retrospective study did not significantly improve the visual recovery of eyes with traumatic optic neuropathy compared to conservative treatment."( Low-dose intravenous methylprednisolone or conservative treatment in the management of traumatic optic neuropathy.
Au Eong, KG; Chng, NW; Heng, WJ; Lim, TH; Lim, WK; Yip, CC,
)
0.13
" Every other week for 8 weeks, one shoulder in each rat was injected with methylprednisolone, betamethasone, or saline in a dosage equivalent to that used in humans."( Effects of methylprednisolone and betamethasone injections on the rotator cuff: an experimental study in rats.
Akpinar, S; Demirors, H; Hersekli, MA; Kayaselcuk, F; Tandogan, RN,
)
0.13
" Reduction of methylprednisolone dosage rather than insulin therapy resulted in better control of glycemia."( Steroid diabetes in children with Crohn disease.
Banac, S; Cvijović, K; Persić, M, 2002
)
0.31
" The dose-response (5-40 mg/kg) and time-course (6-72 h) curves of methylprednisolone on pancreatic HSP60 and HSP72 synthesis were evaluated following methylprednisolone treatment."( The anti-inflammatory effect of methylprednisolone occurs down-stream of nuclear factor-kappaB DNA binding in acute pancreatitis.
Boros, I; Duda, E; Iványi, B; Kaszaki, J; Lonovics, J; Rakonczay, Z; Takács, T, 2003
)
0.32
" The dose-response (3 or 4 g/kg) and time-effect (0."( NF-kappaB activation is detrimental in arginine-induced acute pancreatitis.
Boros, I; Duda, E; Hegyi, P; Jármay, K; Kaszaki, J; Lonovics, J; Mándi, Y; Rakonczay, Z; Takács, T, 2003
)
0.32
"The sirolimus/cyclosporine combination regimen reduced the incidence of acute renal allograft rejection, did not affect renal function, and reduced the dosage of cyclosporine and steroids compared with the cyclosporine regimen."( Effect of sirolimus in combination with low-dose cyclosporine and steroids on acute renal allograft rejection.
Chueh, SC; Hu, RH; Lee, PH; Tsai, MK, 2003
)
0.32
" Dosing of these agents was concentration-controlled and open-labeled."( Bicêtre hospital experience with sirolimus-based therapy in human renal transplantation: the Sirolimus European Renal Transplant Study.
Bäckman, L; Brattström, C; Calne, R; Campistol, JM; Charpentier, B; Claesson, K; Durand, D; Groth, CG; Kreis, H; Lang, P; Morales, JM; Touraine, JL; Wramner, L, 2003
)
0.32
" Psychosis was unpredictable by the routes and dosage of corticosteroid used."( Factors predictive of corticosteroid psychosis in patients with systemic lupus erythematosus.
Chau, SY; Mok, CC, 2003
)
0.32
" The highest dosage of MPA (10 mg/ml) reduced GAG synthesis less than lower dosages of MPA and all dosages of TA."( Effects of dosage titration of methylprednisolone acetate and triamcinolone acetonide on interleukin-1-conditioned equine articular cartilage explants in vitro.
Baxter, GM; Dechant, JE; Frisbie, DD; McIlwraith, CW; Trotter, GW, 2003
)
0.32
" The course and dosage of glucocorticoid, counts of CD(4)(+), CD(8)(+) and CD(3)(+), electrolytes, blood routine, and sera albumin before and after the treatment were analysed."( [Glucocorticoid in the treatment of severe acute respiratory syndrome patients: a preliminary report].
Guo, JZ; Jiang, RM; Li, XW, 2003
)
0.32
" The dosage for 24 patients was 80 - 160 mg/d with the largest being 1,000 mg/d before admission to the hospital."( [Glucocorticoid in the treatment of severe acute respiratory syndrome patients: a preliminary report].
Guo, JZ; Jiang, RM; Li, XW, 2003
)
0.32
" Indications for use of glucocorticoid must strictly controlled and its large dosage is improper."( [Glucocorticoid in the treatment of severe acute respiratory syndrome patients: a preliminary report].
Guo, JZ; Jiang, RM; Li, XW, 2003
)
0.32
" Of 36 cases treated with steroids, 86% received middle or low dosage (80 - 240 mg/d)."( [Clinical features of severe acute respiratory syndrome in forty-one confirmed health care workers].
Dong, PL; Hou, W; Hu, ZJ; Huang, C; Liang, LC; Meng, QH; Zhang, K; Zhao, CH, 2003
)
0.32
" Middle or low dosage of steroid was reasonable to be used as early as possible."( [Clinical features of severe acute respiratory syndrome in forty-one confirmed health care workers].
Dong, PL; Hou, W; Hu, ZJ; Huang, C; Liang, LC; Meng, QH; Zhang, K; Zhao, CH, 2003
)
0.32
" Initial use of pulse methylprednisolone therapy appears to be a more efficacious and an equally safe steroid regimen when compared with regimens with lower dosage and should be considered as the preferred steroid regimen in the treatment of SARS, pending data from future randomized controlled trials."( High-dose pulse versus nonpulse corticosteroid regimens in severe acute respiratory syndrome.
Chan, JW; Chan-Yeung, M; Ho, JC; Ho, PL; Hung, I; Ip, MS; Lai, KN; Lam, B; Lam, WK; Li, PC; Mok, TY; Ng, CK; Ooi, GC; Tsang, KW; Wong, PC, 2003
)
0.32
"05) but only in the 2-g MMF dosing group."( Long-term changes in mycophenolic acid exposure in combination with tacrolimus and corticosteroids are dose dependent and not reflected by trough plasma concentration: a prospective study in 100 de novo renal allograft recipients.
Claes, K; Coosemans, W; Evenepoel, P; Kuypers, DR; Maes, B; Pirenne, J; Vanrenterghem, Y, 2003
)
0.32
" In the dosage used, none of the compounds promoted discernible salt and water retention."( 16a-Methyl corticosteroids; a new series of anti-inflammatory compounds; clinical appraisal of their antirheumatic potencies.
BOLAND, EW, 1958
)
0.24
" Steroid dosage, tacrolimus dosage, tacrolimus trough concentration (C0) and tacrolimus concentration/dose ratio [C0 divided by the 24 h dosage (mg/kg)] were assessed for each dosage group after 1 and 3 months of tacrolimus treatment."( Pharmacokinetic interaction between corticosteroids and tacrolimus after renal transplantation.
Anglicheau, D; Beaune, P; Cassinat, B; Flamant, M; Legendre, C; Martinez, F; Schlageter, MH; Thervet, E, 2003
)
0.32
" At 1 and 3 months, the tacrolimus doses and concentration/dose ratios differed significantly in the three steroid dosage groups."( Pharmacokinetic interaction between corticosteroids and tacrolimus after renal transplantation.
Anglicheau, D; Beaune, P; Cassinat, B; Flamant, M; Legendre, C; Martinez, F; Schlageter, MH; Thervet, E, 2003
)
0.32
" The higher the steroid dosage, the higher the dosage of tacrolimus needed to achieve target trough levels in these patients."( Pharmacokinetic interaction between corticosteroids and tacrolimus after renal transplantation.
Anglicheau, D; Beaune, P; Cassinat, B; Flamant, M; Legendre, C; Martinez, F; Schlageter, MH; Thervet, E, 2003
)
0.32
"In treating SARS, ICWM was superior to the treatment with western medicine alone in aspects of improving clinical symptom, promoting recovery of immune function and absorption of lung inflammation, decreasing the dosage of hormone used and shortening the therapeutic course."( [Controlled clinical study on 49 patients of SARS treated by integrative Chinese and Western medicine].
Jiao, Q; Wang, BG; Zhang, RL, 2003
)
0.32
"Comparing OKT3 and antithymocyte globulin (ATG) in a prospective study, the dosage difference in regard to body weight (ATG: dependent on body weight/OKT3: independent) does not introduce any obvious source of mistake concerning clinical effectiveness or side effects."( Dosage of OKT3 independent of body weight: a mistake?
Bachofen, M; Bock, H; Gallati, H; Landmann, J; Pracht, I; Thiel, G, 1992
)
0.28
" Initial dosage prednisolone was given for 1 month, and then tapered gradually in terms of dosage and interval."( [Quadritherapy with cyclosporine for membranous lupus nephropathy].
Iwasawa, H; Matsumoto, H; Nagaoka, Y; Nakao, T; Okada, T; Tomaru, R; Wada, T, 2003
)
0.32
" Levels of mycophenolic acid (MPA), its glucuronide metabolite, and daclizumab were measured after dosing on days 28 and 56."( Pharmacokinetics of daclizumab and mycophenolate mofetil with cyclosporine and steroids in renal transplantation.
Bumgardner, G; Gaston, RS; Kirkman, RL; Light, S; Nieforth, K; Patel, IH; Pescovitz, MD; Vincenti, F, 2003
)
0.32
" Twenty patients received mega-dose methylprednisolone (MDMP) in a dosage of 30 mg/kg/d for three days and 20 mg/kg/d for four days."( A randomized and comparative study of intravenous immunoglobulin and mega dose methylprednisolone treatments in children with acute idiopathic thrombocytopenic purpura.
Aslan, Y; Erduran, E; Gedik, Y; Orhan, F,
)
0.13
"The aim of this study was to compare the effectiveness of triamcinolone hexacetonide (THA) and methylprednisolone acetate (MPA), given via the intra-articular route at equipotent dosage to patients with symptomatic knee OA with effusion, in a double-blind randomized comparative trial."( Intra-articular steroids in knee osteoarthritis: a comparative study of triamcinolone hexacetonide and methylprednisolone acetate.
Bhanji, A; Ioannou, Y; Mootoo, R; Pyne, D, 2004
)
0.32
" Decreasing the daily maximal dosage may be beneficial to the reduction of corticosteroid-induced of diabetes."( [Glucocorticoid-induced diabetes in severe acute respiratory syndrome: the impact of high dosage and duration of methylprednisolone therapy].
Gao, J; Jiao, JS; Li, GW; Ma, L; Xiao, JZ; Xing, XY; Yang, ZJ; Zhao, HC, 2004
)
0.32
" Our results support the prophylactic administration of methylprednisolone in small dosage to prevent posttraumatic hypoxaemia and probably FES in patients with isolated lower limb long bone fractures, especially when early fracture stabilisation is not possible."( Prevention of posttraumatic hypoxaemia in isolated lower limb long bone fractures with a minimal prophylactic dose of corticosteroids.
Antonogiannakis, E; Babalis, GA; Karliaftis, K; Yiannakopoulos, CK, 2004
)
0.32
"Clinical date of 30 SARS patients without other diseases in whom corticosteroid was used were reviewed including total dosage, duration of use, the highest dosage and its duration, and speed of reduction in dosage."( [Analysis of relation between the usage of corticosteroid in treatment and arthralgia as a sequela of SARS patients].
Chen, LM; Gao, HS; Hui, WL; Jiao, ZS; Li, YM; Wang, SX; Yang, Z; Yuan, SL; Zhao, ZY, 2004
)
0.32
"The average total dosage of methylprednisolone was (4 244."( [Analysis of relation between the usage of corticosteroid in treatment and arthralgia as a sequela of SARS patients].
Chen, LM; Gao, HS; Hui, WL; Jiao, ZS; Li, YM; Wang, SX; Yang, Z; Yuan, SL; Zhao, ZY, 2004
)
0.32
"There is a dosage- effect relation between the degree of arthralgia and the total dosage of corticosteroid, and a time-effect relation between the duration of arthralgia and length of the use of corticosteroids."( [Analysis of relation between the usage of corticosteroid in treatment and arthralgia as a sequela of SARS patients].
Chen, LM; Gao, HS; Hui, WL; Jiao, ZS; Li, YM; Wang, SX; Yang, Z; Yuan, SL; Zhao, ZY, 2004
)
0.32
"Early applying of CH-HZ treatment showed good effects in improving CK, LDH, oxygenation index and absolute value of neutrophils, and could reduce the daily maximal dosage of glucocorticoid needed for SARS patients."( [Clinical observation on treatment of SARS with combination of chaihu droplet pill and huoxiang zhengqi droplet pill].
Li, H; Lu, CZ; Tang, KC, 2004
)
0.32
"Early application of CH-HZ treatment in treating SARS could alleviate the injury in lung of SARS patients and the neutrophil dependent inflammatory reaction, and reduce the dosage of glucocorticoid used."( [Clinical observation on treatment of SARS with combination of chaihu droplet pill and huoxiang zhengqi droplet pill].
Li, H; Lu, CZ; Tang, KC, 2004
)
0.32
" These findings suggest that doses of glucocorticoids should be prescribed on a milligram/kilogram basis instead of empiric dosing schedules."( Pharmacokinetics and pharmacodynamic response of methylprednisolone in premenopausal renal transplant recipients.
Farooqui, M; Gilliland-Johnson, KK; Reed, KA; Tornatore, KM; Venuto, RC, 2004
)
0.32
"The average total dosage of methylprednisolone was (4949 +/- 2959) mg, and the average course of treatment was (24 +/- 5) days (16 to 30 days)."( [Factors of avascular necrosis of femoral head and osteoporosis in SARS patients' convalescence].
Chen, LM; Gao, HS; Hui, WL; Jiao, ZS; Li, YM; Su, B; Wang, JG; Wang, SX; Wei, CS; Yang, Z; Yuan, SL, 2004
)
0.32
" The influencing factors of femoral necrosis included the degree of healing activity, the dosage summation of corticosteroids, and length of ictus therapy."( [Factors of avascular necrosis of femoral head and osteoporosis in SARS patients' convalescence].
Chen, LM; Gao, HS; Hui, WL; Jiao, ZS; Li, YM; Su, B; Wang, JG; Wang, SX; Wei, CS; Yang, Z; Yuan, SL, 2004
)
0.32
" The average dosage of GCS was 160 mg/d in the first week, and then reduced to 80 mg/d and 40 mg/d in the second and the third weeks, respectively."( [Side effects of glucocorticosteroids in the management of 1291 patients of SARS].
Chen, BW; Han, DM; Li, N; Wang, GF; Wang, YX; Wu, YF; Xiao, F; Xie, GQ, 2004
)
0.32
"Hyperglycemia and hypokalemia are correlated with GCS dosage and duration."( [Side effects of glucocorticosteroids in the management of 1291 patients of SARS].
Chen, BW; Han, DM; Li, N; Wang, GF; Wang, YX; Wu, YF; Xiao, F; Xie, GQ, 2004
)
0.32
"Randomised trials comparing different routes of administration and dosage schemes of corticosteroid or adrenocorticotrophic hormone therapy versus a control group where no therapy considered effective for this condition was administered, unless it was also given in a similar way to the experimental group."( Corticosteroids for Bell's palsy (idiopathic facial paralysis).
Alvarez, G; Ferreira, J; Salinas, RA, 2004
)
0.32
" These results suggest that there is an appropriate dosage as well as appropriate timing for MP administration to suppress PIH."( Effects of preinjury administration of corticosteroids on pseudointimal hyperplasia and cytokine response in a rat model of balloon aortic injury.
Kaneda, M; Kitajima, M; Matsumoto, K; Mukai, M; Murayama, T; Nagasaki, K; Shibutani, S; Shimazu, M; Shintani, T; Wakabayashi, G, 2004
)
0.32
" The maximum daily dosage of steroid may significantly influence on the occurrence of avascular abnormalities."( [Report on the investigation of lower extremity osteonecrosis with magnetic resonance imaging in recovered severe acute respiratory syndrome in Guangzhou].
Chen, JY; Chen, RC; Liang, BL; Liu, QY; Shen, J; Zeng, QS; Zhong, NS, 2004
)
0.32
" The treatment regiments included oxygen, small dosage and short period of methylprednisolone (1 to 2 mg/kg), use of ventilator, psychological intervention, and treatment of underlying diseases, after which, all the 7 patients recovered."( [Clinical experience from treatment of seven SARS patients].
Dong, QH; Guo, LM; Li, XH; Li, YR; Wang, XJ; Xiang, P; Yan, J; Yang, LQ; Yang, YY; Zhang, WY, 2004
)
0.32
"IL-10+DC and IL-12+DC in peripheral blood are associated with time after transplantation and dosage of immunosuppression."( Association of circulating interleukin (IL)-12- and IL-10-producing dendritic cells with time posttransplant, dose of immunosuppression, and plasma cytokines in renal-transplant recipients.
Daniel, V; Hergesell, O; Naujokat, C; Opelz, G; Sadeghi, M; Wiesel, M, 2005
)
0.33
"The CC16 was measured in plasma from 15 subjects exposed to LPS by inhalation, during which the kinetics and the dose-response relationship of LPS-induced CC16 were evaluated."( Inhaled LPS induces blood release of Clara cell specific protein (CC16) in human beings.
Bernard, A; Michel, O; Murdoch, R, 2005
)
0.33
" The average lifetime dosage of MP was 75."( Long-term effects of intravenous high dose methylprednisolone pulses on bone mineral density in patients with multiple sclerosis.
Bosco, A; Bratina, A; Cazzato, G; Giuntini, D; Locatelli, L; Nasuelli, D; Rudick, RA; Tommasi, MA; Toncic, M; Zivadinov, R; Zorzon, M, 2005
)
0.33
" Although there were no significant differences in the total dosage of cyclosporine A between the patients with living-relation donors and those with non-heart-beating donors, a significant increase in the total dosage of methylprednisolone was observed in patients with non-heart-beating donors compared with those in the patients with living-relation donors."( Studies on post-transplant dyslipidemia in kidney transplant patients.
Asahara, T; Dohi, K; Doi, S; Fukuda, Y; Hayamizu, K; Kawai, T; Marubayashi, S; Ohdan, H; Okumoto, S; Onoe, T; Taniguchi, Y; Tanji, C; Tashiro, H; Tokita, D, 2005
)
0.33
" The employment of methotrexate attained decrease in the dosage of steroids temporarily."( [Treatment with nebulized lidocaine in steroid-dependent asthma].
de Paz Arranz, S; Fernández Parra, B; Herrera Mozo, I; Pérez Pimiento, A; Rodríguez Mosquera, M; Santaolalla Montoya, M,
)
0.13
"The rabbits were randomly divided into 11 groups: oleic acid group; control group; treatment groups including low, middle and high dosage groups of Qingkailing and MP alone and combined, respectively."( [Therapeutic effect of Qingkailing and methylprednisolone injection alone or combined on the acute lung injury induced by oleic acid in rabbits].
Cui, HF; Du, GY; Gao, SR; Gao, W; He, R; Hui, LQ; Liang, RX; Wang, XR; Wu, ZL; Zhang, CY; Zhao, Y; Zhu, XX, 2005
)
0.33
" (2) A dosage lower than the one recommended in the literature is effective."( Benefits of low weekly doses of methotrexate in steroid-dependent asthmatic patients. A double-blind, randomized, placebo-controlled study.
Amengual, MJ; Comet, R; Domingo, C; Larrosa, M; Marín, A; Morón, A; Rué, M, 2006
)
0.33
" The observation indexes were time in hospital, pneumonia duration, mortality, glucocorticoid's gross dosage, glucocorticoid's average dosage of days and glucocorticoid use time."( [Effect of glucocorticoid with traditional Chinese medicine in severe acute aespiratory syndrome (SARS)].
Gao, FZ; He, LY; Hu, JQ; Jiao, Q; Li, P; Liang, ZW; Liu, BY; Liu, WM; Liu, XM; Ni, Q; Tong, XY; Wen, TC; Xie, YM, 2005
)
0.33
" The median of glucocorticoid' s gross dosage was 1,277."( [Effect of glucocorticoid with traditional Chinese medicine in severe acute aespiratory syndrome (SARS)].
Gao, FZ; He, LY; Hu, JQ; Jiao, Q; Li, P; Liang, ZW; Liu, BY; Liu, WM; Liu, XM; Ni, Q; Tong, XY; Wen, TC; Xie, YM, 2005
)
0.33
"Compared with the group of simplicity western mendicine, in the group of integratived Chinese and western mendicine, time in hospital shorten, pneumonia duration shorten, mortality fall, simultaneity, glucocorticoid's average dosage is decreased."( [Effect of glucocorticoid with traditional Chinese medicine in severe acute aespiratory syndrome (SARS)].
Gao, FZ; He, LY; Hu, JQ; Jiao, Q; Li, P; Liang, ZW; Liu, BY; Liu, WM; Liu, XM; Ni, Q; Tong, XY; Wen, TC; Xie, YM, 2005
)
0.33
"Glucocorticoid (GC) dosing is commonly based on body mass or surface area in children, although the drug effects appear to correlate with steroid exposure, rather than dose."( Methylprednisolone exposure in pediatric renal transplant patients.
Holmberg, C; Jänne, OA; Neuvonen, PJ; Raivio, T; Seikku, P, 2006
)
0.33
" Fecal oocyst production could be perpetuated by dosing at 10-day intervals."( Characterization of a single dose methylprednisolone acetate immune suppression model using Cryptosporidium muris and Cryptosporidium parvum.
Miller, TA; Schaefer, FW, 2006
)
0.33
" In this case, once the dosage of oral prednisone was increased and methotrexate was added to the therapeutic scheme, inflammation was controlled within 1 month."( Combination of azathioprine and corticosteroids in the treatment of serpiginous choroiditis.
Burnier, MN; Deschênes, J; Ozdal, PC; Vianna, RN, 2006
)
0.33
" Reduction in dosage of CNI may delay the development of CAN, leading to longer graft survival."( Stable graft function after reduction of calcineurin inhibitor dosage in paediatric kidney transplant patients.
Amann, K; Benz, K; Dittrich, K; Dötsch, J; Klare, B; Nüsken, KD; Plank, C; Rascher, W; Sauerstein, K; Stuppy, A, 2006
)
0.33
" Over a period of 9 months CNI dosage was stepwise reduced from CSA trough levels of 100-150 ng/ml to 50-70 ng/ml and Tac trough levels of 5-8 ng/ml to 2-3 ng/ml, respectively."( Stable graft function after reduction of calcineurin inhibitor dosage in paediatric kidney transplant patients.
Amann, K; Benz, K; Dittrich, K; Dötsch, J; Klare, B; Nüsken, KD; Plank, C; Rascher, W; Sauerstein, K; Stuppy, A, 2006
)
0.33
" A good prospective multicenter trial of high-dose methylprednisolone for traumatic brain injury should be considered in which dosage and timing parameters similar to those enacted for the NASCIS studies are used."( Are steroids really ineffective for severely head injured patients?
Kamano, S, 2000
)
0.31
" The norepinephrine dose-response curve displayed a shift to the left after incubation with methylprednisolone."( Femoral artery constriction by norepinephrine is enhanced by methylprednisolone in a rat model.
Drescher, W; Hassenpflug, J; Herdegen, T; Liebs, TR; Lohse, J; Pufe, T; Varoga, D, 2006
)
0.33
"03), to have taken a mean dosage >7."( Prevalence of conventional and lupus-specific risk factors for cardiovascular disease in patients with systemic lupus erythematosus: A case-control study.
Ambler, G; Bessant, R; Duncan, R; Gordon, C; Isenberg, DA; Rahman, A; Swanton, J, 2006
)
0.33
" At the age of 14 years, mycophenolate mofetil (MMF) was added to the maintenance therapy and the CSA dosage was reduced."( Fifteen-year remission of a steroid-resistant nephrotic syndrome sustained by cyclosporine A.
Drube, J; Ehrich, JH; Geerlings, C; Mengel, M; Taylor, R, 2007
)
0.34
" Additionally, free hepatic cytosolic GR and its mRNA data from a chronic infusion dosing study of MPL (0."( Assessing the dynamics of nuclear glucocorticoid-receptor complex: adding flexibility to gene expression modeling.
Almon, RR; DuBois, DC; Hazra, A; Jusko, WJ, 2007
)
0.34
" A comparison of datasets from the two different dosing regimens identified 358 genes that were regulated by MPL in response to both dosing regimens."( A microarray analysis of the temporal response of liver to methylprednisolone: a comparative analysis of two dosing regimens.
Almon, RR; DuBois, DC; Jusko, WJ, 2007
)
0.34
" Dosage effects of immunosuppressive drugs (tacrolimus, cyclosporin A, sirolimus, mycophenolic acid, and methylprednisolone) were evaluated in vitro and the assay was applied successfully to dialysis, renal transplant, and liver transplant patients."( Validation of immunological biomarkers for the pharmacodynamic monitoring of immunosuppressive drugs in humans.
Böhler, T; Budde, K; Glander, P; Gurragchaa, P; Kamar, N; Klupp, J; Neumayer, HH; Nolting, J; Reisener, K, 2007
)
0.34
" The use of bosentan for vasculitis had not been reported in children before the treatment of our patient, so its dosage was based on that used to produce vasodilation in children with pulmonary hypertension."( Polyarteritis nodosa resistant to conventional treatment in a pediatric patient.
García-Consuegra, J; González-Fernández, MA, 2007
)
0.34
" The discovered dose-effect relationship allows confirmation of the treatment response, thereby establishing the first step towards optimising the inolimomab dosage in future trials."( Exposure-effect population model of inolimomab, a monoclonal antibody administered in first-line treatment for acute graft-versus-host disease.
Darlavoix, I; Dartois, C; Freyer, G; Girard, P; Hénin, E; Michallet, M; Tranchand, B; Vermot-Desroches, C; You, B, 2007
)
0.34
" Comparison of the two data sets yielded 196 genes identified as regulated by MPL in both dosing regimens."( Microarray analysis of the temporal response of skeletal muscle to methylprednisolone: comparative analysis of two dosing regimens.
Almon, RR; DuBois, DC; Ghimbovschi, S; Hoffman, EP; Jusko, WJ; Yao, Z, 2007
)
0.34
") dosing for use in pharmacodynamic studies."( Pharmacokinetics of methylprednisolone after intravenous and intramuscular administration in rats.
Almon, RR; DuBois, DC; Hazra, A; Jusko, WJ; Pyszczynski, N, 2007
)
0.34
"Methylprednisolone concentrations in the perilymph of patients during cochlear implantation were compared after 3 dosing strategies of methylprednisolone solution for injection (40 mg/ml): 1) IT administration of up to 40 mg was injected into the middle ear through the external auditory canal via a 27-gauge needle passed through a small anterosuperior myringotomy; 2) IV administration of 1 mg/kg was given as a single injection over 30 seconds; 3) IV administration of 10 mg/kg was infused over 30 minutes."( Intratympanic versus intravenous delivery of methylprednisolone to cochlear perilymph.
Balkany, TJ; Begg, EJ; Bird, PA; Keast, AT; Murray, DP; Zhang, M, 2007
)
0.34
" The aim of this dosage finding study was to test the most promising corticosteroid protocol in a smaller but representative series, in order to optimize the settings of upcoming prospective and long-term multicenter studies."( Postoperative high-dose steroids do not improve mid-term survival with native liver in biliary atresia.
Becker, T; Harder, D; Leonhardt, J; Melter, M; Petersen, C; Ure, BM; Wasielewski, RV, 2008
)
0.35
" Of these, 196 genes were controlled by MPL under both dosing conditions."( Mathematical modeling of corticosteroid pharmacogenomics in rat muscle following acute and chronic methylprednisolone dosing.
Almon, RR; Dubois, DC; Ghimbovschi, S; Hoffman, EP; Jusko, WJ; Yao, Z,
)
0.13
" Serum was obtained from each patient with BP at least three times: before the initiation of treatment, during complete disease control just before the decrease in corticosteroid, and when the dosage of corticosteroid was successfully decreased to half the initial dose."( Serum levels of autoantibodies to BP180 correlate with disease activity in patients with bullous pemphigoid.
Feng, S; Jin, P; Lin, L; Sang, H; Shao, C; Wu, Q; Zhou, W, 2008
)
0.35
" Of the 24% who use steroids, the NASCIS II dosing regimen is most commonly followed."( Methylprednisolone for acute spinal cord injury: 5-year practice reversal.
Hamilton, MG; Hurlbert, RJ, 2008
)
0.35
" Dosage was in accordance with their pharmacokinetic properties and experience gained with experimental SCI."( Lack of neuroprotection with pharmacological pretreatment in a paradigm for anticipated spinal cord lesions.
Franco-Bourland, RE; Grijalva, I; Guízar-Sahagún, G; Ibarra, A; Madrazo, I; Martínez-Cruz, A; Rodríguez-Balderas, CA, 2009
)
0.35
" This study aimed to examine in rabbits the temporal relationships and dose-response effects of acute high-dose methylprednisolone succinate on diaphragmatic contractile and structural properties."( Acute effects of high-dose methylprednisolone on diaphragm muscle function.
Baker, MJ; Caiozzo, VJ; Fang, L; Nelson, RS; Pham, HT; Sassoon, CS; Zhu, E, 2008
)
0.35
" On admission, he was administered intravenous immunoglobulins at a dosage of 400 mg/kg/day for 5 days yet continued to worsen."( Corticosteroids can help distinguish between Guillain-Barré syndrome and first attack of chronic inflammatory demyelinating neuropathy: an illustrative case report.
Alexander, KJ; Alshubaili, AF; Santhamoorthy, P; Sharafuddin, KM, 2008
)
0.35
" Our aim was to determine the relationship between the dosage of steroids and the number and distribution of osteonecrotic lesions in patients treated with steroids during the SARS epidemic in Beijing, China in 2003."( Steroid-induced osteonecrosis: the number of lesions is related to the dosage.
Hernigou, P; Li, ZR; Liu, ZH; Wei, HY; Zhang, NF, 2008
)
0.35
" However, long-term dosing caused continuous hyperglycemia during and after infusion."( Pharmacodynamics of glucose regulation by methylprednisolone. II. normal rats.
Jin, JY; Jusko, WJ, 2009
)
0.35
" The results exemplify the importance of the steroid dosing regimen in mediating pharmacological and adverse metabolic effects."( Pharmacodynamics of glucose regulation by methylprednisolone. I. Adrenalectomized rats.
Jin, JY; Jusko, WJ, 2009
)
0.35
" Data were extracted from the published articles relating to: outcome; MP dosing regimen; species/strain; number of animals; methodological quality; type of injury induction; use of anaesthesia; functional scale used; and duration of follow-up."( Animal studies in spinal cord injury: a systematic review of methylprednisolone.
Akhtar, AZ; Pippin, JJ; Sandusky, CB, 2009
)
0.35
" IVIG resulted in a remarkable and durable response at decreased dosage (0."( [Efficacy of intravenous immunoglobulin in Arndt-Gottron scleromyxedema].
Guillet, G; Lopez, L; Villers, A; Wierzbicka-Hainaut, E, 2009
)
0.35
"Randomised trials comparing different routes of administration and dosage schemes of corticosteroid or adrenocorticotrophic hormone therapy versus a control group where no therapy considered effective for this condition was administered, unless it was also given in a similar way to the experimental group."( WITHDRAWN: Corticosteroids for Bell's palsy (idiopathic facial paralysis).
Alvarez, G; Ferreira, J; Salinas, RA, 2009
)
0.35
" No excess of lipid accumulation could be detected with the dosage and exposure time used."( The synthetic liver X receptor agonist GW3965 reduces tissue factor production and inflammatory responses in human islets in vitro.
Collins, JL; Dahle, MK; Foss, A; Korsgren, O; Lund, T; Scholz, H; Wang, JE, 2009
)
0.35
" With a suitable dosage addition of methylprednisolone to donor mice HSC mobilization regimen could avoid the increasing risk of graft rejection."( [Influence of methylprednisolone on cell component of donor graft and on H-2 haploidentical hematopoietic stem cell transplantation in mice].
Ding, BH; Li, YF; Liu, JM; Xuan, HB; Zhang, LS, 2009
)
0.35
" The present study compares the efficacy and safety of 2 different intravenous methylprednisolone (MTPiv) dosing regimens."( Treatment of Graves' ophthalmopathy with high-dose intravenous methylprednisolone: a comparison of two dosing regimens.
Alfayate Guerra, R; Arias Mendoza, N; González Sánchez, V; López Macia, A; Mauri Dot, M; Moreno-Pérez, O; Picó Alfonso, A; Sánchez-Ortiga, R, 2009
)
0.35
" In contrast to the postdose reductions of IMPDH activity observed early posttransplant, IMPDH activity within both treatment groups was elevated throughout the dosing interval at week 13."( Mycophenolate pharmacokinetics and pharmacodynamics in belatacept treated renal allograft recipients - a pilot study.
Bergan, S; Bremer, S; Holdaas, H; Jørgensen, PF; Midtvedt, K; Rootwelt, H; Stenstrøm, J; Vethe, NT, 2009
)
0.35
"The significant influence of MPA on IMPDH1 expression, possibly mediated through reduced guanine nucleotide levels, could explain the elevations of IMPDH activity within dosing intervals at week 13."( Mycophenolate pharmacokinetics and pharmacodynamics in belatacept treated renal allograft recipients - a pilot study.
Bergan, S; Bremer, S; Holdaas, H; Jørgensen, PF; Midtvedt, K; Rootwelt, H; Stenstrøm, J; Vethe, NT, 2009
)
0.35
" The results of the traditional functional methods showed that administration of the NASCIS dosage of MPSS following acute spinal cord contusion did not lead to any significant differences in the functional recovery of MPSS- vs."( Methylprednisolone fails to improve functional and histological outcome following spinal cord injury in rats.
Cabrita, AM; Costa, LM; Couto, PA; Di Scipio, F; Filipe, VM; Fornaro, M; Geuna, S; Magalhães, LG; Maurício, AC; Pereira, JE; Varejão, AS, 2009
)
0.35
" Mono-exponential kinetics after single intravenous dosing is considered."( Mean residence time as estimated from cropped and truncated moments.
Czock, D; Hartmann, B; Keller, F, 2009
)
0.35
" Thirty minutes after ASCI, the subjects in experimental group received MP injection through intraperitoneal with dosage of 30 mg/kg."( [Effects of high dose methylprednisolone on cell apoptosis and Bcl-2 expression after acute spinal cord injuries in rats].
Ma, LJ; Wu, HT; Zhang, JJ, 2009
)
0.35
" The use of systemic corticosteroids in the treatment of TEN is controversial because of a lack of randomized, controlled, prospective studies, and because the effects of steroid therapy vary depending on the dosage and time of its administration during the course of TEN."( Skin biopsies to assess response to systemic corticosteroid therapy in early-stage TEN: case report and review of the literature.
Céspedes, YP; Nigra, TP; O'Donoghue, JM; Rockley, PF, 2009
)
0.35
" Each group was divided into two subgroups by dosage of methylprednisolone (5 or 10 mg/kg body weight)."( Low levels of steroid-metabolizing hepatic enzyme (cytochrome P450 3A) activity may elevate responsiveness to steroids and may increase risk of steroid-induced osteonecrosis even with low glucocorticoid dose.
Azuma, T; Kadoya, Y; Kaneshiro, Y; Kim, M; Masada, T; Oda, Y; Takaoka, K; Tokuhara, Y; Wakitani, S, 2009
)
0.35
" He was effectively managed with methylprednisolone pulse therapy (500 mg/day x 3 days) followed by progressive dosage tapering."( [Case of microscopic polyangiitis presenting initially as prostatic vasculitis].
Akizawa, T; Ashikaga, E; Iyoda, M; Nagai, H; Shibata, T; Suzuki, H, 2009
)
0.35
" In summary, modern immunosuppression today allows us to reduce the dosage of steroids and to avoid the prolonged use of cyclophosphamide."( Induction and maintenance therapy in proliferative lupus nephritis.
Glassock, RJ; Moroni, G; Ponticelli, C,
)
0.13
" Due to lack of evidence, inclusion criteria was revised during the process of the review to include studies comparing different dosage of corticosteroids."( Corticosteroid regimens for treatment of acute and chronic graft versus host disease (GvHD) after allogenic stem cell transplantation.
Banihosseini, S; Ferrara, JL; Rabbani-Anari, M; Rahimi Darabad, R; Rohanizadegan, M; Salmasian, H; Shakiba, A, 2010
)
0.36
" Serum chromium levels were not assessed, so it is uncertain if the patient experienced chromium deficiency or if it was adequately treated with chromium supplementation, and a dose-response relationship could not be ascertained because the patient received a continuous infusion of chromium."( Improved glucose control associated with i.v. chromium administration in two patients receiving enteral nutrition.
Baker, WL; Bell, JL; Coleman, CI; Keating, K; Phung, OJ; Quercia, RA; White, CM, 2010
)
0.36
"Randomised trials comparing different routes of administration and dosage schemes of corticosteroid or adrenocorticotrophic hormone therapy versus a control group where no therapy considered effective for this condition was administered, unless it was also given in a similar way to the experimental group."( Corticosteroids for Bell's palsy (idiopathic facial paralysis).
Alvarez, G; Daly, F; Ferreira, J; Salinas, RA, 2010
)
0.36
" For five consecutively days, each patient received methylprednisolone by intravenous administration at a dosage of 15 mg/kg/day each 8 h, once a month for 3 months."( Methylprednisolone for the treatment of children with refractory epilepsy.
Diaz-Bustos, R; Mora-Puga, M; Palacios, GC; Ramirez-Campos, J; Sevilla-Castillo, RA, 2009
)
0.35
"The dose-response relationship of intrathecal midazolam was not evaluated in our study, so further study should be conducted with different doses of intrathecal midazolam for management of PHN."( Efficacy of intrathecal midazolam with or without epidural methylprednisolone for management of post-herpetic neuralgia involving lumbosacral dermatomes.
Dureja, GP; Jamal, A; Khan, M; Tahseen, M; Usmani, H,
)
0.13
" Fifty percent of the patients received tacrolimus (TRL) and the others cyclosporine (CsA), both dosed according to weight."( Cytomegalovirus infection after liver transplantation: prophylaxis and preemptive treatment--a single-center experience.
Campanella, L; Cuomo, O; Esposito, C; Ioia, G; Perrella, A; Taglialatela, D, 2010
)
0.36
" Our goal was to compare IL-1Ra activity in SLE patients with and without renal involvement and to determine the effect of different dosage of glucocorticosteroids used in 17 patients with active SLE without nephritis, 7 patients with inactive lupus nephritis (LN), and 8 patients with active LN, along with 10 healthy controls."( Measurement of interleukin-1 receptor antagonist in patients with systemic lupus erythematosus could predict renal manifestation of the disease.
Brugos, B; Dul, C; Gubisch, W; Kiss, E; Sipka, S; Szegedi, G; Zeher, M, 2010
)
0.36
" Following reinduction, the appearance of another small new lesion made the patient ineligible, as per protocol, for further dosing despite stabilization of her remaining lesions."( Continuous systemic corticosteroids do not affect the ongoing regression of metastatic melanoma for more than two years following ipilimumab therapy.
Binder, M; Erasim, C; Harmankaya, K; Hoos, A; Ibrahim, R; Koelblinger, C; Pehamberger, H, 2011
)
0.37
" Equivalent daily MP dosing with MP-dendrimer conjugate further diminished these values, with decreases of 87% and 67%, respectively."( In vivo efficacy of dendrimer-methylprednisolone conjugate formulation for the treatment of lung inflammation.
Bassett, DJ; Gao, X; Guru, BR; Inapagolla, R; Kannan, RM; Kurtoglu, YE; Lieh-Lai, M, 2010
)
0.36
" The dosage of immunosuppressive systemic therapy was reduced or able to be stopped in three patients (50%)."( Periocular corticosteroid injection in the management of uveitis in children.
Grigg, JR; Habot-Wilner, Z; Kabasele, PM; Lightman, S; McCluskey, P; Roufas, A; Sallam, A, 2010
)
0.36
" This case suggests that reducing the dosage of immunosuppressive agents can be an effective strategy for GVHD after liver transplantation."( Graft versus host disease after liver transplantation: a case report.
Gao, J; Gao, PJ; Huang, L; Leng, XS; Li, GM; Wang, D; Zhu, JY, 2010
)
0.36
" This review examines the role of a member of the newest class of TCs, the fourth-generation compound methylprednisolone aceponate (MPA) in AD management, with reference to the chemical structure, pharmacokinetics, efficacy in AD, safety assessed in preclinical and clinical trials and dosing considerations."( Balancing efficacy and safety in the management of atopic dermatitis: the role of methylprednisolone aceponate.
Luger, TA, 2011
)
0.37
" The MPL treatments caused reduction of food consumption and body weights in all dosing groups."( Dynamic modeling of methylprednisolone effects on body weight and glucose regulation in rats.
Almon, RR; DuBois, DC; Fang, J; He, Y; Jusko, WJ, 2011
)
0.37
" In particular, we tested the impact of dosing (1-10 μg/kg), mode of delivery (intravenous vs."( Low dose estrogen prevents neuronal degeneration and microglial reactivity in an acute model of spinal cord injury: effect of dosing, route of administration, and therapy delay.
Banik, NL; Das, A; Matzelle, DD; Ray, SK; Samantaray, S; Smith, JA; Varma, AK, 2011
)
0.37
" The aims of this study were to investigate CYP3A5 polymorphism's effect on TAC dosing and the age dependency of TAC dosing by testing blood concentrations, and the interaction between steroids and TAC during the first year after tx."( Influence of CYP3A5 polymorphism on tacrolimus maintenance doses and serum levels after renal transplantation: age dependency and pharmacological interaction with steroids.
Argibay, PF; Belloso, WH; Coccia, PA; Costa, L; Ferraris, JR; Ferraris, V; Ghezzi, LF; Jimenez, G; Larriba, JM; Redal, MA, 2011
)
0.37
" Intravenous methylprednisolone 30 mg/kg/d was given to all patients for 5 days in addition to a stable dosage of the regular antiepileptic drugs."( Interictal encephalography can influence patient selection for methylprednisolone therapy in pediatric refractory epilepsy.
Gandelman-Marton, R; Heyman, E; Lahat, E, 2012
)
0.38
" A daily oral dose of atorvastatin calcium treatment for 70 days weakened the long bones of methylprednisolone acetate treated rabbits irrespective of the dosage (2, 10, or 20 mg)."( Effect of atorvastatin on the cortical bones of corticosteroid treated rabbits.
Braitman, LE; Goldstein, DT; Handal, JA; John, TK; Khurana, JS; Saing, M; Samuel, SP, 2012
)
0.38
"The assessment of the dose-response relationship is important but not straightforward when the therapeutic agent is administered repeatedly with dose-modification in each patient and a continuous response is measured repeatedly."( An autoregressive linear mixed effects model for the analysis of unequally spaced longitudinal data with dose-modification.
Funatogawa, I; Funatogawa, T, 2012
)
0.38
"Male Lewis rats were dosed with lipopolysaccharide (50 μg/kg LPS) alone or with methylprednisolone (10 and 50 mg/kg) and sacrificed at different time points."( Pharmacokinetic/pharmacodynamic modeling of methylprednisolone effects on iNOS mRNA expression and nitric oxide during LPS-induced inflammation in rats.
Almon, RR; DuBois, DC; Jusko, WJ; Lepist, EI; Sukumaran, S, 2012
)
0.38
" LPS increased expression of iNOS mRNA in lung and increased plasma NO, while MPL dosing palliated this increase in a dose-dependent manner."( Pharmacokinetic/pharmacodynamic modeling of methylprednisolone effects on iNOS mRNA expression and nitric oxide during LPS-induced inflammation in rats.
Almon, RR; DuBois, DC; Jusko, WJ; Lepist, EI; Sukumaran, S, 2012
)
0.38
" However, after treating with exogenous steroids, dose-response studies showed hGR-S1(-349A) had a substantial augmentation in activity at higher concentrations of hydrocortisone and methylprednisolone when compared with hGRα, whereas hGR-S1 did not."( Enhanced steroid response of a human glucocorticoid receptor splice variant.
Amini, A; Baker, AC; Chew, VW; Cho, K; Green, TL; Greenhalgh, DG; Lim, D; Tung, K, 2012
)
0.38
" The incidence of calcineurin-inhibitor-induced pain syndrome was related to the dosage of tacrolimus (P > ."( Immunosuppressant-related hip pain after orthotopic liver transplant.
Chen, GH; Fu, BS; He, JW; Jiang, N; Li, H; Wang, GS; Wang, GY; Wang, K; Yang, Y; Zhang, J, 2013
)
0.39
"Pharmacokinetics of MP may differ among IA MPA dosing protocols, and MP may be detected in plasma and urine for a longer time than previously reported."( Pharmacokinetics of methylprednisolone acetate after intra-articular administration and subsequent suppression of endogenous hydrocortisone secretion in exercising horses.
Bertone, AL; Hothem, EA; Menéndez, MI; Phelps, MA, 2012
)
0.38
" Monitoring trough levels helps not only in reducing nephrotoxiicity but also in reducing the chances of acute rejection; although there is no international consensus, the trough concentration is used to determine dosing and the AUC for calculating the exposure of the patient to the drug."( Pharmacokinetics of tacrolimus in adult renal transplant recipients.
Madhavarapu, M; Mayur, P; Naik, P; Nayak, KS; Sritharan, V, 2012
)
0.38
"Trough level determination and a C2, C4 two-point limited sampling strategy may be useful to plan the dosing strategy and estimate the exposure of renal transplant patients to tacrolimus."( Pharmacokinetics of tacrolimus in adult renal transplant recipients.
Madhavarapu, M; Mayur, P; Naik, P; Nayak, KS; Sritharan, V, 2012
)
0.38
" Despite extensive scientific and clinical data on neurogenic osteoporosis, there is no consensus regarding the best pharmacotherapeutic agents, dosing regimens, or rehabilitative strategies for prevention and treatment of bone loss."( The changing landscape of spinal cord injury.
Cooper, JM; Juknis, N; Volshteyn, O, 2012
)
0.38
" Time series experiments showed that both corticosteroids and LPS but not insulin dosing resulted in the transient down-regulation of GRα mRNA."( Evidence for a glucocorticoid receptor beta splice variant in the rat and its physiological regulation in liver.
Almon, RR; DuBois, DC; Jusko, WJ; Sukumaran, S, 2013
)
0.39
" Immunologic studies suggest that unexpected lack of expansion of CD56(bright) NK cells and predictable decline in FoxP3+ T-regs combined with a transient interruption in daclizumab dosing may have contributed to this serious side effect."( CNS vasculitis in a patient with MS on daclizumab monotherapy.
Bielekova, B; Martin, J; McFarland, H; Oh, U; Ohayon, J; Richert, N; Vortmeyer, A, 2013
)
0.39
"Each isoform had a unique dose-response curve with the optimal activity depending on concentration and type of steroid."( Single nucleotide polymorphisms and type of steroid impact the functional response of the human glucocorticoid receptor.
Baker, AC; Chew, VW; Cho, K; Green, TL; Greenhalgh, DG; Lim, D; Tung, K, 2013
)
0.39
" Graded amounts of LPS (1-10,000 pg/ml) were spiked into normal blood to obtain dose-response curves: a good dose-response curve, from 1 to 1,000 pg/ml, was obtained for the LAL assay."( Interleukin-8 induces an elevation in the endotoxin activity assay (EAA) level: does the EAA truly measure the endotoxin level?
Endo, S; Inada, K; Inoue, Y; Kojika, M; Matsumoto, N; Suzuki, Y; Takahashi, G, 2013
)
0.39
" However, the optimal dosing of corticosteroids is unknown and their administration varies considerably between different institutions."( Methylprednisolone in neonatal cardiac surgery: reduced inflammation without improved clinical outcome.
Andersson, S; Keski-Nisula, J; Neuvonen, PJ; Olkkola, KT; Peltola, K; Pesonen, E; Sairanen, H; Suominen, PK; Tuominen, N, 2013
)
0.39
" However, no specific dosing recommendations have been made for children admitted to the PICU."( Corticosteroid therapy in critically ill pediatric asthmatic patients.
Canarie, MF; Carroll, CL; Faustino, EV; Giuliano, JS; Li, S; Pinto, MG, 2013
)
0.39
" Country of practice, years of experience, and PICU size were not associated with corticosteroid dosing preference."( Corticosteroid therapy in critically ill pediatric asthmatic patients.
Canarie, MF; Carroll, CL; Faustino, EV; Giuliano, JS; Li, S; Pinto, MG, 2013
)
0.39
" Future research is needed to determine the most appropriate corticosteroid dosage in this critically ill patient population."( Corticosteroid therapy in critically ill pediatric asthmatic patients.
Canarie, MF; Carroll, CL; Faustino, EV; Giuliano, JS; Li, S; Pinto, MG, 2013
)
0.39
"This study, despite its retrospective design, demonstrated the therapeutic efficacy of IVCY for NMOSD in both the acute and chronic phases of the disease and determined the IVCY dosage for Japanese women with NMOSD."( Efficacy of intravenous cyclophosphamide therapy for neuromyelitis optica spectrum disorder.
Maruo, Y; Nakamura, M; Nishimura, H; Sakushima, K; Sasaki, H; Takahashi, I; Takahashi, T; Tsuzaka, K; Yabe, I; Yaguchi, H; Yashima-Yamada, M, 2013
)
0.39
" A dosage of 500 mg intravenous methylprednisolone once weekly for 6 weeks, followed by 250 mg intravenous methylprednisolone once weekly for 6 weeks, with a total treatment period of 12 weeks was given."( Severe eyelid oedema in Graves' ophthalmopathy.
Adamidou, F; Anagnostis, P; Karras, S; Poulasouchidou, M, 2013
)
0.39
" This randomized trial was designed to prospectively evaluate the effect of specific glucocorticoid dosing protocols on inflammatory markers in neonatal cardiac surgery requiring cardiopulmonary bypass."( Preoperative steroid treatment does not improve markers of inflammation after cardiac surgery in neonates: results from a randomized trial.
Atz, AM; Baker, NL; Bradley, SM; Butts, RJ; Graham, EM; McGowan, FX; McHugh, KE; Reeves, ST; Spinale, FG; Stroud, RE, 2014
)
0.4
" This dosage was continued until oxygenation improved, and the treatment was gradually tapered (by 20 mg every 2-3 days) to the previous maintenance dosage."( Moderate-dose glucocorticoids as salvage therapy for severe pneumonia in renal transplant recipients: a single-center feasibility study.
Han, Y; He, HY; Ju, MJ; Luo, Z; Rong, RM; Tu, GW; Xu, M; Xue, ZG; Zhu, TY, 2014
)
0.4
" Assessed were dynamic changes of food intake and systemic factors (plasma glucose, insulin, free fatty acids (FFA) and leptin) and tissue-specific biomarkers (cAMP, phosphoenolpyruvate carboxykinase (PEPCK) mRNA and enzyme activity, leptin mRNA, interleukin 6 receptor type 1 (IL6R1) mRNA and Insulin receptor substrate-1 (IRS-1) mRNA) after acute and chronic dosing with MPL along with the GC receptor (GR) dynamics in each target organ."( Meta-modeling of methylprednisolone effects on glucose regulation in rats.
Almon, RR; Dubois, DC; Fang, J; Jusko, WJ; Sukumaran, S, 2013
)
0.39
"Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU), and none have evaluated the effect of CS dosing regimens on mortality."( Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary disease.
Allen, RR; Kiser, TH; Moss, M; Valuck, RJ; Vandivier, RW, 2014
)
0.4
" Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials."( Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary disease.
Allen, RR; Kiser, TH; Moss, M; Valuck, RJ; Vandivier, RW, 2014
)
0.4
" However, the clinical benefit is limited by side effects due to the chronic use and generally high dosage that is required for effective treatment."( Systemic treatment with glutathione PEGylated liposomal methylprednisolone (2B3-201) improves therapeutic efficacy in a model of ocular inflammation.
Appeldoorn, CC; de Boer, M; Gaillard, PJ; Reijerkerk, A; Rip, J, 2014
)
0.4
"To analyze the clinical manifestations of refractory Mycoplasma pneumoniae pneumonia (RMPP) which unresponded to methylprednisolone in the dosage of 2 mg/(kg·d) for 3 days."( [Clinical features and treatment of refractory Mycoplasma pneumoniae pneumonia unresponded to conventional dose methylprednisolone in children].
Chen, L; Liu, J; Wu, J; Yang, Y; Zhao, S, 2014
)
0.4
" High dosage steroid treatment was started, with good response."( Cytomegalovirus-related necrotising vasculitis mimicking Henoch-Schönlein syndrome.
Buoncompagni, A; Coccia, MC; D'Alessandro, M; Martini, A; Minoia, F; Picco, P,
)
0.13
" In summary, in the murine MOG-EAE model of MS, a glutathione PEGylated liposomal formulation of MP (2B3-201) is clinically and histologically as effective as free MP at one tenth of the dosage as well as at a lower application frequency and clearly more effective than the same dosage of free MP."( Glutathione PEGylated liposomal methylprednisolone (2B3-201) attenuates CNS inflammation and degeneration in murine myelin oligodendrocyte glycoprotein induced experimental autoimmune encephalomyelitis.
Appeldoorn, CC; Gaillard, PJ; Gladdines, W; Lee, DH; Linker, RA; Reijerkerk, A; Rötger, C, 2014
)
0.4
" Here, we describe a highly reproducible strategy, enabling a global, large-scale investigation of the expression dynamics of corticosteroid-regulated proteins in livers from adrenalectomized rats over 11 time points after drug dosing (0."( Highly multiplexed and reproducible ion-current-based strategy for large-scale quantitative proteomics and the application to protein expression dynamics induced by methylprednisolone in 60 rats.
Almon, RR; Duan, X; DuBois, DC; Jusko, WJ; Li, J; Nouri-Nigjeh, E; Qu, J; Shen, X; Sukumaran, S; Tu, C, 2014
)
0.4
" On multivariable regression, greater number of corticosteroid doses but not cumulative corticosteroid dosage was significantly associated with low 48-hour AVP concentration (β=-4."( Effect of corticosteroids on arginine vasopressin after pediatric cardiac surgery.
Chen, H; Mastropietro, CW; Miletic, K; Rossi, NF, 2014
)
0.4
" Further safety and dose-response studies are required to allow recommendations for general practice."( Preoperative methylprednisolone enhances recovery after endovascular aortic repair: a randomized, double-blind, placebo-controlled clinical trial.
Andersen, A; de la Motte, L; Groenvall, JB; Kehlet, H; Lönn, L; Nielsen, CH; Nielsen, HB; Schroeder, TV; Vogt, K, 2014
)
0.4
"We evaluated histological changes occurring in renal biopsy specimens, between the time before initial induction therapy and after 12 months' maintenance therapy, as well as changes in laboratory parameters, SLE disease activity (SLEDAI), and dosage of corticosteroid (CS) in childhood-onset systemic lupus erythematosus (SLE) patients treated with mycophenolate mofetil (MMF)."( Mycophenolate mofetil as maintenance therapy for childhood-onset systemic lupus erythematosus patients with severe lupus nephritis.
Imagawa, T; Kikuchi, M; Kizawa, T; Miyamae, T; Mori, M; Nagahama, K; Nakamura, T; Nozawa, T; Okudela, K; Tsutsumi, H; Yokota, S, 2015
)
0.42
"Monitoring MPA-C0 and individualized MMF dosing help to prevent acute graft rejection, reducing drug toxicity and complications, and improving graft survival rate after renal transplantation."( [Therapeutic window of mycophenolate mofetil for preventing acute graft rejection following renal transplantation].
Luo, M; Yu, L; Zhou, M, 2014
)
0.4
" Systemic treatment usually begins with high dosage corticosteroids."( Atypical Cogan's syndrome: a case report and summary of current treatment options.
Jančatová, D; Komínek, P; Matoušek, P; Zeleník, K, 2015
)
0.42
" However, the dosing and the duration of immunosuppressive therapy have not been systematically studied in the setting of treating ipilimumab-induced irAEs."( Ipilimumab-induced toxicities and the gastroenterologist.
Bye, W; Cheng, R; Cooper, A; Kench, J; McNeil, C; Shackel, N; Watson, G, 2015
)
0.42
"Thirty adult female SD rats were randomly divided into 5 equal groups, namely the sham-operated group, SCI group, SCI with MP treatment group (MP group, with intramuscular injection of 50 mg/kg MP within 8 hours after SCI and then dosage reduced 10 mg/kg daily), SCI with GB treatment group (GB group, with intragastric gavage of GB 50 mg/kg once daily for 7 days), and combined GB and MP treatment group."( [Effect of Gold Belt combined with methylprednisolone on motor function and brain-derived neurotrophic factor expression in rats following traumatic spinal cord injury].
Li, C; Wang, T; Xu, Z, 2015
)
0.42
" Dosage and treatment decisions were at the discretion of the physicians."( Bortezomib-containing regimens are effective in multiple myeloma--results of a non-interventional phase IV study.
Alkemper, B; Gaede, B; Knauf, W; Reschke, D; Schlag, R; Schmits, R; Schütz, S; Schwarzer, A; Tapprich, C, 2015
)
0.42
" However, symptoms relapsed when the dosage of corticosteroid was tapered, and multiple lung nodules were found with the symptom of dyspnea in chest computed tomography scan during the follow-up period."( Weber-Christian disease presenting with lung nodules dramatically improved with corticosteroid therapy: one case report and literature review.
Ji, LL; Wang, Y; Zhang, S; Zhang, Z; Zhao, J, 2018
)
0.48
" Heterogeneity was related in part to the dosing strategy."( Corticosteroids for treating sepsis.
Annane, D; Bellissant, E; Bollaert, PE; Briegel, J; Keh, D; Kupfer, Y, 2015
)
0.42
" We conducted a retrospective review to compare efficacy of different dosing regimes of IVCS."( Clinical Experience of Use of High-dose Intravenous Methylprednisolone in Children With Acute Moderate to Severe Colitis.
Auth, MK; Baillie, C; Crook, K; Finnamore, HE; Krishnamurthy, B; Venkatesh, K; Vora, R; Whittle, E, 2016
)
0.43
" Cases (1555 patients with SLE who developed HZ) and controls (3049 age- and sex-matched patients with SLE but without HZ) were analyzed for use of various immunosuppressive medications in the preceding 3-month period, and dose-response relationships were determined."( Immunosuppressive medication use and risk of herpes zoster (HZ) in patients with systemic lupus erythematosus (SLE): A nationwide case-control study.
Chen, GS; Hu, SC; Lin, CL; Lin, YC; Wang, TN; Yen, FL, 2016
)
0.43
" The correct timing and corticosteroid dosage in the context of broad-spectrum antimicrobial therapy might further improve the outcomes of patients with LOSP."( Late-onset severe pneumonia after allogeneic hematopoietic stem cell transplantation: prognostic factors and treatments.
Chen, H; Chen, YH; Han, W; Huang, XJ; Liu, KY; Mo, XD; Wang, FR; Wang, JZ; Wang, Y; Xu, LP; Yan, CH; Zhang, XH, 2016
)
0.43
" TCR was administered by oral route at the scheduled dosage while the 50% of oral dosage was used by SL route, taking into account the absence of liver first pass."( Sublingual administration improves systemic exposure of tacrolimus in kidney transplant recipients: comparison with oral administration.
Apicella, L; Balletta, MM; Capone, D; Carrano, R; Federico, S; Mosca, T; Nappi, R; Russo, L; Sabbatini, M; Santangelo, M; Tarantino, G, 2016
)
0.43
" Because of the patient's susceptibility to infections, the attempt to gradually reduce glucocorticoid dosage induced a relapse of PH."( A complicated case of primary hypophysitis with bilateral intracavernous carotid artery occlusion.
Katsiveli, P; Kounadi, T; Lymperopoulos, K; Papanastasiou, L; Piaditis, G; Sfakiotaki, M; Voulgaris, N, 2016
)
0.43
"The HPLC-MS analytical method is an alternative to HPLC-MS/MS methods, sensitive enough for identifying and quantifying steroids in vitreous humor at a therapeutic dosage scale."( Determination of Three Corticosteroids in the Biologic Matrix of Vitreous Humor by HPLC-tandem Mass Spectrometry: Method Development and Validation.
Fraile, JM; Garcia-Martin, E; Mayoral, JA; Otín-Mallada, S; Pablo, LE; Polo-Llorens, V; Prieto, E; Vispe, E, 2017
)
0.46
" The average dosage of exogenous insulin is 5100 U/d."( A systemic lupus erythematosus patient presenting as type B insulin resistance complicated with cryoglobulinemia.
Huang, Q; Yan, Y; Zhao, H; Zuo, L, 2017
)
0.46
"Randomised trials and quasi-randomised trials comparing different routes of administration and dosage schemes of corticosteroid or adrenocorticotrophic hormone therapy versus a control group receiving no therapy considered effective for this condition, unless the same therapy was given in a similar way to the experimental group."( Corticosteroids for Bell's palsy (idiopathic facial paralysis).
Daly, F; Gagyor, I; Gammie, F; Madhok, VB; Somasundara, D; Sullivan, F; Sullivan, M, 2016
)
0.43
" Rituximab use resulted in a significant reduction in steroid dosage during follow-up."( Efficacy and safety of rituximab therapy in patients with pemphigus vulgaris: first report from Turkey.
Akman Karakaş, A; Alpsoy, E; Bilgiç Temel, A; Bozkurt, S; Dicle, Ö; Erat, A; Ergün, E; Eskiocak, AH; Koç, S; Nazlım, B; Özkesici, B; Uğurlu, N; Uzun, S; Yılmaz, E, 2016
)
0.43
" In spite of the temporary remission after re-initiation of oral steroid therapy, reduction of oral steroid dosage resulted in new lesion formation apart from the initial locations."( An adult-onset multiphasic disseminated encephalomyelitis (MDEM) presenting favorable response to steroid therapy.
Fujimura, H; Fukada, K; Hazama, T; Inoue, K; Kinoshita, M; Sugimura, Y, 2016
)
0.43
" Requirement of mean daily dosage of prednisone was significantly lower in RTX group [p = 0."( Efficacy and safety of rituximab in comparison with common induction therapies in pediatric active lupus nephritis.
Babu, BG; Basu, B; Roy, B, 2017
)
0.46
" Moreover, in vivo fluorescence molecular imaging showed that BSA633-MP was mainly accumulated in the liver and kidney after intravenous dosing for 24 h."( Albumin-based nanoparticles as methylprednisolone carriers for targeted delivery towards the neonatal Fc receptor in glomerular podocytes.
Chen, M; Mao, H; Qian, J; Wang, N; Wu, L; Xing, C; Zhang, B; Zhao, X, 2017
)
0.46
" The results of pulmonary function tests, Asthma Control Test (ACT) and Asthma Health Questionnaire (AHQ)-33 scores, the dosage of methylprednisolone during the 12-month treatment period, and the number of emergency visits prior to the start of treatment with omalizumab were compared in patients pre- and post-treatment with omalizumab."( Efficacy of long-term omalizumab therapy in patients with severe asthma.
Arai, M; Mineshita, M; Miyazawa, T; Saji, J; Yamamoto, T, 2017
)
0.46
"020) and the dosage of methylprednisolone (871."( Efficacy of long-term omalizumab therapy in patients with severe asthma.
Arai, M; Mineshita, M; Miyazawa, T; Saji, J; Yamamoto, T, 2017
)
0.46
" While transcriptomic regulation following methylprednisolone (MPL) dosing has been temporally examined in rat liver, proteomic assessments are needed to better characterize the tissue-specific functional aspects of MPL actions."( Functional proteomic analysis of corticosteroid pharmacodynamics in rat liver: Relationship to hepatic stress, signaling, energy regulation, and drug metabolism.
Almon, RR; Ayyar, VS; DuBois, DC; Jusko, WJ; Qu, J; Sukumaran, S, 2017
)
0.46
" After the publication of two randomized clinical trials in postherpetic neuralgia patients treated with similar intrathecal methylprednisolone acetate (MPA) dosing regimes with conflicting results; one showing significant pain reduction (Kotani N, Kushikata T, Hashimoto H, Kimura F, Muraoka M, Yodono M, Asai M, Matsuki A: Intrathecal methylprednisolone for intractable postherpetic neuralgia."( Analgesic properties of intrathecal glucocorticoids in three well established preclinical pain models.
Kalkman, CJ; Rijsdijk, M; Svensson, CI; Wijck, AJ; Yaksh, TL, 2016
)
0.43
" The pharmacokinetic/pharmacodynamic/pharmacogenomic effects of acute and chronic methylprednisolone (MPL) dosing on the tissue-specific dynamics of GILZ expression were examined in rats."( Mechanistic Multi-Tissue Modeling of Glucocorticoid-Induced Leucine Zipper Regulation: Integrating Circadian Gene Expression with Receptor-Mediated Corticosteroid Pharmacodynamics.
Almon, RR; Ayyar, VS; DuBois, DC; Jusko, WJ, 2017
)
0.46
"012), and controversy with other studies could be because of difference in corticosteroid dosage and small number of patients."( Assessment of the Prevalence and Risk Factors Associated With Glucocorticoid-Induced Diabetes Mellitus in Pemphigus Vulgaris Patients.
Alizadeh, N; Darjani, A; Eftekhari, H; Gharaei Nejad, K; Hedayati Emami, MH; Nickhah, N; Rafiei, R, 2017
)
0.46
" Removal of infected teeth should be performed as soon as possible in order to reduce the dosage of corticosteroids and occcurence rate of OFG."( Orofacial granulomatosis: A case report of three cases may be caused by apical periodontitis.
Wang, J; Wang, W; Yu, X; Zhang, W, 2017
)
0.46
" Transdermal drug delivery system is the main route with discrete, self-contained dosage forms when placed on the skin, transporting the medicament through the skin into the systemic circulation in a wellcontrolled manner."( Design and Evaluation of Transdermal Patches of Timolol Maleate.
Jamakandi, VG; Panchayya Hiremath, SS; Reddy, JJ, 2018
)
0.48
" There was no significant correlation between age, body mass index, blood pressure, cumulative dosage, duration time of glucocorticoid, mean daily dosage and glucocorticoid-induced ocular hypertension (P>0."( [Clinical characteristics of glucocorticoid-induced eye adverse reactions in children with primary nephrotic syndrome].
Ding, J; Liu, XY; Su, BG; Wang, F; Xiao, HJ; Zhang, HW; Zhao, Y, 2017
)
0.46
" The effects of the Expanded Disability Status Scale (EDSS), duration of the disease, and cumulative dosage of medications on menopausal age were evaluated."( Effects of multiple sclerosis and medications on menopausal age.
Bilgiç, A; Bölük, C; Köseoğlu Toksoy, C; Taşdemir, M; Türk Börü, Ü, 2018
)
0.48
" Both dose and dosing frequency can be reduced by incorporating free MP in glutathione-PEGylated liposomes, creating a slow-release formulation with reduced toxicity and prolonged peripheral efficacy."( Glutathione-PEGylated liposomal methylprednisolone in comparison to free methylprednisolone: slow release characteristics and prolonged lymphocyte depression in a first-in-human study.
Gaillard, PJ; Gladdines, W; Groeneveld, GJ; Kanhai, KMS; Klaassen, ES; Stavrakaki, I; Zuiker, RGJA, 2018
)
0.48
" oral dexamethasone versus oral prednisone), with consideration for dosing and pharmacokinetic properties, to better identify the optimal IM or oral corticosteroid regimens to improve patient outcomes."( Intramuscular versus oral corticosteroids to reduce relapses following discharge from the emergency department for acute asthma.
Campbell, S; Cross, E; Kirkland, SW; Rowe, BH; Villa-Roel, C, 2018
)
0.48
" Dosage and speed of infusion of Daratumumab have to be strictly controlled."( [Infusion of Daratumumab in Combination Therapies - Practical Information for The Outpatient Area].
Engelhardt, M; Munder, M; Salwender, H; Scheid, C, 2018
)
0.48
"0%) were treated by adjusting the dosage of immunosuppressive agents, and 6 (14."( Acute allograft rejection in liver transplant recipients: Incidence, risk factors, treatment success, and impact on graft failure.
Beckebaum, S; Cicinnati, VR; Dogan, N; Hüsing-Kabar, A; Kabar, I; Schmidt, HH, 2018
)
0.48
" The PFIC2 patient had abnormal liver function 19 months after LT, and recovered after administration of increased dosage of immunosuppressant agents."( Liver Transplantation for Progressive Familial Intrahepatic Cholestasis.
Liu, Y; Qu, W; Sun, LY; Wei, L; Zeng, ZG; Zhu, ZJ, 2018
)
0.48
" Dexamethasone (4 mg/mL) and methylprednisolone (20 mg/mL) were given transtympanically to 22 and 24 patients, respectively, one dosage per day for 5 consecutive days."( Intratympanic Methylprednisolone versus Dexamethasone for the Primary Treatment of Idiopathic Sudden Sensorineural Hearing Loss.
Çetik, F; Dağkıran, M; Doğrusöz, M; Kıroğlu, M; Özdemir, S; Sürmelioğlu, Ö; Tarkan, Ö; Tuncer, Ü, 2018
)
0.48
" No significant statistical differences in the cumulative dosage of methylprednisolone or occurrence of restrictive myopathy, raised intraocular pressure, proptosis, and exposure keratopathy between the groups at 0, 3, 6, 12, and 18 months were found."( Methotrexate as an Adjuvant in Severe Thyroid Eye Disease: Does It Really Work as a Steroid-Sparing Agent?
Chng, CL; Choo, CT; Lang, S; Looi, A; Ming Sie, N; Seah, LL; Shen, S; Yang, M; Yong, KL,
)
0.13
"Frequent injection of high-dose methylprednisolone (MP) is used to treat spinal cord injury (SCI), but free MP is associated with various side effects and its water solubility is low, limiting potential dosing regimes and administration routes."( NEP
Deng, R; Hao, N; Huang, J; Li, C; Li, J; Lin, Y; Lyu, J; Zhang, Q; Zhong, Z, 2019
)
0.51
"Although steroids are effective for multiple types of acute facial palsies, an appropriate dosage remains to be established."( Comparison of the efficacy of various doses of steroids for acute facial palsy.
Choi, J; Han, MS; Jeong, YJ; Nam, KJ; Rah, Y, 2019
)
0.51
" We also conducted a dose-response meta-analysis to analyze the cumulative dosage and SONFH risk in mutation carriers."( Association between genetic polymorphisms and osteonecrosis in steroid treatment populations: a detailed stratified and dose-response meta-analysis.
Jing, M; Yang, J; Yang, X, 2019
)
0.51
" For patients with liver failure and HLH, the dosage of glucocorticoid should be reduced to avoid serious side effects."( Clinical characteristics of liver failure with hemophagocytic lymphohistiocytosis.
Dong, J; Hu, Z; Jia, L; Li, J; Meng, Q; Xie, F; Yao, Q; Yu, H; Zhao, Y; Zhu, Y, 2019
)
0.51
" Potential time-dependent interplay between sex hormone and glucocorticoid signaling in vivo was assessed by comparing the enhancement of GILZ by MPL in the uterus [high estrogen receptor (ER) density] and in liver (lower ER density) from male and female rats dosed within the proestrus (high estradiol/progesterone) and estrus (low estradiol/progesterone) phases of the rodent estrous cycle."( Modeling Corticosteroid Pharmacokinetics and Pharmacodynamics, Part III: Estrous Cycle and Estrogen Receptor-Dependent Antagonism of Glucocorticoid-Induced Leucine Zipper (GILZ) Enhancement by Corticosteroids.
Almon, RR; Ayyar, VS; DuBois, DC; Jusko, WJ, 2019
)
0.51
"Due to the continuing debates on the utility of high-dose methylprednisolone (MP) early after acute spinal cord injury (ASCI), we aimed to evaluate the therapeutic and adverse effects of high-dose MP according to the second National Acute Spinal Cord Injury Study (NASCIS-2) dosing protocol in comparison to no steroids in patients with ASCI by performing a meta-analysis on the basis of the current available clinical trials."( High-dose methylprednisolone for acute traumatic spinal cord injury: A meta-analysis.
He, L; Liu, B; Liu, Z; Luo, C; Pang, M; Rong, L; Yang, Y, 2019
)
0.51
" The decreased recovery of mainly sufentanil and propofol could lead to suboptimal dosing of patients during cardiac surgery with CPB."( In Vitro Recovery of Sufentanil, Midazolam, Propofol, and Methylprednisolone in Pediatric Cardiopulmonary Bypass Systems.
Bogers, AJJC; Kinzig, M; Koch, BCP; Sörgel, F; Stolker, RJ; Tibboel, D; van Hoeven, MPJ; van Rosmalen, J; van Saet, A; Wildschut, ED; Zeilmaker-Roest, GA, 2020
)
0.56
"Methylprednisolone is used in neonates to modulate cardiopulmonary bypass (CPB)-induced inflammation, but optimal dosing and exposure are unknown."( Population Pharmacokinetic/Pharmacodynamic Modeling of Methylprednisolone in Neonates Undergoing Cardiopulmonary Bypass.
Cohen-Wolkowiez, M; Dumond, J; Gonzalez, D; Graham, EM; Hill, KD; Hornik, CP; Wu, H, 2019
)
0.51
" Compared with conventional group, glucocorticoid dosage and the occurrence rate of hematuria and/or proteinuria within 3 months were lower in HP group."( Changes of inflammatory mediators and oxidative stress indicators in children with Henoch-Schönlein purpura and clinical effects of hemoperfusion in the treatment of severe Henoch-Schönlein purpura with gastrointestinal involvement in children.
Deng, F; Dong, Y; Wu, L; Zhu, Y, 2019
)
0.51
" HP can reduce glucocorticoid dosage and the rate of renal involvement in children with severe HSP with GI involvement."( Changes of inflammatory mediators and oxidative stress indicators in children with Henoch-Schönlein purpura and clinical effects of hemoperfusion in the treatment of severe Henoch-Schönlein purpura with gastrointestinal involvement in children.
Deng, F; Dong, Y; Wu, L; Zhu, Y, 2019
)
0.51
" However, to date, the use of glucocorticoid therapy in SMPP is limited to small case series, and the glucocorticoid dosage for children with SMPP has not been established."( Meta-analysis of the Clinical Efficacy and Safety of High- and Low-dose Methylprednisolone in the Treatment of Children With Severe Mycoplasma Pneumoniae Pneumonia.
Deng, ZZ; Sun, LL; Wang, CJ; Ye, C; Zhou, YL; Zuo, SR, 2020
)
0.56
" Changes in serum thyroid hormone concentrations were evaluated in the short-term period (24 h and 7 days) and after a cumulative dosage of 400 and 800 mg equivalents of methylprednisolone; in addition, healing time and duration of exposure to GCs were calculated."( Effect of high-dose intravenous glucocorticoid therapy on serum thyroid hormone concentrations in type 2 amiodarone-induced thyrotoxicosis: an exploratory study.
Bartalena, L; Bogazzi, F; Cappellani, D; Manetti, L; Martino, E; Urbani, C, 2020
)
0.56
"We report the case of a patient suffering from duplicity of myotonic dystrophy type 1 and ulcerative colitis whose treatment for ulcerative colitis included repeated administrations of descending doses of methylprednisolone and in whom we found an association between methylprednisolone dosing and cessation of myotonia."( The Association of methylprednisolone dosing to cessation of myotonia in a patient with myotonic dystrophy type 1.
Bednařík, J; Horák, T; Horáková, M; Voháňka, S, 2020
)
0.56
" Because of suboptimal response after 2 doses, manifested by increasing drowsiness, further fall in platelets and rising ferritin, methylprednisolone dosage was increased to 30 mg/kg/day with the addition of oral cyclosporine (4 mg/kg/day)."( Experience with Cidofovir as an adjunctive therapy in a patient of adenovirus-induced macrophage activation syndrome in systemic arthritis.
Bose, N; Chowdhury, K; Pal, P; Poddar, A; Saha, A, 2020
)
0.56
" During surgery, MP was administered at a dose of 500 mg; thereafter, the dosage was tapered rapidly, and the drug was discontinued on day 14 post transplant."( Early Steroid Withdrawal Protocol With Basiliximab and Rituximab in ABO-Incompatible Kidney Transplant Recipients.
Koyama, I; Nakajima, I; Shirai, H; Tojimbara, T; Yamazaki, T; Yashima, J,
)
0.13
" The patient benefited from a back-titrated regimen of methylprednisolone with the initial dosage of 2 mg/kg and anti-fibrotic effect of nintedanib and was successfully weaned from the ventilator."( Pulmonary fibrosis and cytokine release syndrome after hyperactivation with sintilimab.
Chen, X; Hu, J; Li, Y; Luo, C; Zuo, X, 2020
)
0.56
" For the treatment of COVID-19 pneumonia, systemic and in-depth investigation is needed to determine the timing and dosage of glucocorticoids needed to inhibit overwhelming inflammatory response and not the protective immune response to COVID-19 pneumonia."( Clinical efficacy of glucocorticoid on the treatment of patients with COVID-19 pneumonia: A single-center experience.
Hu, Y; Hu, Z; Li, L; Peng, P; Wang, T; Wang, X; Zhang, Z, 2020
)
0.56
" Discontinuation or dosage reduction of immunosuppressives and other treatment information was documented."( Clinical course of COVID-19 disease in immunosuppressed renal transplant patients
Ateş, ÖF; Çetin, ES; Dheir, H; Fırat, N; Genç, AB; Karabay, O; Köroğlu, M; Muratdağı, G; Özmen, K; Sipahi, S; Tomak, Y; Yaylacı, S, 2021
)
0.62
"A total of 262 patients were grouped as receiving usual care (n = 75), methylprednisolone dosed at least at 1mg/kg/day for ≥ 3 days (n = 104), or dexamethasone dosed at least at 6 mg for ≥7 days (n = 83)."( A Comparison of Methylprednisolone and Dexamethasone in Intensive Care Patients With COVID-19.
Ko, JJ; Mehta, N; Qiao, R; Wald-Dickler, N; Wu, C; Yang, W, 2021
)
0.62
"In COVID-19 patients requiring mechanical ventilation, sufficiently dosed methylprednisolone can lead to a further decreased mortality as compared to dexamethasone."( A Comparison of Methylprednisolone and Dexamethasone in Intensive Care Patients With COVID-19.
Ko, JJ; Mehta, N; Qiao, R; Wald-Dickler, N; Wu, C; Yang, W, 2021
)
0.62
"Currently, no consensus exists on the dosing regimen of corticosteroids in relation to disease severity in pemphigus vulgaris."( Comparison of three different dose regimens of methylprednisolone as initial therapy for pemphigus vulgaris of moderate severity: A single-center retrospective study from Turkey.
Babuna Kobaner, G; Kiliç Sayar, S; Küçükoğlu, R; Polat Ekinci, A, 2021
)
0.62
" Finally, increased Axon miRs dosage with methylprednisolone, significantly promotes functional recovery and remyelination."( A 3D Fiber-Hydrogel Based Non-Viral Gene Delivery Platform Reveals that microRNAs Promote Axon Regeneration and Enhance Functional Recovery Following Spinal Cord Injury.
Chew, EGY; Chew, SY; Chin, JS; Foo, JN; Lian, MM; Lin, J; Lin, VPH; Milbreta, U; Wu, W; Zhang, K; Zhang, N, 2021
)
0.62
" GC hormone that can specifically target the lung might decrease the effective dosage and thus reduce GC-associated side effects."( Development and assessment of the efficacy and safety of human lung-targeting liposomal methylprednisolone crosslinked with nanobody.
Chen, SS; Chen, T; He, X; Li, HP; Li, N; Lu, LQ; Qiu, H; Song, JC; Tang, DL; Weng, D; Wu, Q; Yin, ZF; Zhao, MM; Zhou, NY, 2021
)
0.62
" However, whether higher dosing of steroids results in better outcomes has been debated."( Do high-dose corticosteroids improve outcomes in hospitalized COVID-19 patients?
Dalton, D; Guddati, AK; Hererra, M; Jefferies, D; Kumar, G; Meersman, M; Nanchal, R; Patel, D; Sakhuja, A, 2022
)
0.72
" We examined the effect of corticosteroid dosing on time to alanine aminotransferase (ALT) normalization, need for additional immunosuppression, and steroid-related complications."( Effect of corticosteroid dosing on outcomes in high-grade immune checkpoint inhibitor hepatitis.
Grover, S; Hodi, FS; Li, M; Rahma, OE; Sack, JS; Vogel, AS; Wong, D; Zucker, SD, 2022
)
0.72
" Effects on eGFR slope and albuminuria will also be assessed overall, as well as by the steroid dosing regimen."( The Therapeutic Evaluation of Steroids in IgA Nephropathy Global (TESTING) Study: Trial Design and Baseline Characteristics.
Agarwal, R; Barbour, S; Billot, L; Cass, A; Cattran, D; Chan, TM; Feehally, J; Floege, J; Glassock, R; Hladunewich, MA; Hooi, LS; Jardine, MJ; Jha, V; Johnson, DW; Levin, A; Liu, ZH; Lv, J; Monaghan, H; Perkovic, V; Reich, HN; Remuzzi, G; Wheeler, DC; Wong, MG; Woodward, M; Wu, Y; Zhang, H; Zhao, M, 2021
)
0.62
"Although the most recent systematic review and meta-analyses on acute respiratory distress syndrome (ARDS) have shown that the use of steroids decreases mortality in adult patients, its benefits and risks may differ depending on the type and dosage of the steroid."( Steroid treatment in patients with acute respiratory distress syndrome: a systematic review and network meta-analysis.
Hongo, T; Ihara, S; Ishikawa, J; Kaneko, T; Ohki, S; Sakaguchi, M; Taito, S; Yatabe, T; Yoshihiro, S, 2022
)
0.72
" Dosage of methylprednisolone (1000 mg/day or 500 mg/day) did not significantly influence treatment efficacy (Z = 0."( Factors influencing intravenous methylprednisolone pulse therapy in Chinese patients with isolated optic neuritis associated with AQP4 antibody-seropositive neuromyelitis optica.
Guo, S; Jiang, H; Jiang, L; Liu, H; Peng, J; Wang, J; Wei, W, 2021
)
0.62
"Repeat dosing poses a major hurdle for the development of an adeno-associated virus (AAV)-based gene therapy for cystic fibrosis, in part because of the potential for development of an immune reaction to the AAV1 capsid proteins."( Short-Term Steroid Treatment of Rhesus Macaque Increases Transduction.
Cebotaru, CV; Cebotaru, L; Guggino, WB; Tomar, V; Yanda, MK, 2022
)
0.72
" Dosing in each group occurred at baseline and on day 15 (week 2)."( Intravenous pegylated liposomal prednisolone outperforms intramuscular methylprednisolone in treating rheumatoid arthritis flares: A randomized controlled clinical trial.
Bijlsma, JWJ; Bos, R; Kothekar, M; Lammers, T; Metselaar, JM; Middelink, LM; Raut, A; van Laar, JM; Vonkeman, HE; Westhovens, R; Wortel, CH; Yao, SL, 2022
)
0.72
" Early recognition of ICI-associated myocarditis and sufficient dosage and time course of glucocorticoid therapy are critical for severe cases."( Case Report: Glucocorticoid Effect Observation in a Ureteral Urothelial Cancer Patient With ICI-Associated Myocarditis and Multiple Organ Injuries.
Hu, X; Shuai, X; Wei, Y, 2021
)
0.62
" The dosage of adrenal glucocorticoids was reduced by more than half compared with that before chemotherapy."( Clinical observation of low-dose combination chemotherapy in refractory/recurrent paroxysmal nocturnal hemoglobinuria patients: A single-center retrospective analysis.
Chen, Y; Fu, R; Li, L; Liu, C; Liu, H; Liu, Z; Shao, Z; Wang, H; Zhao, X, 2022
)
0.72
" Hormone dosage was related to the duration of remission in patients, and the cumulative dose of methylprednisolone≥8 mg/kg showed a poor prognosis."( [Efficacy of Chimeric Antigen Receptor T Cell in the Treatment of Refractory/Recurrent B Acute Lymphocytic Leukemia in Children].
DU, WW; He, HL; Hu, SY; Li, BS; Lu, J; Lu, Y; Wang, TY; Xiao, PF; Yang, F, 2022
)
0.72
" Additionally, the control dose and cumulative dosage of steroids, Bullous Pemphigoid Disease Area Index (BPDAI) scores, pruritus scores, and adverse events were assessed."( Dupilumab combined with low-dose systemic steroid therapy improves efficacy and safety for bullous pemphigoid.
Chen, S; Chen, Z; Gao, H; He, S; Hu, Y; Liu, S; Luo, X; Ma, L; Tang, C; Tang, L; Wang, L; Xu, Y; Yang, F; Yang, J; Zhang, Z; Zhao, Y, 2022
)
0.72
" Clinical response in short-term follow-up was independent of prednisone dosage and underlying etiology."( Cohort study of infantile epileptic spasms syndrome: etiological analysis and treatment of corticosteroids.
Cheng, M; Hong, S; Jiang, L; Jiang, Y; Li, T; Liang, X; Liao, S; Luo, Y; Zhong, M; Zou, N, 2022
)
0.72
" The IVIG dosage for the patients in group I was 2 gr/kg, whereas the IVIG dosage for the patients in group II was 2 gr/kg + 2 mg/kg/day of methylprednisolone."( A retrospective comparative analysis of factors affecting the decision and outcome of initial intravenous immunoglobulin alone or intravenous immunoglobulin plus methylprednisolone use in children with the multisystem inflammatory syndrome.
Ağın, H; Arıkan, KÖ; Bayram, N; Besin, D; Böncüoğlu, E; Çelebi, MY; Cem, E; Devrim, İ; Düzgöl, M; Kara, AA; Kıymet, E; Meşe, T; Şahinkaya, Ş; Seven, P; Vuran, G, 2022
)
0.72
" Systemic administration of methylprednisolone (MP) at a higher dosage though can reduce neurological deficits following acute SCI."( A Bibliometric Analysis of Publications on Spinal Cord Injury Treatment With Glucocorticoids Using VOSviewer.
Li, AA; Liu, JM; Liu, ZL; Tong, WL; Wang, SJ; Xiao, SN; Zhang, Y; Zhong, NS, 2022
)
0.72
" Although the United States has made a significant global contribution to this important field of research, it requires rigorous clinical trials designed to verify the therapeutic role of MP in SCI and its appropriate dosage to find solutions for neurological recovery."( A Bibliometric Analysis of Publications on Spinal Cord Injury Treatment With Glucocorticoids Using VOSviewer.
Li, AA; Liu, JM; Liu, ZL; Tong, WL; Wang, SJ; Xiao, SN; Zhang, Y; Zhong, NS, 2022
)
0.72
" The early-onset pulmonary events (EOPEs) of brigatinib are associated with high dosage and older age."( Early-Onset Pulmonary Events with Combined Brigatinib and Afatinib Treatment of L858/cisT790M/cisC797S NSCLC: A Case Report.
Chang, HT; Lee, BJ; Lim, CK; Zhang, JH, 2022
)
0.72
", a hyperimmune anti-COVID-19 intravenous immunoglobulin), methylprednisolone, interferon-beta/standard-of-care (SOC), interferon-beta-1b, convalescent plasma, remdesivir, lopinavir/ritonavir, immunoglobulin gamma, high dosage sarilumab (HS), auxora, and imatinib were effective when compared with placebo or SOC group."( Comparative efficacy and safety of pharmacological interventions for severe COVID-19 patients: An updated network meta-analysis of 48 randomized controlled trials.
Chen, J; Cheng, Q; Fang, Z; Jia, Q; Zhao, G, 2022
)
0.72
"To reveal the recurrence rate of Graves ophthalmopathy (GO) presenting as diplopia in the primary position for 1 year after varied doses of intravenous methylprednisolone (IVMP) followed by oral prednisolone, with dosing based on the magnetic resonance imaging (MRI) findings."( One-year recurrence rate of Graves ophthalmopathy presenting as diplopia in the primary position after varied doses of intravenous methylprednisolone followed by oral prednisolone with dosing based on the magnetic resonance imaging findings.
Fukuchi, T; Hasegawa, Y; Hatase, T; Kiyokawa, M; Ueki, S, 2023
)
0.91
"This study showed that in 20% of patients, GO recurred within 1 year of administration of varied doses of IVMP, with the dosing based on the MRI findings."( One-year recurrence rate of Graves ophthalmopathy presenting as diplopia in the primary position after varied doses of intravenous methylprednisolone followed by oral prednisolone with dosing based on the magnetic resonance imaging findings.
Fukuchi, T; Hasegawa, Y; Hatase, T; Kiyokawa, M; Ueki, S, 2023
)
0.91
"The use of pulse dose corticosteroid therapy (PDCT) in children for treatment of alopecia areata (AA) has been reported, but dosing regimens are not well-established."( Pediatric pulse dose corticosteroid therapy dosing and administration in the treatment of alopecia areata: A review of literature.
Carrillo, B; Gallaga, NM; Good, A; Munoz-Gonzalez, A; Ross, L, 2023
)
0.91
"The results of our study suggest that intravenous methylprednisolone showed dose-response efficiencies, and pulse therapy may benefit critically ill patients with acute COVID-19, such as those requiring iMV."( Intravenous methylprednisolone pulse therapy and the risk of in-hospital mortality among acute COVID-19 patients: Nationwide clinical cohort study.
Moromizato, T; Sakaniwa, R; Shibuya, K; Taniguchi, K; Tokuda, Y, 2023
)
0.91
" As the dosage of corticosteroids was decreased, he developed impaired dorsiflexion of the left ankle, tingling and numbness in his feet, consistent with vasculitis neuropathy."( Thrombocytopenia during avacopan administration: A case report.
Akagi, Y; Ando, F; Fujiki, T; Hanioka, A; Iimori, S; Mandai, S; Mori, K; Mori, T; Mori, Y; Morimoto, N; Naito, S; Sakai, K; Shioji, S; Sohara, E; Susa, K; Uchida, S; Watanabe, H; Yamamura, A, 2023
)
0.91
" Overall, the TESTING trial provided more data regarding the treatment dosage and safety of corticosteroids, a cost-effective therapy, in IgAN, which have important implications for pediatric patients with IgAN."( Corticosteroids in the treatment of IgA nephropathy: lessons from the TESTING trial.
Hu, YT; Lv, JC; Zhang, H; Zhang, Y, 2023
)
0.91
" Further research is needed to establish guidelines on dosage regimens."( Efficacy and safety of intravenous glucocorticoid therapy for IgG4-related ophthalmic disease.
Choi, YA; Kim, GJ; Sa, HS; Yang, MK, 2023
)
0.91
" The initial dosage of corticosteroid therapy should be decided according to the severity of the disease."( Clinical features and "early" corticosteroid treatment outcome of pediatric
He, R; Liu, J; Liu, L; Wang, H; Zhang, X; Zhao, F; Zhao, S, 2023
)
0.91
" Patients who received steroids for irAEs at a dosage of < 2 mg/kg had comparable prognosis to those who did not receive steroids; however, patients who received methylprednisolone pulse therapy, primarily for severe pneumonitis and hepatitis, had shorter overall survival than those who did not receive steroids (7."( Systematic surveillance of immune-related adverse events in clinical practice and impact of subsequent steroid medication on survival outcomes.
Egashira, N; Hata, K; Hirota, T; Ieiri, I; Matsuda, K; Matsukane, R; Minami, H; Nakao, S; Suetsugu, K; Watanabe, H, 2023
)
0.91
"Previous evaluations of medication dosing variance for children in the prehospital setting have been limited regionally or to specific conditions."( Deviation From National Dosing Recommendations for Children Having Out-of-Hospital Emergencies.
Martin-Gill, C; Ramgopal, S, 2023
)
0.91
" We investigated dosing deviations (defined as being ≥20% of the weight-appropriate dose from national guidelines) for the following: lorazepam, diazepam, and midazolam for seizures; fentanyl, hydromorphone, morphine, and ketorolac; intramuscular epinephrine and diphenhydramine for children with allergy or anaphylaxis; intravenous epinephrine; and methylprednisolone."( Deviation From National Dosing Recommendations for Children Having Out-of-Hospital Emergencies.
Martin-Gill, C; Ramgopal, S, 2023
)
0.91
" Appropriate dosing was most common with methylprednisolone (75."( Deviation From National Dosing Recommendations for Children Having Out-of-Hospital Emergencies.
Martin-Gill, C; Ramgopal, S, 2023
)
0.91
"We identified variance in weight-based dosing from national guidelines for common pediatric medications in the prehospital setting, which may be attributable to protocol differences or dosing errors."( Deviation From National Dosing Recommendations for Children Having Out-of-Hospital Emergencies.
Martin-Gill, C; Ramgopal, S, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (6)

RoleDescription
anti-inflammatory drugA substance that reduces or suppresses inflammation.
neuroprotective agentAny compound that can be used for the treatment of neurodegenerative disorders.
antiemeticA drug used to prevent nausea or vomiting. An antiemetic may act by a wide range of mechanisms: it might affect the medullary control centres (the vomiting centre and the chemoreceptive trigger zone) or affect the peripheral receptors.
adrenergic agentAny agent that acts on an adrenergic receptor or affects the life cycle of an adrenergic transmitter.
xenobioticA xenobiotic (Greek, xenos "foreign"; bios "life") is a compound that is foreign to a living organism. Principal xenobiotics include: drugs, carcinogens and various compounds that have been introduced into the environment by artificial means.
environmental contaminantAny minor or unwanted substance introduced into the environment that can have undesired effects.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (3)

ClassDescription
6-methylprednisolone
primary alpha-hydroxy ketoneAn alpha-hydroxy ketone in which the carbonyl group and the hydroxy group are linked by a -CH2 (methylene) group.
tertiary alpha-hydroxy ketoneAn alpha-hydroxy ketone in which the carbonyl group and the hydroxy group are linked by a carbon bearing two organyl groups.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (1)

PathwayProteinsCompounds
Drug induction of bile acid pathway025

Protein Targets (40)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
acetylcholinesteraseHomo sapiens (human)Potency89.35840.002541.796015,848.9004AID1347395
hypoxia-inducible factor 1 alpha subunitHomo sapiens (human)Potency9.52053.189029.884159.4836AID1224846
PPM1D proteinHomo sapiens (human)Potency0.00830.00529.466132.9993AID1347411
GLI family zinc finger 3Homo sapiens (human)Potency9.88950.000714.592883.7951AID1259369; AID1259392
AR proteinHomo sapiens (human)Potency0.19070.000221.22318,912.5098AID1259243; AID1259247; AID1259381; AID743036; AID743040; AID743042; AID743053; AID743054; AID743063
hypoxia-inducible factor 1, alpha subunit (basic helix-loop-helix transcription factor)Homo sapiens (human)Potency0.05010.00137.762544.6684AID914; AID915
progesterone receptorHomo sapiens (human)Potency26.21470.000417.946075.1148AID1346784; AID1346795; AID1347036
nonstructural protein 1Influenza A virus (A/WSN/1933(H1N1))Potency0.31620.28189.721235.4813AID2326
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency0.04190.000214.376460.0339AID720691; AID720692; AID720719
retinoid X nuclear receptor alphaHomo sapiens (human)Potency24.54120.000817.505159.3239AID1159527
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency30.63790.001530.607315,848.9004AID1224849
pregnane X nuclear receptorHomo sapiens (human)Potency30.63790.005428.02631,258.9301AID1346982
estrogen nuclear receptor alphaHomo sapiens (human)Potency1.83870.000229.305416,493.5996AID743069; AID743078; AID743080; AID743091
GVesicular stomatitis virusPotency34.67130.01238.964839.8107AID1645842
bromodomain adjacent to zinc finger domain 2BHomo sapiens (human)Potency0.70790.707936.904389.1251AID504333
IDH1Homo sapiens (human)Potency29.09290.005210.865235.4813AID686970
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency0.03360.001723.839378.1014AID743083
nuclear receptor subfamily 1, group I, member 2Rattus norvegicus (Norway rat)Potency1.58490.10009.191631.6228AID1346983
nuclear factor erythroid 2-related factor 2 isoform 2Homo sapiens (human)Potency0.02930.00419.984825.9290AID504444; AID720524
gemininHomo sapiens (human)Potency0.50120.004611.374133.4983AID624297
muscleblind-like protein 1 isoform 1Homo sapiens (human)Potency100.00000.00419.962528.1838AID2675
Interferon betaHomo sapiens (human)Potency6.94220.00339.158239.8107AID1347407; AID1347411; AID1645842
HLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)Potency34.67130.01238.964839.8107AID1645842
Inositol hexakisphosphate kinase 1Homo sapiens (human)Potency34.67130.01238.964839.8107AID1645842
ATPase family AAA domain-containing protein 5Homo sapiens (human)Potency0.03440.011917.942071.5630AID651632
Ataxin-2Homo sapiens (human)Potency0.03440.011912.222168.7989AID651632
cytochrome P450 2C9, partialHomo sapiens (human)Potency34.67130.01238.964839.8107AID1645842
ATP-dependent phosphofructokinaseTrypanosoma brucei brucei TREU927Potency0.60120.060110.745337.9330AID485367
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)40.97000.20005.677410.0000AID1473741
Bile salt export pumpHomo sapiens (human)IC50 (µMol)100.34330.11007.190310.0000AID1443980; AID1449628; AID1473738
Glucocorticoid receptorHomo sapiens (human)IC50 (µMol)0.01100.00000.495310.0000AID625263
Glucocorticoid receptorHomo sapiens (human)Ki0.00500.00010.38637.0010AID625263
Glycine receptor subunit alpha-1Rattus norvegicus (Norway rat)IC50 (µMol)0.01100.00150.76005.0740AID625263
Glycine receptor subunit alpha-1Rattus norvegicus (Norway rat)Ki0.00500.00070.76537.0010AID625263
Androgen receptorRattus norvegicus (Norway rat)IC50 (µMol)26.68000.00101.979414.1600AID625228
Androgen receptorRattus norvegicus (Norway rat)Ki17.78600.00031.21858.9270AID625228
Glycine receptor subunit betaRattus norvegicus (Norway rat)IC50 (µMol)0.01100.00150.76005.0740AID625263
Glycine receptor subunit betaRattus norvegicus (Norway rat)Ki0.00500.00070.78467.0010AID625263
Glycine receptor subunit alpha-2Rattus norvegicus (Norway rat)IC50 (µMol)0.01100.00150.80445.0740AID625263
Glycine receptor subunit alpha-2Rattus norvegicus (Norway rat)Ki0.00500.00070.78467.0010AID625263
Glycine receptor subunit alpha-3Rattus norvegicus (Norway rat)IC50 (µMol)0.01100.00150.76005.0740AID625263
Glycine receptor subunit alpha-3Rattus norvegicus (Norway rat)Ki0.00500.00070.78467.0010AID625263
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Nuclear receptor subfamily 1 group I member 2Homo sapiens (human)EC50 (µMol)12.60000.00203.519610.0000AID1215087
Nuclear receptor subfamily 1 group I member 2Rattus norvegicus (Norway rat)EC50 (µMol)4.00000.01004.139410.0000AID1215090
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (140)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
negative regulation of DNA-templated transcriptionNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
regulation of DNA-templated transcriptionNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
xenobiotic metabolic processNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
signal transductionNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
steroid metabolic processNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
positive regulation of gene expressionNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
intracellular receptor signaling pathwayNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
xenobiotic catabolic processNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
xenobiotic transportNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
positive regulation of DNA-templated transcriptionNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
positive regulation of transcription by RNA polymerase IINuclear receptor subfamily 1 group I member 2Homo sapiens (human)
cell differentiationNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
negative regulation of transcription by RNA polymerase IINuclear receptor subfamily 1 group I member 2Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
positive regulation of T cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
adaptive immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class I via ER pathway, TAP-independentHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of T cell anergyHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
defense responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
detection of bacteriumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-12 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-6 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protection from natural killer cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
innate immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of dendritic cell differentiationHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class IbHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
negative regulation of transcription by RNA polymerase IIGlucocorticoid receptorHomo sapiens (human)
regulation of gluconeogenesisGlucocorticoid receptorHomo sapiens (human)
chromatin organizationGlucocorticoid receptorHomo sapiens (human)
regulation of DNA-templated transcriptionGlucocorticoid receptorHomo sapiens (human)
apoptotic processGlucocorticoid receptorHomo sapiens (human)
chromosome segregationGlucocorticoid receptorHomo sapiens (human)
signal transductionGlucocorticoid receptorHomo sapiens (human)
glucocorticoid metabolic processGlucocorticoid receptorHomo sapiens (human)
gene expressionGlucocorticoid receptorHomo sapiens (human)
microglia differentiationGlucocorticoid receptorHomo sapiens (human)
adrenal gland developmentGlucocorticoid receptorHomo sapiens (human)
regulation of glucocorticoid biosynthetic processGlucocorticoid receptorHomo sapiens (human)
synaptic transmission, glutamatergicGlucocorticoid receptorHomo sapiens (human)
maternal behaviorGlucocorticoid receptorHomo sapiens (human)
intracellular glucocorticoid receptor signaling pathwayGlucocorticoid receptorHomo sapiens (human)
glucocorticoid mediated signaling pathwayGlucocorticoid receptorHomo sapiens (human)
positive regulation of neuron apoptotic processGlucocorticoid receptorHomo sapiens (human)
negative regulation of DNA-templated transcriptionGlucocorticoid receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIGlucocorticoid receptorHomo sapiens (human)
astrocyte differentiationGlucocorticoid receptorHomo sapiens (human)
cell divisionGlucocorticoid receptorHomo sapiens (human)
mammary gland duct morphogenesisGlucocorticoid receptorHomo sapiens (human)
motor behaviorGlucocorticoid receptorHomo sapiens (human)
cellular response to steroid hormone stimulusGlucocorticoid receptorHomo sapiens (human)
cellular response to glucocorticoid stimulusGlucocorticoid receptorHomo sapiens (human)
cellular response to dexamethasone stimulusGlucocorticoid receptorHomo sapiens (human)
cellular response to transforming growth factor beta stimulusGlucocorticoid receptorHomo sapiens (human)
neuroinflammatory responseGlucocorticoid receptorHomo sapiens (human)
positive regulation of miRNA transcriptionGlucocorticoid receptorHomo sapiens (human)
intracellular steroid hormone receptor signaling pathwayGlucocorticoid receptorHomo sapiens (human)
regulation of transcription by RNA polymerase IIGlucocorticoid receptorHomo sapiens (human)
inositol phosphate metabolic processInositol hexakisphosphate kinase 1Homo sapiens (human)
phosphatidylinositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
negative regulation of cold-induced thermogenesisInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell population proliferationATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of B cell proliferationATPase family AAA domain-containing protein 5Homo sapiens (human)
nuclear DNA replicationATPase family AAA domain-containing protein 5Homo sapiens (human)
signal transduction in response to DNA damageATPase family AAA domain-containing protein 5Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorATPase family AAA domain-containing protein 5Homo sapiens (human)
isotype switchingATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of DNA replicationATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of isotype switching to IgG isotypesATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA clamp unloadingATPase family AAA domain-containing protein 5Homo sapiens (human)
regulation of mitotic cell cycle phase transitionATPase family AAA domain-containing protein 5Homo sapiens (human)
negative regulation of intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of cell cycle G2/M phase transitionATPase family AAA domain-containing protein 5Homo sapiens (human)
negative regulation of receptor internalizationAtaxin-2Homo sapiens (human)
regulation of translationAtaxin-2Homo sapiens (human)
RNA metabolic processAtaxin-2Homo sapiens (human)
P-body assemblyAtaxin-2Homo sapiens (human)
stress granule assemblyAtaxin-2Homo sapiens (human)
RNA transportAtaxin-2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (64)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
RNA polymerase II transcription regulatory region sequence-specific DNA bindingNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
nuclear receptor activityNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
protein bindingNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
zinc ion bindingNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
nuclear receptor bindingNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
sequence-specific double-stranded DNA bindingNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
signaling receptor bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
peptide antigen bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein-folding chaperone bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
RNA polymerase II transcription regulatory region sequence-specific DNA bindingGlucocorticoid receptorHomo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificGlucocorticoid receptorHomo sapiens (human)
core promoter sequence-specific DNA bindingGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription factor activityGlucocorticoid receptorHomo sapiens (human)
RNA bindingGlucocorticoid receptorHomo sapiens (human)
nuclear receptor activityGlucocorticoid receptorHomo sapiens (human)
nuclear glucocorticoid receptor activityGlucocorticoid receptorHomo sapiens (human)
steroid bindingGlucocorticoid receptorHomo sapiens (human)
protein bindingGlucocorticoid receptorHomo sapiens (human)
zinc ion bindingGlucocorticoid receptorHomo sapiens (human)
TBP-class protein bindingGlucocorticoid receptorHomo sapiens (human)
protein kinase bindingGlucocorticoid receptorHomo sapiens (human)
identical protein bindingGlucocorticoid receptorHomo sapiens (human)
Hsp90 protein bindingGlucocorticoid receptorHomo sapiens (human)
steroid hormone bindingGlucocorticoid receptorHomo sapiens (human)
sequence-specific double-stranded DNA bindingGlucocorticoid receptorHomo sapiens (human)
estrogen response element bindingGlucocorticoid receptorHomo sapiens (human)
inositol-1,3,4,5,6-pentakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol heptakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
ATP bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 1-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 3-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol 5-diphosphate pentakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol diphosphate tetrakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
protein bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
ATP bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
ATP hydrolysis activityATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA clamp unloader activityATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
RNA bindingAtaxin-2Homo sapiens (human)
epidermal growth factor receptor bindingAtaxin-2Homo sapiens (human)
protein bindingAtaxin-2Homo sapiens (human)
mRNA bindingAtaxin-2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (47)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
nucleoplasmNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
transcription regulator complexNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
nuclear bodyNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
intermediate filament cytoskeletonNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
chromatinNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
nucleusNuclear receptor subfamily 1 group I member 2Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
Golgi membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
endoplasmic reticulumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
Golgi apparatusHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
cell surfaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
ER to Golgi transport vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
secretory granule membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
phagocytic vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
early endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
recycling endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular exosomeHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
lumenal side of endoplasmic reticulum membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
MHC class I protein complexHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular spaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
external side of plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
nucleusGlucocorticoid receptorHomo sapiens (human)
nucleusGlucocorticoid receptorHomo sapiens (human)
nucleoplasmGlucocorticoid receptorHomo sapiens (human)
cytoplasmGlucocorticoid receptorHomo sapiens (human)
mitochondrial matrixGlucocorticoid receptorHomo sapiens (human)
centrosomeGlucocorticoid receptorHomo sapiens (human)
spindleGlucocorticoid receptorHomo sapiens (human)
cytosolGlucocorticoid receptorHomo sapiens (human)
membraneGlucocorticoid receptorHomo sapiens (human)
nuclear speckGlucocorticoid receptorHomo sapiens (human)
synapseGlucocorticoid receptorHomo sapiens (human)
chromatinGlucocorticoid receptorHomo sapiens (human)
protein-containing complexGlucocorticoid receptorHomo sapiens (human)
plasma membraneGlycine receptor subunit betaRattus norvegicus (Norway rat)
fibrillar centerInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
cytosolInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleusInositol hexakisphosphate kinase 1Homo sapiens (human)
cytoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
Elg1 RFC-like complexATPase family AAA domain-containing protein 5Homo sapiens (human)
nucleusATPase family AAA domain-containing protein 5Homo sapiens (human)
cytoplasmAtaxin-2Homo sapiens (human)
Golgi apparatusAtaxin-2Homo sapiens (human)
trans-Golgi networkAtaxin-2Homo sapiens (human)
cytosolAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
membraneAtaxin-2Homo sapiens (human)
perinuclear region of cytoplasmAtaxin-2Homo sapiens (human)
ribonucleoprotein complexAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (214)

Assay IDTitleYearJournalArticle
AID588460High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, Validation Compound Set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588460High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, Validation Compound Set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588460High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, Validation Compound Set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID588459High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, Validation compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588459High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, Validation compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588459High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, Validation compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID588461High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, Validation compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588461High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, Validation compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588461High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, Validation compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1211792Hepatic clearance in human2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID1449628Inhibition of human BSEP expressed in baculovirus transfected fall armyworm Sf21 cell membranes vesicles assessed as reduction in ATP-dependent [3H]-taurocholate transport into vesicles incubated for 5 mins by Topcount based rapid filtration method2012Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12
Mitigating the inhibition of human bile salt export pump by drugs: opportunities provided by physicochemical property modulation, in silico modeling, and structural modification.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID1221962Efflux ratio of permeability from apical to basolateral side over basolateral to apical side of human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis in presence of 1 uM of P-gp inhibitor LY3359792011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID176988In vivo anti-inflammatory activity in the rat, alpha-tocopherol filled pouch peroral dose1993Journal of medicinal chemistry, Oct-29, Volume: 36, Issue:22
Non-steroidal glucocorticoid-like substances: receptor binding and in vivo activity.
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID91224Antiinflammatory activity measured by using McKenzie-Stoughton human vasoconstrictor assay1986Journal of medicinal chemistry, Nov, Volume: 29, Issue:11
Computer-aided studies of the structure-activity relationships between the structure of some steroids and their antiinflammatory activity.
AID19006Calculated membrane partition coefficient (Kmemb)2004Journal of medicinal chemistry, Mar-25, Volume: 47, Issue:7
Surface activity profiling of drugs applied to the prediction of blood-brain barrier permeability.
AID689046Antiinflammatory activity in oxazolone-induced Sprague-Dawley rat chronic dermatitis model at 0.5 to 5 mg/kg, po qd administered after 7 days of oxazolone sensitization measured after 4 to 5 hrs last post treatment on day 142011Bioorganic & medicinal chemistry, Dec-15, Volume: 19, Issue:24
Discovery of selective glucocorticoid receptor modulator MK-5932.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1215088Competitive binding affinity to human PXR LBD (111 to 434) up to 46 uM by TR-FRET assay2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Identification of clinically used drugs that activate pregnane X receptors.
AID496831Antimicrobial activity against Cryptosporidium parvum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID29811Oral bioavailability in human2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID74386Relative binding affinity against glucocorticoid receptor.1993Journal of medicinal chemistry, Oct-29, Volume: 36, Issue:22
Non-steroidal glucocorticoid-like substances: receptor binding and in vivo activity.
AID679086TP_TRANSPORTER: transepithelial transport of Methylprednisolone at a concentration of 20 uM in MDR1-expressing MDCK cells2003Pharmaceutical research, Aug, Volume: 20, Issue:8
Novel experimental parameters to quantify the modulation of absorptive and secretory transport of compounds by P-glycoprotein in cell culture models of intestinal epithelium.
AID1221958Efflux ratio of permeability from apical to basolateral side over basolateral to apical side of human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis2011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID496826Antimicrobial activity against Entamoeba histolytica2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1211791Fraction unbound in human hepatocytes2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID496827Antimicrobial activity against Leishmania amazonensis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID409954Inhibition of mouse brain MAOA2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1211797Intrinsic clearance in cryopreserved human hepatocytes cells assessed per 10'6 cells by LC-MS/MS method2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID1215091Activation of human PXR expressed in human HepG2 (DPX-2) cells up to 46 uM after 24 hrs by luciferase reporter gene based luminescent analysis2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Identification of clinically used drugs that activate pregnane X receptors.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1215087Activation of human PXR expressed in human HepG2 (DPX-2) cells assessed as induction of CYP3A4 after 24 hrs by luminescent analysis2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Identification of clinically used drugs that activate pregnane X receptors.
AID172538In vivo glucocorticoid profile, depression of thymus weight in rat at 1 mg/kg peroral dose1993Journal of medicinal chemistry, Oct-29, Volume: 36, Issue:22
Non-steroidal glucocorticoid-like substances: receptor binding and in vivo activity.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID977602Inhibition of sodium fluorescein uptake in OATP1B3-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID1215090Activation of rat PXR expressed in human HepG2 cells after 24 hrs by luciferase reporter gene based luminescent analysis2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Identification of clinically used drugs that activate pregnane X receptors.
AID1687199Activation of adipogenic cocktail-induced PPARgamma mRNA expression in mouse 3T3-L1 cells at 1 uM by RT-qPCR analysis2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Tigliane Diterpenoids as a New Type of Antiadipogenic Agents Inhibit GRα-Dexras1 Axis in Adipocytes.
AID373867Hepatic clearance in human hepatocytes in absence of fetal calf serum2009European journal of medicinal chemistry, Apr, Volume: 44, Issue:4
First-principle, structure-based prediction of hepatic metabolic clearance values in human.
AID496818Antimicrobial activity against Trypanosoma brucei brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID977599Inhibition of sodium fluorescein uptake in OATP1B1-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID188016Anti-inflammatory effect in rat granuloma assay, activity relative to hydrocortisone and hydrocortisone 21-acetate1983Journal of medicinal chemistry, Mar, Volume: 26, Issue:3
Structure-activity relationships in the antiinflammatory steroids: a pattern-recognition approach.
AID496828Antimicrobial activity against Leishmania donovani2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID91481Binding constant against human serum albumin (HSA)2001Journal of medicinal chemistry, Dec-06, Volume: 44, Issue:25
Cheminformatic models to predict binding affinities to human serum albumin.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID682043TP_TRANSPORTER: transepithelial transport (basal to apical), inhibited by Verapamil in Caco-2 cells2002Biological & pharmaceutical bulletin, Mar, Volume: 25, Issue:3
Secretory transport of methylprednisolone possibly mediated by P-glycoprotein in Caco-2 cells.
AID679087TP_TRANSPORTER: transepithelial transport of Methylprednisolone at a concentration of 20 uM in Caco-2 cells2003Pharmaceutical research, Aug, Volume: 20, Issue:8
Novel experimental parameters to quantify the modulation of absorptive and secretory transport of compounds by P-glycoprotein in cell culture models of intestinal epithelium.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1221965Transporter substrate index of efflux ratio in human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis in presence of 1 uM of P-gp inhibitor LY3359792011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID1443980Inhibition of human BSEP expressed in fall armyworm sf9 cell plasma membrane vesicles assessed as reduction in vesicle-associated [3H]-taurocholate transport preincubated for 10 mins prior to ATP addition measured after 15 mins in presence of [3H]-tauroch2010Toxicological sciences : an official journal of the Society of Toxicology, Dec, Volume: 118, Issue:2
Interference with bile salt export pump function is a susceptibility factor for human liver injury in drug development.
AID26304Partition coefficient (logD6.5)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID496820Antimicrobial activity against Trypanosoma brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID90104Potency relative to fluocinolone 16,17-acetonide in the human vasoconstictor test1983Journal of medicinal chemistry, Mar, Volume: 26, Issue:3
Structure-activity relationships in the antiinflammatory steroids: a pattern-recognition approach.
AID29360Ionization constant (pKa)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID496817Antimicrobial activity against Trypanosoma cruzi2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID172531In vivo glucocorticoid profile, depression of adrenal weight in rat at 5 mg/kg peroral dose1993Journal of medicinal chemistry, Oct-29, Volume: 36, Issue:22
Non-steroidal glucocorticoid-like substances: receptor binding and in vivo activity.
AID409956Inhibition of mouse brain MAOB2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID22293Delta logD (logD6.5 - logD7.4)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID197376In vivo glucocorticoid profile, depression of body weight gain without altered food consumption in rat at 1 mg/kg peroral dose1993Journal of medicinal chemistry, Oct-29, Volume: 36, Issue:22
Non-steroidal glucocorticoid-like substances: receptor binding and in vivo activity.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1687203Activation of GR-alpha in mouse 3T3-L1 cells assessed as increase in adipogenic cocktail-induced Dexras1 mRNA expression at 10 uM incubated for 4 hrs by RT-qPCR analysis2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Tigliane Diterpenoids as a New Type of Antiadipogenic Agents Inhibit GRα-Dexras1 Axis in Adipocytes.
AID1221982Fraction absorbed in human2011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID7783Unbound fraction (plasma)2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID476929Human intestinal absorption in po dosed human2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Neural computational prediction of oral drug absorption based on CODES 2D descriptors.
AID311524Oral bioavailability in human2007Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24
Hologram QSAR model for the prediction of human oral bioavailability.
AID197379In vivo glucocorticoid profile, depression of body weight gain without altered food consumption in rat at 5 mg/kg peroral dose1993Journal of medicinal chemistry, Oct-29, Volume: 36, Issue:22
Non-steroidal glucocorticoid-like substances: receptor binding and in vivo activity.
AID1221961Apparent permeability from basolateral to apical side of human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis in presence of 1 uM of P-gp inhibitor LY3359792011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID8002Observed volume of distribution2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1215097Activation of rat PXR expressed in human HepG2 cells after 24 hrs by luciferase reporter gene based luminescent analysis relative to dexamethasone2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Identification of clinically used drugs that activate pregnane X receptors.
AID327509Agonist activity at glucocorticoid receptor-mediated luciferase reporter gene assay assessed as ratio of firefly luciferase activity to renilla luciferase activity at 10 uM2008Journal of natural products, Jan, Volume: 71, Issue:1
Microbial transformation of isosteviol and bioactivities against the glucocorticoid/androgen response elements.
AID1687198Lipid increasing activity in mouse 3T3-L1 cells assessed as increase in adipogenic cocktail induced triglyceride levels at 1 uM incubated for 6 days by GPO-POD assay2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Tigliane Diterpenoids as a New Type of Antiadipogenic Agents Inhibit GRα-Dexras1 Axis in Adipocytes.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496824Antimicrobial activity against Toxoplasma gondii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496829Antimicrobial activity against Leishmania infantum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID689047Toxicity in oxazolone-induced Sprague-Dawley rat chronic dermatitis model assessed as increase in plasma insulin level at 0.5 to 5 mg/kg, po qd administered after 7 days of oxazolone sensitization measured after 4 to 5 hrs last post treatment on day 142011Bioorganic & medicinal chemistry, Dec-15, Volume: 19, Issue:24
Discovery of selective glucocorticoid receptor modulator MK-5932.
AID1215089Activation of human PXR expressed in human HepG2 (DPX-2) cells assessed as induction of CYP3A4 after 24 hrs by luminescent analysis relative to rifampicin2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Identification of clinically used drugs that activate pregnane X receptors.
AID681354TP_TRANSPORTER: transepithelial transport in MDR1-expressing LLC-PK1 cells2003Pharmaceutical research, Nov, Volume: 20, Issue:11
Structural determinants of P-glycoprotein-mediated transport of glucocorticoids.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1211793Lipophilicity, log P of the compound2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1221960Apparent permeability from apical to basolateral side of human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis in presence of 1 uM of P-gp inhibitor LY3359792011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID496823Antimicrobial activity against Trichomonas vaginalis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID26380Dissociation constant (pKa)2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID379153Agonist activity at glucocorticoid receptor transfected in mouse RAW264.7 cells assessed as firefly/renilla luciferase ratio at 10 uM by dual liciferase reporter assay2006Journal of natural products, Oct, Volume: 69, Issue:10
Transformation of steviol-16alpha,17-epoxide by Streptomyces griseus and Cunninghamella bainieri.
AID497005Antimicrobial activity against Pneumocystis carinii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496832Antimicrobial activity against Trypanosoma brucei rhodesiense2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID496819Antimicrobial activity against Plasmodium falciparum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496825Antimicrobial activity against Leishmania mexicana2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1221957Apparent permeability from basolateral to apical side of human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis2011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID172541In vivo glucocorticoid profile, depression of thymus weight in rat at 5 mg/kg peroral dose1993Journal of medicinal chemistry, Oct-29, Volume: 36, Issue:22
Non-steroidal glucocorticoid-like substances: receptor binding and in vivo activity.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496821Antimicrobial activity against Leishmania2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID172528In vivo glucocorticoid profile, depression of adrenal weight in rat at 1 mg/kg peroral dose1993Journal of medicinal chemistry, Oct-29, Volume: 36, Issue:22
Non-steroidal glucocorticoid-like substances: receptor binding and in vivo activity.
AID592681Apparent permeability across human Caco2 cell membrane after 2 hrs by LC-MS/MS analysis2011Bioorganic & medicinal chemistry, Apr-15, Volume: 19, Issue:8
QSAR-based permeability model for drug-like compounds.
AID496830Antimicrobial activity against Leishmania major2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1221963Transporter substrate index ratio of permeability from apical to basolateral side in human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis in presence of 1 uM of P-gp inhibitor LY3359792011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1221964Transporter substrate index ratio of permeability from basolateral to apical side in human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis in presence of 1 uM of P-gp inhibitor LY3359792011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID1211794Fraction unbound in blood (not specified)2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID1221956Apparent permeability from apical to basolateral side of human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis2011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID1211798Intrinsic clearance in human using well stirred liver model by LC-MS/MS method2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1347111qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347119qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347114qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347118qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347127qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347109qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347126qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347124qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347115qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347125qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347128qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347116qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347117qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347110qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for A673 cells)2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347112qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347129qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347113qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347123qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347121qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347122qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347414qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: Secondary screen by immunofluorescence2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347412qHTS assay to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: Counter screen cell viability and HiBit confirmation2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347415qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: tertiary screen by RT-qPCR2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1159550Human Phosphogluconate dehydrogenase (6PGD) Inhibitor Screening2015Nature cell biology, Nov, Volume: 17, Issue:11
6-Phosphogluconate dehydrogenase links oxidative PPP, lipogenesis and tumour growth by inhibiting LKB1-AMPK signalling.
AID588519A screen for compounds that inhibit viral RNA polymerase binding and polymerization activities2011Antiviral research, Sep, Volume: 91, Issue:3
High-throughput screening identification of poliovirus RNA-dependent RNA polymerase inhibitors.
AID540299A screen for compounds that inhibit the MenB enzyme of Mycobacterium tuberculosis2010Bioorganic & medicinal chemistry letters, Nov-01, Volume: 20, Issue:21
Synthesis and SAR studies of 1,4-benzoxazine MenB inhibitors: novel antibacterial agents against Mycobacterium tuberculosis.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1224864HCS microscopy assay (F508del-CFTR)2016PloS one, , Volume: 11, Issue:10
Increasing the Endoplasmic Reticulum Pool of the F508del Allele of the Cystic Fibrosis Transmembrane Conductance Regulator Leads to Greater Folding Correction by Small Molecule Therapeutics.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (18,767)

TimeframeStudies, This Drug (%)All Drugs %
pre-19904777 (25.45)18.7374
1990's3745 (19.96)18.2507
2000's4436 (23.64)29.6817
2010's4502 (23.99)24.3611
2020's1307 (6.96)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials2,602 (12.85%)5.53%
Reviews1,343 (6.63%)6.00%
Case Studies7,091 (35.02%)4.05%
Observational104 (0.51%)0.25%
Other9,107 (44.98%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (952)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthrit [NCT00299104]Phase 3755 participants (Actual)Interventional2006-01-31Completed
A Pilot Study of Intensified Lymphodepletion Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Systemic Lupus Erythematosus [NCT00076752]Phase 29 participants (Actual)Interventional2004-01-30Completed
The Safety and Efficacy of Belatacept, Antithymocyte Globulin, and Sirolimus in Recipients of Non-HLA-identical Living-donor Renal Transplants (ITN023ST) [NCT00346151]Phase 25 participants (Actual)Interventional2006-12-31Terminated(stopped due to Stopping rule-acute rejection threshold-was met based on local biopsy results)
Electroretinographic Changes in Healthy Young Men Before and After Induction of Glucose Intolerance by Glucocorticoids Treatment, Hyperphagia and Lack of Exercise [NCT01140932]10 participants (Actual)Interventional2010-02-28Completed
EuroPainClinics® Study II (Prospective Randomized Double Blinded Trial) [NCT02459392]300 participants (Actual)Interventional2021-12-31Completed
Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification [NCT01193504]Phase 4100 participants (Anticipated)Interventional2010-09-30Recruiting
Efficacy and Tolerability of Systemic Methylprednisolone in Children and Adolescents With Chronic Rhinosinusitis [NCT01205984]Phase 448 participants (Actual)Interventional2007-07-31Completed
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With ISN/RPS Class III or IV Lupus Nephritis [NCT00282347]Phase 3144 participants (Actual)Interventional2006-01-31Completed
Vestibular Prognosis Assessment of the Idiopathic Sudden Sensorineural Hearing Loss With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids [NCT03974867]72 participants (Anticipated)Interventional2019-07-31Not yet recruiting
Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome: Open-label, Multi-center, Single Arm, Phase 4 Trial (DoSAKOM) [NCT03794492]Phase 4169 participants (Actual)Interventional2018-03-31Active, not recruiting
Effect of Preoperative Administration of Dexamethasone Versus Methylprednisolone in Surgical Extraction of Retained Lower Third Molars [NCT05752305]Phase 2/Phase 384 participants (Actual)Interventional2022-01-15Completed
A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of LY3884961 in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL) [NCT04127578]Phase 1/Phase 220 participants (Anticipated)Interventional2020-01-03Recruiting
Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial. [NCT01134432]Phase 365 participants (Actual)Interventional2005-03-31Completed
[NCT01137084]300 participants (Anticipated)Interventional2005-01-31Completed
Steroid Treatment as Anti-inflammatory and Neuroprotective Agent Following Out-of-Hospital Cardiac Arrest. A Randomized Trial [NCT04624776]Phase 2158 participants (Actual)Interventional2020-10-10Completed
An Investigator Initiated Open Study to Evaluate the Efficacy and Safety of Intra Arterial Infusion for Treatment of Steroid Resistant Acute Hepatic Graft Versus Host Disease (AGVHD) [NCT01140984]2 participants (Actual)Interventional2010-09-30Terminated(stopped due to technical issues)
Role of Add-on Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis [NCT05842681]30 participants (Anticipated)Interventional2023-06-01Not yet recruiting
Three-dimensional Evaluation of Postoperative Edema After Third Molar Surgery: a Randomized Clinical Trial [NCT05941130]Phase 440 participants (Anticipated)Interventional2022-07-01Recruiting
A Bidimensional Early Intervention Strategy of Standard of Care Combined With Host Immunomodulation in Elderly Patients With Mild or Moderate COVID-19: A Multicentre, Randomized, Controlled, Adaptive Platform Study [NCT05855395]5,815 participants (Anticipated)Interventional2023-05-26Recruiting
Intravenous Methylprednisolone Versus High Dose Oral Prednisolone for the Treatment of Infantile Spasms: a Randomized Open-labelled Trial [NCT03876444]Phase 2/Phase 3128 participants (Anticipated)Interventional2019-04-01Recruiting
First-line Treatment of P53 Mutation With PD-L1 Expression in DLBCL With Anti-PD-1 Mab and R-CHOP: a Randomized, Open, Multicenter Clinical Study [NCT05280626]Phase 2100 participants (Anticipated)Interventional2022-03-25Not yet recruiting
Effect of Corticosteroids On MyocardiaL Injury Among Patients Hospitalized for Community-AcquirEd PneUMonia - COLOSSEUM TRIAL [NCT03745664]Phase 3122 participants (Anticipated)Interventional2021-01-10Recruiting
Establishment of CST1 Predictive Model of Oral Glucocorticoid Therapy Sensitivity for Chronic Rhinosinusitis With Polyps [NCT05598424]Phase 4150 participants (Anticipated)Interventional2022-11-22Recruiting
A Single-Center, Randomized, Double-Masked, Vehicle and Active-Controlled, Dose-Ranging Phase 2 Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis Using the Conjunctival Allergen Challenge M [NCT03320434]Phase 2120 participants (Actual)Interventional2017-10-13Completed
Ruxolitinib and Methylprednisolone as First Line Therapy for Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation [NCT03701698]Phase 230 participants (Anticipated)Interventional2018-11-01Not yet recruiting
A Double-Blind, Placebo -Controlled, Randomized Study to Assess the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation. [NCT00048165]Phase 4434 participants (Actual)Interventional1999-08-31Completed
Efficacy and Safety of Subacromial Corticosteroid Injection in Type-2 Diabetic [NCT03652480]20 participants (Actual)Observational2013-03-31Completed
The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy: A Prospective, Double Blinded, Placebo Controlled Study [NCT01106547]Phase 455 participants (Anticipated)Interventional2009-08-31Completed
Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol. [NCT03942861]50 participants (Anticipated)Observational2019-02-21Recruiting
A Randomized Clinical Trial Comparing Hyaluronic Acid (Hylan G-F 20) and Corticosteroid (Methylprednisolone Acetate) for Knee Osteoarthritis [NCT01132677]78 participants (Anticipated)Interventional2010-05-31Enrolling by invitation
Preemptive Therapy Study of Cetuximab(Erbitux®)Induced Skin Rash Using Doxycycline, Sunscreen, Hydrocortisone and Moisturizer in Colorectal and Head and Neck Cancer Patients [NCT01874860]Phase 224 participants (Actual)Interventional2013-08-31Completed
Comparison Between Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis [NCT03564106]Phase 2/Phase 340 participants (Actual)Interventional2019-03-01Completed
"Maximizing Outcome of Multiple Sclerosis Transplantation: MOST Trial" [NCT03342638]Phase 366 participants (Actual)Interventional2017-11-08Terminated(stopped due to PI Sabbatical)
GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease [NCT03584516]Phase 2/Phase 3155 participants (Actual)Interventional2019-01-17Active, not recruiting
High-dose Busulfan, High-dose Cyclophosphamide, and Allogeneic Bone Marrow Transplantation for Leukemia, Myelodysplastic Syndromes, Multiple Myeloma and Lymphoma [NCT01177371]Phase 213 participants (Actual)Interventional1988-03-31Completed
Effect of Preoperative Intravenous High Dose Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Patients Scheduled for Total Hip-arthroplasty [NCT02445898]Phase 2/Phase 364 participants (Actual)Interventional2015-09-30Completed
Randomized Clinical Trial Comparing Conventional Conservative Treatment for Plantar Fasciopathia With Endoscopic Surgery With Fascial Release. [NCT02448316]Phase 430 participants (Actual)Interventional2015-04-01Completed
Prospective Evaluation of Perioperative Steroid Dosing on Postsurgical Edema in Orthognathic Surgery [NCT03190642]Phase 4180 participants (Actual)Interventional2018-01-01Completed
Single Dose Oral Dexamethasone Versus Multi-dose Prednisolone in the Treatment of Acute Exacerbations of Asthma in Children Who Attend the Emergency Department [NCT03698630]Phase 4250 participants (Actual)Interventional2011-07-06Completed
Analgesic Efficacy of Liposomal Bupivacaine in Total Knee Arthroplasty [NCT02426164]Phase 40 participants (Actual)Interventional2015-06-30Withdrawn(stopped due to Could not receive facility approval)
Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection: A Double Blind Controlled Study [NCT02403856]Phase 4136 participants (Actual)Interventional2015-04-04Completed
Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease [NCT02392780]Phase 210 participants (Anticipated)Interventional2015-04-30Not yet recruiting
DEXTENZA Compared to Topical Steroid Therapy Prior to Cataract Surgery in Patients Who Receive Premium Intraocular Lenses [NCT04479748]Phase 413 participants (Actual)Interventional2020-10-01Completed
A Randomised Phase II Evaluation of Molecular Guided Therapy for Diffuse Large B-Cell Lymphoma With Acalabrutinib [NCT04546620]Phase 2453 participants (Anticipated)Interventional2021-10-19Recruiting
Can Injection of Methylprednisoloneacetate 80 mg, in the Cavity After Mastectomy for Primary Breast Cancer, at the Time of Removal of the Drain, Prevent Seroma Formation? [NCT01380912]160 participants (Anticipated)Observational2010-08-31Recruiting
Evaluating Clinical and Immunological Effects of Rituximab With Cyclophosphamide Compared to Rituximab Alone in AAV Patients [NCT03942887]Phase 3100 participants (Anticipated)Interventional2019-05-03Recruiting
To Study the Effect of Adjunctive Oral Methylprednisolone Therapy in Pediatric Urinary Tract Infection [NCT02331862]Phase 3160 participants (Anticipated)Interventional2015-01-31Not yet recruiting
VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial [NCT05139849]Phase 31,276 participants (Anticipated)Interventional2021-11-17Recruiting
A Single-center, Prospective, Non-comparative Clinical Trial of Ruxolitinib and Methylprednisolone as a First-line Treatment for Macrophage Activation Syndrome [NCT05137496]Phase 340 participants (Anticipated)Interventional2022-06-01Not yet recruiting
Safety and Efficacy of Thymus Transplantation in Complete DiGeorge Anomaly, IND#9836 [NCT01220531]0 participants Expanded AccessApproved for marketing
Evaluation of Effects, Safety, Viral Load and Antibody Level of Functional Food Dietary Supplement Containing Grape Products in Controlled, Randomized Study Using SARSCoV-2 RT-PCR Positive Covid-19 Patients. [NCT05417997]Phase 371 participants (Actual)Interventional2021-05-29Completed
MP3-pulses-COVID-19. Methylprednisolone Pulses Versus Dexamethasone According RECOVERY Protocol in Patients With Pneumonia Due to SARS-COV-2 Coronavirus Infection [NCT04780581]Phase 4127 participants (Actual)Interventional2021-02-01Terminated(stopped due to Impossibility of reaching the sample size established by protocol)
Autologous Hematopoietic Stem Cell Transplantation for Refractory Crohn's Disease [NCT04224558]Phase 1/Phase 215 participants (Anticipated)Interventional2020-12-15Recruiting
Efficacy of CST1-Guided Oral Glucocorticoid Therapy for Chronic Rhinosinusitis With Polyps [NCT05598411]Phase 490 participants (Anticipated)Interventional2022-10-17Not yet recruiting
An Open-Label, Single-Arm, Multiple Center Extension Study to Evaluate One Year of Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer With YONSA™ 500 mg (4 x 125 mg qd) With Methylprednisolone (4 mg Bid) [NCT02962284]Phase 220 participants (Actual)Interventional2016-11-30Completed
Corticosteroids for Acute Migraine. An ED-based, Randomized, Comparative Effectiveness Trial [NCT02847494]Phase 4220 participants (Actual)Interventional2016-09-01Completed
Health Related Quality of Life and Pain Managment Using Infiltration or Suprascapular Nerve Block Ultrasound Guided in Patients With Glenohumeral Arthirtis [NCT03794505]Phase 340 participants (Actual)Interventional2018-04-01Completed
Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis [NCT01305837]Phase 230 participants (Actual)Interventional2011-04-30Completed
A Multi-centre Randomised Double Blind Placebo Controlled Study Comparing Two Regimens of Combination Therapy in Early DMARD Naive Rheumatoid Arthritis. [NCT01308255]Phase 4112 participants (Actual)Interventional2006-09-30Completed
A Randomised Phase II Study Comparing LEnalidomide Plus Rituximab, GEmcitabine and Methylprednisolone (LR-GEM) to Rituximab, Gemcitabine, Methylprednisolone and cisplatiN (R-GEM-P) in Second-line Treatment of Diffuse Large B-cell Lymphoma (DLBCL). [NCT02060656]Phase 292 participants (Anticipated)Interventional2013-09-30Active, not recruiting
Clinical Study of Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of Checkpoint Inhibitor-related Pneumonitis [NCT05280873]Phase 148 participants (Anticipated)Interventional2021-10-10Recruiting
Efficacy and Cost-effectiveness of Intra-Articular Ketorolac Injection for Knee Osteoarthritis: A Randomized, Controlled, Double-Blinded Study [NCT03694821]Phase 418 participants (Actual)Interventional2018-07-05Terminated(stopped due to Low enrollment)
Everolimus in Association With Very Low-dose Tacrolimus Versus Enteric-coated Mycophenolate Sodium With Low-dose Tacrolimus in de Novo Renal Transplant Recipients - A Prospective Single Center Study [NCT02084446]Phase 4120 participants (Actual)Interventional2012-12-31Completed
The Efficacy of Steroid Therapy in Vestibular Neuritis Confirmed by Head Impulse Test: Prospective Randomized Controlled Study [NCT02098330]Phase 340 participants (Actual)Interventional2014-03-31Completed
Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis: Two-arm, Open, Single-center Study [NCT06119490]Early Phase 130 participants (Anticipated)Interventional2023-07-05Recruiting
Corticosteroid(CS) Injections for the Treatment of Common Upper Extremity Pathologies, With or Without Lidocaine [NCT03704584]Phase 462 participants (Actual)Interventional2019-05-14Terminated(stopped due to Enrollment and study activities were initially suspended due to COVID-19. The investigator has also left Emory and the study will not resume.)
Phase II Study of Simvastatin, Zoledronic Acid, Bortezomib, Bendamustine and Methylprednisolone for Relapsed/Refractory Myeloma [NCT01332617]Phase 20 participants (Actual)Interventional2011-04-30Withdrawn(stopped due to Investigators no longer interested in activating study)
Feasibility and Safety of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Trial [NCT01354483]Phase 1/Phase 220 participants (Actual)Interventional2011-09-30Completed
CD34+ Stem Cell Selection for Patients Receiving a Matched or Partially Matched Family or Unrelated Adult Donor Allogeneic Stem Cell Transplant for Malignant Disease [NCT02061800]Phase 1/Phase 215 participants (Anticipated)Interventional2013-06-03Recruiting
The Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients, and the Effect of ABCB1、CYP3A4、CYP3A5、PORGenetic Polymorphism on the Two Drugs [NCT02077556]Phase 414 participants (Actual)Interventional2014-04-30Completed
Double-blind, Placebo-controlled, Randomized Study of the Safety and Tolerability of Isoxsuprine HCL Combined With High Dose Steroid Treatment of Multiple Sclerosis (MS) Relapse [NCT03752307]Phase 1/Phase 22 participants (Actual)Interventional2019-02-15Completed
Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis. [NCT01941589]Phase 4149 participants (Actual)Interventional2013-09-30Completed
Subcutaneous Injection of TNFα Monoclonal Antibody for Treating Traumatic Acute Spinal Cord Injury [NCT04988425]Phase 1/Phase 290 participants (Anticipated)Interventional2022-09-01Not yet recruiting
A Comparative Study of Strategies for Management of Duchenne Myopathy in Assiut University Children Hospital [NCT03633565]Phase 445 participants (Anticipated)Interventional2018-09-30Not yet recruiting
Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma [NCT00109928]Phase 234 participants (Actual)Interventional2005-09-30Completed
A Phase II, Open-labeled, Ophthalmological External Investigator-blinded, Single-center, Randomized, Superiority, Non Profit, Pilot Clinical Trial to Evaluate the Effects of Atorvastatin on Graves' Orbitopathy (GO) in Hypercholesterolemic Patients With Mo [NCT03110848]Phase 288 participants (Actual)Interventional2020-06-01Completed
Manipulation Versus Steroid Injection in the Treatment of Morton's Neuroma [NCT05707572]62 participants (Actual)Interventional2014-09-30Completed
Randomized, Double-blind, Placebo- and Active Comparator- Controlled Crossover Study in Healthy Male Subjects and an Open Label Study in Healthy Subjects and MS Patients to Assess the Safety, Pharmacokinetics and Pharmacodynamics of 2B3-201 [NCT02048358]Phase 147 participants (Actual)Interventional2013-11-30Terminated
Does Injection Site Matter? A Randomized Controlled Trial to Evaluate Efficacy of Knee Intraarticular Injections on Improval of Patient Reported Outcomes. [NCT02176304]Phase 460 participants (Actual)Interventional2014-06-30Completed
[NCT01281748]Phase 483 participants (Actual)Interventional2005-07-31Terminated(stopped due to Low rate of enrollment)
Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata [NCT01167946]Phase 442 participants (Actual)Interventional2003-01-31Completed
DELTA Study Dutch Evaluation in Liver Transplantation To Assess the Efficacy of Cyclosporine A Microemulsion With C-2h Monitoring Versus Tacrolimus With Trough Monitoring in de Novo Liver Transplant Recipients [NCT00149994]Phase 4171 participants (Actual)Interventional2002-12-31Completed
Cyclophosphamide and Hydroxychloroquine for the Treatment of Severe Thrombocytopenia in Systemic Lupus Erythematosus [NCT02444728]Phase 350 participants (Actual)Interventional2015-07-31Terminated(stopped due to Because of insufficient enrollement)
A Phase 2, Randomized, Open-Label Study of Infliximab and Lower Exposure Corticosteroids vs Methylprednisolone and Higher Exposure Oral Corticosteroids for the Management of Immune-Related Severe or Persistent Diarrhea in Patients Treated With Yervoy (Ipi [NCT02763761]Phase 20 participants (Actual)Interventional2016-08-16Withdrawn(stopped due to Insufficient enrollment)
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas [NCT01189864]3,493 participants (Actual)Observational2010-02-01Terminated(stopped due to Terminated to initiate FDA IND-cleared study protocol)
Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study Low Dose Study [NCT01560052]503 participants (Actual)Interventional2012-05-05Completed
Investigating New Onset Diabetes Mellitus in Kidney Transplant Recipients Receiving an Advagraf-Based Immunosuppressive Regimen With or Without Corticosteroids - A Multicenter, Two Arm, Randomized, Open Label Clinical Study [NCT01304836]Phase 41,166 participants (Actual)Interventional2011-01-22Completed
Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA) [NCT00418145]Phase 316 participants (Actual)Interventional2003-09-30Terminated(stopped due to low enrollment - data was not analyzed for this study)
A Randomized, International, Multi Centre Study to Assess the Efficacy and Safety of Intravenous PEG-liposomal Prednisolone Sodium Phosphate (Nanocort®) vs Intravenous Methylprednisolone (Solu-Medrol®) Treatment in Patients With Acute Exacerbation of Rela [NCT01039103]Phase 215 participants (Actual)Interventional2009-12-31Terminated
Corticosteroid Treatment in the Acute Phase of Caustic Ingestion Management for the Prevention of Refractory Stenosis of the Esophagus and Pharynx- The CORTICAU Study [NCT03760354]Phase 230 participants (Anticipated)Interventional2019-02-15Not yet recruiting
Ultrasound-guided Medial Lumbar Bundle Branch Block by Caudal-cranial Approach: Radiographic Comparison of a New Ultrasound-guided Method [NCT05930236]40 participants (Anticipated)Interventional2023-04-21Recruiting
A Single-Cohort, Phase 2 Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1) [NCT02953678]Phase 271 participants (Actual)Interventional2016-12-30Completed
A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab [NCT00379431]Phase 29 participants (Actual)Interventional2006-11-27Completed
Evaluation of clINical reCovery After a Relapse: a Pilot Study assEssing the Neuronal Effects of D-Aspartate in RR-MS Subjects Treated With IntErferon Beta 1a 44 mcg TIW (INCREASE) [NCT03387046]Phase 27 participants (Actual)Interventional2018-03-26Terminated(stopped due to Study was terminated early due to slow recruitment rate.)
A Prospective, Randomized, Controlled, Open Label, Assessor-blinded, Parallel-group Phase III Clinical Trial to Evaluate the Impact of Tapering Systemic Immunosuppressive Therapy in a Treat-to-target Approach on Maintaining Minimal Disease Activity in Adu [NCT04610476]Phase 3270 participants (Anticipated)Interventional2020-10-19Recruiting
A Multicentre Double-blind Randomised Controlled Trial to Assess the Clinical- and Cost-effectiveness of Facet-joint Injections in Selected Patients With Non-specific Low Back Pain: a Feasibility Study [NCT03339362]Phase 49 participants (Actual)Interventional2015-07-31Completed
Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion [NCT03327272]Phase 30 participants (Actual)Interventional2018-05-22Withdrawn(stopped due to Did not enroll, PI decided not to proceed.)
Phase II Trial Of Yttrium-90-Ibritumomab Tiuxetan (Zevalin®) Radioimmunotherapy After Cytoreduction With ESHAP Chemotherapy In Patients With Relapsed Follicular Non-Hodgkin's Lymphoma [NCT00732498]Phase 228 participants (Actual)Interventional2006-05-15Completed
Single Arm Study To Assess Comprehensive Infusion Guidance For The Management Of The Infusion- Associated Reactions (IARs) In Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With LEMTRADA [NCT02205489]Phase 458 participants (Actual)Interventional2014-10-31Completed
A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR) [NCT05436652]Phase 248 participants (Anticipated)Interventional2022-07-22Recruiting
Evaluation of Intraoperative Use of Dexycu on the Signs and Symptoms of Dry Eye [NCT04184999]Phase 440 participants (Actual)Interventional2019-08-10Completed
A Prospective, Randomized, Double-Blind Study to Compare the Effects of Dexamethasone Versus Depo-Medrol When Used in Lumbar Epidural Injections [NCT01397552]8 participants (Actual)Interventional2009-09-30Terminated(stopped due to Low enrollment, too many subjects getting second injection)
Phase II Study of Combination of Hyper-CVAD and Dasatinib (NSC-732517) With or Without Allogeneic Stem Cell Transplant in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) (A BMT Study) [NCT00792948]Phase 297 participants (Actual)Interventional2009-09-01Active, not recruiting
MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE [NCT03355482]Phase 240 participants (Anticipated)Interventional2017-04-10Suspended(stopped due to recruitment, funding)
Prognostic Value of Single-dose Glucocorticoid After Endovascular Repair for Aortic Dissection [NCT02523300]240 participants (Anticipated)Interventional2015-10-31Not yet recruiting
Effects of Intraoperative Local Steroid Utilization in a Single-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion [NCT03308084]Phase 3105 participants (Actual)Interventional2015-11-13Completed
A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract [NCT05191706]Phase 460 participants (Anticipated)Interventional2022-01-04Recruiting
A Phase IIA, Open-label Study Designed to Evaluate Efficacy and Safety of BL-8040 Followed by Anti-Thymocyte Globulin (hATG), Cyclosporine and Methylprednisolone in Adult Subjects With Aplastic Anemia (AA) or Hypoplastic Myelodysplastic Syndrome (MDS) [NCT02462252]Phase 211 participants (Actual)Interventional2015-10-31Completed
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal® Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute GVHD [NCT00562497]Phase 3192 participants (Actual)Interventional2008-01-31Completed
Glucocorticoid Inflammation Paradox in Human Skeletal Muscle [NCT03529929]Phase 30 participants (Actual)Interventional2019-06-01Withdrawn(stopped due to withdrawn)
The Effect of High Dose Steroid and Normobaric Oxygen Therapy on Recent Onset Non-arteritic Anterior Ischemic Optic Neuropathy(NAION); a Randomized Clinical Trial [NCT02439866]Phase 390 participants (Anticipated)Interventional2014-02-28Recruiting
Using A Novel Classification System in Intravenous Glucocorticoids Therapy of TAO: A Multi-central, Randomized, Open, Superior Trial [NCT03107078]Phase 4200 participants (Anticipated)Interventional2016-10-01Recruiting
A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin (IVIg) Versus Standard Therapy for the Treatment of Transverse Myelitis in Adults and Children [NCT02398994]Phase 32 participants (Actual)Interventional2015-03-31Terminated(stopped due to Continued effort did not successfully increase recruitment into the study.)
A Randomized, Parallel Group, Double-masked, Active-controlled Phase 1/2 Clinical Trial to Evaluate the Efficacy and Safety of Dexamethasone Sodium Phosphate Visulex System for the Treatment of Non-infectious Anterior Uveitis [NCT02309385]Phase 1/Phase 244 participants (Actual)Interventional2014-10-31Completed
Non Randomized, Multicenter, Prospective Pediatric Hodgkin Lymphoma Treatment Trial Stratified According to Initial Risk Factors and Response to Chemotherapy, Reduced Cumulative Doses of Antineoplastic Agents and Radiotherapy. [NCT03500133]Phase 4500 participants (Anticipated)Interventional2017-10-06Recruiting
Targeting Steroid Resistance During Acute Exacerbations of Chronic Obstructive Pulmonary Disease With Respiratory Failure - The AECOPD Resistance Study [NCT03680495]46 participants (Anticipated)Observational [Patient Registry]2017-07-21Recruiting
CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid [NCT03492255]49 participants (Actual)Interventional2018-04-12Terminated(stopped due to Significative difference between percentage of renal response (primary outcome) between the two study arms.)
Evaluation of Ultrasound Guided Platelet Rich Plasma Injection Versus Steroids Injection for Pain Relief in Cases of Partial Rotator Cuff Tears [NCT05317624]Early Phase 160 participants (Actual)Interventional2021-08-10Completed
Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study [NCT03674099]Phase 2200 participants (Anticipated)Interventional2018-10-01Recruiting
Calcific Tendinitis: Comparing Minimally Invasive Modalities [NCT02367560]60 participants (Anticipated)Interventional2015-07-31Recruiting
Moscow-Berlin 2015 Multicenter Randomized Study for Treatment of Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults [NCT03390387]4,000 participants (Anticipated)Interventional2015-11-30Recruiting
Effect of Preoperative Intravenous High Dose Methylprednisolone on Complement Activation in Patients Scheduled for Total Knee-arthroplasty [NCT02332616]Phase 370 participants (Actual)Interventional2015-01-31Completed
Early and Late Prognosis in Patients With Guillain-Barre Syndrome [NCT06041451]Phase 4450 participants (Anticipated)Interventional2013-01-02Recruiting
An Open-label, Phase 1/2 Study to Evaluate the Safety and Efficacy of Single-dose LY3884961 in Infants With Type 2 Gaucher Disease [NCT04411654]Phase 1/Phase 215 participants (Anticipated)Interventional2021-06-29Recruiting
Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis: a Multinational, Randomised, Open Label, Phase III Trial - The iCaD Study [NCT05947669]Phase 3195 participants (Anticipated)Interventional2023-08-22Recruiting
[NCT02591953]22 participants (Actual)Interventional2015-11-30Terminated(stopped due to Unable to meet enrollment and follow up criteria)
Pulse Glucocorticoid Therapy in Patients With ST-Segment Elevation Myocardial Infarction [NCT05462730]Phase 2530 participants (Actual)Interventional2022-11-14Active, not recruiting
Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age: a Point-of-care Testing Guided Randomized, Double-blind, Placebo-controlled Trial [NCT05444699]Phase 4210 participants (Anticipated)Interventional2022-10-11Recruiting
Transforaminal Epidural Injection in Acute Sciatica [NCT03924791]142 participants (Anticipated)Interventional2019-06-01Recruiting
Phase II Study of Ofatumumab in Combination With High Dose Methylprednisolone Followed by Ofatumumab and Lenalidomide Consolidative Therapy for the Treatment of Untreated CLL/SLL The HiLOG Trial [NCT01496976]Phase 245 participants (Actual)Interventional2012-03-30Active, not recruiting
A Phase II, Randomized Study to Evaluate the Safety and Efficacy of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) For the Treatment of Acute GVHD in Patients Who Receive Allogeneic Hematopoietic Stem Cell Transplantation [NCT00136903]Phase 232 participants (Actual)Interventional2005-04-27Completed
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of COLAL-PRED in the Treatment of Patients With Moderate to Severe Ulcerative Colitis [NCT00676832]Phase 2190 participants (Actual)Interventional2008-05-31Completed
The Usage of Neuropsychological Tests and Multi-mode Magnetic Resonance Imaging in Patients With Autoimmune Encephalitis for Cognitive Neural Mechanism [NCT03530462]22 participants (Actual)Observational2017-04-07Completed
Ultrasound Guided Continuous Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Patients With Frozen Shoulder [NCT05037994]40 participants (Actual)Interventional2021-04-01Completed
A Phase 3, Multicenter, Randomized, Evaluator-blinded Clinical Trial to Assess the Safety and Efficacy of Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% Compared to Prednisolone Acetate, 1% in the Treatment of Inflammation After Cataract Surgery in [NCT05724446]Phase 360 participants (Anticipated)Interventional2022-12-12Recruiting
Chidamide Combines With Etoposide and Methylprednisolone in the Treatment of Hemophagocytic Lymphohistiocytosis [NCT05137522]20 participants (Anticipated)Interventional2021-07-01Recruiting
Local Steroid Injection vs Wrist Splinting for Carpal Tunnel Syndrome: A Randomized Clinical Trial [NCT02140632]Phase 450 participants (Actual)Interventional2013-12-31Completed
[NCT02253966]Phase 248 participants (Actual)Interventional2014-10-31Completed
"Efficacy of Infliximab as Bridging Therapy in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine" [NCT00796250]Phase 39 participants (Actual)Interventional2003-11-01Terminated(stopped due to Due to poor patient recruitment, a decision was made to terminate this trial.)
Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial. [NCT02160132]Phase 2180 participants (Anticipated)Interventional2014-06-30Recruiting
Efficacy of Steroids on Functional Outcomes After Musculoskeletal Injuries of the Hand [NCT05003596]Phase 2/Phase 360 participants (Anticipated)Interventional2021-09-01Not yet recruiting
Effect of High-dose Glucocorticoids on Markers of Inflammation and Bone Metabolism in Patients With Primary Glomerular Disease [NCT04987450]40 participants (Anticipated)Observational2018-10-01Recruiting
A Parallel-arm, Single Blind Randomised Controlled Trial Comparing 'AIRWAY PRESSURE RELEASE VENTILATION' and 'LOW-TIDAL VOLUME VENTILATION' in Children With Acute Respiratory Distress Syndrome [NCT02167698]52 participants (Actual)Interventional2014-02-28Terminated(stopped due to Increased mortality in the intervention arm at 50% enrolment)
Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy in Biliary Atresia: a Randomized Controlled Trial [NCT05925309]356 participants (Anticipated)Interventional2023-07-01Recruiting
Stop LCNP: High Dose Steroid Therapy for Late Radiation-Associated Lower Cranial Neuropathy: A Phase I/II Dose Finding Trial and Data Registry [NCT04151082]Phase 1/Phase 215 participants (Actual)Interventional2019-10-31Active, not recruiting
Efficacy and Safety of Methylprednisolone Versus Dexamethasone in Caudal Block for Children Undergoing Hypospadias Surgical Repair: A Bi-center Randomized Controlled Study [NCT05717374]80 participants (Anticipated)Interventional2023-02-13Recruiting
The Efficacy and Safety of 36 Weeks Short-Term Optimization Treatment of Glucocorticosteroid in the Patients With Chronic Recurrent Drug-Induced Liver Injury [NCT03266146]Phase 1/Phase 290 participants (Actual)Interventional2017-09-02Completed
The Prospective Evaluation of Peri-Operative Glucocorticoid Use in the Management of Cervicofacial Infections of Odontogenic Origin [NCT05951504]Phase 2/Phase 329 participants (Actual)Interventional2022-06-22Completed
Evaluate the Efficacy and Safety of Various Treatment Schemes for Severe Fever With Thrombocytopenia Syndrome:a Prospective, Multicenter, Non-randomized Controlled Intervention Study [NCT05604859]Phase 4350 participants (Anticipated)Interventional2022-08-19Recruiting
Corticosteroid Pulse Therapy Effects on MRI Asymptomatic Gadolinium-enhancing Lesions Conversion to a Non-enhancing Black Hole With or Without Treatment in MS Clinic of Booalisina Hospital Sari 2021-2023 [NCT04979650]Phase 2104 participants (Anticipated)Interventional2021-05-22Enrolling by invitation
The Impact of Dexamethasone Versus Methylprednisolone Upon Neutrophil/Lymphocyte Ratio (NLR) in COVID-19 Diseased Patients Admitted in ICU [NCT04909918]Phase 360 participants (Actual)Interventional2021-05-28Completed
Prevention of Development of Transcutaneous Sensitization in Children With Atopic Dermatitis During Their First Year of Life: an Observational Study [NCT04900948]Phase 4108 participants (Actual)Interventional2017-12-10Completed
Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing Femtosecond Laser-Assisted Cataract Surgery With Premium Intraocular Lens - The ENHANCE Study [NCT04863742]Phase 430 participants (Anticipated)Interventional2021-04-26Recruiting
Single-blind, Investigator-initiated, Randomized, Controlled Trial to Assess the Safety and Efficacy of Intravenous Corticosteroid Therapy to Treat Patients With Acute Myocarditis With Mildly Reduced Left Ventricular Ejection Fraction [NCT05974462]Phase 3174 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Evaluation of the Feasibility of Depomedrol Added to Bupivacaine in Ultrasound-guided Genicular Nerve Block in the Combination With Adductor Canal Block for Postoperative Analgesia and Rehabilitation After Reconstructive Knee Surgery. [NCT05893771]48 participants (Actual)Interventional2023-06-07Completed
Mechanisms of Neurodynamic Treatments (MONET) [NCT05859412]108 participants (Anticipated)Interventional2023-04-13Recruiting
Methylprednisolone Taper After Total Knee Replacement: A Prospective Randomized Trial [NCT05859269]Phase 4200 participants (Anticipated)Interventional2023-10-16Recruiting
A Pilot Randomized Controlled Trial of De Novo Belatacept-Based Immunosuppression in Lung Transplantation [NCT03388008]Phase 227 participants (Actual)Interventional2019-12-17Completed
Hypertonic Dextrose Versus Corticosteroid Intra-Articular Injections for the Treatment of Trapeziometacarpal Arthritis: A Prospective Double-blind Randomized Controlled Clinical Trial [NCT04791202]Phase 3130 participants (Anticipated)Interventional2021-04-01Not yet recruiting
Lateral Elbow Tendinopathy: A Randomized Controlled Trial Examining The Treatment Effect Of Strength Training Combined With Cortico-Steroid Injection, Dry-Needling Or Placebo [NCT02521298]60 participants (Actual)Interventional2015-10-31Completed
Evaluation of Acute Rejection Rates in de Novo Renal Transplant Recipients Following Thymoglobulin Induction, CNI-free, Nulojix (Belatacept)-Based Immunosuppression [NCT02137239]Phase 258 participants (Actual)Interventional2015-12-31Completed
Clinical and Laboratory Evaluation of Acute Rejection, Myocyte Growth, Repair, and Oxidative Stress Following de Novo Cardiac Transplant: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens With MPA TDM [NCT00157014]Phase 3111 participants (Actual)Interventional2004-05-10Completed
Procollagen-3 Driven Corticosteroids for Persistent Acute Respiratory Distress Syndrome [NCT03371498]Phase 3356 participants (Anticipated)Interventional2018-12-27Recruiting
High-dose Intravenous Methylprednisolone Therapy in Patients With Graves' Orbitopathy is Associated With the Increased Activity of Factor VIII [NCT03535090]26 participants (Actual)Observational2011-01-01Completed
Methylprednisolone Taper to Treat Delayed Post-Operative Recovery After Total Knee Arthroplasty: a Double-Blind Randomized Controlled Trial [NCT05113901]Phase 44 participants (Actual)Interventional2022-03-03Terminated(stopped due to Extremely low participation, decided to focus on similar study instead)
Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial [NCT03875690]Phase 31,200 participants (Anticipated)Interventional2019-07-02Recruiting
Comparative Study Between the Uses of High Dose Corticosteroid Therapy for Short Duration Versus Low Dose Corticosteroid for Long Duration in Severe Lung Contusion With ARDS [NCT04467892]Phase 2240 participants (Actual)Interventional2018-01-02Completed
A Sequential Multiple Assignment Randomized Trial (SMART) Developing and Optimizing Patient-Tailored Adaptive Treatment Strategies (ATS) for Acute Severe Ulcerative Colitis [NCT05867329]Phase 4162 participants (Anticipated)Interventional2023-09-30Recruiting
International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones [NCT03007147]Phase 3475 participants (Anticipated)Interventional2017-08-08Recruiting
Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura [NCT03647852]150 participants (Anticipated)Interventional2019-09-01Recruiting
A Randomised Controlled Trial to Compare the Clinical Effectiveness of Lower Extremity Manipulation to That of Steroid Injection in the Treatment of Morton's Neuroma [NCT02304094]64 participants (Anticipated)Interventional2015-10-31Recruiting
GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease [NCT03139604]Phase 3439 participants (Actual)Interventional2017-07-19Completed
The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study [NCT03491098]Early Phase 160 participants (Anticipated)Interventional2018-05-15Not yet recruiting
Mycophenolate Mofetil and Prednisolone Versus Prednisolone Alone in Fibrotic Hypersensitivity Pneumonitis: a Randomized Controlled Trial [NCT05626387]Phase 4144 participants (Anticipated)Interventional2022-11-23Recruiting
A Prospective, Randomized, Controlled Phase Ⅱ Study of Preventively Use of Methylprednisolone After Split-course Chemoradiotherapy to Reduce the Risk of Radiation-induced Pulmonary Injury For Bulky Local Advanced None-small Cell Lung Cancer [NCT03661567]Phase 252 participants (Actual)Interventional2018-08-09Terminated(stopped due to slow enrollment)
A Double-masked, Methylprednisolone-control, Efficacy and Safety Study of 99Tc-MDP for Thyroid Associated Ophthalmopathy. [NCT03948191]Phase 450 participants (Actual)Interventional2017-10-16Completed
A Prospective, Open-label Trial of Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children [NCT01217099]47 participants (Actual)Interventional2007-05-31Terminated(stopped due to terminated)
Double-Masked, Randomized, Parallel Group Study for Evaluation of Non-Inferiority of 0.3%Gatifloxacin/1.0% Prednisolone Association Compared With Their Isolated Administration in the Prevention of Ocular Infection/Inflammation After LASIK Surgery [NCT01218737]Phase 3101 participants (Actual)Interventional2009-01-31Completed
A Phase 2 Trial of Standard of Care Treatment Versus Mesenchymal Stromal Cell Therapy Together With Standard of Care for the Treatment of de Novo Acute Graft Versus Host Disease Following Allogeneic Bone Marrow Transplantation [NCT01589549]Phase 266 participants (Anticipated)Interventional2012-04-30Recruiting
Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment [NCT01156883]76 participants (Actual)Interventional2010-04-30Completed
Evaluation of Corticosteroid as Modulators of Humeral and Cellular Immune Response in Open Heart Surgery in Egyptian Population [NCT03876041]Phase 460 participants (Actual)Interventional2019-09-01Completed
The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation [NCT02495662]Phase 230 participants (Actual)Interventional2015-11-30Terminated(stopped due to Slow inclusion)
Clinical Trial of Belimumab Combined With Multi-target Induction Therapy in Adult Patients With Severe Lupus Nephritis [NCT05863936]Phase 315 participants (Anticipated)Interventional2023-04-01Recruiting
Steroid Metabolism in Obese and Non-Obese Pediatric Patients Hospitalized for Status Asthmaticus [NCT04874610]15 participants (Actual)Observational2021-08-16Completed
A Phase II Study of Ofatumumab-High Dose Methylprednisolone Followed by Ofatumumab-Alemtuzumab in 17p Deletion CLL [NCT01465334]Phase 230 participants (Actual)Interventional2011-12-31Terminated(stopped due to Terminated early due to change in practice.)
The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease, a Double Blind Placebo Controlled Randomized Clinical Trial [NCT02422368]Phase 2/Phase 30 participants (Actual)Interventional2022-09-01Withdrawn(stopped due to Do not access to the drug)
A Phase I, Single Center, Placebo-Controlled, Blinded Pilot Study of Ipratropium Bromide in Children Admitted to the Intensive Care Unit With Status Asthmaticus [NCT02872597]Phase 130 participants (Actual)Interventional2016-09-05Completed
A Phase II Study Evaluating Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Double and Triple Hit Lymphoma, Double Expressor Lymphoma and High-Gr [NCT04479267]Phase 249 participants (Anticipated)Interventional2020-08-21Recruiting
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY) [NCT04221477]Phase 3252 participants (Anticipated)Interventional2020-08-10Active, not recruiting
An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate [NCT01000610]Phase 418 participants (Actual)Interventional2008-03-17Completed
Phase 4, Randomized Study of Oral Glucocorticosteroid Administration in the Treatment of Acute Severe Asthma Exacerbation in Hospitalized Patients [NCT00627731]Phase 450 participants (Actual)Interventional2007-06-30Completed
Open-Label, Randomized, Multicenter, Parallel-Group Efficacy and Safety Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation [NCT00717379]Phase 450 participants (Actual)Interventional2007-05-31Completed
Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) for Stage IV Indolent Lymphoma [NCT00577993]Phase 3210 participants (Actual)Interventional1998-03-16Completed
Impact of the Administration of Systemic Glucocorticoids on Inflammatory Response and Clinical Evolution of Patients Diagnosed With Moderate- Severe Bronchiolitis [NCT02571517]Phase 494 participants (Actual)Interventional2011-11-30Completed
Viral Inception of Asthma: Prospective Study From Infancy to School-age. [NCT00731575]200 participants (Anticipated)Interventional2007-06-30Active, not recruiting
Immunomodulatory Effect of Extracorporeal Cytokine Adsorption in Cardiac Surgery [NCT02666703]Phase 360 participants (Actual)Interventional2016-02-01Completed
Comparison of Intravenous Low Dose Versus High Dose Cyclophosphamide as Induction Therapy in the Treatment of Proliferative Lupus Nephritis [NCT02645565]Phase 475 participants (Actual)Interventional2015-12-31Completed
Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain: A Randomized Controlled Trial [NCT05971004]62 participants (Actual)Interventional2022-04-13Completed
Phase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated Vasculitis [NCT00753103]Phase 237 participants (Actual)Interventional2003-01-31Completed
Treatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment? [NCT00764413]57 participants (Actual)Interventional2009-04-30Terminated(stopped due to Low inclusion frequency and not enough human resources for completing study)
Efficacy of Nebulized Magnesium Sulfate as an Adjunct to Standard Therapy in Asthma Exacerbation. A Randomized Controlled Trial [NCT02584738]Phase 4152 participants (Anticipated)Interventional2015-09-30Recruiting
Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial [NCT03913702]Phase 21 participants (Actual)Interventional2019-09-09Terminated(stopped due to Inadequate patient enrollment)
Phase 2/3 Study of Rituximab for Graves' Ophthalmopathy [NCT00595335]Phase 2/Phase 325 participants (Actual)Interventional2008-04-30Completed
Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis [NCT03479502]Phase 41 participants (Actual)Interventional2018-01-05Terminated(stopped due to Lack of personnel to help with recruiting)
A Phase IV Trial of Neuroprotection With ACTH in Acute Optic Neuritis [NCT01838174]Phase 437 participants (Actual)Interventional2013-05-31Terminated(stopped due to Sponsor requested)
Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee Treated With Fixed Dose Combination of Glucosamine and Chondroitin Sulfate. [NCT00805519]Phase 4230 participants (Actual)Interventional2009-02-28Completed
A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate [NCT00634933]Phase 2222 participants (Actual)Interventional2008-03-31Terminated(stopped due to The study was terminated on 21 June 2010 due to results not meeting the primary endpoint. No safety reasons contributed to the termination of the study.)
Multicenter, Randomized, Double-blind Clinical Trial to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse. [NCT01986998]Phase 449 participants (Actual)Interventional2013-10-31Completed
Personalized Variable Versus Fixed Dose Corticosteroids Therapy in Hospitalized Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease [NCT02147015]248 participants (Actual)Interventional2014-06-30Completed
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of a BI 653048 BS H3PO4 Capsule Formulation Administered as Multiple Doses of 25 mg to 200 mg Once Daily (qd) for 3 Days Assessing Pharmacodynamics as Endotoxin-induced Inflammatory Response of a [NCT02224105]Phase 156 participants (Actual)Interventional2010-03-31Completed
Hematopoietic Stem Cell Transplantation in High Risk Patients With Fanconi Anemia MT2002-02 [NCT00258427]Phase 214 participants (Actual)Interventional2002-03-26Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled TRial Evaluating Immunosuppressive Treatment in Patients With Chronic Virus-Negative Inflammatory cardiomyopaThY (TRINITY Trial) [NCT05570409]Phase 2/Phase 3130 participants (Anticipated)Interventional2023-03-28Recruiting
Assessment of the Efficacy of Medrol Dose Pack for Post-Concussive Headaches [NCT04685772]25 participants (Anticipated)Observational [Patient Registry]2021-04-01Recruiting
Methylprednisolone Pulse Therapy for Coronary Artery Dilatation or Aneurysm Formation in Kawasaki Disease [NCT04509219]Phase 110 participants (Anticipated)Interventional2020-04-15Recruiting
The Effect on Wrist Range of Motion With Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures: A Randomized Controlled Trial [NCT03898154]Phase 4200 participants (Anticipated)Interventional2019-07-10Recruiting
The Outcome of Dexamethasone and Methylprednisolone Treatment for Patients With ARDS Caused by COVID-19 [NCT04499313]Phase 360 participants (Anticipated)Interventional2020-08-02Recruiting
A Feasibility Study to Undertake a Definitive Randomised Multi-centre, Double-blind, Double-dummy Controlled Study of a Novel Agent Anakinra vs. Depo-Medrone for Acute Gout Attacks in Patients With Moderate Chronic Kidney Disease [NCT02578394]Phase 2/Phase 321 participants (Actual)Interventional2016-04-30Completed
Effects of Methylprednisolone Plus Ropivacaine Infiltration Before Wound Closure on Laminoplasty or Laminectomy [NCT04493463]Phase 4132 participants (Actual)Interventional2020-07-31Completed
The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS) Applied on Cardiac Surgery With Cardiopulmonary Bypass: a Single Center, Randomized, Controlled Clinical Study [NCT02479581]Phase 2226 participants (Actual)Interventional2015-07-31Completed
Syndrome du Tunnel Carpien - Essai Clinique randomisé évaluant l'efficacité de l'Utilisation de l'échographie Lors de l'Infiltration de corticostéroïdes [NCT02036125]50 participants (Anticipated)Interventional2013-10-31Recruiting
Zonisamide and Methylprednisolone to Prevent Noise-induced Temporary Hearing Loss [NCT02049073]Phase 1/Phase 20 participants (Actual)Interventional2017-10-31Withdrawn(stopped due to new data makes this trial unethical)
Randomised Trial of Intra-articular Injection of Lidocaine Versus Placebo in Inflammatory Arthritis [NCT05302232]80 participants (Anticipated)Interventional2022-04-18Not yet recruiting
Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia [NCT03913559]Phase 232 participants (Anticipated)Interventional2019-05-14Recruiting
A Prospective, Multi-center, Single-arm, Interventional Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant in China [NCT03099122]Phase 4115 participants (Actual)Interventional2017-08-16Completed
Comparison of High-dose, Short-term Steroid and Low-dose Long-term Steroid Use in ARDS Caused by COVID-19 - Retrospective Cross-sectional Study [NCT05047874]200 participants (Anticipated)Observational2021-09-20Recruiting
An Open-Label, Parallel Group, Controlled Study in Healthy Subjects to Characterize Biological Responses to Immunological Challenges and to Measure the Effect of Marketed Anti-Inflammatory Agents on Those Responses [NCT02252809]Early Phase 151 participants (Actual)Interventional2008-11-30Completed
Comparative Evaluation of Preoperative Methylprednisolone or Ibuprofen on Anesthetic Efficacy of Inferior Alveolar Nerve Blocks in Patients With Symptomatic Irreversible Pulpitis [NCT04157036]Phase 33 participants (Actual)Interventional2020-02-01Terminated(stopped due to COVID halted recruitment for 2 years. A majority of patients eligible for the study had already taken preoperative analgesics, which disqualified them for the study.)
A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome [NCT04933292]Phase 478 participants (Anticipated)Interventional2021-06-16Recruiting
Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia: A Randomized, Controlled, 2x2 Factorial Study [NCT04485429]Phase 30 participants (Actual)Interventional2020-07-20Withdrawn(stopped due to It was not possible to perform the study due to the availability and logistics of porcine heparin)
A Single Center Open Label Pilot Study of Alpha1-Antitrypsin: A Novel Treatment to Mitigate Neuromyelitis Optica Attacks [NCT02087813]Phase 10 participants (Actual)Interventional2014-03-31Withdrawn
Phase 2a, Double-blind, Randomized, Placebo-controlled Trial of Methylprednisolone Versus Placebo in Patients With Cognitive Deficits in Post-COVID-19 Syndrome (PCS) [NCT05986422]Phase 2418 participants (Anticipated)Interventional2023-10-01Recruiting
Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Crescents : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial. [NCT04833374]Phase 3200 participants (Anticipated)Interventional2021-05-24Recruiting
Open-label Pilot Study of Methylprednisolone for the Treatment of Patients With Friedreich Ataxia (FRDA) [NCT02424435]Early Phase 111 participants (Actual)Interventional2015-06-30Completed
Comparison Of Efficacy Of Hydrocortisone And Methyl Prednisolone In Acute Severe Asthma [NCT06171932]60 participants (Anticipated)Observational [Patient Registry]2023-11-26Enrolling by invitation
A Pilot Study Examining Selinexor's Ability to Overcome Resistance in Multiple Myeloma Patients Who Are Refractory to Lenalidomide-containing Therapy. [NCT04519476]Phase 122 participants (Anticipated)Interventional2020-11-01Recruiting
Evaluation of the Efficacy of 2% Cyclosporine in Preventing Graft Rejection [NCT02206789]200 participants (Anticipated)Interventional2012-02-29Recruiting
Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering [NCT06072768]Phase 2200 participants (Anticipated)Interventional2023-03-09Recruiting
Impact of Cyclosporine or Steroid Withdrawal at 3 Months Post Transplantation on Graft Function, Patient Survival and Cardiovascular Surrogate Markers the First 5 Years After Renal Transplantation. [NCT00903188]Phase 4152 participants (Anticipated)Interventional2008-10-31Recruiting
Comparative Evaluation of the Efficacy and Tolerability of Prednisolone Acetate 0.5% Cream Versus Betamethasone Valerate 0.1% Cream in the Treatment of Pediatric and Adult Dermatosis [NCT01011621]Phase 3170 participants (Anticipated)Interventional2010-02-28Not yet recruiting
A Multicentric, Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion (SDI) in Patients With Previously Untreated Advanced Follicular Lymphoma [NCT03817853]Phase 4114 participants (Actual)Interventional2019-02-26Completed
Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI) [NCT00104299]Phase 2/Phase 3197 participants (Actual)Interventional2005-01-31Completed
Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses [NCT00984984]Phase 3200 participants (Anticipated)Interventional2008-03-31Recruiting
To Assess the Role of Sphingosine-1-phosphate in the Pathobiology of Pneumonia: Generate a New Strategy for Treatment of Severe Community-acquired Pneumonia [NCT04007328]Phase 2/Phase 3400 participants (Anticipated)Interventional2019-06-15Recruiting
(REASON) Double-blind, Randomized Phase II Study to Evaluate the Safety and Efficacy of Acetyl-l-carnitine in the Prevention of Sagopilone-induced Peripheral Neuropathy. [NCT00751205]Phase 2150 participants (Actual)Interventional2008-08-31Completed
A Randomized Double-Blind, Placebo-Controlled Trial of Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Idiopathic Pneumonia Syndrome Following Allogeneic Cell Transplantation (BMTCTN0403) [NCT00421174]Phase 337 participants (Actual)Interventional2007-08-31Completed
A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus [NCT00539838]Phase 333 participants (Actual)Interventional2007-12-19Terminated(stopped due to The study was terminated prematurely when the decision was made that ocrelizumab was not likely to benefit this patient population.)
Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment [NCT00977444]Phase 2/Phase 3114 participants (Actual)Interventional2007-11-30Active, not recruiting
A Pilot Study To Determine The Toxicity Of The Addition Of Rituximab To The Induction And Consolidation Phases And The Addition Of Rasburicase To The Reduction Phase In Children With Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated With LMB/FAB T [NCT00057811]Phase 297 participants (Actual)Interventional2004-06-30Completed
Phase II Study of Cyclophosphamide, Prednisone and Rituximab (CPR) in Children, Adolescents and Young Adults With B-lymphocyte Antigen CD20 (CD20) Positive Post-Transplant Lymphoproliferative Disease (PTLD) Following Solid Organ Transplantation (SOT) [NCT00066469]Phase 255 participants (Actual)Interventional2004-04-30Completed
A Phase II Study of Panobinostat (LBH589) as Second-Line Therapy in Patients With Chronic Graft-Versus-Host Disease [NCT01028313]Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to A decision was made to not move forward with the study. No participants were enrolled or treated.)
Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag. [NCT00888901]Phase 430 participants (Actual)Interventional2009-05-31Completed
Prospective Donor-specific Cellular Alloresponse Assessment for Immunosuppression Minimization in de Novo Renal Transplantation [NCT02540395]184 participants (Actual)Interventional2015-03-31Completed
A Randomized Pilot Trial of a Steroid-free Immunosuppressant Regimen in Pediatric Liver Transplantation [NCT00694408]Phase 315 participants (Actual)Interventional2008-06-30Terminated(stopped due to Study terminated due to withdrawal from market of Daclizumab)
Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL) [NCT00900445]0 participants (Actual)Observational2008-03-24Withdrawn
Use of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid Arthritis [NCT00908089]Phase 4100 participants (Actual)Interventional2003-03-31Active, not recruiting
Corticoids in Severe Community-acquired Pneumonia [NCT00908713]Phase 4120 participants (Actual)Interventional2004-01-31Completed
Targeting Inflammation and Alloimmunity in Heart Transplant Recipients With Tocilizumab (RTB-004) [NCT03644667]Phase 2200 participants (Anticipated)Interventional2018-12-20Recruiting
The Impact of Early Protocol Biopsy in Kidney Transplant Recipients Receiving TAC and MMF; a Prospective Observational Study [NCT02733510]200 participants (Anticipated)Observational2016-04-30Recruiting
ACP Max™ PRP System for Knee Osteoarthritis: A Feasibility Trial [NCT05765266]45 participants (Anticipated)Interventional2023-08-12Not yet recruiting
Clinical Treatment of Traumatic Optic Neuropathy: Optic Nerve Decompression Randomized Controlled Study [NCT02711982]2 participants (Anticipated)Interventional2010-01-31Recruiting
Greater Occipital Nerve Block for Migraine Prophylaxis [NCT00915473]Phase 470 participants (Actual)Interventional2009-06-30Completed
A Pilot Randomized Controlled Trial of Efficacy of Perineural Local Anesthetics and Steroids for Chronic Post-traumatic Neuropathic Pain in the Ankle and the Foot: The PREPLAN Study [NCT02680548]Early Phase 18 participants (Actual)Interventional2015-11-30Completed
Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia: A Randomized Controlled Pilot Study [NCT04051203]Phase 135 participants (Anticipated)Interventional2019-02-01Active, not recruiting
Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial [NCT04244591]Phase 2/Phase 380 participants (Actual)Interventional2020-01-26Completed
Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain Following Total Knee Arthroplasty: a Pilot Prospective, Randomized, Crossover Trial [NCT03973177]Phase 40 participants (Actual)Interventional2019-05-24Withdrawn(stopped due to Covid restrictions on recruitment)
An Open, Multicentre, Randomised, Parallel Group Pilot-Study to Compare Safety and Efficacy of Discontinuation of Mycophenolate Mofetil From a Tacrolimus/MMF/Steroid Triple Regimen Following Kidney Transplantation [NCT00693381]Phase 3152 participants (Actual)Interventional2003-02-28Completed
A Prospective Study to Assess the Safety and Effectiveness of Medrol® in Acute Asthma in Indian Patients [NCT00971893]0 participants (Actual)Observational2009-10-31Withdrawn
A Phase Ib Feasibility Study of Personalized Kinase Inhibitor Therapy Combined With Induction in Acute Leukemias Who Exhibit In Vitro Kinase Inhibitor Sensitivity [NCT02779283]Phase 17 participants (Actual)Interventional2016-01-13Completed
Cadaveric Organ Donor Management: Thyroid and Adrenocortical Hormone Replacement [NCT04528797]199 participants (Actual)Interventional2010-09-02Completed
Sitagliptin Prophylaxis for Glucocorticoid-Induced Impairment of Glucose Metabolism and Beta-Cell Dysfunction in Males With the Metabolic Syndrome X: A Randomized, Placebo-controlled, Double-blind Intervention Study With a 2x2 Factorial Design [NCT00721552]82 participants (Actual)Interventional2008-10-31Completed
An Open-label, Prospective, Randomized, Controlled Clinical Trial of the Use of Reduced Duration Versus Standard Duration Steroid Replacement Therapy for Acute Adrenal Insufficiency in Patients With Septic Shock [NCT00842933]Phase 432 participants (Anticipated)Interventional2007-05-31Terminated(stopped due to Unable to meet enrollment goal prior to PI transfer)
DFCI ALL Adult Consortium Protocol: Adult ALL Trial [NCT01005758]Phase 2180 participants (Anticipated)Interventional2009-01-31Not yet recruiting
Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD) [NCT04918147]Phase 275 participants (Anticipated)Interventional2021-10-13Recruiting
Effects of Volume and Dose of Local Anaesthetic Solution in Epidural Steroidal Injections for Patients With Chronic Lower Back Pain [NCT00887003]252 participants (Actual)Interventional2005-05-31Completed
TAP Block With Dexamethasone Versus TAP Block With Methyl-prednisolone as a Pain Treatment Modality After Total Abdominal Hysterectomy Procedures: Randomized Controlled Trial [NCT06131593]50 participants (Anticipated)Interventional2023-07-01Recruiting
A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma [NCT05675410]Phase 31,875 participants (Anticipated)Interventional2023-05-11Recruiting
A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis [NCT04548999]Phase 3770 participants (Actual)Interventional2020-12-03Active, not recruiting
A Phase 3 Trial Investigating Blinatumomab (NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphom [NCT03914625]Phase 36,720 participants (Anticipated)Interventional2019-07-03Recruiting
Transplantation of Umbilical Cord Blood for Myeloid Leukemia Patients Not in CR With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen and UCB NK Cells [NCT00354172]Phase 216 participants (Actual)Interventional2006-02-28Terminated(stopped due to Competing study was started.)
A Comparison of Three Different Formulations of Topical Prednisolone Acetate 1% for Control of Post Glaucoma and/or Cataract Surgery Inflammation. [NCT00345046]Phase 460 participants (Actual)Interventional2002-09-30Completed
Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome in In-vitro Fertilization Cycles: A Randomized Controlled Trial [NCT01014104]Phase 1/Phase 2218 participants (Actual)Interventional2009-10-31Completed
Evaluation of Fludarabine, Busulfan and Alemtuzumab as a Reduced Toxicity Ablative Bone Marrow Stem Cell Transplant Regimen for Children With Stem Cell Defects, Marrow Failure Syndromes, or Myelodysplastic Syndrome (MDS)/Leukemia [NCT00301834]Phase 235 participants (Actual)Interventional2005-01-31Completed
Trial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA) [NCT00443430]Phase 485 participants (Actual)Interventional2007-05-31Completed
Effects of Pre-operative Methylprednisolone (125mg iv) After Total Hip Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail [NCT00968903]Phase 448 participants (Actual)Interventional2010-04-30Completed
Comparison of Monthly Pulse ACTH (Acthar Gel) Therapy With Methylprednisolone (MP, Solumedrol) for Long-Term Treatment of Multiple Sclerosis (MS) as an Add on Therapy to Beta-interferons (Avonex, Betaseron or Rebif) [NCT01049451]Phase 123 participants (Actual)Interventional2009-11-30Completed
Methylprednisolone Combined Electric-acupuncture Treatment Effects on Cognitive Function After Surgery for Elderly Patients With General Anesthesia [NCT02535039]Phase 1/Phase 280 participants (Anticipated)Interventional2015-10-31Recruiting
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma [NCT00481832]Phase 250 participants (Actual)Interventional2007-01-31Terminated(stopped due to Accrual Factor)
Comparison of the Efficacy and Safety of Tocilizumab Versus Methylprednisolone in the Cytokine Release Syndrome of Patients With COVID-19. A Prospective Randomized Controlled Phase II Trial [NCT04377503]Phase 230 participants (Actual)Interventional2020-05-01Terminated(stopped due to The number of critically ill patients wirh COVID-19 decrease abruptly)
Preoperative Methylprednisolone in Endovascular Aortic Repair - a Randomized Double Blind Placebo Controlled Clinical Trial [NCT00989729]150 participants (Actual)Interventional2009-10-31Completed
SIMPLE Study: A Prospective and Randomized Trial of a Simplified Immunosuppressive Protocol Utilizing Low Dose EnvarsusXR [NCT04773392]Phase 480 participants (Anticipated)Interventional2021-11-23Recruiting
Phase 2 Clinical Trial for Comprehensive Treatment Program for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Tagraxofusp (SL-401) in Combination With HCVAD/Mini-CVD and VENETOCLAX [NCT04216524]Phase 240 participants (Anticipated)Interventional2020-05-29Recruiting
Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma - Open Label, Dose-escalation Followed by Open Label, Single-arm Study [NCT00574288]Phase 2104 participants (Actual)Interventional2008-03-26Completed
A Prospective, Randomized Single-Masked Clinical Trial Comparing OCT and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone [NCT00698724]Phase 4200 participants (Anticipated)Interventional2008-06-30Completed
The MAGIC Algorithm Probability Guided Preemption of Steroid-refractory Graft-versus-host Disease With Methylprednisolone [NCT05368181]Phase 256 participants (Anticipated)Interventional2022-05-01Recruiting
A Multicenter, Three Arm, Randomized, Open Label Clinical Study to Compare Renal Function in Liver Transplant Recipients Receiving an Immunosuppressive Regimen of Advagraf (Immediately or Delayed Post-transplant) and MMF With or Without a Monoclonal Anti- [NCT01011205]Phase 3893 participants (Actual)Interventional2009-09-30Completed
Comparing Subacromial Injection of Platelet-rich Plasma Versus Methylprednisolone in the Treatment of Shoulder Subacromial Impingement Syndrome [NCT02669303]19 participants (Actual)Interventional2015-09-30Terminated(stopped due to low recruitment rate and high rate of loss-to-followup)
Incidence of Flare Reaction Following Shoulder Steroid Injections: Comparison of Depo-medrol (Methylprednisolone) and Kenalog (Triamcinolone) [NCT05438277]Phase 4421 participants (Actual)Interventional2020-01-01Completed
PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial [NCT02594241]42 participants (Actual)Interventional2016-03-31Completed
High-Dose Methotrexate Plus Steroid Followed by Concurrent Whole Brain Chemoradiation With Temozolomide for Immunocompetent Patients With Primary Central Nervous System Lymphoma - a Phase II Study [NCT00455286]Phase 225 participants Interventional2006-11-30Recruiting
Renal Allograft Tolerance Through Mixed Chimerism [NCT00801632]Phase 25 participants (Actual)Interventional2008-12-31Completed
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Drop Regimen Treating Pain and inflamMation Following Cataract Surgery Compared to SOC Topical Drop Regimen [NCT05626478]Phase 4100 participants (Anticipated)Interventional2023-06-01Recruiting
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Prednisolone Acetate 1% Treating Pain, and inflamMation Following Corneal Transplant Surgery Compared to Topical Prednisolone Acetate 1%. [NCT04521140]Phase 436 participants (Actual)Interventional2020-10-16Completed
A Prospective, Multicenter, Randomized Controlled Trial of Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN) [NCT00657059]Phase 3151 participants (Actual)Interventional2007-09-30Completed
Low Dose Versus High Dose Steroids in Treatment of Viral Encephalitis [NCT04103684]Phase 4100 participants (Anticipated)Interventional2020-03-30Not yet recruiting
Prospective Observational Trial to Evaluate Clinical Prognosis and the Risk Factors for Progression for Myasthenia Gravis Patients [NCT04101578]2,000 participants (Anticipated)Observational2017-02-08Recruiting
Effectiveness of Transtympanic Steroids in Unilateral Ménière's Disease: a Randomised Controlled Double-Blind Trial [NCT00802529]Phase 2/Phase 360 participants (Actual)Interventional2009-04-30Completed
"Are Steroids Efficacious in Hospitalized Patients With Bronchiolitis Who Show an Objective Clinical Improvement After Albuterol (Albuterol Responders)?" [NCT00798616]0 participants (Actual)InterventionalWithdrawn(stopped due to We were unable to enroll a sufficient number of patients due to manpower.)
Assessment of Clinical Efficacy of 1% Prednisolone Acetate (Ster ®), Produced by união química, Compared to 1% Prednisolone Acetate (Pred ® Fort), Produced by Allergan, in the Control of Postoperative Inflammation in Cataract Surgery. [NCT01227876]Phase 3106 participants (Actual)Interventional2011-01-31Completed
Prospective Comparison of Sirolimus Against Corticosteroids in Treatment of Patients With Active Thyroid Eye Disease [NCT04936854]Phase 260 participants (Anticipated)Interventional2023-01-01Recruiting
A Phase 1, Exploratory, Randomized, Open-label, 2-Arm Study to Characterize the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Alemtuzumab 12mg Administered Subcutaneously or Intravenously in Patients With Progressive Multiple Sclerosis [NCT02583594]Phase 124 participants (Actual)Interventional2015-12-06Completed
A Phase 2 Study in Poor Risk Diffuse Large B-cell Lymphoma of Total Lymphoid Irradiation & Antithymocyte Globulin Followed by Matched Allogeneic Hematopoietic Transplantation as Consolidation to Autologous Hematopoietic Cell Transplantation [NCT00482053]Phase 23 participants (Actual)Interventional2006-10-31Terminated(stopped due to Low accrual)
Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial. [NCT00755859]Phase 4206 participants (Actual)Interventional1998-05-31Completed
Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery [NCT00758199]Phase 449 participants (Actual)Interventional2008-07-31Completed
An Observational, Retrospective, Single-center, Clinical Study to Evaluate the Efficacy of Sirolimus (Rapamycin) in Patients With Graves' Disease and Moderate-to-severe and Active Graves' Orbitopathy (GO) [NCT05345119]30 participants (Actual)Observational2020-01-15Completed
A Multicentre Randomised Controlled Trial to Assess the Efficacy of Adding Rituximab to Standard of Care in Treating Acute Antibody-mediated Rejection in Kidney Transplantation [NCT03994783]Phase 33 participants (Actual)Interventional2019-07-17Active, not recruiting
Phase I/II Study of Hyper-CVAD Plus RAD001 (Everolimus) for Patients With Relapsed or Refractory Acute Lymphocytic Leukemia (ALL) [NCT00968253]Phase 1/Phase 224 participants (Actual)Interventional2009-11-30Completed
An Open-label Extension (OLE), Expanded Access Study, to Assess Long-term Safety of SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) With Methylprednisolone (4mg Bid) in Patients Who Completed Study Number CHL-AA-201 [NCT02887976]Phase 32 participants (Actual)Interventional2016-09-30Completed
The Effect of Steroid Pulse Therapy for the Reduction of Acute Rejection Episode in Subclinical Borderline Changes: An Open-Label, Randomized Clinical Trial [NCT02664493]154 participants (Anticipated)Interventional2016-02-29Recruiting
Treatment of Chronic Subdural Hematoma by Corticosteroids [NCT02650609]Phase 3202 participants (Actual)Interventional2016-06-24Completed
Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men [NCT00957801]Phase 429 participants (Actual)Interventional2009-03-31Completed
A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients [NCT00782717]Phase 2263 participants (Actual)Interventional2008-11-30Completed
A Multicenter, Four Arm, Randomized, Open Label Clinical Study Investigating Optimized Dosing in a Prograf®-/Advagraf®-Based Immunosuppressive Regimen in Kidney Transplant Subjects (OSAKA Study) [NCT00717470]Phase 41,252 participants (Actual)Interventional2008-05-14Completed
Phase 4, Randomized Study of Three Months-prednisolone Therapy in the Treatment of Chronic Eosinophilic Pneumonia [NCT00632554]Phase 450 participants (Anticipated)Interventional2008-06-30Completed
Phase II Trial of the Addition of PEG-Asparaginase to the Hyper-CVAD Regimen in Adult Newly-Diagnosed Acute Lymphoblastic Leukemia [NCT01005914]Phase 211 participants (Actual)Interventional2009-06-30Terminated(stopped due to Increased rate of bacterial infections)
Effect of Anti-inflammatory Topical Prednisolone Acetate 1%, Nepafenac of 0.1% and Ketorolac Tromethamine 0.4% in Intra-operative Mydriasis in Facetectomies [NCT00865540]Phase 430 participants (Actual)Interventional2009-03-31Active, not recruiting
Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial [NCT00804531]Phase 4137 participants (Actual)Interventional2009-04-30Completed
A Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis [NCT05232825]Phase 3236 participants (Actual)Interventional2022-05-03Active, not recruiting
A Phase 1/2 Study of Intravenous Gene Transfer With an AAV9 Vector Expressing Human Beta-galactosidase in Type I and Type II GM1 Gangliosidosis [NCT03952637]Phase 1/Phase 217 participants (Actual)Interventional2019-08-19Active, not recruiting
Vasopressin, Epinephrine, and Corticosteroids for Inhospital Cardiac Arrest: A Multicenter Randomized Controlled Trial [NCT00729794]Phase 3300 participants (Actual)Interventional2008-09-30Completed
Role of Doxycycline in the Management of Patients With Chronic Rhinosinusitis With Nasal Polyps [NCT05157412]Phase 360 participants (Anticipated)Interventional2022-03-01Not yet recruiting
The Role of Anterior Segment Optical Coherence Tomography in Management of Acquired Punctal Stenosis [NCT04318652]Phase 480 participants (Actual)Interventional2018-09-02Completed
L-DEP Regimen as a Salvage Therapy for Refractory Epstein Barr Virus-induced Hemophagocytic Lymphohistiocytosis [NCT02631109]Phase 3120 participants (Anticipated)Interventional2015-12-31Recruiting
Randomized, Prospective Single-center Study Comparing a Rapid Discontinuation of Corticosteroids (Steroid Withdrawal) With Corticosteroid Therapy in Kidney Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy [NCT00596947]Phase 418 participants (Actual)Interventional2005-10-31Terminated(stopped due to due to low study enrollment)
The Effects of Treatment of Subclinical Rejection on Renal Histology and Graft Function in Renal Transplant Patients Receiving Tacrolimus and Mycophenolate Mofetil [NCT00885820]Phase 4240 participants (Actual)Interventional2001-09-30Completed
Evaluation of High-dose Corticosteroids on Microcirculation Alterations in Cardiac Surgery, by FMD (Flow Mediated vasoDilation), Near Infrared Spectrophotometry (NIRS) and Biological Analysis (Syndecan-1) [NCT02798068]Phase 460 participants (Anticipated)Interventional2016-05-31Recruiting
Evaluation of Efficacy in the Resolution of Post-Operative Inflammation and Pain in Patients Receiving Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery [NCT04316936]Phase 415 participants (Actual)Interventional2019-12-10Completed
GON-injection for a Sooner and Better Treatment of Cluster Headache: a Double-blind Randomized Controlled Trial [NCT04014634]Phase 480 participants (Anticipated)Interventional2019-08-01Recruiting
A Phase I, Randomised, Single-blind Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567 in Healthy Volunteers Using Prednisolone as Positive Control [NCT02760316]Phase 164 participants (Anticipated)Interventional2016-05-02Completed
Budesonide Inhalation Suspension for Acute Asthma in Children [NCT00393367]Phase 4179 participants (Actual)Interventional2006-12-31Completed
An Open Label, Multicenter, Phase I/II Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease [NCT04220632]Phase 1/Phase 21 participants (Actual)Interventional2020-06-18Terminated(stopped due to Adverse events of the first patient)
A Phase IIIB, Multicenter, Randomized, Double-Masked, Parallel-Group, Active-Controlled Study of the Safety and Efficacy of Difluprednate Ophthalmic Emulsion, 0.05% (Durezol™) 4 Times Daily (QID) and Prednisolone Acetate Ophthalmic Suspension, 1.0% (Pred [NCT01124045]Phase 380 participants (Actual)Interventional2010-08-31Completed
Intrathecal Rituximab in Progressive Multiple Sclerosis [NCT02545959]Phase 210 participants (Actual)Interventional2015-11-30Completed
Randomized, Placebo-Controlled Trial of Bilateral 3rd/4th Common Digital Foot Nerve Injections to Treat Restless Legs Syndrome [NCT00656110]60 participants (Anticipated)Interventional2008-04-30Recruiting
Topical Epidural Steroid Usage in Patients Undergoing Posterior Lumbar Decompression: A Randomized Control Trial [NCT05058287]Phase 3150 participants (Anticipated)Interventional2021-11-05Recruiting
Multicenter, Randomized, Double Blind, Clinical Trial to Compare the Clinical and Radiological Efficacy of Equivalent Doses of Methylprednisolone Administered Orally or Intravenously in Patients With Multiple Sclerosis During Relapse [NCT00753792]Phase 449 participants (Actual)Interventional2008-11-30Completed
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II:A Randomized Controlled Open-label Clinical Trial [NCT04617561]Phase 490 participants (Anticipated)Interventional2020-11-01Recruiting
Steroid Injection for the Treatment of Greater Trochanteric Pain Syndrome: A Randomized Controlled Trial [NCT00863889]Phase 40 participants (Actual)Interventional2009-03-31Withdrawn
An Unusual Association Between Pancreatic Cancer and Purtscher-like Retinopathy: Presentation of a Unique Case [NCT05350384]1 participants (Actual)Observational2021-06-18Completed
Steroids and Azathioprine in Early and Advanced IgA Nephropathy: Amendments to a Prospective Randomised Multicenter Trial [NCT01392833]Phase 346 participants (Actual)Interventional1999-12-31Completed
Phase I Study of Escalating Doses of Carfilzomib With Hyper-CVAD in Patients With Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma [NCT02293109]Phase 110 participants (Actual)Interventional2015-12-17Completed
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 16 Mg Tablet Under Fasting Conditions [NCT01405157]Phase 10 participants (Actual)Interventional2012-01-01Withdrawn
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 32 Mg Tablet Under Fed Conditions [NCT01405170]Phase 10 participants (Actual)Interventional2011-10-14Withdrawn
A Phase IV Single Blind Placebo-controlled Cross Over Study to Investigate the Efficacy of Greater Occipital Nerve Block With Local Anesthetic and Steroid in Patients With Chronic Migraine [NCT04017741]Phase 48 participants (Actual)Interventional2018-02-14Completed
Randomised Trial of Plasma Exchange or High Dose Methyl Prednisolone as Adjunctive Therapy for Severe Renal Vasculitis [NCT01408836]Phase 2/Phase 3150 participants (Actual)Interventional1995-03-31Terminated(stopped due to Completed)
Comparison Between Standard Dose Methyl Prednisolone and Megadose Methyl Prednisolone as Regards Outcome in SARS.COV.2 Patients in Intensive Care Unit : Retrospective Study [NCT05279482]104 participants (Actual)Observational2022-01-19Completed
The Treatment of Hematologic Malignancies With Single or Double Umbilical Cord Blood Unit Transplantation Followed by Graft-versus-Host Prophylaxis With Tacrolimus and Mycophenolate Mofetil [NCT00608517]6 participants (Actual)Interventional2005-09-30Terminated(stopped due to slow accrual)
A Randomized Phase II Study for the Evaluation of Extracorporeal Photopheresis (ECP) in Combination With Corticosteroids for the Initial Treatment of Acute Graft-Versus-Host Disease (GVHD) [NCT00609609]Phase 281 participants (Actual)Interventional2008-01-31Completed
Effects of Pre-operative Methylprednisolone (125mg iv) After Total Knee Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail [NCT00968578]Phase 448 participants (Actual)Interventional2009-08-31Completed
Study Characterizing the Impact of Different Therapeutic Strategies on Event Occurrence at 2 Years, 5 Years, 10 Years, and 15 Years, According to Prognostic Groups in Patients With Hodgkin Lymphoma [NCT00920153]Phase 3442 participants (Actual)Interventional2008-05-31Terminated(stopped due to Other new drugs)
A Prospective Study on the Modified DEP Regimen Induction Therapy in Lymphoma Induced Hemophagocytic Lymphohistiocytosis [NCT04077905]Phase 3160 participants (Anticipated)Interventional2019-08-31Recruiting
Phase II Study of Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOX) for Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma [NCT00336583]Phase 227 participants (Actual)Interventional2006-06-30Completed
Phase II Study of The Modified Hyper-CVAD Program for Acute Lymphoblastic Leukemia [NCT00671658]Phase 2220 participants (Actual)Interventional2002-11-30Completed
Effect of Preoperative Intravenous High Dose Methylprednisolone on Immune Signaling in Patients Scheduled for Total Hip-arthroplasty [NCT02542592]Phase 2/Phase 364 participants (Actual)Interventional2015-09-30Completed
Umbilical Cord Blood (UCB) Allogeneic Stem Cell Transplant for Hematologic Malignancies [NCT01093586]Phase 214 participants (Actual)Interventional2007-09-30Completed
An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Different Hormone Doses in the Treatment of 2019-nCoV Severe Pneumonia [NCT04263402]Phase 4100 participants (Anticipated)Interventional2020-02-01Recruiting
A Randomized, Parallel-Cohort Phase 1 Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute Graft Versus Host Disease [NCT02614612]Phase 131 participants (Actual)Interventional2015-12-31Completed
Prednisolone-induced Impairment of Glucose Metabolism and Beta-cell Dysfunction and the Protective Effects of Exenatide: a Single-center, Randomized, Double-blind, Placebo-controlled Crossover Study in Healthy Volunteers [NCT00744224]8 participants (Anticipated)Interventional2009-02-28Completed
A Comparison of Effects of Standard Dose vs. Low Dose Advagraf® With IL-2 Receptor Antibody Induction, MMF and Steroids, With or Without ACEi/ARB - Based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune Response [NCT00933231]Phase 3281 participants (Actual)Interventional2009-08-17Completed
[NCT02603575]60 participants (Anticipated)Interventional2015-11-30Recruiting
Treatment of Acute Graft vs. Host Disease With Steroids Plus Daclizumab (Zenapax) or Placebo [NCT00053976]Phase 3105 participants (Actual)Interventional2001-01-31Completed
Phase III Randomised Study on Liposomal Cytarabine (DepoCyte®) vs. Intrathecal Triple for CNS-Treatment During Maintenance Therapy in High-Risk Acute Lymphoblastic Leukemia Patients in NOPHO ALL 2008 Treatment Protocol [NCT00991744]Phase 3100 participants (Anticipated)Interventional2009-01-31Suspended(stopped due to Sterility problems in DepoCyte production)
Efficacy of Vigabatrin With High Dose Prednisolone Combination Therapy Versus Vigabatrin Alone for Infantile Spasm: a Randomized Trial [NCT04302116]250 participants (Anticipated)Interventional2020-05-18Recruiting
Pilot Randomized, Placebo-Controlled Trial to Evaluate The Effect of Oral Pulsed Methylprednisolone on Seizure Frequency in Pediatric Patients With Idiopathic Intractable Convulsive Epilepsy [NCT04219995]Phase 1/Phase 210 participants (Anticipated)Interventional2020-02-03Recruiting
Soluble Tumor Necrosis Factor Receptor: Enbrel® (Etanercept) for the Treatment of Acute Non-Infectious Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation [NCT00309907]Phase 239 participants (Actual)Interventional2006-04-30Completed
A Randomized Phase 3 Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Young Adults [NCT02166463]Phase 3600 participants (Actual)Interventional2015-03-19Active, not recruiting
A Prospective Randomized Controlled Study to Compare Efficacy of Caspofungin Combined With Trimethoprim-sulfamethoxazole Versus Trimethoprim/Sulfamethoxazole as First-line Therapy in Non-HIV Patients With Severe Pneumocystis Pneumonia [NCT03978559]Phase 4122 participants (Anticipated)Interventional2019-08-14Recruiting
Swiss PACK-CXL (Photoactivated Chromophore for Infectious Keratitis Cross-linking) Multicenter Trial for the Treatment of Infectious Keratitis [NCT02717871]Phase 335 participants (Actual)Interventional2016-03-31Completed
A PHASE II RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN COMBINATION WITH METHOTREXATE, COMPARED TO INFLIXIMAB PLUS METHOTREXATE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS CURRENTLY RESPONDING INADE [NCT00808210]Phase 228 participants (Actual)Interventional2009-03-05Terminated(stopped due to Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA.)
Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL) [NCT00720109]Phase 2/Phase 363 participants (Actual)Interventional2008-07-14Completed
Relative Efficacy of Repeat Course of Intravenous methyLprednisolone and Intramuscular ACTH in the Treatment of Acute Relapse of Multiple Sclerosis After Sub Response to Initial Course of Intravenous Methylprednisolone (RECLAIM): a Single Center Pilot Stu [NCT00947895]Phase 2/Phase 330 participants (Actual)Interventional2009-10-31Terminated(stopped due to Study reached halfway point in approximately one year time period and was halted to analyze data.)
A Multi-Center Phase II Study to Evaluate Tumor Response to Ipilimumab (BMS-734016) Monotherapy in Subjects With Melanoma Brain Metastases [NCT00623766]Phase 299 participants (Actual)Interventional2008-07-31Completed
A Phase I Open-Label, Safety Study of Haploidentical Bone Marrow Transplantation (BMT) After Ex Vivo Treatment of Bone Marrow With Anti-B7.1 and Anti-B7.2 Antibodies [NCT00005988]Phase 15 participants (Actual)Interventional2000-02-29Completed
[NCT00006054]0 participants Interventional2000-03-31Terminated
[NCT00006055]10 participants Interventional2000-03-31Active, not recruiting
T-cell Depletion In Unrelated Donor Marrow Transplantation [NCT00006451]Phase 30 participants (Actual)Interventional1996-04-30Withdrawn(stopped due to Terminated (due to no accrual))
Non-Ablative Chemotherapeutic Conditioning Before Allogeneic Stem Cell Transplantation [NCT00008307]Phase 252 participants (Anticipated)Interventional1998-04-30Active, not recruiting
[NCT00000147]0 participants Interventional1988-07-31Active, not recruiting
Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) [NCT00000579]Phase 30 participants Interventional1994-09-30Completed
A Controlled Randomized Trial to Study the Efficacy of Adjunctive Methylprednisolone for the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Pediatric AIDS Patients [NCT00000741]Phase 30 participants (Actual)InterventionalWithdrawn
Allogeneic Bone Marrow Transplantation for Marrow Failure States [NCT00005852]Phase 20 participants Interventional1996-06-30Terminated(stopped due to low accrual)
Assessment of the Operative Course in Connection With Removal of Lower Third Molars With Particular Consideration to the Occurence of Pain and Swelling [NCT00805298]154 participants (Actual)Interventional2008-08-31Completed
Intérêt de la corticothérapie Dans la Pneumocystose Grave du Patient immunodéprimé Non VIH. Essai Prospectif Multicentrique Randomisé Contrôlé : PIC [NCT02944045]Phase 3222 participants (Anticipated)Interventional2017-02-15Recruiting
Efficacy of Methylprednisolone in Severe Community-acquired Pneumonia,A Multi-center Randomized Controlled Trial [NCT02552342]Phase 4610 participants (Anticipated)Interventional2015-05-31Recruiting
A Phase 2 Randomized, Investigator-Masked, Comparator-controlled Trial to Evaluate the Safety and Efficacy of NS2 Eye Drops in Patients With Anterior Uveitis [NCT02406209]Phase 245 participants (Actual)Interventional2015-03-31Completed
Acute Unilateral Vestibulopathy and Corticosteroid Treatment [NCT02912182]Phase 478 participants (Actual)Interventional2015-12-31Terminated(stopped due to Placebo medication expired)
An Open-label Study to Assess the Efficacy and Safety of Alipogene Tiparvovec (AMT-011), Human LPL [S447X], Expressed by an Adeno-Associated Viral Vector After Intramuscular Administration in LPL-deficient Adult Subjects [NCT00891306]Phase 2/Phase 35 participants (Actual)Interventional2009-02-28Completed
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas [NCT01024322]1,189 participants (Actual)Observational2009-10-01Terminated(stopped due to Terminated to initiate FDA IND-cleared study protocol)
Hematopoietic Stem Cell Transplant For Patients With Dyskeratosis Congenita and Severe Aplastic Anemia [NCT00455312]Phase 2/Phase 336 participants (Actual)Interventional2007-08-31Completed
The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis in Children [NCT02532777]Phase 2100 participants (Anticipated)Interventional2015-08-31Recruiting
Utility of Intramuscular Corticosteroids for Radicular Low Back Pain [NCT00290589]Phase 382 participants (Actual)Interventional2003-06-30Completed
Randomized Trial of Plasma Exchange as Adjunctive Therapy for Severe Crescentic GlomerUlonephritis of IgA NEphropathy (RESCUE Study) [NCT02647255]Phase 2/Phase 310 participants (Actual)Interventional2016-03-31Terminated(stopped due to Due to the rarity and rapid progressive course of the disease, patients were less likely to participate in randomization.)
Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients. A Single-blind Randomized Clinical Trial [NCT03742466]50 participants (Actual)Interventional2018-11-10Completed
A Randomised Evaluation of Molecular Guided Therapy for Diffuse Large B-cell Lymphoma With Bortezomib [NCT01324596]Phase 31,132 participants (Actual)Interventional2011-04-30Completed
A Randomized, Multicenter, Open-label, 6-month Study to Explore the Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare [NCT00423098]Phase 281 participants (Actual)Interventional2007-02-28Completed
An Open-label, Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft Versus Host Disease After TLI/ARG Nonmyeloablative Allogeneic Stem Cell Transplantation [NCT00186628]Phase 236 participants (Actual)Interventional2005-06-30Completed
A Phase II Trial of T-Cell Depleted Marrow Grafts Combined With Infusions of G-CSF Stimulated, CD34 Ceprate Stem Cell Column Selected, E-Rosette Depleted Peripheral Blood Progenitor Cells Derived From HLA Haplotype Matched Related Donors for Patients With [NCT00002718]Phase 231 participants (Actual)Interventional1995-11-30Completed
Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Tiral [NCT01046786]Phase 1/Phase 28 participants (Actual)Interventional2010-01-31Completed
An Oral Methylprednisolone Taper Within a Multimodal Analgesic Regimen After Total Knee Arthroplasty: a Double-Blind Randomized Placebo-Controlled Trial [NCT05097976]Phase 4420 participants (Anticipated)Interventional2022-03-01Recruiting
Rituximab Plus Short-term Methylprednisolone Versus Standard Dose Methylprednisolone in Newly Diagnosed Participants With Immune Thrombocytopenia (ITP): A Multicenter, Randomized Phase II Study in China [NCT02757196]Phase 2112 participants (Anticipated)Interventional2016-05-31Not yet recruiting
Evaluation of the Effect of Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis [NCT00332696]Phase 264 participants (Actual)Interventional2005-09-30Completed
A Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy in Infants With Biliary Atresia [NCT00294684]141 participants (Actual)Interventional2005-11-30Completed
A Randomized, Placebo Controlled, Double-blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate, Compared to Methotrexate Monotherapy, in Patients With Active Rheumatoid Arthritis [NCT00299130]Phase 3511 participants (Actual)Interventional2005-10-31Completed
A Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Tolerability and Safety of Rituximab When Given in Combination With Methotrexate and Etanercept (Enbrel) or Methotrexate and Adalimumab (Humira) in Subjects With Active Rheumatoid Arth [NCT00298272]Phase 254 participants (Actual)Interventional2006-05-31Terminated(stopped due to Sponsor decided to end long term extension phase for business reasons unrelated to safety.)
Steroid Free Immunosuppression in Liver Transplantation [NCT00296244]Phase 440 participants (Actual)Interventional2006-02-28Completed
A Randomized Trial of Rituximab in Induction Therapy for Living Donor Renal Transplantation [NCT01095172]Phase 4100 participants (Actual)Interventional2010-11-30Active, not recruiting
High Dose Cyclophosphamide & ATG With Hematopoietic Stem Cell Transplantation in Patients With Refractory Idiopathic Inflammatory Myopathy Diseases: A Phase I Trial [NCT00278564]Phase 17 participants (Actual)Interventional2005-09-30Terminated(stopped due to high relapse rate)
Pain Relief and Functional Improvement Provided by ESWT in Plantar Fasciitis is Better Than Corticosteroid Injection and Kinesiotherapy: A Randomized Trial [NCT05647291]90 participants (Actual)Interventional2021-10-15Completed
An Open-Label, Phase 1 Study to Examine the Pharmacokinetic Interactions Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects [NCT01886209]Phase 128 participants (Anticipated)Interventional2013-06-30Completed
Evaluation of Inhaled Corticosteroid Treatment in Sinusitis [NCT01907204]Phase 2/Phase 350 participants (Actual)Interventional2013-07-31Completed
A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis [NCT04544436]Phase 3865 participants (Anticipated)Interventional2020-11-26Active, not recruiting
Assessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Comparison to Topical Prednisolone Acetate Following Bilateral Small Incision Lenticule Extraction (SMILE) [NCT04380857]Phase 420 participants (Actual)Interventional2020-06-18Completed
Regulatory T Cell Modulation in Kidney Transplantation With Biologic Blockade of Dual Effector Pathways, CD28 and IL-6 (CTOT-24) [NCT04066114]Phase 1/Phase 210 participants (Actual)Interventional2019-12-11Completed
A Phase II Study to Evaluate Low-Dose Alemtuzumab as a Glucocorticoid-Sparing Agent for Initial Systemic Treatment of Acute Graft-Versus-Host Disease [NCT00410657]Phase 253 participants (Anticipated)Interventional2006-07-31Completed
Maintenance in Autologous Stem Cell Transplant for Crohn's Disease (MASCT - CD) [NCT03219359]Phase 250 participants (Anticipated)Interventional2017-07-12Recruiting
Macular Edema Nepafenac vs. Difluprednate Uveitis Trial [NCT01939691]Phase 49 participants (Actual)Interventional2018-09-12Terminated(stopped due to Difficulty enrolling)
Autologous Blood or Marrow Transplantation for Aggressive Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning [NCT00238368]Phase 259 participants (Actual)Interventional2004-02-29Completed
Efficiency of Multi-Modal Anesthesia (MMA) Protocol in Pain Control and Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion Surgery [NCT05413902]Phase 4100 participants (Actual)Interventional2021-04-05Completed
A Double-blind, Two-arm, Multicenter, Randomized Trial to Evaluate Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Recent Secondary Progressive Multiple Sclerosis: P.R.OM.E.S.S Study [NCT00241254]Phase 3138 participants (Actual)Interventional2005-12-31Completed
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Itolizumab in Subjects With Newly Diagnosed Acute Graft Versus Host Disease [NCT05823675]Phase 144 participants (Anticipated)Interventional2023-05-19Recruiting
Phase II Study of High-dose Methylprednisolone and Rituximab in Previously Treated Patients With High Risk Chronic B Lymphocytic Leukemia [NCT00558181]Phase 229 participants (Actual)Interventional2007-09-30Completed
European Multicenter and Open-Label Controlled Randomized Trial to Evaluate the Efficacy of Sequential Treatment With Tacrolimus-Rituximab Versus Steroids Plus Cyclophosphamide in Patients With Primary Membranous Nephropathy (The STARMEN Study) [NCT01955187]Phase 386 participants (Actual)Interventional2014-01-31Completed
Steroid Injections vs. Platelet Rich Plasma Injections in Patients With Plantar Fasciitis: A Comparison of Clinical and Ultrasound Findings [NCT01957631]Phase 2/Phase 30 participants (Actual)Interventional2013-06-30Withdrawn(stopped due to Lack of funding)
A Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy [NCT01969019]Phase 470 participants (Anticipated)Interventional2010-01-31Recruiting
Antiemetic Corticosteroid Rotation From Dexamethasone to Methylprednisolone to Prevent Dexamethasone-Induced Hiccup in Cancer Patients Treated With Chemotherapy: A Randomized, Single-Blind, Crossover Phase III Trial [NCT01974024]Phase 365 participants (Actual)Interventional2013-10-01Completed
A Prospective Randomized 3-arm Trial Comparing Intra-articular Corticosteroid Injection vs Arthrographic Distention vs Arthrographic Distention Plus Intra-articular Corticosteroid Injection in the Treatment of Adhesive Capsulitis [NCT01983527]132 participants (Anticipated)Interventional2013-12-31Not yet recruiting
Comparing the Effectiveness of Steroid Injection Versus Placebo and Immobilization Versus no Immobilization in Treating Patients With Lateral Epicondylitis [NCT01986465]Phase 2/Phase 378 participants (Actual)Interventional2013-05-31Completed
Optimal Treatment of Plantar Fasciitis: A Randomized Clinical Trial Using Physical Training, Glucocorticoid Injections or a Combination Thereof. [NCT01994759]Phase 490 participants (Actual)Interventional2013-09-01Completed
Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease [NCT04603729]Phase 3100 participants (Actual)Interventional2020-05-30Completed
PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia [NCT01995019]Phase 456 participants (Actual)Interventional2013-12-10Completed
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars) [NCT04593706]40 participants (Anticipated)Interventional2020-11-01Not yet recruiting
Preoperative Glucocorticoid Use in Major Hepatectomy - A Randomized Controlled Trial [NCT01997658]Phase 2/Phase 3200 participants (Actual)Interventional2014-10-31Completed
High Doses of Methylprednisolone in the Management of Caustic Esophageal Burns in Children [NCT02002078]Phase 483 participants (Actual)Interventional2007-02-28Completed
Efficacy of the Intralesional Infusion of Local Anesthetic and Steroids After Major Abdominal Surgery: a Randomized Double Blind Phase III Trial [NCT02002663]Phase 3120 participants (Actual)Interventional2013-08-31Completed
A Phase I Randomized, Double-blind, Placebo-controlled, Dose-increasing Single Dose Study Evaluating the Safety, Tolerability,Pharmacokinetics and Pharmacodynamics Analysis of Pegloticase in Subjects With Asymptomatic Hyperuricemia [NCT05302388]Phase 145 participants (Actual)Interventional2022-04-11Completed
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients With Uncontrolled Gout Receiving KRYSTEXXA® (Pegloticase) (MIRROR Randomized Controlled Trial [RCT]) [NCT03994731]Phase 4152 participants (Actual)Interventional2019-06-13Completed
Randomised, Multicentre, Open Label, Parallel Group Pragmatic Clinical Trial of Local Steroid Injection Versus Night Splinting in Mild to Moderate Carpal Tunnel Syndrome (CTS) [NCT02038452]Phase 4234 participants (Actual)Interventional2014-04-30Completed
Influence of Corticoids on Renal Function in Cardiac Surgery [NCT00879931]Phase 280 participants (Actual)Interventional2013-01-31Completed
Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass [NCT00934843]77 participants (Actual)Interventional2007-03-31Completed
Do Intraoperative Topical Corticosteroids Aid in the Prevention of Postoperative Dysphagia Following Elective Anterior Cervical Discectomy and Fusion? A Randomized, Controlled, Double Blinded Clinical Trial [NCT02539394]128 participants (Actual)Interventional2015-08-31Completed
[NCT00005898]Phase 1/Phase 230 participants Interventional2000-02-29Completed
Efficacy and Safety of Two Glucocorticoid Regimens in the Treatment of Sarcoidosis: a Randomized Controlled Trial [NCT03265405]Phase 486 participants (Actual)Interventional2017-04-01Completed
Steroid Administration for Articular Fractures of the Elbow (SAFE Trial): A Randomized, Controlled Trial of Perioperative Glucocorticoids During Treatment of Intraarticular Elbow Fractures [NCT04738318]Phase 43 participants (Actual)Interventional2022-06-16Terminated(stopped due to Switched to observational study type.)
Efficacy and Safety of Difluprednate Ophthalmic Emulsion vs. a Fixed-Combination of Prednisolone Acetate - Phenylephrine Ophthalmic Suspension on Post-operative Inflammation Following Cataract Surgery. [NCT04631315]Phase 4255 participants (Actual)Interventional2019-03-24Completed
Study on the Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica and Gene Polymorphism: a Cohort Study [NCT04601142]350 participants (Anticipated)Observational2020-10-31Recruiting
Peking University Third Hospital Medical Science Research Ethics Committee [NCT04590183]30 participants (Anticipated)Interventional2020-10-01Recruiting
Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of Low-Dose Glucocorticoid Infusion in Acute Respiratory Distress Syndrome (ARDS) [NCT00562835]Phase 2/Phase 3400 participants (Anticipated)Interventional2008-02-29Not yet recruiting
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroid [NCT01085097]Phase 246 participants (Actual)Interventional2010-09-01Completed
The Efficacy Of Magnesium In Radicular Lower Limb Pain When It Is Added To Local Anesthetics And Steroids In The Transforaminal Epidural Injections. A Comparative Study [NCT04532775]Phase 1100 participants (Anticipated)Interventional2020-08-30Not yet recruiting
Comparison of Methylprednisolone or Methotrexate With Standard Treatment in the Maintenance Treatment of Medically and Surgically Treated Chronic Rhinosinusitis With Nasal Polyposis [NCT04532736]Phase 241 participants (Actual)Interventional2017-09-02Completed
A Phase 3 Multicenter, Randomized, Double-Masked Study of the Safety and Efficacy of Difluprednate 0.05% Ophthalmic Emulsion Compared to Prednisolone Acetate 1% Ophthalmic Suspension in the Treatment of Endogenous Anterior Uveitis [NCT01201798]Phase 3111 participants (Actual)Interventional2010-10-31Completed
Comparison of the Efficacy Between Ultrasound-guided Dextrose Injection Versus Dextrose With Methylprednisolone Injection in Patients With Carpal Tunnel Syndrome: a Prospective, Randomized Double-blind Clinical Trial. [NCT06045013]Phase 370 participants (Anticipated)Interventional2023-09-13Recruiting
A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifyi [NCT03368664]Phase 316 participants (Actual)Interventional2017-10-24Active, not recruiting
Ultrasound Guided Sacroiliac Joint Injections With Ketorolac Versus Corticosteroid: A Prospective Non-inferiority Study [NCT06081101]Early Phase 180 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Lessdrops™ Prophylactic Treatment After Routine Phacoemulsification Compared to Standard Drops Regimen [NCT03578276]Phase 435 participants (Actual)Interventional2018-06-22Completed
Risk Stratification-directed Low-dose Glucocorticoid Prophylaxis for Acute GVHD After Unmanipulated Haploidentical Blood and Marrow Transplantation--a Randomized, Controlled, Clinical Trial [NCT01607580]145 participants (Actual)Interventional2012-06-30Completed
Evaluation of the Bioavailability of Methylprednisolone Succinate Administered Intranasally [NCT05649878]8 participants (Actual)Interventional2021-11-05Completed
Non-Invasive Mechanical Ventilation in Elderly Patients Affected by Acute Hypercapnic Respiratory Failure:A Randomized Control Study vs Standard Medical Therapy A Multicentric Randomized Controlled Trial [NCT00600639]Phase 482 participants (Actual)Interventional2004-01-31Terminated
Comparison Between Prednisolone and Dexamethasone on D28 Mortality in Patients on Oxygen Therapy, With CoViD-19: Multicenter, Randomized, Open-label Non-inferiority Study [NCT04765371]Phase 389 participants (Actual)Interventional2021-03-03Completed
Local Steroid Injection in the Treatment of Idiopathic Carpal Tunnel Syndrome: A Randomized Double-blind Placebo-controlled Trial Among Patients Planned for Surgical Treatment [NCT00806871]Phase 2/Phase 3112 participants (Actual)Interventional2008-11-30Completed
Hematopoietic Stem Cell Therapy for Patients With Refractory Myasthenia Gravis [NCT00424489]Phase 19 participants (Actual)Interventional2002-02-28Terminated(stopped due to No participants enrolled for more than two years. No plan to continue study.)
Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study [NCT04168112]Phase 420 participants (Actual)Interventional2020-02-12Completed
Incretin Physiology and Beta-Cell Function Before and After Treatment With Steroid Hormone in Healthy Individuals [NCT00713440]10 participants (Actual)Interventional2008-07-31Completed
Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial [NCT03640949]Phase 2/Phase 3501 participants (Actual)Interventional2018-09-17Completed
A Phase 2 Study of SNDX-5613 in Combination With Chemotherapy for Patients With Relapsed or Refractory KMT2A-Rearranged Infant Leukemia [NCT05761171]Phase 278 participants (Anticipated)Interventional2023-11-20Recruiting
Abatacept for Graft Versus Host Disease Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease: a Sickle Transplant Alliance for Research Trial [NCT02867800]Phase 124 participants (Actual)Interventional2016-07-31Active, not recruiting
Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy [NCT02711449]Phase 278 participants (Actual)Interventional2016-04-30Completed
An Open-label Multicenter Trial to Study the Efficacy and Safety of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura [NCT04074187]Phase 2/Phase 321 participants (Actual)Interventional2019-10-21Completed
A Randomized Controlled Clinical Trial on the Efficacy and Safety of Glucocorticosteroid in the Patients With Chronic Recurrent Drug-induced Liver Injury [NCT02651350]Phase 1/Phase 280 participants (Actual)Interventional2015-12-31Completed
Efficacy of Intra-operative Subacromial Corticosteroid Injections on Surgical Outcomes After Arthroscopic Shoulder Surgery [NCT02867904]Phase 412 participants (Actual)Interventional2016-03-31Terminated(stopped due to It was difficult to recruit patients to get the appropriate sample size.)
"Screening Protein Predictive of Response to Tumor Necrosis Factor-α Inhibitors Treatment in Chinese Rheumatoid Arthritis From Real World and Investigating Its Mechanism Through Signal Pathway" [NCT02878161]Phase 4240 participants (Anticipated)Interventional2016-01-31Enrolling by invitation
Comparison of Corticosteroids Versus Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the Intensive Care Unit: a Multicentre Randomized Controlled Trial [NCT04163536]Phase 3440 participants (Anticipated)Interventional2021-10-25Recruiting
Selective CD28 Blockade With Lulizumab Compared to CNI Inhibition With Tacrolimus in Renal Transplant Recipients [NCT04903054]Phase 20 participants (Actual)Interventional2022-01-10Withdrawn(stopped due to Limited period of availability of a supply of the study drug and difficulties in enrollment)
Desensitization for Preformed Anti-HLA Antibodies in Kidney Transplantation [NCT00908583]Phase 444 participants (Actual)Interventional2009-05-31Completed
Corticosteroids for Cancer Pain [NCT00676936]Phase 350 participants (Actual)Interventional2008-04-30Completed
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, 2 Period Crossover Bioequivalence Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 32 Mg Tablet Under Fasted Conditions [NCT01405131]Phase 10 participants (Actual)Interventional2012-01-01Withdrawn
Early Short Course Corticosteroids in Hospitalized Patients With COVID-19 [NCT04374071]250 participants (Actual)Observational2020-03-12Completed
Assessment of Corticosteroid Effect in the Prevention of Facial Palsy After Cerebella-pontine Angle Surgery [NCT00438087]Phase 3313 participants (Actual)Interventional2007-03-31Completed
A Phase I Study to Examine the Toxicity of Killer IG-Like Receptor (KIR) Mismatched Umbilical Cord Blood for Pediatric Patients With Malignant Solid Tumors [NCT00436761]Phase 120 participants (Anticipated)Interventional2004-05-31Active, not recruiting
Retrospective Study of Intrapleural Methylprednisolone Injection for Multiple Organ Failure With Acute Respiratory Distress Syndrome [NCT01423864]Phase 229 participants (Actual)Interventional2005-06-30Completed
A Randomized, Multicentre, Double-blind Study to Evaluate the Efficacy of High-dose Administration of Methylprednisolone in Addition to Standard Treatment, in SARS-CoV2 (COVID-19) Pneumonia Patients [NCT04673162]Phase 3260 participants (Actual)Interventional2020-12-17Completed
Efficacy of High-dose Corticosteroid Pulses Added to Conventional Oral Corticosteroid Course for Moderate Flares of Ulcerative Colitis. [NCT02921555]Phase 475 participants (Actual)Interventional2018-10-11Completed
Assessing the Efficacy and Safety of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment [NCT04464629]Phase 47 participants (Actual)Interventional2020-07-14Terminated(stopped due to Poor enrollment)
Randomized Treatment Interruption of Natalizumab [NCT01071083]Phase 2175 participants (Actual)Interventional2010-03-31Completed
The Ideal Management of Crohn's Disease: Top Down Versus Step Up Strategies. A Prospective Controlled Trial in the Benelux [NCT00554710]Phase 4129 participants (Actual)Interventional2001-05-31Completed
Evaluation of the Tolerability and Efficacy of Erythropoietin (EPO) Treatment in Spinal Shock: Comparative Study VS Methylprednisolone (MP) [NCT00561067]Phase 310 participants (Actual)Interventional2008-04-30Terminated(stopped due to Italian Medicines Agency decision)
Double-Blind, Placebo Controlled, Randomized, Multicenter, Parallel-Group Study to Compare the Efficacy and Safety of Advantan Cream Twice Weekly With Advabase Cream During a Maintenance Phase of 16 Weeks After Successful Treatment of Atopic Dermatitis Wi [NCT00185510]Phase 4250 participants (Actual)Interventional2005-03-31Completed
Can Montelukast Shorten Corticosteroid Therapy In Children With Mild To Moderate Acute Asthma? [NCT00213252]Phase 2130 participants (Actual)Interventional2005-09-30Completed
Multisystem Inflammatory Syndrome Therapies in Children (MISTIC) Comparative Effectiveness Study [NCT04898231]Phase 2/Phase 3180 participants (Anticipated)Interventional2020-12-22Active, not recruiting
A Phase 2b, Double-Blind, Three Arm, Randomized, Placebo Controlled Trial With Restricted Response Adaptive Randomization Testing the Efficacy and Safety of High Dose Methylprednisolone or Equine Anti-Thymocyte Globulin as Treatment for Acute Liver Failur [NCT04862221]Phase 2163 participants (Anticipated)Interventional2022-02-09Recruiting
T Cell Receptor Alpha/Beta T Cell Depleted (α/β TCD) Hematopoietic Cell Transplantation in Patients With Fanconi Anemia (FA) [NCT03579875]Phase 248 participants (Anticipated)Interventional2018-11-13Recruiting
Treatment of Acute Lymphoblastic Leukemia in Children [NCT00400946]Phase 3800 participants (Actual)Interventional2005-04-30Completed
Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled Trial [NCT01870128]Phase 360 participants (Actual)Interventional2009-08-31Completed
Comparison of the Efficacy and Safety of Two Corticosteroid Regimens in the Treatment of Diffuse Lung Disease After Coronavirus Disease 2019 (COVID-19) Pneumonia [NCT04657484]130 participants (Actual)Interventional2020-12-01Completed
Phase II, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Effects and Safety of Infusion of Low-Doses of Methylprednisolone in Early ALI and ARDS in Children [NCT01757899]Phase 20 participants (Actual)Interventional2014-01-31Withdrawn(stopped due to Technical problems)
Comparison of the Effectiveness of the Ultrasound Guided Subacromial, Acromioclavicular With Subacromial Injection and Suprascapular Nerve Block in Patients With Shoulder Impingement Syndrome ; A Randomized Controlled, Single Blind, Clinical Trial [NCT05015322]Phase 488 participants (Actual)Interventional2017-01-01Completed
Use of Topical Euphrasia, a Homeopathic Remedy in Ophthalmology [NCT02416128]0 participants (Actual)Interventional2015-04-30Withdrawn(stopped due to No participants enrolled)
A Two-Part, Multi-Center, Prospective, Phase 2/3 Clinical Study to Evaluate the Safety and Efficacy of GLASSIA as an Add-On Biopharmacotherapy to Conventional Steroid Treatment in Subjects With Acute Graft-Versus-Host Disease With Lower Gastrointestinal I [NCT02956122]Phase 2/Phase 31 participants (Actual)Interventional2017-04-26Terminated(stopped due to The decision to discontinue the study was based on business reasons.)
[NCT00000138]Phase 30 participants Interventional1989-05-31Active, not recruiting
[NCT00004482]Phase 240 participants Interventional1999-12-31Completed
The Efficacy of Exercise Therapy Followed by Ultrasound Guided Injection in Patients With a Painful Shoulder - a Randomised Controlled Study With Blinded Observer [NCT01506804]99 participants (Actual)Interventional2010-11-30Completed
Phase IV Study of Perioperative Steroid's Effects on Death or MI in High-Risk Patients Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass [NCT00427388]Phase 47,507 participants (Actual)Interventional2007-06-30Active, not recruiting
[NCT00480675]65 participants (Actual)Interventional2007-03-31Completed
A Multi-Centre, Open Label Study to Investigate the Recovery of IFN-beta Efficacy in Relapsing-Remitting Multiple Sclerosis Patients With Neutralising IFN-beta Antibodies and Reduced Bioavailability [NCT00493116]Phase 420 participants (Actual)Interventional2003-10-31Completed
[NCT00469781]Phase 495 participants (Actual)Interventional2007-05-31Completed
[NCT00501579]Phase 30 participants InterventionalCompleted
A Randomized, Masked Multi-center Safety & Efficacy Study of the Effects of Preoperative & Postoperative Cataract Surgery Use of Difluprednate Ophthalmic Emulsion, 0.05% Compared to Prednisolone Acetate Ophthalmic Suspension 1% on Visual Acuity & Corneal [NCT01244334]Phase 452 participants (Actual)Interventional2009-03-31Completed
Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY) [NCT04826588]Phase 376 participants (Actual)Interventional2021-05-23Completed
A Multicenter, Double-blinded, Randomized, Placebo-controlled Trial to Compare the Effectiveness of Intratympanic Injections methylPREDnisolon Versus Placebo in the Treatment of Vertigo Attacks in MENière's Disease (PREDMEN Trial). [NCT05851508]Phase 3148 participants (Anticipated)Interventional2023-10-01Recruiting
Prednisolone and Vitamin B1, B6, and B12 in Patients With Post-COVID-19-Syndrome (PC19S) - a Randomized Controlled Trial in Primary Care [NCT05638633]Phase 3340 participants (Anticipated)Interventional2022-11-11Recruiting
A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement [NCT02828358]Phase 278 participants (Actual)Interventional2017-04-01Active, not recruiting
Mesenchymal Stem Cells Under Basiliximab/Low Dose RATG to Induce Renal Transplant Tolerance [NCT00752479]Phase 1/Phase 24 participants (Actual)Interventional2008-05-31Terminated(stopped due to Necessity of major revision of the protocol)
NON-T-CELL DEPLETED HLA-HAPLOIDENTICAL FAMILIAL DONOR HEMATOPOIETIC CELL TRANSPLANTATION AFTER REDUCED INTENSITY CONDITIONING [NCT00521430]30 participants (Anticipated)Interventional2004-04-30Completed
Remission Induction in Very Early Rheumatoid Arthritis: a Comparison of Etanercept Plus Methotrexate Plus Steroid With Standard Therapy [NCT00523692]Phase 420 participants (Anticipated)Interventional2007-09-30Not yet recruiting
A Multicentre Placebo-Controlled Evaluation of Prednisolone and/or Valaciclovir for the Treatment of Bell's Palsy [NCT00510263]Phase 4839 participants (Actual)Interventional2001-05-31Completed
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for OligoRecurrenT Prostate Cancer (VA STARPORT) [NCT04787744]Phase 2/Phase 3464 participants (Anticipated)Interventional2021-07-01Recruiting
Timing of Corticosteroids in COVID-19, II. Post COVID-19 Follow-up [NCT04530409]Phase 4752 participants (Actual)Interventional2021-03-20Active, not recruiting
Non-interventional Clinical Trial to Establish a Glucocorticoid-induced Osteoporosis Databank for Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis and Therapy With Glucocorticoids [NCT02719314]10,000 participants (Anticipated)Observational [Patient Registry]2015-12-31Recruiting
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care [NCT01431326]3,520 participants (Actual)Observational2011-11-30Completed
A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807) [NCT00557193]Phase 3218 participants (Actual)Interventional2008-01-15Active, not recruiting
Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants [NCT02935101]Phase 24 participants (Actual)Interventional2016-10-31Terminated(stopped due to difficulties in recruiting study participants)
Pilot Study Investigating the Utility of Epidural AlloGen-LI Injection for Treatment of Spinal Stenosis Symptoms [NCT02932020]0 participants (Actual)Interventional2016-10-31Withdrawn
A Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, Crossover Bioavailability Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/Ml to Methylprednisolone 32 Mg Tablet Under Fasted Conditions [NCT01267201]Phase 124 participants (Actual)Interventional2010-11-30Completed
Clinical and Radiological Comparison of the Efficacy of Hyaluronic Acid, PRP and Steroid Injections in Partial Rotator Cuff Tears: A Prospective Randomized Study [NCT04681937]80 participants (Anticipated)Interventional2021-06-01Not yet recruiting
High-Dose Corticosteroids for Immune Reconstitution Inflammatory Syndrome in Patients Who Develop Progressive Multifocal Leukoencephalopathy on Natalizumab [NCT01211665]Phase 43 participants (Actual)Interventional2010-09-30Terminated(stopped due to This study was stopped prematurely due to lack of enrollment within a 1-5-year period.)
DEXTENZA for the Treatment of Post-Surgical Pain and Inflammation ComparEd to StandaRd of Care Topical Cortico-Steroid Treatment In PatientS Who Undergo BilaTeral Pterygium Surgery PERSIST Study [NCT04351737]Phase 420 participants (Anticipated)Interventional2020-07-15Active, not recruiting
A PedAL/EuPAL Phase 1/2 Trial of IMGN632 in Pediatric Patients With Relapsed or Refractory Leukemia [NCT05320380]Phase 1/Phase 20 participants (Actual)Interventional2023-08-01Withdrawn(stopped due to Withdrawn per CS0150757)
Effects of Peri-Operative Glucosteroid Administration on Outcomes Following Distal Radius Fracture [NCT05655130]Phase 160 participants (Anticipated)Interventional2018-11-06Active, not recruiting
An Open-label, Single-arm Study to Describe Glucocorticoid Use in Rheumatoid Arthritis Patients Treated With Tocilizumab in Daily Clinical Practice and to Evaluate Systematic Glucocorticoid Dose Reduction Once Low Disease Activity is Reached (ACT-ALONE) [NCT01219933]Phase 468 participants (Actual)Interventional2011-01-31Completed
A Randomized Controlled Trial of L-DEP as an Initial Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis [NCT02912702]Phase 3120 participants (Anticipated)Interventional2016-09-30Recruiting
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma [NCT00882895]Phase 218 participants (Actual)Interventional2009-05-05Active, not recruiting
Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm [NCT04355247]Phase 220 participants (Anticipated)Interventional2020-04-14Recruiting
Treatment Of Giant Cell Arteritis Patients With Ultra-short Glucocorticosteroids And tociliZumab: Role of Imaging in a Observational Study [NCT05394909]20 participants (Actual)Observational2020-02-07Active, not recruiting
A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With Severe Aplastic Anemia, Inborn Errors in Metabolism, or Inherited Hematologic Stem Cell Disorders [NCT00003336]Phase 26 participants (Actual)Interventional1998-01-31Completed
Matched Unrelated and Haploidentical Bone Marrow Transplantation for Hematologic Malignancies [NCT00003960]Phase 236 participants (Anticipated)Interventional1998-04-30Completed
Effect of Steroids on Cerebrospinal Fluid Markers of Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement [NCT01755338]30 participants (Actual)Interventional2012-12-31Completed
A Phase II Study to Evaluate Efficacy and Tolerability of Methotrexate in Combination With Glucocorticoids for the Treatment of Newly Diagnosed Acute Graft-Versus-Host Disease After Nonmyeloablative Hematopoietic Cell Transplantation [NCT00357084]Phase 253 participants (Anticipated)Interventional2006-05-31Completed
Phase I-II Clinical Trial for the Evaluation of Brentuximab Vedotin Plus Etoposide, Solumoderin (Methylprednisolone), High Dose ARA-C (Cytarabine) and Cisplatin in the Transplant and Post-transplant Management for Relapsed or Refractory Classical Hodgkin [NCT02243436]Phase 1/Phase 267 participants (Actual)Interventional2014-11-11Completed
Research on the Treatment of Severe Community-acquired Pneumonia in Children [NCT05768204]Phase 4160 participants (Anticipated)Interventional2023-03-10Recruiting
Open Randomized Study on the Efficacy of corticoïd Infiltration Versus Physiological Solution Infiltration Versus Feigning of Infiltration Via Sacro-coccygien Hiatus Versus Natural Evolution in Discal Sciatica [NCT01482897]Phase 313 participants (Actual)Interventional2011-12-31Terminated(stopped due to Enrolment stopped on December 01, 2014 since after 3 years, only 13 patients were included (instead of 274) (Date of last visit last patient : October 3, 2013).)
A Randomized, Open Label, Phase II Multicenter Study of Non-Myeloablative Autologous Transplantation With Auto-CD34+HPC Versus Currently Available Immunosuppressive/Immunomodulatory Therapy for Treatment of Systemic Lupus Erythematosus [NCT00230035]Phase 20 participants (Actual)Interventional2005-09-30Withdrawn(stopped due to Recommended by DSMB due to lack of accrual)
A Randomized Study To Compare The Safety And Efficacy Of Two Immunosuppressive Regimens In De Novo Renal Allograft Recipients:Sirolimus Plus Mycophenolate Mofetil Plus Corticosteroids Following A Rabbit Anti-Human Thymocyte Globulin Induction (RATG) Vs Ta [NCT00261820]Phase 4160 participants InterventionalCompleted
Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans [NCT00281710]Phase 420 participants Interventional2005-10-31Completed
REPLACE: Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids [NCT00284947]Phase 47 participants (Actual)Interventional2006-01-31Completed
Prospective Phase II Study of Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome (ARDS) After Thoracic Surgery (E-START) [NCT00290602]Phase 240 participants Interventional2004-02-29Completed
Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma [NCT00307606]Phase 440 participants (Anticipated)Interventional2005-12-31Recruiting
Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis [NCT00307645]Phase 3160 participants Interventional2003-05-31Terminated
The Efficacy and Safety of Intravenous Pulse Steroids Compared to Standard Oral Steroids in the Treatment of Problematic Hemangiomas in Infants: A Randomized Controlled Trial [NCT00312520]Phase 320 participants Interventional2002-07-31Completed
Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus [NCT04233164]Early Phase 147 participants (Actual)Interventional2020-03-04Active, not recruiting
The Use Of Umbilical Cord Blood As A Source Of Hematopoietic Stem Cells [NCT00084695]Phase 225 participants (Anticipated)Interventional2003-09-30Recruiting
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment [NCT05665270]Phase 440 participants (Anticipated)Interventional2023-01-30Enrolling by invitation
[NCT00433225]Phase 40 participants InterventionalCompleted
A Masked Comparison of Acular LS Plus Steroid Versus Steroid Alone for the Prevention of Macular Leakage in Cataract Patients [NCT00348244]Phase 40 participants InterventionalCompleted
A Multi-Center, Randomized, Blinded, Parallel-Group Study of AVONEX Compared With AVONEX in Combination With Oral Methotrexate, Intravenous Methylprednisolone, or Both in Subjects With Relapsing Remitting MS Who Have Breakthrough Disease on AVONEX Monothe [NCT00112034]Phase 4350 participants Interventional2003-06-30Completed
Double-Blind Randomized Placebo-Controlled Trial on Clinical and Biological Effects of Oral Corticosteroids or Doxycyclin in Patients With Nasal Polyposis [NCT00480298]Phase 248 participants Interventional2002-11-30Completed
A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With MMF and Steroids in Patients Undergoing Kidney Transplantation and a Pharmacokinetics Study. [NCT00481819]Phase 3240 participants (Actual)Interventional2007-07-31Completed
A Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta Antibodies [NCT00492466]Phase 414 participants (Actual)Interventional2003-03-31Completed
The Effect of 6-Methyl-Prednisolone on Organ Dysfunction and Mortality of Patients With Unresolving Multiple Organ Dysfunction Syndrome [NCT00127985]Phase 4240 participants (Anticipated)Interventional2005-08-31Recruiting
A Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship [NCT00134693]Phase 277 participants (Actual)Interventional2005-06-21Completed
Medication Overuse Headache: A Randomised Double Blind Study of Prednisolone or Placebo in Withdrawal Therapy (Phase 3), and a Randomised 1 Year Follow up by Neurologist or General Physician After Successful Withdrawal Therapy [NCT00135122]Phase 3100 participants (Actual)Interventional2003-09-30Completed
A Phase I/II Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases [NCT05789589]Phase 1/Phase 246 participants (Anticipated)Interventional2023-08-16Recruiting
Assessment of the Efficacy of Glucocorticoids in Improving Post-operative Organ Dysfunction in Patients With Acute Type A Aortic Dissection(GLAD): a Randomized Controlled Trial [NCT05329740]Phase 4212 participants (Actual)Interventional2022-02-07Completed
Repeated Corticosteroid Injections Around the Greater Occipital Nerve (GON) as Prophylactic Treatment in Chronic Cluster Headache [NCT05324748]Phase 350 participants (Anticipated)Interventional2022-11-07Recruiting
A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma [NCT04759586]Phase 3244 participants (Anticipated)Interventional2021-10-05Recruiting
The Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques: An Investigator-Blinded Study [NCT02784210]Phase 230 participants (Anticipated)Interventional2016-10-05Recruiting
A Randomized, Multicenter, Open-Label Study of Single Dose Filgrastim-SD/01 Versus Daily Filgrastim Following ESHAP Chemotherapy for Non-Hodgkin's Lymphoma [NCT00004192]Phase 260 participants (Anticipated)Interventional2000-05-01Completed
An Open-label, Single-arm, Multicenter Phase II/III Extension Study to Evaluate the Safety of Rituximab Re-treatment in Subjects With Moderate to Severe Systemic Lupus Erythematosus Previously Enrolled in Protocol U2971g [NCT00381810]Phase 331 participants (Actual)Interventional2006-06-22Terminated(stopped due to During a safety review of studies U2970g and U2971g, the Data Monitoring Committee recommended that enrollment in this extension trial be terminated.)
A Multi-center Randomized Controlled Trial of Efficacy and Safety of Perineural Local Anesthetics and Steroids for Chronic Peripheral Post-traumatic Neuropathic Pain: The Resperist Study [NCT03009500]Phase 33 participants (Actual)Interventional2017-01-31Completed
Trial of High Dose Immunosuppressive Therapy With Hematopoietic Stem Cell Support in Devic's Disease [NCT00787722]Phase 1/Phase 213 participants (Actual)Interventional2009-10-10Completed
Phase II Study of Combination of Thymoglobulin, Cyclosporine, Methylprednisone, and Granulocyte Colony-stimulating Factor (GCSF) in Patients With Newly Diagnosed Aplastic Anemia or With Hypoplastic or Low/Intermediate-1 Risk Myelodysplastic Syndrome [NCT00806598]Phase 253 participants (Actual)Interventional2005-05-31Completed
A Prospective Randomized Controlled Trial of Early Non-Invasive Positive Pressure Ventilation in Patients With Hypoxemic Respiratory Failure and Malignancies [NCT02464696]256 participants (Anticipated)Interventional2015-10-06Recruiting
Lymphodepleting Chemotherapy and T-Cell Suppression Followed By Allogeneic Natural Killer Cells and IL-2 in Patients With Recurrent Ovarian, Fallopian Tube, Primary Peritoneal Cancer and Advanced Metastatic Breast Cancer (MT2009-30) [NCT01105650]Phase 213 participants (Actual)Interventional2010-07-31Completed
Injection of Dorsal Scapular n at Different Levels, Dose it Make Difference? [NCT04693312]Phase 2/Phase 360 participants (Actual)Interventional2020-01-01Completed
Multi-center, Randomized, Double Masked, Vehicle Controlled Phase IV Study to Compare the Efficacy, Ocular Safety and Tolerability of a Two Day Treatment With Eye Drops (0.5% Prednisolone Acetate, One Drop Four Times Per Day) in Patients With Intraocular [NCT00170729]Phase 462 participants (Actual)Interventional2004-08-17Completed
The Impact of Pre-emptive Large Doses of Methylprednisolone Combined With Gabapentin on Pain Treatment and Convalescence After Total Knee Arthroplasty in Elderly: A Double-blind Randomized Study [NCT04653415]Phase 4160 participants (Actual)Interventional2019-06-01Completed
Gene Transfer for Patients With Fanconi Anemia Complementation Group A (FANCA) [NCT01331018]Phase 13 participants (Actual)Interventional2012-02-22Active, not recruiting
A Phase III Study to Determine Efficacy and Safety of Low-Dose Glucocorticoids for Initial Treatment of Acute Graft-versus-Host Disease [NCT00929695]Phase 3164 participants (Actual)Interventional2009-06-30Completed
CSP #574 - Evaluate the Safety and Efficacy of Methylprednisolone in Hospitalized Veterans With Severe Community-Acquired Pneumonia [NCT01283009]Phase 3584 participants (Actual)Interventional2012-01-09Completed
Comparison of Efficacy and Safety of Intravenous Pulsed Methylprednisolone and Oral Methotrexate Versus Intravenous Pulsed Methylprednisolone and Oral Placebo in the Treatment of Active Moderate and Severe Thyroid Eye Disease - a Prospective, Randomized, [NCT00348413]80 participants (Anticipated)Interventional2003-06-30Completed
A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Docetaxel Combined With Platinum-based Drugs Compared With Docetaxel Alone for Metastatic Hormone-sensitive Prostate Cancer Patients Carrying DNA Repair Mutation [NCT05461261]Phase 250 participants (Anticipated)Interventional2022-07-01Recruiting
Intradiscal Gelified Ethanol Versus Intradiscal Steroid in Refractory Lumbar Discogenic Pain: a Randomized Single-blind Study [NCT03415828]83 participants (Actual)Interventional2018-05-29Active, not recruiting
Pilot, Phase I, Single Blind Trial to Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers. (PRURITUS- Nimpa Study). [NCT01529320]Phase 118 participants (Actual)Interventional2012-02-29Completed
Non-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and Disorders [NCT00053989]Phase 241 participants (Actual)Interventional2002-01-29Completed
A RANDOMIZED TRIAL OF UNMODIFIED VERSUS T-CELL DEPLETED ALLOGENEIC HLA-IDENTICAL BONE MARROW TRANSPLANTATION FOR THE TREATMENT OF ACUTE LEUKEMIAS [NCT00002534]Phase 30 participants Interventional1993-05-31Completed
A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Severe Type of Hand, Foot, and Mouth Disease [NCT01554930]230 participants (Actual)Interventional2010-05-31Completed
A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Children and Adults With Hematologic Malignancies [NCT00003661]Phase 23 participants (Actual)Interventional1998-06-30Completed
The Unrelated Donor Marrow Transplantation Trial [NCT00003187]Phase 2/Phase 319 participants (Actual)Interventional1995-05-31Completed
Phase II Clinical Trial Incorporating Alemtuzumab (Campath-1H) in Combination With FK506 and Methylprednisolone for Treatment of Severe Acute Graft vs Host Disease [NCT00109993]Phase 234 participants (Actual)Interventional2005-01-31Completed
A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Pediatric Solid Tumors With Relapsed or Therapy Refractory Disease [NCT00112645]Phase 110 participants (Anticipated)Interventional2005-04-30Completed
Transplantation of Unrelated Donor Hematopoietic Stem Cells for the Treatment of Hematological Malignancies [NCT00281879]Phase 2200 participants (Actual)Interventional2006-02-28Terminated
A Study of Modified Augmented BFM Therapy for Infants With Acute Lymphoblastic Leukemia [NCT00022126]Phase 26 participants (Actual)Interventional2002-11-30Completed
[NCT00000146]Phase 30 participants Interventional1988-07-31Active, not recruiting
[NCT02115997]Phase 430 participants (Actual)Interventional2015-07-06Completed
[NCT00017628]Phase 120 participants Interventional2001-04-30Completed
A Phase III, Randomized, Placebo-Controlled, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Oral Beclomethasone 17, 21-Dipropionate (BDP) in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Gr [NCT00043147]Phase 30 participants Interventional2002-04-30Completed
Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study [NCT00135967]Phase 2/Phase 330 participants Interventional2002-05-31Completed
Randomised, Double-Arm, Controlled, Open-Label Study Comparing Calcineurin Inhibitor-Free Immunosuppression (Zenapax®, CellCept® and Prednisolone) and Cyclosporine A Based Immunosuppression (Sandimmun Neoral®, CellCept® and Prednisolone) on the Outcome of [NCT00138970]Phase 470 participants Interventional2002-01-31Completed
A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Tacrolimus and Corticosteroid as Immunosuppressive Treatment for Lupus Membra [NCT00404794]Phase 320 participants (Anticipated)Interventional2005-11-30Completed
A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Conventional Immunosuppressive Treatment on Proteinuria in Idiopathic Membranous Nephropathy (MN) and Focal Segmental Glomerulosclerosis (FSGS) [NCT00404833]Phase 316 participants (Anticipated)Interventional2003-01-31Completed
[NCT00017654]3 participants Interventional2001-04-30Active, not recruiting
A Double-Blind Randomized Trial of Steroid Withdrawal in Sirolimus- and Cyclosporine-Treated Primary Transplant Recipients [NCT00023244]Phase 2274 participants (Actual)Interventional2001-01-31Terminated(stopped due to Effective August 13, 2004: Unanticipated high incidence of post-transplant lymphoproliferative disorder)
Phase IV Study of Early RA: a Randomized Magnetic Resonance Imaging Study Comparing the Effects of Methotrexate Alone or in Combination With Infliximab or Intravenous Pulse Methylprednisolone [NCT00396747]Phase 445 participants (Actual)Interventional2003-06-30Completed
A Phase IV, Randomized, Multi-center Clinical Trial to Compare the Efficacy of Orbital Radiotherapy in Association With Intravenous Glucocorticoids vs Intravenous Glucocorticoids Alone for Moderately Severe and Active Graves' Orbitopathy [NCT03098225]Phase 4120 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Induction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF [NCT04702256]Phase 3196 participants (Anticipated)Interventional2021-12-09Recruiting
Calcineurin Inhibitor Sparing Protocol in Living Donor Pediatric Kidney Transplantation [NCT00023231]35 participants (Actual)Interventional2001-02-28Completed
Unrelated Umbilical Cord Blood As An Alternate Source Of Stem Cells Transplantation [NCT00055653]Phase 20 participants Interventional2003-01-31Completed
An Open Label Pilot Study of Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event: Comparison With CHAMP [NCT00037115]Phase 40 participants (Actual)Interventional2002-05-31Withdrawn(stopped due to Lack of funding)
A Phase II Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin (BSHAP) as Salvage in Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma [NCT00069966]Phase 20 participants Interventional2003-04-30Active, not recruiting
Pilot Study Of T-Cell-Depleted Peripheral Blood Stem Cell Transplantation From Partially Matched Related Donors For Patients With High-Risk Leukemia [NCT00066417]Phase 251 participants (Anticipated)InterventionalTerminated(stopped due to Trial was withdrawn for drug availability issues.)
Immunomodulation by Ultraviolet B-Irradiation (UVB) to Facilitate Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies [NCT00068523]10 participants (Actual)Interventional2003-06-30Completed
Single-Center, Randomized, Double Masked, Two-Period Cross-Over, Three Days Per Period, Phase IV Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 0.5% Eye Drops Versus Vehicle in Healthy Volunteers [NCT00134992]Phase 430 participants Interventional2004-08-31Completed
The Role of Topical Prednisolone Acetate Following Selective Laser Trabeculoplasty [NCT00406042]25 participants Interventional2005-09-30Completed
Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease [NCT00152620]40 participants Interventional2004-06-30Terminated(stopped due to study completed)
A Phase I Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin in the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma [NCT00053105]Phase 10 participants Interventional2002-02-28Active, not recruiting
Pilot Study Of Multiple Umbilical Cord Blood Unit Transplantation Following Non-Myeloablative Conditioning In Patients With Hematologic Disorders Or Severe Aplastic Anemia [NCT00054236]Phase 155 participants (Actual)Interventional2002-05-31Completed
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-beta-1a for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis [NCT00168766]Phase 4345 participants (Actual)Interventional2003-01-31Completed
[NCT00854061]Phase 3172 participants (Actual)Interventional2009-02-28Completed
A Multi-Center, Randomized, Double Masked, Bioequivalence Study of Tobramycin and Prednisolone Acetate (0.3/1.0%, ISTA) Ophthalmic Suspension Compared to PredForte (1.0% Prednisolone Acetate, Allergan) Ophthalmic Suspension [NCT00198523]Phase 3132 participants Interventional2005-07-31Completed
Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids: a Prospective, Double-Blind, Placebo-Controlled Trial. [NCT00199576]Phase 3670 participants Interventional2000-12-31Completed
the Effect of Single Dose of Etomidate Used During Emergency Intubation on Hemodynamics and Adrenal Cortex: a Randomized Clinical Trial [NCT01792037]Phase 490 participants (Actual)Interventional2012-12-31Completed
Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery [NCT04200651]Phase 425 participants (Actual)Interventional2020-01-13Completed
Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy [NCT01381874]Phase 2297 participants (Actual)Interventional2011-08-24Completed
Peri-articular Injections Containing a Corticosteroid During Total Knee Arthroplasty [NCT00492973]101 participants (Actual)Interventional2006-03-31Completed
Danish Non-inferiority Study of Ocrelizumab and Rituximab in MS (DanNORMS): A Randomized Study Comparing the Efficacy of Ocrelizumab and Rituximab in Active Multiple Sclerosis [NCT04688788]Phase 3594 participants (Anticipated)Interventional2021-04-28Recruiting
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy of CRx-102 in Subjects With Symptomatic Knee Osteoarthritis and Optional One-Year Extension [NCT00521989]Phase 2279 participants (Actual)Interventional2007-08-31Terminated(stopped due to CRx-102-006 study results, negative)
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Superiority of CRx-102 Over Each of Its Components When Given to Subjects With Active Rheumatoid Arthritis (RA) [NCT00551707]Phase 251 participants (Actual)Interventional2007-10-31Completed
A California Cooperative Clinical Study Comparing Allogeneic Hematopoietic Cell Transplantation Using Nonmyeloablative Host Conditioning With Total Lymphoid Irradiation and Anti-thymocyte Globulin Versus Best Standard of Care in Acute Myeloid Leukemia (AM [NCT00568633]Phase 358 participants (Actual)Interventional2007-08-31Terminated(stopped due to Poor accrual)
Cytosine Arabinoside and Mitoxantrone for Patients With Juvenile Myelomonocytic Leukemia Receiving Repeat Stem Cell Transplantation [NCT00609739]Phase 1/Phase 21 participants (Actual)Interventional1999-06-30Terminated(stopped due to Low accrual)
A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrex [NCT00578305]Phase 3185 participants (Actual)Interventional2007-11-30Completed
A Study of Cyclophosphamide, Fludarabine, and Antithymocyte Globulin Followed by Matched Sibling Donor Hematopoietic Cell Transplantation in Patients With Fanconi Anemia [NCT00630253]Phase 1/Phase 231 participants (Actual)Interventional2000-02-17Completed
Adrenal Cortical Function and Vitamin A Deficiency in Sepsis, Severe Sepsis and Septic Shock: Prospective Randomized, Double Blind Placebo Controlled Clinical Trials [NCT03152474]Phase 4300 participants (Actual)Interventional1993-02-28Completed
Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis [NCT00682357]25 participants (Actual)Interventional2008-05-31Completed
Pilot Study of Methylprednisolone Replacement for Dexamethasone-induced Hiuup Patients [NCT01277731]0 participants (Actual)Interventional2010-07-31Withdrawn
Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2 [NCT05736549]Phase 266 participants (Anticipated)Interventional2023-02-07Recruiting
Effect of Preoperative Low-dose of Methylprednisolone on Postoperative Pain and Immune Functions After Video-assisted Thoracoscopic Surgery: A Prospective Randomized Controlled Trial [NCT03393949]Phase 4112 participants (Actual)Interventional2015-07-01Completed
An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Pediatric Subjects [NCT03721965]Phase 1/Phase 22 participants (Actual)Interventional2019-12-31Terminated(stopped due to The study was terminated due to insufficient efficacy in a separate phase III study)
[NCT00699803]Phase 264 participants (Actual)Interventional2008-05-31Completed
Azithromycin for Preventing the Development of Upper Respiratory Tract Illness Into Lower Respiratory Tract Symptoms in Children and Oral Corticosteroids for Treating Episodes of Significant Lower Respiratory Tract Symptoms in Children [NCT01272635]Phase 3607 participants (Actual)Interventional2011-03-31Completed
An Open-label, Randomized, Cross-over Interventional Study to Evaluate the Efficacy and Safety of Tocilizumab Versus Corticosteroids in Hospitalised COVID-19 Patients With High Risk of Progression [NCT04345445]Phase 3310 participants (Anticipated)Interventional2020-04-15Not yet recruiting
Phase II Randomized Double Blind Trial of Methylprednisolone and N-acetylcysteine in Hepatic Resections. [NCT01726465]Phase 250 participants (Actual)Interventional2012-11-30Terminated(stopped due to The first phase was completed)
Efficacy and Safety Evaluation of Rapamycin Combined With Methylprednisolone in the Treatment of Hyperthyroidism Exophthalmos: A Randomized, Controlled, Multicenter Clinical Trial. [NCT05532072]Early Phase 1140 participants (Anticipated)Interventional2022-09-30Not yet recruiting
A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) [NCT01086540]Phase 257 participants (Actual)Interventional2011-06-24Completed
Non-myeloablative Hematopoietic Stem Cell Transplantation for Stiff Person Syndrome (SPS) and Anti-GAD Antibody Variants: Progressive Encephalomyelitis With Rigidity and Myoclonus (PERM), and Adult Onset Autoimmune Anti-GAD Positive Cerebellar Ataxia [NCT02282514]Phase 1/Phase 223 participants (Actual)Interventional2014-10-31Terminated(stopped due to Could not predict who would respond, relapse or go into remission)
B-Cell Targeted Therapy for Acute Renal Allograft Rejection With an Antibody Mediated Component: A Prospective, Randomized, Open-Label Study [NCT00771875]Phase 230 participants (Actual)Interventional2008-09-30Completed
Intraorbital Injection Versus Oral Steroid in Patients With Anterior Idiopathic Orbital Inflammation: A Randomized Clinical Trial [NCT03958344]Phase 3120 participants (Anticipated)Interventional2022-01-01Recruiting
Extended Follow-up of a Randomized Placebo-controlled Trial of Local Steroid Injection in Carpal Tunnel Syndrome [NCT02652390]Phase 4111 participants (Actual)Interventional2016-02-29Completed
Multicenter, PrOspective, Randomized, Controlled Trial Comparing GenIcular Artery EmbOlization Using Embosphere Microspheres to Corticosteroid iNjections for the Treatment of Symptomatic Knee Osteoarthritis: MOTION Study [NCT05818150]264 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Addition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled Trial [NCT01828437]Phase 362 participants (Actual)Interventional2012-11-30Completed
"RANDOMIZED COMPARISON OF ALTERNATING TRIPLE THERAPY (ATT) VERUS CHOP IN PATIENTS WITH INTERMEDIATE GRADE LYMPHOMAS AND IMMUNOBLASTIC LYMPHOMAS WITH INTERNATIONAL INDEX 2-5" [NCT00002565]Phase 361 participants (Actual)Interventional1994-05-25Completed
Perks of Methylprednisolone for Hospitalized COVID-19 Patients: A Clinical Trial [NCT04559113]200 participants (Anticipated)Interventional2020-05-01Recruiting
Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation [NCT02212210]Early Phase 1135 participants (Actual)Interventional2012-02-29Terminated(stopped due to PI permanently closed accrual for the study based on FDA warning issued in April 2014. Study is closed)
The Use of Intra-articular Corticosteroid Injection to Treat Osteoarthritis of the Carpometacarpal Joint: A Randomized Control Trial [NCT04177433]Phase 490 participants (Anticipated)Interventional2020-12-02Recruiting
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Biomarkers) of BI 653048 BS H3PO4 Capsule Formulation Administered as Multiple Doses of 25 mg to 200 mg qd for 10 Days. A Randomised, Double-blind Within Dose Groups, Placebo-controlled, Multipl [NCT02217631]Phase 1140 participants (Actual)Interventional2009-10-31Completed
Steroids and Unfractionated Heparin in Critically Ill Patients With Pneumonia From COVID-19 Infection. A Multicenter, Interventional, Randomized, Three Arms Study Design [NCT04528888]Phase 3210 participants (Anticipated)Interventional2020-11-25Recruiting
A Proof of Concept Study to Determine the Local Delivery and Efficacy of Intravenously Injected PEG-liposomal Prednisolone Sodium Phosphate (Nanocort) in Atherosclerotic Tissue in Subjects With Peripheral Artery Disease. [NCT01647685]Phase 1/Phase 221 participants (Anticipated)Interventional2012-05-31Recruiting
Transplantation of Umbilical Cord Blood From Related and Unrelated Donors [NCT00290628]43 participants (Actual)Interventional1999-10-31Terminated(stopped due to Replaced with another study)
Efficacy of Moxifloxacin 0.5%/Prednisolone 1% Fixed Combination Compared With Individual Administration of Moxifloxacin 0.5% and Prednisolone 1% in the Prevention of Post Operative Inflammation in Patients Having Lasik Surgery [NCT01603030]Phase 366 participants (Anticipated)Interventional2012-06-30Not yet recruiting
Preemptive Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery: a Split-mouth Randomized Triple-blind Clinical Trial [NCT01603498]18 participants (Actual)Interventional2011-04-30Completed
A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis [NCT00299013]Phase 3796 participants (Actual)Interventional2006-03-31Completed
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants [NCT00307671]Phase 4108 participants (Actual)Interventional2005-07-31Completed
Phase II Study of Induction Therapy Comprising Etoposide, Methylprednisolone, Cytarabine, and Cisplatin (ESHAP) Followed by Consolidation Therapy Comprising Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Patients With Relapsed or Refractory AIDS-Relat [NCT00310128]Phase 20 participants (Actual)Interventional2006-02-28Withdrawn(stopped due to Drug supply unavailable)
A Randomized, Controlled, Parallel-Group, Multicenter Study of Extracorporeal Photoimmune Therapy With THERAKOS* UVADEX* for the Treatment of Patients With Newly Diagnosed Acute Graft Versus-Host Disease [NCT00282503]Phase 319 participants (Actual)Interventional2006-01-31Terminated(stopped due to Lack of recruitment)
A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease [NCT00311961]Phase 4256 participants Interventional2001-06-30Completed
Long Term Tapering or Standard Steroids for Nephrotic Syndrome [NCT00308321]Phase 450 participants (Anticipated)Interventional2003-09-30Recruiting
Multicenter, Open-label, Randomized Study on Steroid-free Immunosuppression, in Comparison With Daily Steroid Therapy, in Children With Stable Renal Transplant Function Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF) [NCT00309218]Phase 342 participants (Actual)Interventional1999-03-31Completed
Comparison of Efficacy of Intra-articular Morphine vs Methylprednisolone in Patients With Knee Osteoarthritis. A Single - Blind, Randomized-controlled Study [NCT06163755]Phase 20 participants (Actual)Interventional2018-01-01Withdrawn(stopped due to Lack of funding)
A Phase III, International, Multicenter, Randomised Open Label Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Patients With Childhood Onset Idiopathic Nephrotic Syndrome [NCT05627557]Phase 380 participants (Anticipated)Interventional2023-03-29Recruiting
A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours [NCT05489211]Phase 2670 participants (Anticipated)Interventional2022-09-06Recruiting
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus Erythematosus [NCT04963296]Phase 3300 participants (Anticipated)Interventional2021-10-26Recruiting
Epidural Steroid Following Discectomy for Herniated Lumbar Disc Reduces Neurological Impairment and Enhances Recovery. A Randomized Study With Two-year Follow-up [NCT01499641]200 participants (Actual)Interventional2001-05-31Completed
A Prospective, Multi-Center, Randomized, Double-Masked, Positive-Controlled Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspen [NCT01505088]Phase 3193 participants (Actual)Interventional2011-12-31Completed
Standard Chemotherapy (CHOP Regimen) Versus Sequential High-Dose Chemotherapy With Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas and Poor Prognostic Factors: A Randomized Phase III Study (MISTRAL) [NCT00003215]Phase 3400 participants (Anticipated)Interventional1997-04-30Completed
[NCT01627236]120 participants (Anticipated)Interventional2012-12-31Recruiting
Biomarkers of Lupus Disease: Study of Biomarker Changes Before and After Treatment With Depomedrol and Background Medication Withdrawal in Patients With Mild to Moderate SLE Disease Activity [NCT00987831]Phase 1/Phase 2158 participants (Actual)Interventional2009-05-31Completed
Effect of Different Therapeutic Strategies on Regulatory T Cells in Kidney Transplantation: a Randomized Study [NCT01640743]58 participants (Actual)Interventional2010-03-31Completed
Randomized, Multicentric Study Evaluating the Efficacy and the Safety of Methylprednisolone Bolus in the Treatment of Renal Sarcoidosis [NCT01652417]40 participants (Actual)Interventional2012-10-31Terminated(stopped due to insufficient recruitment)
Clinical Study of Chemoimmunotherapy With Fresh Frozen Plasma, High Dose Methylprednisolone and Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia [NCT01670812]Phase 3100 participants (Anticipated)Interventional2012-01-31Recruiting
The Effect of Different Intra-articular Injections on Pain and Function in Primary Gonarthrosis [NCT05291793]80 participants (Actual)Interventional2020-04-01Completed
Single Center, Randomized, Double-Masked Evaluation of the Efficacy of PredAcetate 1% Ophthalmic Suspension Compared to Pred Acetate 0.12% Ophthalmic Suspension, Lot Etab 0.2% Ophthalmic Suspension, and Placebo in a Modified CAC Model [NCT00689078]Phase 436 participants (Actual)Interventional2008-05-31Completed
Combined T Cell Depleted Haploidentical Peripheral Blood Stem Cell and Unrelated Umbilical Cord Blood Transplantation in Patients With Hematologic Malignancies Using a Total Lymphoid Irradiation Based Preparative Regimen [NCT02199041]Phase 224 participants (Actual)Interventional2014-07-11Terminated(stopped due to The study was halted early due to slow accrual.)
Phase I/II Trial of Thymus Transplantation With Immunosuppression, #950 [NCT00579527]Phase 1/Phase 214 participants (Actual)Interventional2005-12-19Completed
Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies. [NCT01694134]Phase 350 participants (Actual)Interventional2012-07-12Completed
Alternative Treatment Paradigm for Natalizumab Trial [NCT01710228]Phase 20 participants (Actual)Interventional2013-07-31Withdrawn(stopped due to sponsor stopped)
CHEMO-T: Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone (CHOP) Versus Gemcitabine, Cisplatin and Methyl Prednisolone (GEM-P) in the First Line Treatment Of T-cell Lymphoma,a Multicentre Randomised Phase II Study [NCT01719835]Phase 287 participants (Actual)Interventional2012-03-31Active, not recruiting
Determining Optimal Dose of Corticosteroids in COPD Exacerbations: A Pilot Study [NCT01742338]Phase 4125 participants (Anticipated)Interventional2012-05-03Suspended(stopped due to The study has been suspended to address research staffing and the feasibility of continued recruitment)
A Double-Blind, Randomized, Multicenter, Phase II Study of the Safety and Efficacy of Two Rituximab Regimens in Subjects With Moderate to Severe Active Rheumatoid Arthritis Receiving Stable Doses of Methotrexate [NCT00243412]Phase 242 participants (Actual)Interventional2005-08-31Completed
A Randomised, Single Blind, Placebo-Controlled, Cross-over, Phase 1 Methodology Study to Validate the Cantharidin Blister Model in Healthy Male Volunteers [NCT01762787]Phase 140 participants (Actual)Interventional2010-08-17Completed
Phase 3 Open Label Randomised Multicentre Controlled Trial of Rituxmab and Mycophenolate Mofetil Without Oral Steroids for the Treatment of Lupus Nephritis [NCT01773616]Phase 324 participants (Actual)Interventional2015-04-30Terminated(stopped due to Study assessments for patients recruited continuing per protocol so patients receive a minimum of 6 months follow up. No safety concerns have been raised.)
FDG PET/CT: Reducing False Positive Mediastinal Uptake by Premedicating With Methylprednisolone [NCT01789892]0 participants (Actual)Interventional2011-06-30Withdrawn(stopped due to no patient accrual)
Safety and Efficacy of Nonsteroidal Antiinflammatory Drug and Glucocorticoids in Acute Sciatica [NCT01816334]Phase 450 participants (Actual)Interventional2013-01-31Completed
Kidney Graft Function Under the Immunosuppression Strategies With Low Dose of Neoral®(Cyclosporine) and Standard Dose of Myfortic®(Enteric-Coated Mycophenolate Sodium) vs. With Conventional Dose of Neoral®(Cyclosporine) and Reduced Dose of Myfortic®(Enter [NCT01817322]Phase 4140 participants (Actual)Interventional2011-06-30Completed
Lymphodepleting Chemotherapy With Rituximab and Allogeneic Natural Killer Cells for Patients With Refractory Lymphoid Malignancies (MT2009-15) [NCT01181258]Phase 216 participants (Actual)Interventional2010-08-31Completed
Study of Visual Recovery After Erythropoietin (EPO) Injection, in Patients With Traumatic Optic Neuropathy (TON) [NCT01783847]Phase 1/Phase 2117 participants (Actual)Interventional2015-02-28Completed
Phase 2 Study of Rituximab and ESHAP (Etoposide, Methylprednisolone, Cytarabine, and Cisplatin) in Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma [NCT00367497]Phase 25 participants (Actual)Interventional2005-08-31Terminated(stopped due to The stopping rule was applied because of low response rates.)
Cord Blood Transplantation for Hematologic Malignancies and Bone Marrow Failure Syndromes [NCT00003270]Phase 220 participants (Actual)Interventional1997-09-04Completed
Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint [NCT03232749]Phase 425 participants (Actual)Interventional2018-04-18Terminated(stopped due to The physician in charge is leaving the University of Florida)
Double-blind Randomized Controlled Trial of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis [NCT01809132]Phase 2/Phase 3104 participants (Actual)Interventional2013-09-30Completed
A Randomized Study of IVIG vs. IVIG With High Dose Methylprednisolone in Rapidly Augmenting Platelet Counts in Childhood ITP. [NCT00376077]Phase 332 participants (Actual)Interventional2005-08-31Completed
SMART Trial: Steroid Dosing by bioMARker Guided Titration in Critically Ill Patients With Pneumonia [NCT03852537]Phase 244 participants (Actual)Interventional2019-12-02Completed
Killer Immunoglobulin-like Receptor (KIR) Incompatible Unrelated Donor Hematopoietic Cell Transplantation (SCT) for AML With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory and Relapsed Acute Myelogenous Leukemia (AML) in Children: A Children's Oncolo [NCT00553202]Phase 2158 participants (Actual)Interventional2008-01-31Completed
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients With Active Class III or IV Lupus Nephritis, Including an Evaluation of Open Label Sa [NCT05039619]Phase 240 participants (Anticipated)Interventional2022-05-12Recruiting
Towards a Self-Administered Hearing Protection Regimen [NCT04826237]Phase 4100 participants (Anticipated)Interventional2023-02-09Recruiting
Efficacy of Injectable Methylprednisolone Sodium Succinate in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome Under the New Coronavirus (SARS-CoV2): a Phase IIb, Randomized, Double-blind, Placebo-controlled, Clinical Trial. [NCT04343729]Phase 2416 participants (Actual)Interventional2020-04-18Completed
A Randomized, Controlled, Open-Label Study to Evaluate the Efficacy of Extracorporeal Photopheresis (ECP) Versus Corticosteroids in the Treatment of Patients With Secondary Progressive Multiple Sclerosis (SPMS) [NCT02296346]13 participants (Actual)Interventional2014-10-31Terminated(stopped due to Low enrollment/PI relocated. New site couldn't reach agreement with manufacturer)
A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5% [NCT01437982]Phase 4140 participants (Anticipated)Interventional2010-08-05Completed
Efficacy of Peripheral Nerve Blocks for Episodic Migraine Treatment and Prophylaxis [NCT05734625]Phase 260 participants (Anticipated)Interventional2023-07-10Recruiting
The Evaluation of the Safety and Efficacy of Sustained Release Dexamethasone Intracanalicular Insert (DEXTENZA) in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia (TENDER) [NCT05620901]Early Phase 130 participants (Anticipated)Interventional2023-02-01Recruiting
Focal Cerebral Arteriopathy Steroid Trial [NCT06040255]Phase 480 participants (Anticipated)Interventional2023-10-01Not yet recruiting
Single Blind Randomized Controlled Trial to Assess the Safety and Efficacy of High Dose Pulse Intravenous Corticosteroid Therapy to Treat Patients With Complicated/Fulminant Acute Myocarditis [NCT05150704]Phase 3288 participants (Anticipated)Interventional2021-10-07Recruiting
Randomized Multicenter Phase 3 Single-blind Trial Comparing the Efficacy of Corticosteroid Control to Mesenchymal Stem Cell Preparations From Autologous Bone Marrow Concentrate (BMAC), Adipose-derived Stem Cells in the Form of Stromal Vascular Fraction (S [NCT03818737]Phase 3475 participants (Actual)Interventional2019-03-28Completed
Glucocorticoid Treatment in Patients Undergoing TAVR to Reduce the Incidence of Atrioventricular Block and Pacemaker Implantation [NCT06076824]Phase 4100 participants (Anticipated)Interventional2023-08-12Recruiting
Systemic Corticosteroids in Treatment of Post-COVID-19 Interstitial Lung Disease [NCT04988282]Phase 4262 participants (Actual)Interventional2021-05-24Completed
Medrol® In Contact Dermatitis: A Prospective Study To Assess The Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Subjects [NCT00929981]80 participants (Actual)Observational2009-09-30Completed
A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy [NCT03018535]Phase 376 participants (Actual)Interventional2012-01-31Active, not recruiting
The Effect of 4.5 Gram Methylprednisolone Administered Once Weekly for 12 Weeks on Bone Metabolism in Graves´ Ophthalmopathy [NCT03122847]30 participants (Anticipated)Observational2017-06-07Active, not recruiting
Delayed Infusion of Ex Vivo Anergized Peripheral Blood Mononuclear Cells Following CD34 Selected Peripheral Blood Stem Cell Transplantation From a Haploidentical Donor for Patients With Acute Leukemia and Myelodysplasia [NCT00376480]Phase 119 participants (Actual)Interventional2005-06-30Completed
Phase 2/Phase 3 of the Randomized Control Trial to Evaluate the Efficacy of Autologous Blood Injection Versus Local Corticosteroid Injection for Treatment of Lateral Epicondylitis. [NCT00947765]Phase 2/Phase 360 participants (Actual)Interventional2007-01-31Completed
Autologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac Dysfunction [NCT03593902]Phase 2/Phase 39 participants (Actual)Interventional2018-05-17Terminated(stopped due to PI Sabbatical)
Clinical Evaluation of New Treatment Strategy of Mucous Membrane Pemphigoid Using Large Dose of Prednisolone Plus Intra-lesional of Triamcinolone Acetonide Followed by Combination of Mycophenolate Mofetil, Dapsone and Low Dose Prednisolone [NCT04744623]Phase 2/Phase 310 participants (Actual)Interventional2020-09-30Active, not recruiting
Prolonged Low Doses of Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome [NCT04323592]173 participants (Actual)Observational [Patient Registry]2020-03-23Completed
Low Dose Versus High Dose Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia : a Multicenter Randomized Blinded Trial [NCT02303587]424 participants (Actual)Interventional2014-12-31Completed
Clinical Effectiveness of Symptomatic Therapy Compared to Standard Step up Care for the Treatment of Low Impact Psoriatic Oligoarthritis: a 2 Arm Parallel Group Feasibility Study [NCT03797872]Phase 41 participants (Actual)Interventional2019-04-17Completed
Effect of Preoperative Intravenous High Dose Methylprednisolone on Endothelial Function in Patients Scheduled for Total Knee-arthroplasty [NCT02332629]Phase 370 participants (Actual)Interventional2015-01-31Completed
A Randomized, Comparative Trial of Trimetrexate With Leucovorin Rescue Versus Standard Anti-Pneumocystis Therapy Versus Standard Anti-Pneumocystis Therapy With High Dose Steroids for AIDS Patients With Pneumocystis Pneumonia Who Appear to Be Refractory to [NCT00000730]Phase 3240 participants InterventionalTerminated
Phase 2 Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular Dystrophy [NCT02167217]Phase 225 participants (Actual)Interventional2014-04-17Completed
Pilot Study in AIDS-Related Lymphomas [NCT00002524]Phase 246 participants (Actual)Interventional1993-06-30Completed
A Prospective Randomized Double-blinded Controlled Single Center Clinical Study of the Efficacy and Safety for Tofacitinib Compared With Glucocorticoid in the Remission-reduction Treatment of Active Takayasu's Arteritis [NCT05749666]Phase 350 participants (Anticipated)Interventional2023-01-20Recruiting
Treatment of Metastatic Prostate Cancer That is Hormone-Independent: Evaluation of the Role of Chemotherapy on the Quality of Life of Patients. Phase II Study [NCT00003682]Phase 3160 participants (Anticipated)Interventional1998-10-31Terminated(stopped due to lack of inclusions)
Sudden Hearing Loss Multicenter Treatment Trial [NCT00097448]Phase 3255 participants (Actual)Interventional2004-12-31Completed
Phase II Trial of Natalizumab (Tysabri®) Plus Prednisone for Initial Therapy of Acute Graft Versus Host Disease (aGVHD) of the Gastrointestinal Tract [NCT02176031]Phase 221 participants (Actual)Interventional2015-01-31Completed
STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS) [NCT03229538]Phase 31,263 participants (Actual)Interventional2017-10-18Completed
A Randomised, Comparator Controlled, Two Part, Open-label Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Multiple Doses of Otelixizumab in Patients With Thyroid Orbitopathy [NCT01114503]Phase 22 participants (Actual)Interventional2010-07-07Terminated(stopped due to Clinical study in Graves' ophthalmopathy terminated until there is a better understanding of an efficacious dose with Otelixizumab from other clinical studies.)
Single Center, Randomized, Double-Blind, Placebo-Controlled Treatment Of Knee Osteoarthritis With Intra-Articular Infliximab [NCT01144143]Phase 416 participants (Actual)Interventional2007-07-31Completed
Effect of Bevacizumab on Radiation-induced Brain Necrosis in Patients With Nasopharyngeal Carcinoma [NCT01621880]Phase 2112 participants (Actual)Interventional2012-06-30Completed
Intratympanic Dexamethasone or Methylprednisolone for Sudden Hearing Loss as a Salvage Treatment: a Randomized, Double-blind, Multi-center Study [NCT04129697]30 participants (Anticipated)Interventional2020-01-01Not yet recruiting
Comparison of the Efficacy of Two Different Glucocorticoid Regimens for Treatment of Active Moderate-to-severe Graves' Orbitopathy [NCT05793359]62 participants (Actual)Observational [Patient Registry]2017-07-25Completed
Efficacy and Safety of Corticosteroids in COVID-19: A Prospective Randomized Controlled Trails [NCT04273321]86 participants (Actual)Interventional2020-02-14Completed
Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis. Randomized Controlled Trial. [NCT04942002]Phase 2/Phase 350 participants (Anticipated)Interventional2021-06-15Recruiting
Safety and Efficacy of Topical Loteprednol Etabonate 0.5%, Versus Prednisolone Acetate 1%, for the Treatment of Intraocular Inflammation Following Surgery for Childhood Cataract [NCT01475643]Phase 3107 participants (Actual)Interventional2013-06-30Completed
Glucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial [NCT04553003]Phase 480 participants (Anticipated)Interventional2020-08-01Recruiting
Hyper-CVAD With Liposomal Vincristine (Hyper-CMAD) in Acute Lymphoblastic Leukemia [NCT01319981]Phase 231 participants (Actual)Interventional2013-03-05Completed
The Use of Campath-1H, Tacrolimus, and Sirolimus Followed by Sirolimus Withdrawal in Renal Transplant Patients [NCT00078559]Phase 1/Phase 210 participants (Actual)Interventional2003-11-30Completed
Evaluation of DEXTENZA on the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids [NCT04426734]Phase 430 participants (Anticipated)Interventional2020-07-01Not yet recruiting
Treatment of Refractory Gout With Adrenocorticotropic Hormone or Methylprednisolone [NCT04808856]60 participants (Anticipated)Interventional2021-04-01Recruiting
Corticosteriods vs. Saline vs. Air Placebo Intra-articular Injections for Knee Osteoarthritis: A Single Blinded Prospective Randomized Trial [NCT02995083]Early Phase 10 participants (Actual)Interventional2017-06-30Withdrawn(stopped due to Study deemed not feasible)
Yale Steroid Enhanced Versus Exparel Nerveblock TKA Randomized Controlled Trial (RCT) Study [NCT05279092]Phase 2250 participants (Anticipated)Interventional2022-09-08Recruiting
Oral Prednisolone Dosing in Children Hospitalized With Asthma [NCT00257933]Phase 4152 participants (Actual)Interventional2006-02-28Completed
Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial. [NCT05748561]Phase 2/Phase 318 participants (Anticipated)Interventional2022-04-05Recruiting
Musculoskeletal Ultrasound Changes in the Plantar Fascia After a Single Injection of Platelet Rich Plasma Compared to Steroid [NCT05339542]98 participants (Actual)Interventional2022-03-10Completed
Randomized Controlled Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery [NCT01559675]121 participants (Actual)Interventional2010-09-30Completed
Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes [NCT04977427]Phase 4200 participants (Anticipated)Interventional2021-07-31Not yet recruiting
A Pilot Study Investigating the Feasibility and Efficacy of Locoregional Intra-arterial Administration of Methylprednisolone as a Bridge Therapy to Treat Symptomatic Flares in Inflammatory Bowel Disease. [NCT05587673]Phase 130 participants (Anticipated)Interventional2022-10-06Recruiting
Comparison of Efficacy and Safety of Two Different Ultrasound-Guided Suprascapular Nerve Block Techniques in Chronic Shoulder Pain: A Prospective Double-Blinded Randomized Controlled Study [NCT04938037]80 participants (Anticipated)Interventional2021-06-01Recruiting
A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus [NCT03054259]Phase 230 participants (Anticipated)Interventional2017-09-21Recruiting
Transverse Abdominis Plane Block Using Liposomal Bupivacaine for Post-operative Cesarean Delivery Analgesia- Walking Towards Recovery [NCT04393207]Phase 4300 participants (Anticipated)Interventional2022-02-01Recruiting
Intracanalicular Dexamethasone Insert for Management of Post-operative Pain and Inflammation in Patients Undergoing Vitreoretinal Surgery [NCT04371445]Phase 430 participants (Anticipated)Interventional2020-12-01Enrolling by invitation
Evaluation of Sleep EEG Changes in Paediatric Patients With Language Dysfunction: A Follow up Study. Evaluation of Sleep EEG Changes in Paediatric Patients With Language Dysfunction: A Follow up Study. Evaluation of Sleep EEG Changes in Pediatric Patients [NCT05487521]Phase 393 participants (Actual)Interventional2020-02-20Completed
Clinical Study of the Effect of Methylprednisolone Combined With Two Hydroxypropyl Theophylline on Respiratory Dynamics During Thoracoscopic Lobectomy [NCT04810819]110 participants (Anticipated)Interventional2021-07-01Not yet recruiting
Comparison of Dropless Prophylaxis After Routine Phacoemulsification to Standard Drops Regimen [NCT02515045]Phase 459 participants (Actual)Interventional2015-01-31Completed
Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease [NCT05510323]Phase 3208 participants (Anticipated)Interventional2022-08-31Not yet recruiting
The Effectiveness of Pulsed Radiofrequency of the Suprascapular Nerve and Shoulder Joint Compared to Intra-articular Corticosteroid Injection for Hemiplegic Shoulder Pain Management and Functional Improvement. [NCT05563571]20 participants (Anticipated)Interventional2022-04-01Recruiting
DEXTENZA VS. PREDNISOLONE ACETATE 1% in the Incidence of Pseudophakic Macular Edema in Patients With Diabetic Retinopathy Undergoing Cataract Surgery [NCT04362241]Phase 430 participants (Anticipated)Interventional2020-08-07Recruiting
The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy [NCT01579539]Phase 318 participants (Actual)Interventional2013-06-27Completed
Pre-operative Intravenous Steroid in Unilateral Primary Total Knee Replacement for Pain Relief and Recovery: A Double-Blind Randomized Controlled Trial [NCT03082092]Phase 460 participants (Actual)Interventional2017-06-01Completed
Autologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD) [NCT03829566]Phase 2/Phase 30 participants (Actual)Interventional2019-11-30Withdrawn(stopped due to Discontinued by Investigator)
Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment [NCT02283996]Phase 4260 participants (Anticipated)Interventional2014-11-30Recruiting
Efficacy and Safety of Granulocyte-colony Stimulating Factor in Patients With Severe Alcoholic Hepatitis With Null or Partial Response to Steroid: A Randomized, Double-blind, Placebo-controlled, Nationwide Multi-center Study [NCT02442180]Phase 364 participants (Actual)Interventional2015-07-31Terminated(stopped due to failure to recruit eligible patients)
Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL) - a 12-week, Prospective, Open-label, Pilot Study [NCT01790022]Phase 220 participants (Actual)Interventional2012-07-31Active, not recruiting
A Phase 2a Single-arm, Prospective, Open-label Pilot Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant [NCT04046549]Phase 225 participants (Actual)Interventional2019-10-30Completed
Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery [NCT01872611]Phase 3819 participants (Actual)Interventional2013-06-30Completed
A Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous Nephropathy [NCT04629248]Phase 3140 participants (Anticipated)Interventional2021-06-25Recruiting
[NCT00425724]Phase 420 participants (Anticipated)Interventional2000-01-31Completed
Phase II Study of Ofatumumab in Combination With High Dose Methylprednisolone Followed by Ofatumumab and Lenalidomide Consolidative Therapy for the Treatment of Relapsed or Refractory CLL/SLL The HiLOG Trial [NCT01497496]Phase 229 participants (Actual)Interventional2012-01-26Completed
Dextenza in Pterygium Surgery [NCT04403516]Phase 430 participants (Actual)Interventional2020-10-01Completed
Randomized Controlled Trial of Infliximab (Remicade®) Induction Therapy for Deceased Donor Kidney Transplant Recipients (CTOT-19) [NCT02495077]Phase 2290 participants (Actual)Interventional2015-11-02Completed
Prospective, Randomized Clinical Trial of Meibomian Gland Probing Versus Sham Procedure for Refractory Meibomian Gland Dysfunction [NCT02256969]Phase 445 participants (Actual)Interventional2014-10-31Completed
MYELOMA VII MEDICAL RESEARCH COUNCIL WORKING PARTY ON LEUKEMIA IN ADULTS: MYELOMATOSIS THERAPY TRIAL [NCT00002599]Phase 3750 participants (Anticipated)Interventional1994-09-30Active, not recruiting
Phase III Study of Combination Chemotherapy in Children With T Cell and Pre-B Cell Non-Hodgkin's Lymphoma [NCT00003650]Phase 3179 participants (Actual)Interventional1997-02-28Completed
A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Adults and Children With Bone Marrow Failure Syndromes or Inherited Metabolic or Hematologic Diseases [NCT00003662]Phase 290 participants (Anticipated)Interventional1998-08-31Completed
Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Infants Less Than 1 Year of Age. [NCT00002785]Phase 20 participants Interventional1996-07-31Completed
Augmenting Bone Marrow With CD34 Enriched Peripheral Blood Hematopoietic Stem Cells for Allogeneic Transplantation of Hematologic Malignancies [NCT00004232]Phase 10 participants Interventional1999-10-31Completed
The Value of Dexamethasone Versus Prednisolone During Induction and Maintenance Therapy of Prolonged Versus Conventional Duration of L-Asparaginase Therapy During Consolidation and Late Intensification, and of Corticosteroid + VCR Pulses During Maintenanc [NCT00003728]Phase 31,500 participants (Anticipated)Interventional1998-12-31Active, not recruiting
"Phase I Study of T Cell Depleted (TCD) Partially Matched Related Donor (PMRD) Hematopoietic Stem Cell Transplantation for High Risk Hematologic Diseases Using Intense Pre and Post Transplant Immunosuppression and Megadose CD34 Veto Cells" [NCT00004904]Phase 10 participants Interventional1999-10-31Completed
Use of G-CSF Stimulated HLA-Identical Allogeneic Peripheral Blood Stem Cells for Patients With High Risk Acute Myelogenous Leukemia or CML in Blast Crisis [NCT00002833]Phase 253 participants (Actual)Interventional1994-10-31Completed
Safety and Effectiveness of Single-dose Subconjunctival Triamcinolone Compared to Topical Prednisolone Eye Drops in Manual Small Incision Cataract Surgery [NCT05248139]100 participants (Anticipated)Interventional2022-10-31Not yet recruiting
A Multicenter Study of Unrelated Umbilical Cord Blood as an Alternate Source of Stem Cells for Transplantation [NCT00003913]Phase 2390 participants (Anticipated)Interventional1998-12-31Completed
A Multi-Center, Open Label, Randomized, Active Controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Processed Unrelated Bone Marrow in Patients With Acute or Chronic Leukemia [NCT00004255]Phase 2/Phase 30 participants Interventional2000-03-31Completed
Phase II Study of Prednisolone/Methylprednisolone Absorption in Children With Juvenile Dermatomyositis [NCT00004357]Phase 26 participants (Actual)Interventional1997-09-30Completed
T-Cell Depletion for Graft-Versus-Host Disease (GVHD) Prevention in High Risk Matched and Mismatched Allogeneic Bone Marrow Transplantation [NCT00005641]Phase 20 participants Interventional1997-09-30Terminated(stopped due to low study accrual)
Phase III Randomized, Double-Blind Study of Methylprednisolone by 24- Versus 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury [NCT00004759]Phase 3497 participants Interventional1991-12-31Completed
Bone Marrow Transplantation and High Dose Post-Transplant Cyclophosphamide for Chimerism Induction and Renal Allograft Tolerance (ITN054ST) [NCT02029638]Phase 24 participants (Actual)Interventional2014-01-07Terminated(stopped due to Slow accrual)
Phase II Trial of Intensive, Short-Course Combination Chemotherapy in the Treatment of Newly Diagnosed Patients With Poor-Risk Nonlymphoblastic Lymphoma and Acute B-Lymphoblastic Leukemia and in Patients With Recurrent Non-Hodgkin's Lymphoma [NCT00002471]Phase 20 participants Interventional1990-02-28Completed
De Novo Everolimus Versus Tacrolimus in Combination With Mofetil Mycophenolate and Low Dose Corticosteroids to Reduce Tacrolimus Induced Nephrotoxicity in Liver Transplantation: a Prospective, Multicentric, Randomised Study [NCT02909335]Phase 30 participants (Actual)Interventional2016-11-30Withdrawn
Does Anesthetic Contribute to Symptomatic Relief in Corticosteroid Injections for Knee Osteoarthritis? A Double-Blind Randomized Trial Comparing Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections [NCT02576249]Phase 429 participants (Actual)Interventional2015-10-31Completed
A Multicenter, Randomized, Open-label, Blinded-assessor, Follow-up, Phase 4 Study in Patients With Rheumatoid Arthritis Who Have Completed the Initial Treatment Part in the NORD-STAR Study and Have Reached Stable Low Disease Activity [NCT02466581]Phase 425 participants (Actual)Interventional2015-02-03Active, not recruiting
Preoperative Methylprednisolone on Thoracic Endovascular Repair for Reducing Post-implantation Syndrome [NCT05349071]158 participants (Anticipated)Interventional2022-05-01Not yet recruiting
Safety and Efficacy of Topical Tacrolimus 0.05% in the Treatment of Ocular Graft-Versus-Host Disease [NCT01977781]Phase 140 participants (Actual)Interventional2013-12-31Completed
A Prospective, Randomized Trial Comparing the Efficacy of Body-weight Based Versus Fixed Corticosteroid Dosage on Remission in Patients With Moderate to Severe Crohn's Disease Flares [NCT02392286]Phase 415 participants (Actual)Interventional2015-03-31Terminated(stopped due to insufficient enrollment)
Efficacy and Safety of Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis. [NCT05990894]248 participants (Actual)Observational2018-01-01Completed
High Dose Steroids for Liver Resection - Effect on Complications and Endothelial Function in the Immediate Postoperative Phase - a Randomized, Doubleblind, Controlled Trial [NCT03403517]Phase 4174 participants (Actual)Interventional2017-12-11Completed
A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab (SAR650984) in Patients Awaiting Kidney Transplantation [NCT04294459]Phase 1/Phase 223 participants (Actual)Interventional2020-06-18Terminated(stopped due to Terminated due to non-safety reasons)
Safety and Efficacy of KPI-121 1% Ophthalmic Suspension Versus Prednisolone Acetate Ophthalmic Suspension 1% for the Treatment of Inflammation Following Cataract Surgery in Children 0 to 3 Years of Age [NCT03596723]Phase 32 participants (Actual)Interventional2018-07-03Terminated(stopped due to NDA #210565 did not trigger the need for a Pediatric Research Equity Act study.)
Post-operative Methylprednisolone Taper Course for Orthopedic Surgery [NCT03661645]Phase 41,000 participants (Anticipated)Interventional2018-09-07Enrolling by invitation
A Randomized Prospective Study of Early Intensification Versus Alternating Triple Therapy for Patients With Poor Prognosis Lymphoma [NCT00002835]Phase 3116 participants (Actual)Interventional1995-10-30Completed
[NCT00004323]Phase 210 participants Interventional1995-02-28Completed
[NCT00004785]Phase 354 participants Interventional1995-11-30Completed
Phase I/II Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) [NCT02464657]Phase 1/Phase 244 participants (Actual)Interventional2015-07-31Completed
Open Randomized Single Centre Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With Severe Lung Injury Secondary to COVID-19 [NCT04341038]Phase 384 participants (Anticipated)Interventional2020-04-01Recruiting
Physiologic Effects of Stress Dose Corticosteroids in the Management of Inhospital Cardiac Arrest - CORTICA [NCT02790788]Phase 1/Phase 2100 participants (Actual)Interventional2016-11-04Completed
Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients [NCT02954198]40 participants (Actual)Interventional2016-12-01Completed
Efficacy and Safety of Loteprednol 0.5% Gel for Routine Prophylaxis After Photorefractive Keratectomy Compared to Prednisolone Acetate 1% Suspension and Fluorometholone 0.1% Suspension [NCT03123614]Phase 4131 participants (Actual)Interventional2014-09-19Completed
Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients Converted From Twice-daily Tacrolimus [NCT02953873]Phase 425 participants (Actual)Interventional2017-05-05Completed
Phase II Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease [NCT02133924]Phase 276 participants (Actual)Interventional2016-08-31Completed
A Phase 4, Randomized, Double-Masked, Single Center, Placebo-Controlled Adaptive Clinical Trial, Using Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, in Subjects With Allergic Conjunctivitis to Evaluate a Modified Conjunctival Allergen Challenge ( [NCT01534195]Phase 411 participants (Actual)Interventional2012-01-31Completed
Treatment of COVID-19 Pneumonia With Glucocorticoids. A Randomized Controlled Trial [NCT04438980]Phase 372 participants (Actual)Interventional2020-05-15Completed
Combined Radiotherapy and Intravenous Steroids for Early Progressive Thyroid Eye Disease [NCT02339142]Phase 4100 participants (Anticipated)Interventional2015-01-31Not yet recruiting
Targeting Iatrogenic Cushing's Syndrome With 11β-hydroxysteroid Dehydrogenase Type 1 Inhibition (TICSI) [NCT03111810]Phase 232 participants (Actual)Interventional2017-05-25Completed
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis [NCT02550652]Phase 2126 participants (Actual)Interventional2015-11-13Completed
A Multicenter, Open-Label Study to Estimate the Effect Sizes of HRCT Endpoints in Response to GLUCOCORTICOID Induction Therapy in Subjects With Pulmonary Sarcoidosis [NCT03324503]8 participants (Actual)Interventional2017-12-08Completed
Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis, Which is Better? A Prospective Study of a Single-blind Randomized Control Trial RCT From the Iraqi Population [NCT04980105]Phase 3150 participants (Actual)Interventional2020-03-02Active, not recruiting
Hit Hard and Early. The Effect of High Dose Methylprednisolone on Nailfold Capillary Changes and Biomarkers in Early SSc: a 12-week Randomised Explorative Double-blind Placebo-controlled Trial. [NCT03059979]Early Phase 130 participants (Anticipated)Interventional2017-01-31Recruiting
Second Affiliated Hospital, College of Medicine, Zhejiang University [NCT04918953]Phase 290 participants (Anticipated)Interventional2021-06-02Not yet recruiting
The Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma [NCT03045471]50 participants (Anticipated)Observational2017-03-01Not yet recruiting
Study of the Excretion of Orally Administered Corticosteroids for the Improval of the Detection of Said Substances in Anti-doping Controls [NCT04791345]Phase 150 participants (Anticipated)Interventional2021-02-26Recruiting
Autologous Platelet Rich Fibrin Versus Steroid in Ultrasound-Guided Sacroiliac Joint Injection for Joint Dysfunction (Randomized Comparative Study) [NCT04757740]Phase 494 participants (Anticipated)Interventional2021-03-01Recruiting
The Role of Doxycycline in Management of Moderate to Severe Chronic Rhinosinusitis With Nasal Polyps [NCT02569437]Phase 249 participants (Actual)Interventional2014-09-30Terminated(stopped due to A high percentage of patients were dropping out of the study and were not able to complete the protocol.)
Topical Use of Corticosteroid to Prevent Epiretinal Membrane Formation in Eyes With Retinal Tear Undergoing Laser Retinopexy: a Pilot Prospective Clinical Study [NCT02412059]200 participants (Actual)Interventional2015-08-31Completed
An Open-label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera®/Rituxan®) in Patients With Active Rheumatoid Arthritis [NCT02093026]Phase 2465 participants (Actual)Interventional2002-08-31Completed
Triamcinolone Versus Methylprednisolone in Ultrasound Guided Transversus Abdominis Plane Block in Major Open Abdominal Surgery [NCT04480775]Phase 2/Phase 384 participants (Actual)Interventional2020-07-15Completed
Safety and Efficacy of Steroids in the Management of Fulminant Hepatic Failure Due to Hepatitis A Virus in the Pediatric Age Group [NCT02375867]Phase 433 participants (Actual)Interventional2015-01-31Completed
Once a Month High-dose Methylprednisolone During Wash-out Period Between Natalizumab and Fingolimod Treatments in Patients With Multiple Sclerosis: a Randomised, Controlled, Double-blind Trial (NTZ2FTY) [NCT02769689]Phase 456 participants (Anticipated)Interventional2019-06-12Recruiting
Intra-Arterial Steroid Administration of De Novo Acute Graft-vs-Host Disease of the Gastrointestinal Tract: A Phase II Study [NCT02425813]Phase 20 participants (Actual)Interventional2015-10-31Withdrawn(stopped due to Slow Accrual)
An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure [NCT02006706]Phase 315 participants (Actual)Interventional2006-08-10Completed
Intra-articular and Intravenous Infliximab in the Treatment of Resistant Seronegative Oligoarthritis of the Knee [NCT01216631]Phase 21 participants (Actual)Interventional2010-09-30Terminated(stopped due to Unable to recruit)
Comparison of the Treatment Efficacy of High-Dose Corticosteroid and Tocilizumab During Clinical Worsening in Patients With COVID-19 Pneumonia [NCT05133635]Phase 40 participants (Actual)Interventional2021-02-01Withdrawn(stopped due to A recent study suggested a new corticosteroid regime for intensive care unit patients.)
A Randomized Multi-Center Treatment Study (COALL 08-09) to Improve the Survival of Children With Acute Lymphoblastic Leukemia on Behalf of the German Society of Pediatric Hematology and Oncology [NCT01228331]Phase 2/Phase 3745 participants (Actual)Interventional2010-10-31Active, not recruiting
Corticosteroids in Severe Alcoholic Hepatitis Patients With Early Spontaneous Improvement [NCT03160651]140 participants (Anticipated)Interventional2018-02-09Recruiting
Comparison Between Ultrasound Guided Ozone, Platelet-Rich Plasma or Steroid Injection in the Treatment of Sacroiliitis; a Randomized Double Blinded Controlled Study [NCT05914350]105 participants (Anticipated)Interventional2023-06-23Recruiting
Investigating Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections Using Betamethasone and Methylprednisolone [NCT04900220]Phase 466 participants (Actual)Interventional2021-09-15Completed
Genomic Response of Human Immune and Non-Immune Cells to Glucocorticoids [NCT02798523]Phase 133 participants (Actual)Interventional2017-01-24Completed
Steroid Versus Platelet Rich Plasma in Ultrasound Guided Sacroiliac Joint Injection for Chronic Low Back Pain [NCT02334475]40 participants (Actual)Interventional2013-07-31Completed
Effect of Preoperative Intravenous High Dose Methylprednisolone on Glucose Homeostasis in Patients Scheduled for Total Hip- and Knee-arthroplasty [NCT02332603]Phase 3134 participants (Actual)Interventional2015-01-31Completed
Randomized, Unicentric, Open, Controlled Clinical Trial, in Phase Iii, to Demonstrate the Effectiveness of Tocilizumab Against Systemic Corticotherapy in Patients Admitted by Covid-19 With Bilateral Pneumonia and Poor Evolution [NCT05002517]Phase 360 participants (Anticipated)Interventional2020-09-03Active, not recruiting
Antiviral Treatment in Facial Palsy. Randomized Control Trial [NCT02328079]50 participants (Actual)Interventional2013-04-30Completed
Comparison Of Two Corticosteroid Dosing Regimens For Prevention Of Corneal Transplant Rejection Episodes After Descemet's Membrane Endothelial Keratoplasty [NCT01448213]Phase 2264 participants (Actual)Interventional2011-10-31Completed
Optimization of NULOJIX® (Belatacept) Usage as a Means of Avoiding CNI and Steroids in Renal Transplantation (CTOT-10) [NCT01436305]Phase 219 participants (Actual)Interventional2011-09-30Terminated(stopped due to Secondary to safety concerns plus change in Campath® (alemtuzumab) availability.)
A Two-Part, Phase I Randomized, Double-Blind, Active-Comparator Controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of MK-8808 and to Compare the Pharmacokinetics of MK-8808 With EU-approved MabThera® and US-licensed [NCT01390441]Phase 1100 participants (Actual)Interventional2011-07-31Terminated(stopped due to The study was terminated early by the Sponsor for business reasons.)
A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Methylprednisolone as a Treatment for Presumed Hantavirus Cardiopulmonary Syndrome [NCT00128180]Phase 266 participants (Actual)Interventional2003-01-31Completed
Randomized Study of Different Non-myeloablative Conditioning Regimens With Hematopoietic Stem Cell Support in Patients With Scleroderma (Autologous Systemic Sclerosis Immune Suppression Trial - II ASSIST-IIb) [NCT01445821]Phase 344 participants (Actual)Interventional2011-09-15Terminated(stopped due to Developed a better regimen: DIAD. Cast. 2018 NCT03593902)
A Phase II Study of Rituximab and Temozolomide in Recurrent Primary CNS Lymphoma [NCT00248534]Phase 216 participants (Actual)Interventional2005-09-30Terminated(stopped due to slow accrual/lack of resources/low priority due to combining 2 consortia)
Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to a Single Intrabursal Injection of Corticosteroids in Patients With Shoulder Calcific Tendinopathy [NCT01652495]Phase 444 participants (Actual)Interventional2012-03-31Completed
A Phase 1/2 Trial Evaluating Treatment of Emergent Graft Versus Host Disease (GvHD) With AP1903 After Planned Donor Infusions (DLIs) of T-cells Genetically Modified With the iCasp9 Suicide Gene in Patients With Hematologic Malignancies [NCT01875237]Phase 1/Phase 23 participants (Actual)Interventional2013-12-27Terminated
Prospective, Randomized Comparison of Corticosteroid Dosing Regimens Following Endothelial Keratoplasty [NCT01853696]Phase 4167 participants (Actual)Interventional2013-03-31Completed
Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery [NCT01853072]Phase 3881 participants (Actual)Interventional2013-06-30Completed
Blood Pressure Profile and NT-proBNP Dynamics in Response to Intravenous Methylprednisolone Pulse Therapy of Severe Graves' Orbitopathy [NCT03590080]32 participants (Actual)Observational2011-01-01Completed
Impact of Preoperative Single Corticosteroid Flash on Morbidity After Colorectal Resection: Monocentric Prospective Pilot Study [NCT03437746]Phase 278 participants (Actual)Interventional2018-03-01Terminated(stopped due to insufficient rate of inclusion)
Effect of Depo-Medrol Application on the Psoas Muscle After Transpsoas LLIF on Post-operative Hip Flexor Weakness, Thigh Pain and Numbness [NCT05929755]Phase 480 participants (Anticipated)Interventional2023-05-12Recruiting
Effect of Methylprednisolone on Systemic Inflammatory Response and Clinical Parameters During Pediatric Congenital Open-Heart Surgery: A Randomized Controlled Trial [NCT05927233]Phase 460 participants (Anticipated)Interventional2023-04-01Recruiting
The D3 Study: Drug Delivery vs Drops - A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1% in Controlling Post-operative Pain and Inflammation in Patients Undergoing Sequential Cataract Surgery [NCT04273282]Phase 431 participants (Actual)Interventional2019-12-16Completed
A Novel Immunosuppression Intervention for the Treatment of Amyotrophic Lateral Sclerosis (ALS) [NCT01884571]Phase 231 participants (Actual)Interventional2013-10-31Completed
A 12-Month, Open Label Study of Extended Release Tacrolimus (Envarsus XR®, LCPT) With Mycophenolate, Rabbit Antithymocyte Globulin (rATG) and Early Steroid Withdrawal in de Novo Kidney Transplant Recipients [NCT03828682]Phase 460 participants (Anticipated)Interventional2019-06-21Recruiting
The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy [NCT01451710]30 participants (Actual)Interventional2011-03-31Completed
Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects With Osteoarthritis of the Knee [NCT01209364]Phase 3442 participants (Actual)Interventional2007-03-31Completed
High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: Paediatric Arteriopathy Steroid Aspirin (PASTA) Project. A Multicentre Randomized Trial. [NCT03249844]Phase 30 participants (Actual)Interventional2022-09-01Withdrawn(stopped due to discontinuation of the trial)
Allogeneic Hematopoietic Cell Transplantation of Positively Selected CD34+ Cells and Defined Inoculum of T Cells From Related Haploidentical Donors for Older Patients With Indolent Hematologic Malignancies [NCT00185692]Phase 216 participants (Actual)Interventional2000-08-31Completed
Evaluation of a Strategy Based on the 3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation: the I4BiS Study [NCT02444429]Phase 3346 participants (Anticipated)Interventional2015-09-30Recruiting
Proteomics Combined With Metabolomics Studies on the Efficacy of Telitacicept in Chinese Patients of Systemic Lupus Erythematosus [NCT05666336]Phase 430 participants (Anticipated)Interventional2022-12-31Recruiting
Optimization of NULOJIX® (Belatacept) Usage as a Means of Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation (CTOT-15) [NCT01790594]Phase 246 participants (Actual)Interventional2013-02-28Terminated(stopped due to Slow accrual within enrollment time period: projected accrual goal not achieved.)
Phase II Study of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring. [NCT00458848]Phase 2470 participants (Actual)Interventional2004-10-31Completed
Steroid and Tacrolimus Avoidance Using NULOJIX® (Belatacept) in Renal Transplantation (CTOT-16) [NCT01856257]Phase 271 participants (Actual)Interventional2013-07-31Terminated(stopped due to Safety: Stopping rule not met.)
Effect of Azole/Echinocandin Use on Tacrolimus Pharmacokinetics in Kidney Transplant Recipients [NCT06044558]507 participants (Actual)Observational2022-09-01Completed
[NCT00733096]Phase 2/Phase 384 participants (Actual)Interventional2008-08-31Completed
Steroids in Pediatric Acute Lung Injury/ARDS Trial: A Blinded, Placebo-controlled, Randomized Clinical Trial [NCT01274260]Phase 2100 participants (Anticipated)Interventional2010-10-31Active, not recruiting
SAAB: Randomized, Double Blind STudy of Corticosteroid Pulse After Ablation [NCT00807586]Phase 4119 participants (Actual)Interventional2008-12-31Completed
A Randomized International Phase 3 Trial of Imatinib and Chemotherapy With or Without Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or Philadelphia Chromosome-Like ABL-Class B-Cell Acute Lymphoblastic Leukemia [NCT06124157]Phase 3680 participants (Anticipated)Interventional2024-01-22Not yet recruiting
A Phase 1/2 Ascending Dose Study to Evaluate the Safety and Effects on Progranulin Levels of LY3884963 in Patients With Fronto-Temporal Dementia With Progranulin Mutations (FTD-GRN) [NCT04408625]Phase 1/Phase 223 participants (Anticipated)Interventional2020-11-09Recruiting
The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis: A Pilot Study [NCT03511625]Phase 36 participants (Anticipated)Interventional2018-10-02Active, not recruiting
Phase II Study of Infliximab for the Treatment of Ipilimumab Colitis [NCT04305145]Phase 242 participants (Anticipated)Interventional2020-08-31Recruiting
High Dose Methylprednisolone Verses Low Dose in Correction of Congenital Acynotic Heart Disease [NCT05103397]Phase 475 participants (Anticipated)Interventional2021-10-16Recruiting
Patient PReference, Efficacy, and SaFety of an Intracanalicular DExamenthasone InseRt comparEd to Topical PrednisoloNe in PatienTs UndergoIng SequentiAl PhacoemuLsification With Intraocular Lens Surgery OR Combined Phacoemulsification With IOL and a Minim [NCT04563559]Phase 2/Phase 30 participants (Actual)Interventional2020-11-30Withdrawn(stopped due to PI decided not to open study)
Health Sciences University Bursa Yüksek Ihtisas Training and Research Hospital [NCT04847687]300 participants (Actual)Observational2021-03-01Completed
Is the Effect of Systemic Steroids Treating Pollen Induced Allergic Rhinitis Mainly Due to a Placebo Effect [NCT04622917]Phase 444 participants (Actual)Interventional2019-04-10Active, not recruiting
Randomized Controlled Trial on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow [NCT05062681]Phase 460 participants (Anticipated)Interventional2021-09-15Recruiting
Methylprednisolone and Hyaluronic Acid Versus Each Agent Alone to Control Post-extraction Complications of Impacted Mandibular Third Molar [NCT04816253]72 participants (Actual)Interventional2021-02-10Completed
Analgesia After Total Knee Arthroplasty: Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI). A Double-Blinded Randomized Controlled Trial [NCT03094663]86 participants (Anticipated)Interventional2017-02-28Recruiting
[NCT03067753]Phase 228 participants (Anticipated)Interventional2016-12-31Recruiting
A Phase I/II Study of High-Dose Deoxyazacytidine, Busulfan, and Cyclophosphamide With Allogeneic Stem Cell Transplantation for Hematologic Malignancies [NCT00002831]Phase 1/Phase 224 participants (Actual)Interventional1995-08-01Completed
A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With High Risk Hematologic Malignancies [NCT00003335]Phase 244 participants (Actual)Interventional1998-01-31Completed
Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections [NCT04563299]Phase 410 participants (Actual)Interventional2020-12-09Terminated(stopped due to Subject Enrollment)
Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids for Treatment of Minnesota High-Risk Acute GVHD (aGVHD): A Phase I/II Study [NCT05123040]Phase 1/Phase 255 participants (Anticipated)Interventional2023-06-05Recruiting
A Multicenter, Open-label, Single-arm Study to Evaluate the Safety Administering Rituximab at a More Rapid Infusion Rate in Patients With Rheumatoid Arthritis [NCT01382940]Phase 4351 participants (Actual)Interventional2011-07-26Completed
Niacin (as a Vasodilator), and a Topical Steroid (for Macular Edema), Non-Ischemic CRVO,HRVO,BRVO [NCT00493064]Phase 2/Phase 363 participants (Actual)Interventional2006-10-31Completed
A Phase II, Randomized, Clinical Trial Assessing Efficacy And Safety Of Oral Prednisolone vs Intravenous Vincristine In The Treatment Of Infantile [NCT00555464]Phase 28 participants (Actual)Interventional2007-11-30Terminated(stopped due to The introduction of oral propranolol as a highly efficacious agent for infantile hemangiomas)
Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass [NCT01579513]190 participants (Actual)Interventional2012-06-30Completed
A Pilot Study: Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas [NCT00624416]Phase 1/Phase 210 participants (Actual)Interventional2007-10-31Completed
The Effect of Moderate-Dose Steroid Therapy in Sepsis: A Placebo-Controlled, Randomized Study [NCT01275638]Phase 455 participants (Actual)Interventional2005-04-30Completed
A Phase II, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Withdrawal Design Trial Using Adaptive Randomization Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis [NCT01369745]Phase 2294 participants (Actual)Interventional2011-06-30Completed
A Phase 1, Three-Part, Open-Label, Parallel-Cohort Safety and Tolerability Study of Relugolix in Combination With Abiraterone Acetate Plus a Corticosteroid, Apalutamide, or Docetaxel With or Without Prednisone in Men With Metastatic Castration-Sensitive P [NCT04666129]Phase 172 participants (Anticipated)Interventional2021-02-18Recruiting
Effect of Drop-less Surgery Compared to Topical NSAID Alone and Combination of Steroid and NSAID on Central Macular Thickness After Cataract Surgery, a Randomized Controlled Trial [NCT03383328]Phase 4470 participants (Actual)Interventional2018-02-01Completed
Randomized Controlled Trial of Ultrasound-guided Steroid Injection Versus Wrist Splint in Patients With Carpal Tunnel Syndrome [NCT04515966]Phase 470 participants (Anticipated)Interventional2020-12-01Recruiting
Rituximab (RTX) Therapy in Steroid Resistant Patients or Patients Relapsing After Intravenous Steroids With Active TAO [NCT02378298]Phase 426 participants (Actual)Interventional2011-12-31Active, not recruiting
A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma [NCT05800366]Phase 240 participants (Anticipated)Interventional2023-04-06Recruiting
High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial PASTA (Paediatric Arteriopathy Steroid Aspirin) Trial [NCT04873583]Phase 370 participants (Anticipated)Interventional2021-11-16Recruiting
A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy [NCT03959085]Phase 34,772 participants (Anticipated)Interventional2019-10-31Recruiting
Improvement in Function and Pain Due to Subacromial Bursitis in Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone [NCT02242630]61 participants (Actual)Interventional2014-09-30Completed
A Single-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Compared to Placebo in a Modified Conjunctival Allergen Challenge (CAC) Model [NCT01730872]Phase 416 participants (Actual)Interventional2012-11-30Completed
The Utility of feNO in the Differential Diagnosis of Chronic Cough: The Response to Anti-inflammatory Therapy With Prednisolone and Montelukast [NCT02479074]Phase 449 participants (Actual)Interventional2016-01-31Completed
First Line Treatment of Familiar Lymphohistiocytosis by Alemtuzumab (CAMPATH®) [NCT02472054]Phase 1/Phase 229 participants (Actual)Interventional2015-06-29Completed
Increased Heart Rhythm in Response to High-dose Intravenous Methylprednisolone Pulse Therapy of Moderate-to-severe Graves' Orbitopathy [NCT04391439]40 participants (Actual)Observational2011-01-01Completed
A Randomized, Open-label, Mutli-centre Study to Evaluate Patient Preference With Subcutaneous Administration of Rituximab Versus Intravenous Rituximab in Previously Untreated Patients With CD20+ Diffuse Large B-cell Lymphoma or CD20+ Follicular Non-Hodgki [NCT01724021]Phase 3743 participants (Actual)Interventional2012-12-31Completed
The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI) [NCT02292082]Phase 4111 participants (Actual)Interventional2014-11-30Completed
Zoledronic Acid or Methylprednisolone in the Management of Active Charcot's Neuroarthropathy of Foot in Patients With Diabetes Mellitus: A Randomized, Double-blind, Placebo Controlled Trial [NCT03289338]Phase 2/Phase 336 participants (Actual)Interventional2016-06-01Completed
The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol [NCT04349410]Phase 2/Phase 31,800 participants (Actual)Interventional2020-04-11Completed
A Randomized Phase II Study Comparing Inotuzumab Plus Chemotherapy Versus Standard Chemotherapy in Older Adults With Philadelphia-Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia [NCT05303792]Phase 266 participants (Anticipated)Interventional2023-02-27Recruiting
A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients [NCT03110822]Phase 1134 participants (Anticipated)Interventional2017-02-01Recruiting
A Phase 2 Study of Weekly 70 mg/m2 Carfilzomib for Multiple Myeloma Patients Refractory to 27 mg/m2 Carfilzomib [NCT02294357]Phase 245 participants (Anticipated)Interventional2014-12-31Terminated(stopped due to Early termination due to the difficulties to enroll subjects.)
The Effect of Positive Airway Pressure on Idiopathic Sudden Sensorineural Hearing Loss Comorbided With Obstructive Sleep Apnea: A Clinical Randomized Controlled Study [NCT04192656]Phase 4102 participants (Anticipated)Interventional2019-11-01Recruiting
Effect of Preoperative Intravenous High Dose Methylprednisolone on Quadriceps Muscle Function in Patients Scheduled for Total Knee-arthroplasty [NCT02319343]Phase 370 participants (Actual)Interventional2015-01-31Completed
Phase III Study to Evaluate the Efficacy and Safety of NPB-01 in Patients With Autoimmune Encephalitis Refractory to Steroid Pulse Therapy [NCT05177939]Phase 340 participants (Anticipated)Interventional2022-03-03Recruiting
Multicentre Prospective Open Label Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy. [NCT04662723]Phase 4878 participants (Anticipated)Interventional2023-05-01Recruiting
Multicenter, Randomized, Observer-blind, Controlled Study of the Anti-IL-6 Receptor Antibody Tocilizumab (TCZ) or Methylprednisolone (MP) Treatment in Patients With Active Moderate-severe Graves' Orbitopathy [NCT04876534]Phase 264 participants (Anticipated)Interventional2019-12-18Recruiting
A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Co-Administration of FOV1101-00 (Cyclosporine 0.01% or 0.02%) and Prednisolone Acetate 0.12% (PredMild®) Compared to Prednisolone Acetate 1% Alone or Vehicle Alone in Patients With Mi [NCT00833495]Phase 2155 participants (Actual)Interventional2009-01-31Completed
Parasitic Ulcer Treatment Trial Pilot [NCT03484507]Phase 249 participants (Actual)Interventional2018-01-01Active, not recruiting
A National Prospective Study of Patients With Hepatitis Induced by Immune Checkpoint Inhibitors; Characterization of Liver Injury, Outcome of Therapy and Randomization to Either Prednisolone or Mycophenolate Mofetil Treatment in Case of Relapse [NCT04810156]Phase 260 participants (Anticipated)Interventional2021-04-07Recruiting
Prednisolone vs. Vigabatrin in the First-line Treatment of Infantile Spasms [NCT02299115]Phase 30 participants (Actual)Interventional2017-09-05Withdrawn(stopped due to Most centres are now using oral steroids as 1st line treatment so question of efficacy is no longer of high interest.)
Randomized, Open-Label Trial of Tacrolimus/Everolimus vs. Tacrolimus/Enteric-Coated Mycophenolate Sodium to Prevent Biopsy-Proven Acute Rejection and Chronic Allograft Injury in Adult, Primary Kidney Transplantation [NCT01680861]Phase 332 participants (Actual)Interventional2012-11-30Completed
Pre-emptive Scalp Infiltration With Ropivacaine Plus Methylprednisolone vs Ropivacaine Alone for Relief of Postoperative Pain After Craniotomy in Children (RP/MP vs RP) [NCT03636165]Phase 490 participants (Anticipated)Interventional2022-09-01Not yet recruiting
Preoperative Single-high Dose Glucocorticoid for Patients Undergoing Hip Fracture Surgery and the Effect on Postoperative Delirium. [NCT02317601]Phase 4122 participants (Actual)Interventional2014-12-31Completed
Randomized Controlled Trial of Methylprednisolone Versus Dexamethasone in COVID-19 Pneumonia (MEDEAS Trial) [NCT04636671]Phase 3690 participants (Actual)Interventional2021-04-14Completed
A Prospective, Multi-Center, Randomized, Double-Masked, Positive Controlled, Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspe [NCT02517619]Phase 3251 participants (Actual)Interventional2016-01-16Completed
Effectiveness and Safety of Efgartigimod in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Controlled, Retrospective, Real-Word Study [NCT06118398]24 participants (Anticipated)Observational2023-11-05Not yet recruiting
Phase II Study of Horse Anti-Thymocyte Globulin (hATG), Cyclosporine, Methylprednisolone, and GCSF (Filgrastim or Pegfilgrastim) in Patients With Aplastic Anemia (AA), or Low/Int-1 Risk Myelodysplastic Syndrome (MDS) [NCT01624805]Phase 2100 participants (Anticipated)Interventional2012-06-25Recruiting
CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients [NCT05220319]Phase 4672 participants (Anticipated)Interventional2022-02-03Recruiting
An Open-label, Multicenter, Phase 2 Trial Investigating the Efficacy and Safety of Daratumumab in Subjects With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and IMiD) or Are Double Refractory to a [NCT01985126]Phase 2124 participants (Actual)Interventional2013-09-27Completed
A Randomized Study Comparing the Incidence of Acute Clinical or Subclinical Rejection With Two Dosing Regimens of CellCept in de Novo Renal Transplant Recipients Receiving Induction, Cyclosporine and Brief Steroid Therapy [NCT02005562]Phase 3252 participants (Actual)Interventional2006-05-31Completed
Comparison of Follow-up and Steroid Treatment Results in Intussusception in Children [NCT05640375]Phase 1/Phase 2120 participants (Anticipated)Interventional2019-12-24Recruiting
A Randomized Controlled Pilot Trial of Cyclosporine vs Steroids in DRESS [NCT04988256]Early Phase 150 participants (Anticipated)Interventional2021-09-27Enrolling by invitation
The Effects of Intraoperative Local and Systemic Corticosteroid Administration on Postoperative Dysphagia After Anterior Cervical Fusion [NCT03311425]Phase 3140 participants (Actual)Interventional2014-08-01Completed
Effects of a Multiple Sclerosis Relapse Therapy With Methylprednisolone (MP) During Pregnancy on Offspring Cognitive Function, Stress Sensitivity, Behaviour and Functional and Structural Brain Development [NCT04832269]80 participants (Anticipated)Observational2020-10-19Recruiting
Randomized, Double-blinded, Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections [NCT06000709]Phase 440 participants (Anticipated)Interventional2023-10-20Not yet recruiting
A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation [NCT01950819]Phase 42,037 participants (Actual)Interventional2013-12-03Completed
Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis (ITN055AI) [NCT02260934]Phase 243 participants (Actual)Interventional2015-07-09Completed
A Randomized Clinical Trial of Efficacy and Safety on the Use of Belatacept as Compared to Tacrolimus in the Setting of Rabbit Antithymocyte Globulin Induction and Rapid Steroid Discontinuation in Deceased Donor Renal Transplant Recipients With a Focus on [NCT02152345]Phase 457 participants (Actual)Interventional2014-06-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00003270 (1) [back to overview]Progression-free Survival
NCT00048165 (14) [back to overview]Number of Participants With Marked Laboratory Abnormalities: Hematology Parameters
NCT00048165 (14) [back to overview]Median Change From Baseline for Lipid Profile (Total Cholesterol, Low Density Lipoproteins, High Density Lipoproteins, and Triglycerides)
NCT00048165 (14) [back to overview]Median Time to First Acute Rejection Episode Within the First 6 Months and 12 Months PT
NCT00048165 (14) [back to overview]Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT
NCT00048165 (14) [back to overview]Number of Participant Who Died Within 6 Months 12 Months and 3 Years PT
NCT00048165 (14) [back to overview]Number of Participants Using Monomurab Cluster of Differentiation 3, Orthoclone Polyclonal Antithymocyte Globulin or Antilymphocyte Globulin in the First 6 Months and 12 Months PT
NCT00048165 (14) [back to overview]Number of Participants With Any Adverse Events and Any Serious Adverse Event, and Adverse Events Leading to Premature Withdrawal
NCT00048165 (14) [back to overview]Number of Participants With Malignancies and Opportunistic Infections
NCT00048165 (14) [back to overview]Number of Participants With Marked Laboratory Abnormalities: Biochemistry Parameters
NCT00048165 (14) [back to overview]Number of Participants With Worst ISHLT Biopsy Grade Within First 6 Months and 12 Months PT
NCT00048165 (14) [back to overview]Median Change From Baseline for LDL/HDL Ratio
NCT00048165 (14) [back to overview]Mean Maintenance Doses of Mycophenolate Mofetil, Cyclosporine, and Cumulative Dose of Corticosteroids at 6 and 12 Months PT
NCT00048165 (14) [back to overview]Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT
NCT00048165 (14) [back to overview]Number of Participants Who Developed Acute Rejection Episode Within 6 Months Post-Transplant
NCT00053989 (4) [back to overview]PFS
NCT00053989 (4) [back to overview]OS
NCT00053989 (4) [back to overview]Acute GvHD
NCT00053989 (4) [back to overview]Day 100 TRM
NCT00057811 (4) [back to overview]Minimal Residual Disease
NCT00057811 (4) [back to overview]Response Rate
NCT00057811 (4) [back to overview]Grade ≥ 3 Stomatitis
NCT00057811 (4) [back to overview]Toxic Death
NCT00066469 (1) [back to overview]Event-free Survival
NCT00076752 (16) [back to overview]Cluster of Differentiation 8 (CD8) + Cells
NCT00076752 (16) [back to overview]Extractable Nuclear Antigen (ENA)
NCT00076752 (16) [back to overview]Natural Killer Cells
NCT00076752 (16) [back to overview]Platelet Count
NCT00076752 (16) [back to overview]Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
NCT00076752 (16) [back to overview]White Blood Cells
NCT00076752 (16) [back to overview]Cluster of Differentiation 4 (CD4) + Cells
NCT00076752 (16) [back to overview]Number of Participants With Adverse Events
NCT00076752 (16) [back to overview]Absolute Lymphocyte Count
NCT00076752 (16) [back to overview]Absolute Neutrophil Count
NCT00076752 (16) [back to overview]Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody
NCT00076752 (16) [back to overview]Anti-Nuclear Antibody
NCT00076752 (16) [back to overview]Anti-Smith-Ribonuclear Protein Antibody
NCT00076752 (16) [back to overview]Cluster of Differentiation 19 (CD19) + Cells
NCT00076752 (16) [back to overview]Cluster of Differentiation 3 (CD3) + Cells
NCT00076752 (16) [back to overview]Relapse-free Complete Clinical Response
NCT00078559 (14) [back to overview]Number of Alemtuzumab Associated Adverse Events, Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Deaths Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Acute Rejections in All Enrolled Participants
NCT00078559 (14) [back to overview]Number of Participants Requiring Anti-lymphocyte Therapy for an Acute Rejection, Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Participants Who Experienced Graft Loss Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Severe Acute Rejections Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Side Effects of Conventional Immunosuppression, Stratified by Withdrawal Status
NCT00078559 (14) [back to overview]Number of Acute Rejections Between Initiation of Sirolimus Withdrawal and End of Study
NCT00078559 (14) [back to overview]Time From Transplantation to Acute Rejection in Participants for Whom Acute Rejection Occurred During the 1 Year Post-transplant Period
NCT00078559 (14) [back to overview]Change in Renal Function as Measured by Serum Creatinine, Stratified by Withdrawal Status
NCT00078559 (14) [back to overview]Time From Transplantation to Acute Rejection in Participants for Whom Sirolimus Withdrawal Was Not Initiated
NCT00078559 (14) [back to overview]Number of Sirolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Tacrolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Acute Rejections in All Enrolled Participants Following Sirolimus Withdrawal
NCT00097448 (1) [back to overview]Hearing Improvement
NCT00104299 (8) [back to overview]Number of Subjects Experiencing Serious Adverse Events
NCT00104299 (8) [back to overview]Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups
NCT00104299 (8) [back to overview]Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups
NCT00104299 (8) [back to overview]The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups
NCT00104299 (8) [back to overview]The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups
NCT00104299 (8) [back to overview]Disease Remission
NCT00104299 (8) [back to overview]Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization
NCT00104299 (8) [back to overview]Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy
NCT00109928 (4) [back to overview]2-year Overall Survival Rate
NCT00109928 (4) [back to overview]Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00109928 (4) [back to overview]Response Rate
NCT00109928 (4) [back to overview]2-year Progression-free Survival Rate
NCT00128180 (10) [back to overview]Duration of Shock and/or Pressor/Inotropic Support
NCT00128180 (10) [back to overview]Length of Time on a Ventilator
NCT00128180 (10) [back to overview]Number of Participants Intubated and Placed on a Ventilator After Study Entry.
NCT00128180 (10) [back to overview]Number of Participants on Extracorporeal Membrane Oxygenation (ECMO)
NCT00128180 (10) [back to overview]Duration of ICU Stays
NCT00128180 (10) [back to overview]Development of Serum Creatinine Greater Than or Equal to 3.0 mg/dL After Study Entry
NCT00128180 (10) [back to overview]Duration of Hospital Stay in Days
NCT00128180 (10) [back to overview]Number of Participants With SAEs
NCT00128180 (10) [back to overview]The Proportion of Subjects Who Develop Death, PaO2/FiO2 Ratio Less Than or Equal to 55, Cardiac Index Less Than or Equal to 2.2, Pulseless Electrical Activity, Ventricular Tachycardia or Fibrillation
NCT00128180 (10) [back to overview]Number of Participants Who Developed Refractory Shock Despite Fluid Resuscitation After Study Entry
NCT00149994 (1) [back to overview]Percentage of Participants With an Occurrence of Biopsy Proven Acute Rejection (BPAR) During the First 3 Months Post de Novo Liver Transplantation.
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: s-ICAM
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: T-bars
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Troponin T
NCT00157014 (36) [back to overview]Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria
NCT00157014 (36) [back to overview]Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria (Pediatric Population)
NCT00157014 (36) [back to overview]Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52
NCT00157014 (36) [back to overview]Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52 (Pediatric Population)
NCT00157014 (36) [back to overview]Number of Patients With Treatment Failure and Crossover for Treatment Failure
NCT00157014 (36) [back to overview]Number of Patients With Treatment Failure and Crossover for Treatment Failure (Pediatric Population)
NCT00157014 (36) [back to overview]The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies
NCT00157014 (36) [back to overview]The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies (Pediatric Population)
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation and Oxidation: Cystatin-C (Pediatric Population)
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Osteopontin
NCT00157014 (36) [back to overview]Mean Cases of Acute Rejection (MCAR) Per Patient
NCT00157014 (36) [back to overview]Mean Cases of Acute Rejection (MCAR) Per Patient (Pediatric Population)
NCT00157014 (36) [back to overview]Number of Cardiac Rejection Episodes Requiring Treatment
NCT00157014 (36) [back to overview]Number of Cardiac Rejection Episodes Requiring Treatment (Pediatric Population)
NCT00157014 (36) [back to overview]Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection
NCT00157014 (36) [back to overview]Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection (Pediatric Population)
NCT00157014 (36) [back to overview]Time to First Acute Rejection Episode Following de Novo Cardiac Transplant
NCT00157014 (36) [back to overview]Time to First Acute Rejection Episode Following de Novo Cardiac Transplant (Pediatric Population)
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation and Oxidation: F2 Isoprostanes (Pediatric Population)
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation and Oxidation: hsCRP (Pediatric Population)
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation and Oxidation: Nitrotyrosine (Pediatric Population)
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: BNP
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Cystatin-C
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: E-selectin
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: F2 Isoprostanes
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Fibrinogen
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: GSH/GSSG
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Homocysteine
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: hsCRP
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-18
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-6
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: MCP-1
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Nitrotyrosine
NCT00185692 (2) [back to overview]Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant
NCT00185692 (2) [back to overview]Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning
NCT00186628 (4) [back to overview]Mortality
NCT00186628 (4) [back to overview]Overall Survival
NCT00186628 (4) [back to overview]Incidence of Relapse
NCT00186628 (4) [back to overview]Chronic Graft-vs-Host Disease (cGvHD)
NCT00243412 (10) [back to overview]Number of Participants With American College of Rheumatology (ACR) Major Clinical Response and/or Remission
NCT00243412 (10) [back to overview]DAS28-4 Erythrocyte Sedimentation Rate(ESR)
NCT00243412 (10) [back to overview]Change From Baseline in Short Form 36 (SF 36) Summary and Subscale Scores
NCT00243412 (10) [back to overview]Number of Participants With European League Against Rheumatism (EULAR) Response and Remission Using Disease Activity Score 28-4 (DAS28-4)C-reactive Protein (CRP)
NCT00243412 (10) [back to overview]Number of Participants With Either an Infection or a Grade III or IV Adverse Event (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI CTCAE], Version 3.0)
NCT00243412 (10) [back to overview]Change From Baseline in Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F)
NCT00243412 (10) [back to overview]Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
NCT00243412 (10) [back to overview]Number of Participants With American College of Rheumatology Responses (ACR20, ACR50, and ACR70)
NCT00243412 (10) [back to overview]Change From Baseline in Rheumatoid Factor (RF)
NCT00243412 (10) [back to overview]Change From Baseline in Disease Activity Score 28-4 C-reactive Protein (DAS28-4(CRP))
NCT00248534 (4) [back to overview]Number of Participants Alive at 3 Years
NCT00248534 (4) [back to overview]1 Year Overall Survival Rate
NCT00248534 (4) [back to overview]6-month Progression-free Survival
NCT00248534 (4) [back to overview]Percentage of Participants With Objective Response
NCT00257933 (1) [back to overview]Time Measured From the Administration of the Loading Dose of Prednisolone (2mg/kg up to Max 60mg) in the Emergency Department (ED) Until the Home Dose of Albuterol is Administered
NCT00258427 (8) [back to overview]Number of Participants Experiencing Acute Graft-Versus-Host Disease
NCT00258427 (8) [back to overview]Number of Participants Experiencing Chronic Graft-Versus-Host Disease
NCT00258427 (8) [back to overview]Number of Participants Experiencing Acute Graft-Versus-Host Disease
NCT00258427 (8) [back to overview]Number of Participants Experiencing Relapse
NCT00258427 (8) [back to overview]Number of Participants Experiencing Chronic Graft-Versus-Host Disease
NCT00258427 (8) [back to overview]Number of Participants Experiencing Graft Failure
NCT00258427 (8) [back to overview]Number of Participants Experiencing Major Infections
NCT00258427 (8) [back to overview]Number of Participants Experiencing Overall Survival
NCT00278564 (1) [back to overview]Survival
NCT00282347 (9) [back to overview]Percentage of Participants Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52
NCT00282347 (9) [back to overview]Percentage of Participants Who Achieved a Complete Renal Response at Week 52
NCT00282347 (9) [back to overview]Percentage of Participants With a Baseline Urine Protein to Creatinine Ratio of > 3.0 Who Achieved a Urine Protein to Creatinine Ratio of < 1.0 at Week 52
NCT00282347 (9) [back to overview]Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52
NCT00282347 (9) [back to overview]Time to Achieve a Complete Renal Response
NCT00282347 (9) [back to overview]Change From Baseline in C3 and C4 Complement Levels at Week 52
NCT00282347 (9) [back to overview]British Isles Lupus Assessment Group (BILAG) Index Score Over 52 Weeks
NCT00282347 (9) [back to overview]Change From Baseline in Anti-double-stranded DNA at Week 52
NCT00282347 (9) [back to overview]Change From Baseline in the Systemic Lupus Erythematosus Expanded Health Survey Physical Function Score at Week 52
NCT00290589 (3) [back to overview]Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable
NCT00290589 (3) [back to overview]Number of Patients Using Analgesics
NCT00290589 (3) [back to overview]Functional Disability Scales
NCT00294684 (9) [back to overview]Weight Z-Score
NCT00294684 (9) [back to overview]Total Bilirubin Concentration at 24 Months of Age
NCT00294684 (9) [back to overview]The Percentage of Patients With Serum Total Bilirubin <1.5 mg/dL and With Native Liver at 6 Months After Portoenterostomy
NCT00294684 (9) [back to overview]Survival With Native Liver at 24 Months of Age
NCT00294684 (9) [back to overview]Serum Total Bilirubin Concentration
NCT00294684 (9) [back to overview]Presence of Ascites at 24 Months
NCT00294684 (9) [back to overview]Presence of Ascites at 12 Months
NCT00294684 (9) [back to overview]Height Z-Score
NCT00294684 (9) [back to overview]Total Bilirubin Concentration at 12 Months
NCT00296244 (6) [back to overview]New-onset Diabetes Mellitus (NODM) as Secondary Outcome
NCT00296244 (6) [back to overview]Infection as an Adverse Effect of Steroids
NCT00296244 (6) [back to overview]Acute Rejection Rate
NCT00296244 (6) [back to overview]Incidence and Severity of HCV Recurrence Post-OLT
NCT00296244 (6) [back to overview]Patient Survival Rate
NCT00296244 (6) [back to overview]Graft Survival Rate
NCT00298272 (8) [back to overview]Proportion of Participants With at Least One Serious Infection Through Week 24
NCT00298272 (8) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Week 24
NCT00298272 (8) [back to overview]Number of Participants With Any Infections or Any Grade 3/4 Infections Through Week 24
NCT00298272 (8) [back to overview]Proportion of Participants Achieving an American College of Rheumatology 70 (ACR70) Response at Week 24
NCT00298272 (8) [back to overview]Proportion of Participants Achieving an American College of Rheumatology 50 (ACR50) Response at Week 24
NCT00298272 (8) [back to overview]Proportion of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 24
NCT00298272 (8) [back to overview]Number of Participants With Clinically Significant Immunological and Laboratory Assessment Findings
NCT00298272 (8) [back to overview]Maximum Duration of Infections Through Week 24
NCT00299104 (30) [back to overview]The Percentage of Participants With Major Clinical Response at Week 52
NCT00299104 (30) [back to overview]Change From Baseline in the SF-36 Mental Health Component Summary Score at Week 52 and Week 104
NCT00299104 (30) [back to overview]Change From Baseline in the SF-36 Physical Health Component Summary Score at Week 52 and Week 104
NCT00299104 (30) [back to overview]Percentage of Participants With Categorical Change in Health Assessment Questionnaire- Disability Index (HAQ-DI) From Baseline at Week 52
NCT00299104 (30) [back to overview]Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Week 52
NCT00299104 (30) [back to overview]Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 104
NCT00299104 (30) [back to overview]Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52
NCT00299104 (30) [back to overview]Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 24
NCT00299104 (30) [back to overview]Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 52
NCT00299104 (30) [back to overview]Change From Baseline in Modified Sharp Erosion Score at Week 52
NCT00299104 (30) [back to overview]Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52
NCT00299104 (30) [back to overview]Change From Baseline in the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 52
NCT00299104 (30) [back to overview]Change From Baseline in the Modified Total Sharp Score at Week 104
NCT00299104 (30) [back to overview]Change From Baseline in the Modified Total Sharp Score at Week 24
NCT00299104 (30) [back to overview]Change From Baseline in the Total Erosion Score at Week 104
NCT00299104 (30) [back to overview]Change From Baseline in the Total Erosion Score at Week 24
NCT00299104 (30) [back to overview]Change in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score From Baseline at Week 52
NCT00299104 (30) [back to overview]Percentage of Participants With American College of Rheumatology (ACR) ACR20 Response at Week 52
NCT00299104 (30) [back to overview]Percentage of Participants With American College of Rheumatology (ACR) ACR50 Response at Week 52
NCT00299104 (30) [back to overview]Percentage of Participants With American College of Rheumatology (ACR) ACR70 Response at Week 52
NCT00299104 (30) [back to overview]Percentage of Participants With American College of Rheumatology (ACR) ACR90 Response at Week 52
NCT00299104 (30) [back to overview]Percentage of Participants With DAS28-ESR Low Disease Activity at Week 52
NCT00299104 (30) [back to overview]Percentage of Participants With DAS28-ESR Remission at Week 52
NCT00299104 (30) [back to overview]Percentage of Participants Without Radiographic Progression at Week 104
NCT00299104 (30) [back to overview]Percentage of Participants Without Radiographic Progression at Week 24
NCT00299104 (30) [back to overview]Percentage of Participants Without Radiographic Progression in the Total Erosion Score at Week 104
NCT00299104 (30) [back to overview]Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Mental Health Component Score at Week 52
NCT00299104 (30) [back to overview]Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Physical Health Component Score at Week 52
NCT00299104 (30) [back to overview]Percentage of Patients Without Radiographic Progression at Week 52
NCT00299104 (30) [back to overview]Percentage of Patients Without Radiographic Progression in Total Erosion Score at Week 52
NCT00299130 (32) [back to overview]Percent Change From Baseline in Erythrocyte Sedimentation Rate
NCT00299130 (32) [back to overview]Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24
NCT00299130 (32) [back to overview]Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 48
NCT00299130 (32) [back to overview]Change From Baseline in Short Form 36 Health Survey (SF-36) Social Functioning Domain Score
NCT00299130 (32) [back to overview]Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Role Limitations Domain Score
NCT00299130 (32) [back to overview]Percentage of Participants With an ACR70 Response at Week 48
NCT00299130 (32) [back to overview]Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
NCT00299130 (32) [back to overview]Change From Baseline in Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score
NCT00299130 (32) [back to overview]Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scores
NCT00299130 (32) [back to overview]Time to Repletion of Peripheral CD19+ B-cells
NCT00299130 (32) [back to overview]Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 24
NCT00299130 (32) [back to overview]Percentage of Participants With an ACR70 Response at Week 24
NCT00299130 (32) [back to overview]Percentage of Participants With an ACR50 Response at Week 48
NCT00299130 (32) [back to overview]Percentage of Participants With an ACR50 Response at Week 24
NCT00299130 (32) [back to overview]Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24
NCT00299130 (32) [back to overview]Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24
NCT00299130 (32) [back to overview]Percent Change From Baseline in Patient's Global Assessment of Disease Activity
NCT00299130 (32) [back to overview]Percent Change From Baseline in Patient's Pain Assessment
NCT00299130 (32) [back to overview]Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score
NCT00299130 (32) [back to overview]Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Health Domain Score
NCT00299130 (32) [back to overview]Change From Baseline in Short Form 36 Health Survey (SF-36) General Health Domain Score
NCT00299130 (32) [back to overview]Change From Baseline in Short Form 36 Health Survey (SF-36) Emotional Role Limitations Domain Score
NCT00299130 (32) [back to overview]Change From Baseline in Short Form 36 Health Survey (SF-36) Vitality Domain Score
NCT00299130 (32) [back to overview]Percent Change From Baseline in Physician's Global Assessment of Disease Activity
NCT00299130 (32) [back to overview]Percent Change From Baseline in Short Form 36 Health Survey (SF-36) Summary Scores (Physical and Mental Components)
NCT00299130 (32) [back to overview]Percent Change From Baseline in Tender Joint Count
NCT00299130 (32) [back to overview]Percent Change From Baseline in C-Reactive Protein
NCT00299130 (32) [back to overview]Percent Change From Baseline in Swollen Joint Count
NCT00299130 (32) [back to overview]Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 48
NCT00299130 (32) [back to overview]Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 24
NCT00299130 (32) [back to overview]Percentage of Participants With Low Immunoglobulin Concentrations Pre- and Post-Rituximab Treatment
NCT00299130 (32) [back to overview]Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 48
NCT00301834 (5) [back to overview]Number of Participants Achieving Durable Engraftment (Presence of Donor Cells) at 6 Weeks Post Transplantation
NCT00301834 (5) [back to overview]Cytomegalovirus (CMV) Viral Infection and Disease Symptoms
NCT00301834 (5) [back to overview]Toxicity Grade ≥ 3 From Start of Conditioning Through the First Year Post Transplantation
NCT00301834 (5) [back to overview]Treatment-related Mortality at 100 Days and 1 Year Post Transplantation
NCT00301834 (5) [back to overview]Disease-free Survival With Correction of Disease at One Year Post Transplantation
NCT00309907 (6) [back to overview]Survival Rate
NCT00309907 (6) [back to overview]Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0
NCT00309907 (6) [back to overview]Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy
NCT00309907 (6) [back to overview]Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.
NCT00309907 (6) [back to overview]Plasma Cytokine IL6 Level
NCT00309907 (6) [back to overview]C-reactive Protein Levels
NCT00332696 (11) [back to overview]Participant's Quality of Life Using the Edmonton Scale
NCT00332696 (11) [back to overview]Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14
NCT00332696 (11) [back to overview]Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1
NCT00332696 (11) [back to overview]Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14
NCT00332696 (11) [back to overview]Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7
NCT00332696 (11) [back to overview]Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1
NCT00332696 (11) [back to overview]Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2
NCT00332696 (11) [back to overview]Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3
NCT00332696 (11) [back to overview]Number of Participants With Relief From Obstruction at Day 7 and Day 14
NCT00332696 (11) [back to overview]Number of Participants With Treatment Success From Day 10 to Day 13
NCT00332696 (11) [back to overview]Number of Participants With Treatment Success From Day 5 to Day 7
NCT00336583 (2) [back to overview]Worst Toxicity Grade by Patient
NCT00336583 (2) [back to overview]Overall Response Rate
NCT00345046 (1) [back to overview]Percent Change in Flare at Resolution
NCT00346151 (15) [back to overview]Acute Rejection at 12-Months
NCT00346151 (15) [back to overview]Acute Rejection at 6-Months
NCT00346151 (15) [back to overview]Graft Survival at 12 Months Post-transplant
NCT00346151 (15) [back to overview]Participant Survival at 12 Months Post-Transplant
NCT00346151 (15) [back to overview]Proportion of Participants Requiring Antilymphocyte Therapy for Acute Rejection
NCT00346151 (15) [back to overview]Proportion of Participants With a Sirolimus Associated Adverse Event
NCT00346151 (15) [back to overview]Proportion of Participants With Chronic Allograft Nephropathy
NCT00346151 (15) [back to overview]Proportion of Participants With Delayed Graft Function
NCT00346151 (15) [back to overview]Proportion of Participants With Malignancies
NCT00346151 (15) [back to overview]Proportion of Participants With Post-transplant Diabetes Mellitus
NCT00346151 (15) [back to overview]Proportion of Participants With Post-transplant Infections
NCT00346151 (15) [back to overview]Proportion of Participants With Wound Complications
NCT00346151 (15) [back to overview]Renal Function as Measured by Glomerular Filtration Rate (GFR) at 24 Weeks
NCT00346151 (15) [back to overview]Time From Transplant to Acute Rejection
NCT00346151 (15) [back to overview]Tolerance Induction
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Experienced Relapse by 12 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Attained Neutrophil Engraftment
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Experienced Relapse by 24 Months
NCT00354172 (15) [back to overview]Chimerism After Double Umbilical Cord Blood Transplant (UCBT)
NCT00354172 (15) [back to overview]Number of Patients Who Were Disease-free and Alive at 24 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Chronic Graft-Versus-Host Disease
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Attained Platelet Engraftment
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Successful Natural Killer Cell Expansion
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Died by 12 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Died by 24 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Died Due to Transplant.
NCT00381810 (1) [back to overview]Percentage of Participants With at Least 1 Serious Adverse Event
NCT00393367 (12) [back to overview]Serious Adverse Events
NCT00393367 (12) [back to overview]Number of Participants With Adverse Events (Non-serious).
NCT00393367 (12) [back to overview]Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category
NCT00393367 (12) [back to overview]Median Change in Asthma Score 2 Hours After Intervention
NCT00393367 (12) [back to overview]Mean Change in Respiratory Rate.
NCT00393367 (12) [back to overview]Mean Change in Asthma Score at 2 Hours
NCT00393367 (12) [back to overview]Change in Mean Heart Rate
NCT00393367 (12) [back to overview]Oxygen Saturation.
NCT00393367 (12) [back to overview]Number of Subjects Moving From the Severe Asthma to Mild Asthma Category
NCT00393367 (12) [back to overview]Number of Patients Hospitalized
NCT00393367 (12) [back to overview]Number of Subjects Remaining in the Severe Asthma Category
NCT00393367 (12) [back to overview]Relapse / Readmission Numbers.
NCT00400946 (10) [back to overview]Post-Induction Nadir Serum Asparaginase Activity Level
NCT00400946 (10) [back to overview]Induction Therapeutic Nadir Serum Asparaginase Activity Rate
NCT00400946 (10) [back to overview]Induction Serum Asparaginase Activity Level
NCT00400946 (10) [back to overview]Post-Induction Therapeutic Nadir Serum Asparaginase Activity Rate
NCT00400946 (10) [back to overview]Asparaginase-Related Toxicity Rate
NCT00400946 (10) [back to overview]5-Year Disease-Free Survival by MRD Day 32 Status
NCT00400946 (10) [back to overview]5-year Disease-Free Survival by CNS Directed Treatment Group
NCT00400946 (10) [back to overview]Induction Infection Toxicity Rate
NCT00400946 (10) [back to overview]5-Year Disease-Free Survival
NCT00400946 (10) [back to overview]5-Year Disease-Free Survival by Bone Marrow Day 18 Status
NCT00421174 (10) [back to overview]Discontinuation of Supplemental Oxygen
NCT00421174 (10) [back to overview]Overall Mortality
NCT00421174 (10) [back to overview]Incidence of Relapse
NCT00421174 (10) [back to overview]Incidence of Infection
NCT00421174 (10) [back to overview]Incidence of Graft-vs-Host-Disease (GVHD)
NCT00421174 (10) [back to overview]Corticosteroid Dose
NCT00421174 (10) [back to overview]Response to Therapy
NCT00421174 (10) [back to overview]Response Rate
NCT00421174 (10) [back to overview]Incidence of Toxicity
NCT00421174 (10) [back to overview]Overall Survival
NCT00423098 (10) [back to overview]Number of Patients With Complete Remission
NCT00423098 (10) [back to overview]Number of Patients With Moderate to Severe Flares
NCT00423098 (10) [back to overview]Number of Patients With Partial Remission
NCT00423098 (10) [back to overview]Number of Patients With Treatment Failure
NCT00423098 (10) [back to overview]Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)
NCT00423098 (10) [back to overview]Number of Patients With Adverse Events and Infections
NCT00423098 (10) [back to overview]Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)
NCT00423098 (10) [back to overview]Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)
NCT00423098 (10) [back to overview]Duration of Exposure to Study Medication
NCT00423098 (10) [back to overview]Number of Patients With Complete Remission
NCT00424489 (1) [back to overview]Survival
NCT00443430 (3) [back to overview]Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events
NCT00443430 (3) [back to overview]Proportion of Participants Who Attain Inactive Disease by 6 Months
NCT00443430 (3) [back to overview]Clinical Remission on Medication
NCT00455312 (10) [back to overview]Overall Survival
NCT00455312 (10) [back to overview]Neutrophil Engraftment
NCT00455312 (10) [back to overview]Incidence of Regimen Related Mortality at 100 Days
NCT00455312 (10) [back to overview]Incidence of Pulmonary Complications
NCT00455312 (10) [back to overview]Incidence of Grade 3-4 Acute Graft Versus Host Disease (GVHD)
NCT00455312 (10) [back to overview]Incidence of Late Secondary Malignancies
NCT00455312 (10) [back to overview]Incidence of Grade 2-4 Acute Graft Versus Host Disease (GVHD)
NCT00455312 (10) [back to overview]Incidence of Chronic GVHD
NCT00455312 (10) [back to overview]Incidence of Chronic GVHD
NCT00455312 (10) [back to overview]Overall Survival
NCT00458848 (3) [back to overview]Percentage of Participants Reaching Overall Survival
NCT00458848 (3) [back to overview]Number of Patients Reaching Complete Hematological Response After Induction Therapy
NCT00458848 (3) [back to overview]Percentage of Participants Reaching Disease Free Survival
NCT00481832 (10) [back to overview]Relapse Rate
NCT00481832 (10) [back to overview]Incidence of Chemotherapy-associated Pneumonitis
NCT00481832 (10) [back to overview]Incidence of Acute Graft Versus Host Disease (GvHD)
NCT00481832 (10) [back to overview]Achieving Full Donor Chimerism
NCT00481832 (10) [back to overview]Event-free Survival (EFS)
NCT00481832 (10) [back to overview]Incidence of Chronic Graft Versus Host Disease (GvHD)
NCT00481832 (10) [back to overview]Overall Mortality Rate
NCT00481832 (10) [back to overview]Median Time to Platelet Engraftment
NCT00481832 (10) [back to overview]Median Time to Neutrophile Engraftment
NCT00481832 (10) [back to overview]Overall Survival (OS)
NCT00482053 (7) [back to overview]Median Time to Platelet Engraftment After Allogeneic Transplant
NCT00482053 (7) [back to overview]Overall Survival (OS)
NCT00482053 (7) [back to overview]Median Time to Platelet Engraftment After Autologous Transplant
NCT00482053 (7) [back to overview]Median Time to Neutrophil Engraftment After Autologous Transplant
NCT00482053 (7) [back to overview]Median Time to Neutrophil Engraftment After Allogeneic Transplant
NCT00482053 (7) [back to overview]Incidence of Chronic Graft vs Host Disease (GvHD)
NCT00482053 (7) [back to overview]Event-free Survival (EFS) Per Protocol
NCT00492973 (5) [back to overview]Amount of Pain Medication Taken Per Day
NCT00492973 (5) [back to overview]Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.
NCT00492973 (5) [back to overview]Knee Range of Motion
NCT00492973 (5) [back to overview]Length of Hospital Stay
NCT00492973 (5) [back to overview]Knee Society Scores
NCT00493064 (1) [back to overview]Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart.
NCT00521989 (1) [back to overview]Change From Baseline to Day 98 Using the WOMAC Pain Question #1
NCT00551707 (2) [back to overview]Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population
NCT00551707 (2) [back to overview]Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population
NCT00553202 (2) [back to overview]Cumulative Incidence of NK Cell Reconstitution
NCT00553202 (2) [back to overview]Overall Survival (OS)
NCT00555464 (2) [back to overview]Toxicity to Medications
NCT00555464 (2) [back to overview]Response of Hemangioma (IH) to Treatment
NCT00557193 (10) [back to overview]Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2
NCT00557193 (10) [back to overview]Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm
NCT00557193 (10) [back to overview]Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
NCT00557193 (10) [back to overview]Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)
NCT00557193 (10) [back to overview]Percent Probability for Event-free Survival (EFS) for Patients on Arm A
NCT00557193 (10) [back to overview]Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT)
NCT00568633 (8) [back to overview]Relapse Rate
NCT00568633 (8) [back to overview]Complete Donor Hematopoietic Cell Chimerism
NCT00568633 (8) [back to overview]Disease-free Survival (DFS)
NCT00568633 (8) [back to overview]Non-relapse Mortality
NCT00568633 (8) [back to overview]Overall Survival (OS)
NCT00568633 (8) [back to overview]Patients Completing the Intended Therapy in Both Arms
NCT00568633 (8) [back to overview]Early Graft Loss
NCT00568633 (8) [back to overview]Transplant-related Mortality
NCT00574288 (9) [back to overview]Part 2: Progression-Free Survival
NCT00574288 (9) [back to overview]Part 1: Time to Response
NCT00574288 (9) [back to overview]Part 2: Overall Survival
NCT00574288 (9) [back to overview]Part 2: Duration of Response as Assessed Using the Method of Kaplan-Meier
NCT00574288 (9) [back to overview]Overall Response Rate
NCT00574288 (9) [back to overview]Number of Participants With Adverse Events
NCT00574288 (9) [back to overview]Part 2: Time to Response
NCT00574288 (9) [back to overview]Part 2: Time to Response
NCT00574288 (9) [back to overview]Part 2: Time to Progression (TTP)
NCT00577993 (2) [back to overview]Number of Participants With Progression Free Survival (10 Years) by Treatment
NCT00577993 (2) [back to overview]Number of Participants With Overall Survival (10 Years) by Treatment
NCT00578305 (16) [back to overview]Percentage of Participants Achieving a Major Clinical Response at Week 52
NCT00578305 (16) [back to overview]Percentage of Participants With an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Weeks 24 and 52
NCT00578305 (16) [back to overview]Percentage of Participants With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 24 and 52
NCT00578305 (16) [back to overview]Percentage of Participants With Improvement in Osteitis at Weeks 24 and 52
NCT00578305 (16) [back to overview]Change From Baseline in the Disease Activity Score 28 (DAS28) at Weeks 24 and 52
NCT00578305 (16) [back to overview]Percentage of Participants With Improvement in Synovitis at Weeks 24 and 52
NCT00578305 (16) [back to overview]Percentage of Participants With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Weeks 24 and 52
NCT00578305 (16) [back to overview]Percentage of Participants With no Newly Eroded Joints at Weeks 24 and 52
NCT00578305 (16) [back to overview]Percentage of Participants With no Progression/no Worsening in Bone Erosion at Weeks 24 and 52
NCT00578305 (16) [back to overview]Change in Magnetic Resonance Imaging (MRI) Osteitis Score From Baseline to Weeks 12, 24, and Week 52
NCT00578305 (16) [back to overview]Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 24 and 52
NCT00578305 (16) [back to overview]Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Week 24
NCT00578305 (16) [back to overview]Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Weeks 12 and 52
NCT00578305 (16) [back to overview]Change in Magnetic Resonance Imaging (MRI) Synovitis Score From Baseline to Weeks 12, 24, and Week 52
NCT00578305 (16) [back to overview]Correlation of Magnetic Resonance Imaging Assessments and Clinical Outcome Measures
NCT00578305 (16) [back to overview]Percentage of Participants in Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Weeks 24 and 52
NCT00579527 (8) [back to overview]Immune Reconstitution Efficacy - Naive CD4 T Cells
NCT00579527 (8) [back to overview]Immune Reconstitution Efficacy - Naive CD8 T Cells
NCT00579527 (8) [back to overview]Immune Reconstitution Efficacy - Total CD8 T Cells
NCT00579527 (8) [back to overview]Survival at 2 Years Post-CTTI
NCT00579527 (8) [back to overview]Survival at 1 Year Post-CTTI
NCT00579527 (8) [back to overview]Immune Reconstitution Efficacy - Response to Mitogens
NCT00579527 (8) [back to overview]Immune Reconstitution Efficacy - Total CD4 T Cells
NCT00579527 (8) [back to overview]Immune Reconstitution Efficacy - Total CD3 T Cells
NCT00595335 (8) [back to overview]Failure Rate
NCT00595335 (8) [back to overview]Graves' Ophthalmopathy Quality of Life Score Using the Short Form-12 (SF-12) Health Survey
NCT00595335 (8) [back to overview]Change in Disease Severity
NCT00595335 (8) [back to overview]Failure Rate at One Year
NCT00595335 (8) [back to overview]Change in Lid Fissure
NCT00595335 (8) [back to overview]Change in Clinical Activity Score (CAS)
NCT00595335 (8) [back to overview]Change in Proptosis
NCT00595335 (8) [back to overview]Change in Extraocular Motility
NCT00608517 (7) [back to overview]Number of Subjects With All-cause Mortality
NCT00608517 (7) [back to overview]Overall Survival
NCT00608517 (7) [back to overview]Number of Participants With 100-day Non-relapse Mortality
NCT00608517 (7) [back to overview]Number of Participants With Acute Graft-versus-host Disease (GVHD)
NCT00608517 (7) [back to overview]Number of Participants With Chronic Graft Versus Host Disease (GVHD)
NCT00608517 (7) [back to overview]Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells
NCT00608517 (7) [back to overview]Number of Participants Who Relapsed at 1 Year
NCT00609609 (3) [back to overview]Percentage of Participants Alive, In Remission & Without GVHD Progression Day 28 & Day 56
NCT00609609 (3) [back to overview]Non-relapse Mortality (NRM) at 6 Months
NCT00609609 (3) [back to overview]Day 56 Treatment Success
NCT00609739 (4) [back to overview]Disease-free Survival
NCT00609739 (4) [back to overview]Patients Who Relapsed
NCT00609739 (4) [back to overview]Patients With Graft-Versus-Host-Disease
NCT00609739 (4) [back to overview]Patients With Regimen-Related Toxicity
NCT00623766 (9) [back to overview]Overall Survival (OS)
NCT00623766 (9) [back to overview]Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria
NCT00623766 (9) [back to overview]Duration of Response (DOR) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)
NCT00623766 (9) [back to overview]Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)
NCT00623766 (9) [back to overview]Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
NCT00623766 (9) [back to overview]Onset of Response by Modified World Health Organization (mWHO) Criteria and Immune-related Response Criteria (irRC)
NCT00623766 (9) [back to overview]Progression-free Survival (PFS) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)
NCT00623766 (9) [back to overview]Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)
NCT00623766 (9) [back to overview]Disease Control Rate by Immune-related Response Criteria (irRC)
NCT00624416 (3) [back to overview]The Number of Lipoma Increased in Volume.
NCT00624416 (3) [back to overview]The Number of Subjects Elected to Have the Lipoma Removed.
NCT00624416 (3) [back to overview]The Average Percent Volume Reduction in the Lipoma.
NCT00630253 (5) [back to overview]Number of Participants With Transplant Related Deaths
NCT00630253 (5) [back to overview]Number of Participants With Chronic Graft-Versus-Host Disease (GVHD)
NCT00630253 (5) [back to overview]Number of Participants With Acute Graft-Versus-Host Disease (GVHD)
NCT00630253 (5) [back to overview]Number of Participants Experiencing Overall Survival
NCT00630253 (5) [back to overview]Number of Participants Experiencing Graft Failure
NCT00634933 (12) [back to overview]Visual Analogue Scale for Pain (VAS-pain)
NCT00634933 (12) [back to overview]Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
NCT00634933 (12) [back to overview]Health Assessment Questionnaire Disability Index (HAQ-DI)
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24
NCT00634933 (12) [back to overview]Disease Activity Score Based on 28-joints Count (DAS28)
NCT00634933 (12) [back to overview]Number of Swollen Joints
NCT00634933 (12) [back to overview]Number of Tender Joints
NCT00634933 (12) [back to overview]Patient Global Assessment (PtGA) of Disease Activity
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
NCT00634933 (12) [back to overview]Physician Global Assessment (PGA) of Disease Activity
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
NCT00671658 (1) [back to overview]Number of Participants With a Response
NCT00682357 (4) [back to overview]Change in Serum Cortisol
NCT00682357 (4) [back to overview]Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)
NCT00682357 (4) [back to overview]Change in Testosterone
NCT00682357 (4) [back to overview]Change in Serum Osteocalcin
NCT00689078 (10) [back to overview]Ocular Itching at Day 7
NCT00689078 (10) [back to overview]Ocular Redness at Day 7
NCT00689078 (10) [back to overview]Ocular Redness at Day 6
NCT00689078 (10) [back to overview]Ocular Redness at Day 28
NCT00689078 (10) [back to overview]Ocular Redness at Day 27
NCT00689078 (10) [back to overview]Ocular Redness at Baseline (Day 0)
NCT00689078 (10) [back to overview]Ocular Itching at Day 6
NCT00689078 (10) [back to overview]Ocular Itching at Day 28
NCT00689078 (10) [back to overview]Ocular Itching at Day 27
NCT00689078 (10) [back to overview]Ocular Itching at Baseline (Day 0)
NCT00699803 (1) [back to overview]Mean Aqueous Humor Prednisolone Acetate Concentration
NCT00720109 (5) [back to overview]Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation
NCT00720109 (5) [back to overview]Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)
NCT00720109 (5) [back to overview]Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy
NCT00720109 (5) [back to overview]Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy
NCT00720109 (5) [back to overview]Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events
NCT00732498 (4) [back to overview]Complete Response Rate
NCT00732498 (4) [back to overview]Median Time to Progression
NCT00732498 (4) [back to overview]Overall Response Rate
NCT00732498 (4) [back to overview]Progression-free Survival at 1 Year
NCT00733096 (4) [back to overview]Oswestry Disability Score
NCT00733096 (4) [back to overview]Numerical Rating Leg Pain Score
NCT00733096 (4) [back to overview]Medication Reduction
NCT00733096 (4) [back to overview]Global Perceived Effect
NCT00771875 (7) [back to overview]Renal Allograft Survival
NCT00771875 (7) [back to overview]Number of Patients With Allografts With C4d Focal Positive Pretreatment Biopsy
NCT00771875 (7) [back to overview]Number of Patients With Allografts With C4d Diffuse Positive Pretreatment Biopsy
NCT00771875 (7) [back to overview]Mean Serum Creatinine
NCT00771875 (7) [back to overview]Incidence of Death
NCT00771875 (7) [back to overview]Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)
NCT00771875 (7) [back to overview]Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection
NCT00782717 (2) [back to overview]Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).
NCT00782717 (2) [back to overview]Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery
NCT00787722 (6) [back to overview]Survival
NCT00787722 (6) [back to overview]Post HSCT Immune -Modulating Medication and Relapse
NCT00787722 (6) [back to overview]Quality of Life (QOL) Short Form - 36 (SF-36)
NCT00787722 (6) [back to overview]Disability Score: Expanded Disability Status Scale (EDSS)
NCT00787722 (6) [back to overview]NMO-IgG Aquaporin- 4 Autoantibody Titer
NCT00787722 (6) [back to overview]Number of Patients Who Require No Device Assistance for Ambulation
NCT00792948 (3) [back to overview]Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation
NCT00792948 (3) [back to overview]Overall Survival (OS)
NCT00792948 (3) [back to overview]Continuous Complete Remission (CCR) Rate
NCT00801632 (8) [back to overview]Change in Renal Function
NCT00801632 (8) [back to overview]Time to Platelet Recovery Following Transplant
NCT00801632 (8) [back to overview]Percentage of Participants With Graft Survival Through 156 Weeks
NCT00801632 (8) [back to overview]Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks
NCT00801632 (8) [back to overview]Percentage of Participants Experiencing a Clinically Significant Invasive or Resistant Opportunistic Infection
NCT00801632 (8) [back to overview]Percentage of Participants Experiencing Acute Rejection
NCT00801632 (8) [back to overview]Time to Neutrophil Recovery Following Transplant
NCT00801632 (8) [back to overview]Percentage of Participants Surviving Through 156 Weeks
NCT00802529 (3) [back to overview]Vertigo Attacks
NCT00802529 (3) [back to overview]Change in Speech Discrimination
NCT00802529 (3) [back to overview]Change in Hearing
NCT00806598 (1) [back to overview]Overall Response
NCT00807586 (3) [back to overview]Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks
NCT00807586 (3) [back to overview]Repeat Intervention
NCT00807586 (3) [back to overview]Cardiac Pain Assessment
NCT00808210 (1) [back to overview]Percentage of Participants With Adverse Events (AEs)
NCT00854061 (1) [back to overview]Means Aqueous Humor Prednisolone Acetate Concentration
NCT00908583 (4) [back to overview]Number of Patients Whose Cytotoxic Panel Reactive Antibody (PRA) is Decreased by 50%
NCT00908583 (4) [back to overview]Number of Living Donor Transplant Candidates That Are Transplanted
NCT00908583 (4) [back to overview]Acute Rejection Rate
NCT00908583 (4) [back to overview]Overall Safety of Bortezomib
NCT00915473 (4) [back to overview]Mean Frequency of Days With a Migraine
NCT00915473 (4) [back to overview]Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period
NCT00915473 (4) [back to overview]Mean Number of Hours With Moderate or Severe Migraine
NCT00915473 (4) [back to overview]Mean Number of Days With Acute Medication Use
NCT00929695 (12) [back to overview]Chronic Extensive GVHD
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Myopathy
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Hypertension
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Hyperglycemia
NCT00929695 (12) [back to overview]Overall Survival
NCT00929695 (12) [back to overview]Non-relapse Mortality
NCT00929695 (12) [back to overview]Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Quality of Life
NCT00929695 (12) [back to overview]Progression to Grade III-IV Acute GVHD
NCT00929695 (12) [back to overview]Recurrent or Progressive Malignancy
NCT00929695 (12) [back to overview]Secondary Therapy for Acute GVHD Beyond Prednisone
NCT00929981 (7) [back to overview]Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits
NCT00929981 (7) [back to overview]Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits
NCT00929981 (7) [back to overview]Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit
NCT00929981 (7) [back to overview]Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits
NCT00929981 (7) [back to overview]Treatment Status (Success/Failure) of CD at the Final Follow-up Visit
NCT00929981 (7) [back to overview]Treatment Status (Success/Failure) of CD at the First Follow-up Visit
NCT00929981 (7) [back to overview]Treatment Status (Success/Failure) of CD at the Third Follow-up Visit
NCT00934843 (5) [back to overview]Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery
NCT00934843 (5) [back to overview]Inotropic Score
NCT00934843 (5) [back to overview]Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery.
NCT00934843 (5) [back to overview]Total Intake/Output of Fluid
NCT00934843 (5) [back to overview]Urine Output
NCT00947765 (8) [back to overview]Pain(at 6 Months): Nirschl Staging
NCT00947765 (8) [back to overview]Pain(at 12 Weeks): Nirschl Staging
NCT00947765 (8) [back to overview]Pain(at 1 Week): Nirschl Staging (0 to 7)
NCT00947765 (8) [back to overview]Pain (at 1 Week): Visual Analogue Scale(0 to 10)
NCT00947765 (8) [back to overview]Pain(at 4 Weeks): Nirschl Staging
NCT00947765 (8) [back to overview]Pain(at 6 Months): Visual Analogue Scale
NCT00947765 (8) [back to overview]Pain(at 12 Weeks): Visual Analogue Scale
NCT00947765 (8) [back to overview]Pain(at 4 Weeks): Visual Analogue Scale
NCT00957801 (40) [back to overview]Serum Estradiol Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Insulin Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Insulin Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Hematocrit Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Hematocrit Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week
NCT00957801 (40) [back to overview]Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week
NCT00957801 (40) [back to overview]Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol
NCT00957801 (40) [back to overview]Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol
NCT00957801 (40) [back to overview]Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol
NCT00957801 (40) [back to overview]Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol
NCT00957801 (40) [back to overview]C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Triglycerides Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Triglycerides Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Total Cholesterol Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Total Cholesterol Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 7
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 6
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 5
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 4
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 3
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 2
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Serum Estradiol Measured on Treatment Day 8 (Post Study)
NCT00968253 (3) [back to overview]Overall Response Rate (OR) Where OR = CR + CRp + CRi
NCT00968253 (3) [back to overview]Participant Responses by Daily Dose Level Assignment (RAD001 5 mg, 10 mg and MTD 5 mg)
NCT00968253 (3) [back to overview]Maximum Tolerated Dose [MTD] Determination by Number of Participants With Dose Limiting Toxicity (DLT)
NCT00987831 (2) [back to overview]Time to Flare Comparing Patients With Moderate vs Severe Disease Activity at Baseline
NCT00987831 (2) [back to overview]Time to Flare Comparing Patients With (at Baseline) British Isles Lupus Assessment Group Index (BILAG) >/= 17 (Severe Disease) to Those With BILAG < 17 (Moderate Disease Activity).
NCT01000610 (4) [back to overview]Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24
NCT01000610 (4) [back to overview]Change in Bone Density (in Participants Untreated With Bisphosphonates)
NCT01000610 (4) [back to overview]Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24
NCT01000610 (4) [back to overview]Number of Participants Reporting Adverse Events (AEs)
NCT01071083 (2) [back to overview]Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria.
NCT01071083 (2) [back to overview]Time Course to Return of Radiological and/or Clinical Evidence of Multiple Sclerosis Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) and/or Clinical Relapse Rescue Criteria.
NCT01085097 (2) [back to overview]Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
NCT01085097 (2) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01086540 (19) [back to overview]Time to the Change or Addition of New Pulmonary Arterial Hypertension (PAH) Therapeutic Medications
NCT01086540 (19) [back to overview]Change From Baseline in Quality of Life as Measured by the Short Form Health Survey (SF-36): Physical Component Summary Score
NCT01086540 (19) [back to overview]Percent Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization
NCT01086540 (19) [back to overview]Number of Infection-Related Adverse Events (AEs) Through Week 48
NCT01086540 (19) [back to overview]Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization at Week 24
NCT01086540 (19) [back to overview]Change From Baseline in Distance Walked During a Six Minute Walk Test
NCT01086540 (19) [back to overview]All-Cause Mortality: From Treatment Initiation to Week 48
NCT01086540 (19) [back to overview]All-Cause Mortality: From Treatment Initiation to Week 104
NCT01086540 (19) [back to overview]Change From Baseline in Quality of Life as Measured by the Short Form Health Survey (SF-36): Mental Component Summary Score
NCT01086540 (19) [back to overview]Treatment-Related Mortality: From Treatment Initiation to Week 48
NCT01086540 (19) [back to overview]Change From Baseline in Distance Walked During a Six Minute Walk Test at Week 24 and Week 48
NCT01086540 (19) [back to overview]Time to Clinical Worsening
NCT01086540 (19) [back to overview]Number of New Digital Ulcers
NCT01086540 (19) [back to overview]Oxygen Saturation Levels at Week 24 and Week 48
NCT01086540 (19) [back to overview]Number of Infusion-Related Toxicities
NCT01086540 (19) [back to overview]Number of Grade 3 or Higher Adverse Events (AEs) Through Week 48
NCT01086540 (19) [back to overview]Change in Severity of Raynaud's Phenomenon
NCT01086540 (19) [back to overview]Change in Quality of Life as Measured by the Disability Index of the Scleroderma Health Assessment Questionnaire (HAQ-DI)
NCT01086540 (19) [back to overview]Change in Carbon Monoxide Diffusing Capacity (DLCO)
NCT01093586 (14) [back to overview]Recurrence or Relapse
NCT01093586 (14) [back to overview]Transplant Related Mortality
NCT01093586 (14) [back to overview]Transplant Related Mortality
NCT01093586 (14) [back to overview]Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0
NCT01093586 (14) [back to overview]Recurrence or Relapse
NCT01093586 (14) [back to overview]Occurrence of Serious Infections
NCT01093586 (14) [back to overview]Disease Free
NCT01093586 (14) [back to overview]Overall Survival
NCT01093586 (14) [back to overview]Disease Free
NCT01093586 (14) [back to overview]Overall Survival
NCT01093586 (14) [back to overview]Overall Survival
NCT01093586 (14) [back to overview]Incidence of Chronic GVHD
NCT01093586 (14) [back to overview]Hematologic Engraftment
NCT01093586 (14) [back to overview]Incidence of Acute Graft-versus-host Disease (GVHD)
NCT01105650 (4) [back to overview]Number of Participants With Progressive Disease at One Year
NCT01105650 (4) [back to overview]Overall Survival
NCT01105650 (4) [back to overview]Response Rate
NCT01105650 (4) [back to overview]Time to Disease Progression
NCT01114503 (8) [back to overview]Number of Participants With Thyroid Function Assessment, Hormone and Glucose Assay Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With an Epstein Barr Virus (EBV) Viral Load Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With Electrocardiogram (ECG) Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With Laboratory Clinical Chemistry Abnormalities Meeting the Criteria for Potential Clinical Concern (PCC)
NCT01114503 (8) [back to overview]Number of Participants With Laboratory Hematology Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With Laboratory Urinalysis Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With Vital Signs Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With at Least One Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event
NCT01124045 (13) [back to overview]Global Assessment Score of Postoperative Inflammation by Visit
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
NCT01124045 (13) [back to overview]Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
NCT01144143 (5) [back to overview]Change in Joint Effusions From Day 0 to Day 56 Target Knee
NCT01144143 (5) [back to overview]Change in Levels of Serum IL-6
NCT01144143 (5) [back to overview]Change in Serum CRP Day 0 to Day 56
NCT01144143 (5) [back to overview]Change in Serum SAA Levels Day 0 to Day 56
NCT01144143 (5) [back to overview]Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score Target Knee
NCT01181258 (4) [back to overview]Serious Adverse Events
NCT01181258 (4) [back to overview]Patients With Expansion of NK Cells
NCT01181258 (4) [back to overview]Time to Disease Progression
NCT01181258 (4) [back to overview]Number of Patients With an Objective Response
NCT01201798 (10) [back to overview]Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0
NCT01201798 (10) [back to overview]Proportion of Subjects With Anterior Chamber Cell Grade ≤1
NCT01201798 (10) [back to overview]Proportion of Subjects Who Discontinued Due to Lack of Efficacy
NCT01201798 (10) [back to overview]Proportion of Subjects With Anterior Chamber Cell Count of 0
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points
NCT01201798 (10) [back to overview]Proportion of Subjects With Anterior Chamber Cell Grade of 0
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14
NCT01211665 (3) [back to overview]Number of Participants Who Survived at 6 Months Following Completion of Plasma Exchange (PLEX)
NCT01211665 (3) [back to overview]Severity of AEs and SAEs
NCT01211665 (3) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01219933 (33) [back to overview]Short-Form 36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS) During the Interventional Phase
NCT01219933 (33) [back to overview]SJC and TJC During the Interventional Phase
NCT01219933 (33) [back to overview]Type of GC Taken at the End of the Noninterventional Phase
NCT01219933 (33) [back to overview]VAS for Pain (VAS-Pain) During the Interventional Phase
NCT01219933 (33) [back to overview]VAS-Physician's Global Assessment of Disease Activity (GDA) During the Interventional Phase
NCT01219933 (33) [back to overview]Median Dose of Tocilizumab During the Noninterventional Phase
NCT01219933 (33) [back to overview]Median Time Interval Between V1 and V2
NCT01219933 (33) [back to overview]Number of Participants With Changes in Tocilizumab Dose During the Noninterventional Phase
NCT01219933 (33) [back to overview]Number of Participants With GC Switches During the Noninterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants Able to Discontinue GCs During the Interventional Phase by V9
NCT01219933 (33) [back to overview]Percentage of Participants Able to Reduce Oral GCs by ≥50 Percent (%) During the Interventional Phase by V9
NCT01219933 (33) [back to overview]Percentage of Participants Able to Start the GC Reduction Phase at V3
NCT01219933 (33) [back to overview]Percentage of Participants Acheiving Remission Assessed Using DAS28 While Receiving Oral GC on Background TocilizumabTreatment During the Noninterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks
NCT01219933 (33) [back to overview]Percentage of Participants With Changes in RA Treatment During the Noninterventional Phase
NCT01219933 (33) [back to overview]Time-Averaged GC Dose Changes During the Interventional Phase
NCT01219933 (33) [back to overview]CDAI Score During the Interventional Phase
NCT01219933 (33) [back to overview]Clinical Disease Activity Index (CDAI) During the Noninterventional Phase
NCT01219933 (33) [back to overview]DAS28-CRP During the Interventional Phase
NCT01219933 (33) [back to overview]DAS28-CRP During the Noninterventional Phase
NCT01219933 (33) [back to overview]DAS28-ESR During the Noninterventional Phase
NCT01219933 (33) [back to overview]Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score During the Interventional Phase
NCT01219933 (33) [back to overview]HAQ-DI During the Interventional Phase
NCT01219933 (33) [back to overview]Health Assessment Questionnaire Disability Index (HAQ-DI) During the Noninterventional Phase
NCT01219933 (33) [back to overview]Median GC Dose Taken During the Noninterventional Phase
NCT01219933 (33) [back to overview]Number of Erosions During the NonInterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants Positive for Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody During the Noninterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants Positive for Rheumatoid Factor (RF) During the Noninterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants With Erosions During the NonInterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using CDAI
NCT01219933 (33) [back to overview]Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using DAS28-CRP
NCT01219933 (33) [back to overview]SF-36 Subscale Scores During the Interventional Phase
NCT01267201 (4) [back to overview]Maximum Observed Plasma Concentration (Cmax)
NCT01267201 (4) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
NCT01267201 (4) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax)
NCT01267201 (4) [back to overview]Plasma Decay Half-life (t1/2)
NCT01272635 (5) [back to overview]Drug Related Side Effects
NCT01272635 (5) [back to overview]Urgent Care Visits, ED Visits and Hospitalizations
NCT01272635 (5) [back to overview]Progression to Clinically Significant Lower Respiratory Tract Symptoms
NCT01272635 (5) [back to overview]Asthma Related Symptoms Among RTI Progressing to Severe LRTI
NCT01272635 (5) [back to overview]OCELOT: Pediatric Respiratory Assessment Measure
NCT01283009 (1) [back to overview]60-day Mortality
NCT01319981 (3) [back to overview]Complete Response Duration
NCT01319981 (3) [back to overview]Overall Survival
NCT01319981 (3) [back to overview]Number of Patients With Complete Remission at One Year
NCT01369745 (1) [back to overview]Change From Baseline in DAS28-CRP at 12 Weeks
NCT01381874 (7) [back to overview]Overall Survival (OS)
NCT01381874 (7) [back to overview]Overall Response Rate (ORR)
NCT01381874 (7) [back to overview]Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment
NCT01381874 (7) [back to overview]Duration of Response
NCT01381874 (7) [back to overview]Clinical Benefit Rate
NCT01381874 (7) [back to overview]Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment
NCT01381874 (7) [back to overview]Progression-Free Survival (PFS)
NCT01382940 (7) [back to overview]Percentage of Participants Experiencing Any Serious IRR (SIRR) Associated With the Second Rituximab Infusion
NCT01382940 (7) [back to overview]Percentage of Participants Experiencing Any Infusion-related Reaction (IRR) Associated With the Second Rituximab Infusion
NCT01382940 (7) [back to overview]Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Third Rituximab Infusion
NCT01382940 (7) [back to overview]Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Second Rituximab Infusion
NCT01382940 (7) [back to overview]Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Third Rituximab Infusion
NCT01382940 (7) [back to overview]Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Second Rituximab Infusion
NCT01382940 (7) [back to overview]Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion
NCT01390441 (7) [back to overview]Part A: Area Under the Concentration-time Curve From Day 0 to Day 84 (AUC0-84day) After a Single Course of Treatment
NCT01390441 (7) [back to overview]Number of Participants Who Discontinued Study Drug Due to Adverse Events
NCT01390441 (7) [back to overview]Number of Participants Who Experienced at Least One Adverse Event
NCT01390441 (7) [back to overview]Part A: Maximum Concentration (Cmax) After the Second Infusion of a Single Course of Treatment
NCT01390441 (7) [back to overview]Change From Baseline in Disease Activity in 28 Joints C-Reactive Protein Score (DAS28-CRP) by Time-point
NCT01390441 (7) [back to overview]Part A: Number of ACR20, ACR50, and ACR70 Responders at Week 24
NCT01390441 (7) [back to overview]Part B: Number of ACR20, ACR50, and ACR70 Responders at Week 24
NCT01436305 (31) [back to overview]Count of Participants With Estimated Glomerular Filtration Rate (GFR) < 60 mL/Min/1.73 m^2 by CKD EPI
NCT01436305 (31) [back to overview]Count of Participants With Infections Requiring Hospitalization or Systemic Therapy Reported as Serious Adverse Events
NCT01436305 (31) [back to overview]Number of All Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01436305 (31) [back to overview]Total Daily Prescribed Pill Number at Days 28 and 84, and Wks 24, 36, 52, 72, 104 and 156
NCT01436305 (31) [back to overview]Type of Treatment of Rejection
NCT01436305 (31) [back to overview]Count of Participants With Rejection
NCT01436305 (31) [back to overview]Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156
NCT01436305 (31) [back to overview]Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90mm Hg Within 24 Hours of Onset of Transplant Procedure
NCT01436305 (31) [back to overview]HbA1c Measured at Days 28 & 84, and Weeks 24, 36, 52, 72, 104 and 156
NCT01436305 (31) [back to overview]Count of Participants With Use of Lipid Lowering Medications at Baseline and Wks 24, 52, 104 and 156
NCT01436305 (31) [back to overview]Count of Participants by Severity of First Acute Cellular Rejection by Wk 52
NCT01436305 (31) [back to overview]Mean Calculated eGFR Using MDRD 4 Variable Model
NCT01436305 (31) [back to overview]Standardized Blood Pressure Measurement at Wk 52
NCT01436305 (31) [back to overview]Count of Participants With Treated Diabetes Between Day 14 and Wk 52
NCT01436305 (31) [back to overview]Count of Participants With Use of Anti-hypertensive Medications at Wk 52
NCT01436305 (31) [back to overview]Mean Glomerular Filtration Rate (GFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52
NCT01436305 (31) [back to overview]The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine
NCT01436305 (31) [back to overview]Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Wk 52 Based on Criteria Specified by the ADA and WHO
NCT01436305 (31) [back to overview]Count of Participants With CKD Stage 4 or 5
NCT01436305 (31) [back to overview]Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant
NCT01436305 (31) [back to overview]Count of Participants With BKV and CMV Viremia (Local Center Monitoring) Reported as Adverse Events
NCT01436305 (31) [back to overview]Count of Participants With EBV Infection as Reported on the Case Report Form as Adverse Events
NCT01436305 (31) [back to overview]Count of Participants With Delayed Graft Function Post-Transplant
NCT01436305 (31) [back to overview]Number of Events of Death or Graft Loss
NCT01436305 (31) [back to overview]HbA1c Measured at Days 28 & 84, and Weeks 24, 36, 52, 72, 104 and 156
NCT01436305 (31) [back to overview]Count of Participants With CAN/IFTA Grade I, II or III at Any Time Post-transplant
NCT01436305 (31) [back to overview]Count of Participants With Biopsy Proven Acute Rejection at Any Time Post-Transplant
NCT01436305 (31) [back to overview]Count of Participants With Antibody Mediated Rejection
NCT01436305 (31) [back to overview]Count of Participants With Acute Cellular Rejection Grade Equal to or Greater Than IA, by the Banff 2007 Criteria
NCT01436305 (31) [back to overview]Total Daily Prescribed Pill Number at Days 28 and 84, and Wks 24, 36, 52, 72, 104 and 156
NCT01436305 (31) [back to overview]Count of Participants With de Novo Anti-donor HLA Antibodies at Wk 52
NCT01445821 (2) [back to overview]Number of Participants With Treatment Failure
NCT01445821 (2) [back to overview]Survival of Treatment
NCT01448213 (2) [back to overview]Number of Eyes With Intraocular Pressure (IOP) Elevation
NCT01448213 (2) [back to overview]Number of Eyes With Immunologic Graft Rejection Episodes
NCT01465334 (11) [back to overview]3-Year Progression-Free Survival (PFS) Probability
NCT01465334 (11) [back to overview]Induction Overall Response Rate (ORR)
NCT01465334 (11) [back to overview]3-year Overall Survival (OS) Probability
NCT01465334 (11) [back to overview]Overall MRD Negative Rate
NCT01465334 (11) [back to overview]Overall Objective Response Rate (ORR)
NCT01465334 (11) [back to overview]Transplant Rate
NCT01465334 (11) [back to overview]Number of Participants Completing Part A Treatment
NCT01465334 (11) [back to overview]Number of Participants With Overall CR
NCT01465334 (11) [back to overview]Number of Participants Completing Only 2 Cycles of Part A Treatment
NCT01465334 (11) [back to overview]Number of Participants With Treatment-Related Grades 1-3 Hyperglycemia During Part A Induction
NCT01465334 (11) [back to overview]Number of Participants Achieving Induction Complete Response (CR)
NCT01475643 (2) [back to overview]Anterior Chamber Cells & Flare
NCT01475643 (2) [back to overview]Anterior Chamber Inflammation
NCT01496976 (4) [back to overview]Rate of Progression/Relapse Free Survival (PFS)
NCT01496976 (4) [back to overview]Number of Participants With Overall Survival (OS)
NCT01496976 (4) [back to overview]Number of Participants With Complete Response (CR)
NCT01496976 (4) [back to overview]Number of Participants With Partial Response (PR)
NCT01497496 (1) [back to overview]Objective Response Rate (ORR)
NCT01534195 (4) [back to overview]Ocular Itching Change From Baseline to Day 11
NCT01534195 (4) [back to overview]Episcleral Redness Change From Baseline to Day 6
NCT01534195 (4) [back to overview]Conjunctival Redness Change From Baseline to Day 11
NCT01534195 (4) [back to overview]Ciliary Redness Change From Baseline to Day 6
NCT01559675 (1) [back to overview]Orthostatic Hypotension
NCT01579513 (5) [back to overview]Neurodevelopmental Outcome
NCT01579513 (5) [back to overview]Number of Participants With a Clinically Derived Composite Morbidity-mortality Outcome
NCT01579513 (5) [back to overview]Intensive Care Unit Stay
NCT01579513 (5) [back to overview]Hospital Stay
NCT01579513 (5) [back to overview]Duration of Mechanical Ventilation Post Cardiac Surgery.
NCT01621880 (2) [back to overview]Number of Participants With a Treatment Response
NCT01621880 (2) [back to overview]Percentage Change in Radiological Measures of Lesion Volume
NCT01652495 (3) [back to overview]Reduction of Pain Severity Expressed as Percentage Change in VAS Score
NCT01652495 (3) [back to overview]Functional Improvement Measured According to Percentage Change in Constant Score
NCT01652495 (3) [back to overview]Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis
NCT01680861 (7) [back to overview]BPAR (Biopsy-proven Acute Rejection) Incidence During the First 12 Months Post-transplant
NCT01680861 (7) [back to overview]Discontinuance of Any Study Medication (Tacrolimus, Everolimus, or EC-MPS)
NCT01680861 (7) [back to overview]eGFR (Renal Function) at Month 3 Post-transplant
NCT01680861 (7) [back to overview]Graft Loss (Return to Permanent Dialysis or Death)
NCT01680861 (7) [back to overview]Incidence of Chronic Allograft Nephropathy (CAI) at 12 Months Post-transplant
NCT01680861 (7) [back to overview]eGFR (Calculated Glomerular Filtration Rate), i.e., Renal Function, at 1 Month Post-transplant.
NCT01680861 (7) [back to overview]eGFR (Renal Function) at 6 Months Post-transplant
NCT01724021 (14) [back to overview]Progression-free Survival (PFS)
NCT01724021 (14) [back to overview]Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])
NCT01724021 (14) [back to overview]Cancer Therapy Satisfaction Questionnaire (CTSQ) Score
NCT01724021 (14) [back to overview]Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time
NCT01724021 (14) [back to overview]Percentage of Participants With Anti-Rituximab Antibodies Over Time
NCT01724021 (14) [back to overview]Rituximab Administration Satisfaction Questionnaire (RASQ) Score
NCT01724021 (14) [back to overview]Summary of Observed Serum Rituximab Concentration
NCT01724021 (14) [back to overview]Complete Response (CR) Rate
NCT01724021 (14) [back to overview]Disease-free Survival (DFS)
NCT01724021 (14) [back to overview]Event-free Survival (EFS)
NCT01724021 (14) [back to overview]Number of Participants With Treatment Emergent Adverse Events (AEs)
NCT01724021 (14) [back to overview]Overall Survival (OS)
NCT01724021 (14) [back to overview]Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
NCT01724021 (14) [back to overview]Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8
NCT01730872 (3) [back to overview]Ocular Redness Change From Baseline to Day 6
NCT01730872 (3) [back to overview]Inflammation Change From Baseline to Day 6
NCT01730872 (3) [back to overview]Ocular Itching Change From Baseline to Day 6
NCT01783847 (2) [back to overview]Number of Participants With Change/Improvement Visual Acuity From the Beseline
NCT01783847 (2) [back to overview]Number of Participants With Relative Afferent Papillary Defect (RAPD) Grade +4
NCT01790594 (30) [back to overview]Type of Treatment(s) Participants Received for Biopsy-Proven Pancreatic Allograft Rejection During the First 52 Weeks Post-Transplant
NCT01790594 (30) [back to overview]Count of Participants With Full Pancreatic Graft Function (Insulin Independent) at Wk 52 Post-Transplant
NCT01790594 (30) [back to overview]Count of Participants With Evidence of Partial Pancreatic Graft Function at Week 52 Post-Transplant
NCT01790594 (30) [back to overview]Count of Participants With Evidence of Pancreatic Loss at Week 52 Post-Transplant
NCT01790594 (30) [back to overview]Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant
NCT01790594 (30) [back to overview]Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant
NCT01790594 (30) [back to overview]Count of Participants With an Infectious Disease Serious Adverse Event(s) Requiring Hospitalization or Systemic Therapy
NCT01790594 (30) [back to overview]Count of Participants Diagnosed With Malignancy as an Adverse Event
NCT01790594 (30) [back to overview]Count of Participants Diagnosed With Epstein-Barr Virus (EBV) Infection as an Adverse Event
NCT01790594 (30) [back to overview]Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant
NCT01790594 (30) [back to overview]Fasting Lipid Profile at Baseline (Pre-Transplant)
NCT01790594 (30) [back to overview]Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant
NCT01790594 (30) [back to overview]Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant
NCT01790594 (30) [back to overview]Severity Grade of First Biopsy-Proven Acute Rejection (AR) During the First 52 Weeks Post-Transplant
NCT01790594 (30) [back to overview]Lipid Profile at Wk 52 Post-Transplant
NCT01790594 (30) [back to overview]HbA1c at Baseline (Pre-Transplant) Through Wk 52 Post-Transplant
NCT01790594 (30) [back to overview]Fasting Lipid Profile at Wk 28 Post-Transplant
NCT01790594 (30) [back to overview]Fasting Blood Sugar (FBS) From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant
NCT01790594 (30) [back to overview]Count of Participants With Use of Lipid Lowering Medications at Baseline, Wk 28 and Wk 52 Post-Transplant
NCT01790594 (30) [back to overview]Count of Participants With Use of Anti-hypertensive Medication From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant
NCT01790594 (30) [back to overview]Count of Participants With the Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01790594 (30) [back to overview]Count of Participants With Event of Death, Graft Loss, or Undetectable C-peptide
NCT01790594 (30) [back to overview]Count of Participants With De Novo Anti-Donor Antibodies or Anti-Human Leukocyte Antigen (HLA) Antibodies During the First 52 Weeks Post-Transplant
NCT01790594 (30) [back to overview]Count of Participants With Biopsy-Proven Humoral Rejection During the First 52 Weeks Post-Transplant
NCT01790594 (30) [back to overview]Count of Participants With Acute Rejection (AR) of Kidney or Pancreatic Transplant During the First 52 Wks Post-Transplant
NCT01790594 (30) [back to overview]Count of Participant Diagnosed With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia As Adverse Events
NCT01790594 (30) [back to overview]The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant
NCT01790594 (30) [back to overview]Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant
NCT01790594 (30) [back to overview]Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant
NCT01790594 (30) [back to overview]Count of Participants With Successful Discontinuation of Tacrolimus in Recipients Randomized to the Investigational Arm
NCT01809132 (4) [back to overview]MELD Score at 180 Days
NCT01809132 (4) [back to overview]180 Days Mortality
NCT01809132 (4) [back to overview]MELD Score at 28 Days
NCT01809132 (4) [back to overview]MELD Score at 90 Days
NCT01853072 (6) [back to overview]Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90
NCT01853072 (6) [back to overview]Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit
NCT01853072 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60
NCT01853072 (6) [back to overview]Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]
NCT01853072 (6) [back to overview]Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)
NCT01853072 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90
NCT01853696 (2) [back to overview]Immunologic Graft Rejection Episode
NCT01853696 (2) [back to overview]Intraocular Pressure
NCT01856257 (29) [back to overview]Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies
NCT01856257 (29) [back to overview]Total Daily Prescribed Pill Count
NCT01856257 (29) [back to overview]Standardized Blood Pressure Measurement at Wk 52 Post-Transplant
NCT01856257 (29) [back to overview]Hemoglobin A1c (HbA1c) Measurements Over Time
NCT01856257 (29) [back to overview]Fasting Lipid Profile at Wk 52 Post-Transplant
NCT01856257 (29) [back to overview]Fasting Lipid Profile at Wk 28 Post-Transplant
NCT01856257 (29) [back to overview]Fasting Lipid Profile at Baseline (Pre-Transplant)
NCT01856257 (29) [back to overview]Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset of Transplant Procedure
NCT01856257 (29) [back to overview]Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Week 52 Post-Transplant -Based on Criteria Specified by the ADA and WHO
NCT01856257 (29) [back to overview]Count of Participants With Treated Diabetes Between Day 14 and Wk 52 Post-Transplant
NCT01856257 (29) [back to overview]Count of Participants With Use of Anti-hypertensive Medication at Wk 52 Post-Transplant
NCT01856257 (29) [back to overview]Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant
NCT01856257 (29) [back to overview]Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant
NCT01856257 (29) [back to overview]Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant
NCT01856257 (29) [back to overview]Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 52
NCT01856257 (29) [back to overview]Type of Treatment for Detected Graft Rejection
NCT01856257 (29) [back to overview]Count of Participant Deaths or Graft Loss by Wk 52 Post-Transplant
NCT01856257 (29) [back to overview]Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant
NCT01856257 (29) [back to overview]The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant
NCT01856257 (29) [back to overview]Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant
NCT01856257 (29) [back to overview]Count of Participants With Acute Cellular Rejection Grade ≥ IA Defined by Banff 2007 Criteria By Wk 52 Post-Transplant
NCT01856257 (29) [back to overview]Count of Participants With Antibody Mediated Rejection by Wk 52 Post-Transplant
NCT01856257 (29) [back to overview]Count of Participants With Biopsy Proven Acute Rejection By Wk 52 Post-Transplant
NCT01856257 (29) [back to overview]Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant
NCT01856257 (29) [back to overview]Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant
NCT01856257 (29) [back to overview]Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant
NCT01856257 (29) [back to overview]Count of Participants With Epstein-Barr Virus (EBV) Infection as Reported on the Case Report Form as Adverse Events
NCT01856257 (29) [back to overview]Count of Participants With Graft Rejection by Wk 52 Post-Transplant
NCT01856257 (29) [back to overview]Count of Participants With Infections Requiring Hospitalization or Systemic Therapy by Wk 52 Post-Transplant
NCT01872611 (6) [back to overview]Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit
NCT01872611 (6) [back to overview]Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90
NCT01872611 (6) [back to overview]Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)
NCT01872611 (6) [back to overview]Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit
NCT01872611 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90
NCT01872611 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60
NCT01875237 (8) [back to overview]To Assess Post Donor Lymphocyte Infusion (DLI) Chimerism
NCT01875237 (8) [back to overview]To Assess the Proportion of Patients Developing Grade I-IV Acute GvHD
NCT01875237 (8) [back to overview]To Assess the Proportions of GvHD Response Post-administration of AP1903.
NCT01875237 (8) [back to overview]To Assess the Incidence of Acute GvHD Flare After CR/PR Requiring Additional Agent for Systemic Therapy Before Day 56 Post-administration of AP1903.
NCT01875237 (8) [back to overview]To Assess the Incidence of GvHD Treatment Failure Post-administration of AP1903.
NCT01875237 (8) [back to overview]Number of Participants Assessed Post Donor Lymphocyte Infusion (DLI): Disease-free Survival & Non-relapse Mortality, Chimerism and GVHD.
NCT01875237 (8) [back to overview]To Assess the Incidence of Epstein-Barr Virus -PTLD or EBV Reactivation Requiring Therapy Post DLI.
NCT01875237 (8) [back to overview]To Evaluate the Safety of Donor Lymphocyte Infusion Followed by Dimerizer Drug, AP1903 by Number of Participants With Adverse Events.
NCT01884571 (8) [back to overview]Mean Rate of Change of Slow Vital Capacity (SVC) During Treatment Compared to Pre-Treatment
NCT01884571 (8) [back to overview]Mean Rate of Change of Hand-Held Dynamometry (HHD) During Treatment Compared to Pre-Treatment
NCT01884571 (8) [back to overview]Mean Rate of Change of ALSFRS-R Scores During Treatment Compared to Pre-Treatment
NCT01884571 (8) [back to overview]Mean Rate of Change in Grip Strength Treatment Compared to Pre-Treatment
NCT01884571 (8) [back to overview]Collection of Cerebrospinal Fluid for Future Analysis of Cytokine Levels
NCT01884571 (8) [back to overview]Collection of Blood for Future Analysis of Peripheral Blood Mononuclear Cells (PBMCs)
NCT01884571 (8) [back to overview]Mean Rate of Change of T-cell Subsets in Blood Treatment Compared to Pre-Treatment
NCT01884571 (8) [back to overview]Number of Participants With an Average Increase in ALSFRS-R Score of One Point Per Month
NCT01950819 (22) [back to overview]Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death
NCT01950819 (22) [back to overview]Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up
NCT01950819 (22) [back to overview]Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects.
NCT01950819 (22) [back to overview]Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2.
NCT01950819 (22) [back to overview]Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2
NCT01950819 (22) [back to overview]Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections
NCT01950819 (22) [back to overview]Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events)
NCT01950819 (22) [back to overview]Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants)
NCT01950819 (22) [back to overview]Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR
NCT01950819 (22) [back to overview]Renal Function Assessed by Creatinine Lab Values
NCT01950819 (22) [back to overview]Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported
NCT01950819 (22) [back to overview]Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios.
NCT01950819 (22) [back to overview]Evolution of Renal Function, as eGFR, Over Time by Slope Analysis.
NCT01950819 (22) [back to overview]Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation.
NCT01950819 (22) [back to overview]Incidence of Major Cardiovascular Events.
NCT01950819 (22) [back to overview]Incidence of Malignancies.
NCT01950819 (22) [back to overview]Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup
NCT01950819 (22) [back to overview]Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events.
NCT01950819 (22) [back to overview]Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection
NCT01950819 (22) [back to overview]Incidence of eGFR < 50 mL/Min/1.73m2
NCT01950819 (22) [back to overview]Incidence of Failure on the Composite Endpoint of Graft Loss or Death.
NCT01950819 (22) [back to overview]Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2
NCT01977781 (7) [back to overview]Tear Film Break-Up Time
NCT01977781 (7) [back to overview]Schirmer Tear Test (mm)
NCT01977781 (7) [back to overview]Ocular Surface Disease Index (OSDI) Questionnaire
NCT01977781 (7) [back to overview]Intraocular Pressure
NCT01977781 (7) [back to overview]Corneal Epitheliopathy (Corneal Fluorescein Staining Using the NEI Grading Scheme)
NCT01977781 (7) [back to overview]Visual Acuity
NCT01977781 (7) [back to overview]Ocular Burning Sensation, Ocular Discharge, Ocular Redness, Ocular Itching, Foreign Body Sensation
NCT01985126 (7) [back to overview]Progression Free Survival
NCT01985126 (7) [back to overview]Percentage of Participants With Overall Response
NCT01985126 (7) [back to overview]Percentage of Participants With Clinical Benefit
NCT01985126 (7) [back to overview]Overall Survival
NCT01985126 (7) [back to overview]Duration of Response
NCT01985126 (7) [back to overview]Time to Response
NCT01985126 (7) [back to overview]Time to Disease Progression
NCT02005562 (12) [back to overview]Graft Histology - Percentage of Participants With at Least One Borderline Lesion at Week 12 and Week 52
NCT02005562 (12) [back to overview]Creatinine Clearance Values Estimated With the Modification of Diet in Renal Disease (MDRD) Simplified Equation
NCT02005562 (12) [back to overview]Creatinine Clearance Values Estimated With the Cockcroft-Gault Equation (Milliliters Per Minute [mL/Min])
NCT02005562 (12) [back to overview]Time to Occurrence of First BPAR Between Day 0 and Week 52 - Percentage of Participants With an Event
NCT02005562 (12) [back to overview]Time to Occurrence of First BPAR Between Day 0 and Week 52
NCT02005562 (12) [back to overview]Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Before Week 12 or Acute Subclinical Rejection on Protocol Biopsy at Week 12
NCT02005562 (12) [back to overview]Time to Graft Loss
NCT02005562 (12) [back to overview]Participant Survival
NCT02005562 (12) [back to overview]Graft Loss - Percentage of Participants With an Event
NCT02005562 (12) [back to overview]Serum Creatinine Values [Micromoles Per Liter (µmol/L)]
NCT02005562 (12) [back to overview]Percentage of Participants With at Least One BPAR at Week 12 and Week 52
NCT02005562 (12) [back to overview]Graft Histology - Percentage of Participants With at Least One Chronic Graft Nephropathy at Week 12 and Week 52
NCT02006706 (2) [back to overview]Health Assessment Questionnaire-Disability Index (HAQ-DI)
NCT02006706 (2) [back to overview]Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24
NCT02029638 (18) [back to overview]Number of Transplanted Participants Who Developed Donor- Specific Antibody After Initiation of Immunosuppression Withdrawal
NCT02029638 (18) [back to overview]Number of Transplanted Participants Who Developed Donor-Specific Antibody During Study Participation
NCT02029638 (18) [back to overview]Number of Transplanted Participants Who Died
NCT02029638 (18) [back to overview]Number of Transplanted Participants Who Remained Off Immunosuppression for at Least 52 Weeks, Including Those in Whom the 52 Week Biopsy Was Not Performed
NCT02029638 (18) [back to overview]Number of Transplanted Participants With Acute Renal Allograft Rejection
NCT02029638 (18) [back to overview]Number of Transplanted Participants With Chronic T Cell-Mediated or Antibody-Mediated Rejection
NCT02029638 (18) [back to overview]Number of Transplanted Participants With Engraftment Syndrome
NCT02029638 (18) [back to overview]Percent of Participants Who Achieved Operational Tolerance
NCT02029638 (18) [back to overview]Number of Days From Transplant to Platelet Count Recovery
NCT02029638 (18) [back to overview]Duration in Days of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy
NCT02029638 (18) [back to overview]Duration in Days of Graft-versus-Host Disease in Transplanted Participants
NCT02029638 (18) [back to overview]Number of Days From Neutrophil Nadir to Absolute Neutrophil Recovery
NCT02029638 (18) [back to overview]Number of Days Post-Transplant to the First Episode of Acute Rejection Requiring Treatment
NCT02029638 (18) [back to overview]Number of Participants Experiencing an Incidence of Graft-versus-Host Disease Post-Transplant
NCT02029638 (18) [back to overview]Number of Participants Free From Return to Immunosuppression for the Duration of the Study
NCT02029638 (18) [back to overview]Number of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy
NCT02029638 (18) [back to overview]Number of Adverse Events (AEs) by Severity- Including Infection, Wound Complications, Post-Transplant Diabetes, Hemorrhagic Cystitis and Malignancy
NCT02029638 (18) [back to overview]Histological Severity of Biopsies Demonstrating Acute Rejection as Defined by Banff 2007 Classification Renal Allograft Pathology
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Months
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Months (CC)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention)
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Weeks (CC)
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Weeks (PP)
NCT02038452 (44) [back to overview]NHS Cost Differences at 6 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Months (PP)
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Months (CC)
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity Over 24 Months: 24 Months
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Weeks (PP)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP))
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC))
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity Over 24 Months: 6 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity Over 24 Months: 6 Weeks
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Months (PP)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Months (CC)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Months
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection)
NCT02038452 (44) [back to overview]NHS Cost Differences at 12 Months
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Weeks (PP)
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Weeks (CC)
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Weeks
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Months (PP)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Months (PP)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Months
NCT02038452 (44) [back to overview]NHS Cost Differences at 24 Months
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Months (CC)
NCT02038452 (44) [back to overview]Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks
NCT02038452 (44) [back to overview]Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months
NCT02038452 (44) [back to overview]QALYS at 6 Months (Cross-walk Tariff)
NCT02038452 (44) [back to overview]QALYS at 24 Months (Cross-walk Tariff)
NCT02038452 (44) [back to overview]QALYS at 12 Months (Cross-walk Tariff)
NCT02038452 (44) [back to overview]NHS Cost Differences at 6 Months (CC)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Weeks
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Weeks (CC)
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity Over 24 Months: 12 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Weeks
NCT02093026 (14) [back to overview]Percentage of Participants With ACR20 Response After Third Course
NCT02093026 (14) [back to overview]Percentage of Participants Who Discontinued Treatment Due to Insufficient Response
NCT02093026 (14) [back to overview]Percentage of Participants With ACR50 and ACR70 Response
NCT02093026 (14) [back to overview]Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR
NCT02093026 (14) [back to overview]Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 24 Weeks Following Each Course
NCT02093026 (14) [back to overview]Percentage of Participants With ACR20 Response After Seventh Course
NCT02093026 (14) [back to overview]Percentage of Participants With ACR20 Response After Second Course
NCT02093026 (14) [back to overview]Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response After First Course
NCT02093026 (14) [back to overview]Percentage of Participants With ACR20 Response After Fourth Course
NCT02093026 (14) [back to overview]Percentage of Participants With ACR20 Response After Fifth Course
NCT02093026 (14) [back to overview]American College of Rheumatology Index of Improvement (ACRn) Response
NCT02093026 (14) [back to overview]Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'
NCT02093026 (14) [back to overview]Percentage of Participants With ACR20 Response After Sixth Course
NCT02093026 (14) [back to overview]Time Since Last Treatment Course
NCT02133924 (8) [back to overview]Number of Participants With Overall Response Rate (CR + PR)
NCT02133924 (8) [back to overview]Number of Participants With Complete Response (CR)
NCT02133924 (8) [back to overview]Number of Participants Who Received Additional GVHD Therapies
NCT02133924 (8) [back to overview]Number of Participants With Non-Relapse Mortality (NRM)
NCT02133924 (8) [back to overview]Time to Discontinuation of Steroid Therapy
NCT02133924 (8) [back to overview]Number of Serious Infections
NCT02133924 (8) [back to overview]Number of Participants With SR GVHD
NCT02133924 (8) [back to overview]Number of Participants With Overall Survival (OS)
NCT02137239 (28) [back to overview]Absolute Values of Fasting Lipid Values: Mean
NCT02137239 (28) [back to overview]Percentage of Participants With Serious Adverse Events (SAEs)
NCT02137239 (28) [back to overview]Percentage of Participants With Adverse Events (AEs)
NCT02137239 (28) [back to overview]Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months
NCT02137239 (28) [back to overview]Absolute Values of Fasting Lipid Values: Median
NCT02137239 (28) [back to overview]Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months
NCT02137239 (28) [back to overview]Mean and Mean Change From Baseline in Blood Glucose
NCT02137239 (28) [back to overview]Urine Protein Creatinine Ratio (UPr/Cr)
NCT02137239 (28) [back to overview]Treatment Differences in Therapeutic Modalities
NCT02137239 (28) [back to overview]Time to Event: Graft Loss and Death
NCT02137239 (28) [back to overview]Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
NCT02137239 (28) [back to overview]Percentage of Participants With New Onset Diabetes After Transplant
NCT02137239 (28) [back to overview]Mean and Mean Change From Baseline in Whole Blood HbA1c
NCT02137239 (28) [back to overview]Mean Change From Month 3 in cGFR
NCT02137239 (28) [back to overview]Mean Changes From Baseline Values for Blood Pressure
NCT02137239 (28) [back to overview]Mean Changes From Baseline Values of Lipid Values
NCT02137239 (28) [back to overview]Median Calculated Glomerular Filtration Rate (cGFR)
NCT02137239 (28) [back to overview]Number of Participants Deaths Post Transplant
NCT02137239 (28) [back to overview]Number of Participants Who Experience Graft Loss Post Transplant
NCT02137239 (28) [back to overview]Number of Participants Who Survive With a Functioning Graft
NCT02137239 (28) [back to overview]Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
NCT02137239 (28) [back to overview]Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)
NCT02137239 (28) [back to overview]Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)
NCT02137239 (28) [back to overview]Percentage of Participants With Events of Special Interest (ESIs)
NCT02137239 (28) [back to overview]Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR).
NCT02137239 (28) [back to overview]Absolute Calculated Glomerular Filtration Rate (cGFR): Mean
NCT02137239 (28) [back to overview]Absolute Values of Blood Pressure: Mean
NCT02137239 (28) [back to overview]Absolute Values of Blood Pressure: Median
NCT02152345 (4) [back to overview]Percentage of Participants With Allograft Survival
NCT02152345 (4) [back to overview]Number of Participants With Delayed Graft Function (DGF)
NCT02152345 (4) [back to overview]Number of Participants With an Allograft Rejection Episode
NCT02152345 (4) [back to overview]Estimated Glomerular Filtration Rate (eGFR)
NCT02166463 (3) [back to overview]Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale
NCT02166463 (3) [back to overview]Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review
NCT02166463 (3) [back to overview]Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death
NCT02167217 (1) [back to overview]Bayley III Gross Motor Scaled Score (Change From Baseline to 12 Month)
NCT02176031 (6) [back to overview]GVHD-free Survival Rate
NCT02176031 (6) [back to overview]Overall Survival (OS) Rate
NCT02176031 (6) [back to overview]Rate of GVHD Flares
NCT02176031 (6) [back to overview]GI aGVHD Response Rate
NCT02176031 (6) [back to overview]Percentage Steroid Dose Was Reduced at Day 28, 56, and 100 in Comparison to Steroid Dose at First Administration of Natalizumab.
NCT02176031 (6) [back to overview]Graft-verus-host Disease (GVHD) Response Rate
NCT02199041 (9) [back to overview]Number of Participants With Secondary Graft Failure
NCT02199041 (9) [back to overview]Number of Participants With Event-free Survival (EFS)
NCT02199041 (9) [back to overview]Number of Participants by Severity With Chronic Graft Versus Host Disease (GVHD) in the First 100 Days After HCT
NCT02199041 (9) [back to overview]Number of Participants by Severity With Acute Graft Versus Host Disease (GVHD) in the First 100 Days After HCT
NCT02199041 (9) [back to overview]Number of Participants With Transplant-related Mortality (TRM)
NCT02199041 (9) [back to overview]Number of Participants With Transplant-related Morbidity
NCT02199041 (9) [back to overview]Number of Participants With Malignant Relapse
NCT02199041 (9) [back to overview]Number of Participants With Overall Survival (OS)
NCT02199041 (9) [back to overview]Number of Participants With Neutrophil Engraftment
NCT02242630 (2) [back to overview]Change in Shoulder Function, as Measured by the QuickDASH ®
NCT02242630 (2) [back to overview]Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale
NCT02256969 (4) [back to overview]Corneal Fluorescein Staining (CFS)
NCT02256969 (4) [back to overview]Ocular Surface Disease Index (OSDI)
NCT02256969 (4) [back to overview]Tear Break Up Time (TBUT)
NCT02256969 (4) [back to overview]Symptom Assessment in Dry Eye (SANDE)
NCT02260934 (15) [back to overview]Percentage of Participants With a Sustained Complete Response
NCT02260934 (15) [back to overview]Count of Participants: Frequency of Non-renal Flares by Week 24
NCT02260934 (15) [back to overview]Count of Participants: Frequency of Non-renal Flares by Week 48
NCT02260934 (15) [back to overview]Frequency of Specific Adverse Events of Interest By Event by Week 96
NCT02260934 (15) [back to overview]Frequency of Specific Adverse Events of Interest By Participant, By Week 96
NCT02260934 (15) [back to overview]Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Count of Participants: Frequency of Non-renal Flares by Week 96
NCT02282514 (3) [back to overview]Reduction of Muscle Relaxation Anti-spasmatic Medications
NCT02282514 (3) [back to overview]Short-form 36 Quality of Life Questionnaire (SF-36 QOL)
NCT02282514 (3) [back to overview]Overall Survival
NCT02292082 (11) [back to overview]Time to Meet Physical Therapy Discharge Criteria
NCT02292082 (11) [back to overview]NRS Pain Score With Movement POD2
NCT02292082 (11) [back to overview]Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1
NCT02292082 (11) [back to overview]Opioid Consumption POD2
NCT02292082 (11) [back to overview]Opioid Consumption Postoperative Day (POD) 1
NCT02292082 (11) [back to overview]Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively
NCT02292082 (11) [back to overview]Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively
NCT02292082 (11) [back to overview]Hospital Length of Stay
NCT02292082 (11) [back to overview]Knee Society Score (KSS) at 6 Weeks Postoperatively
NCT02292082 (11) [back to overview]Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively
NCT02292082 (11) [back to overview]Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively
NCT02296346 (1) [back to overview]Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)
NCT02392286 (6) [back to overview]Number of Participants With Response or Remission at End of 4 Weeks
NCT02392286 (6) [back to overview]Number of Participants With Response or Remission at End of 12 Weeks
NCT02392286 (6) [back to overview]Number of Participants With Response or Remission at End of 1 Week
NCT02392286 (6) [back to overview]Number of Participants With Response at End of 2 Weeks
NCT02392286 (6) [back to overview]Number of Participants With Corticosteroid-associated Side Effects
NCT02392286 (6) [back to overview]Number of Participants in Remission at End of 2 Weeks
NCT02406209 (1) [back to overview]Anterior Chamber Cell Grade at Week 8
NCT02464657 (4) [back to overview]Relapse Free Survival
NCT02464657 (4) [back to overview]Overall Survival
NCT02464657 (4) [back to overview]Maximum Tolerated Dose (MTD) of Nivolumab
NCT02464657 (4) [back to overview]Event-Free Survival (EFS)
NCT02495077 (44) [back to overview]Change in eGFR Between 6 Months and 24 Months as Measured by CKD-EPI
NCT02495077 (44) [back to overview]Change in eGFR Between 6 Months and 24 Months as Measured by MDRD
NCT02495077 (44) [back to overview]Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by CKD-EPI
NCT02495077 (44) [back to overview]Percent of Participants With de Novo DSA.
NCT02495077 (44) [back to overview]Percent of Participants With Death or Graft Failure.
NCT02495077 (44) [back to overview]Percent of Participants With Impaired Wound Healing Manifested by Wound Dehiscence, Wound Infection, or Hernia at the Site of the Transplant Incision
NCT02495077 (44) [back to overview]Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.
NCT02495077 (44) [back to overview]Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.
NCT02495077 (44) [back to overview]Percent of Participants With Malignancy.
NCT02495077 (44) [back to overview]Percent of Participants With Mycobacterial or Fungal Infections
NCT02495077 (44) [back to overview]Percent of Participants With Only Graft Failure.
NCT02495077 (44) [back to overview]Percent of Participants With Primary Non-Function (PNF), Defined as Dialysis-dependency for More Than 3 Months.
NCT02495077 (44) [back to overview]The Difference Between the Mean eGFR (Modified MDRD) in the Experimental vs. Control Groups.
NCT02495077 (44) [back to overview]The Percent of Participants Who Need Dialysis After Week 1.
NCT02495077 (44) [back to overview]The Percent of Participants Whose Day 2 Serum CRR Was Less Than 30%.
NCT02495077 (44) [back to overview]The Percent of Participants Whose Day 5 Serum CRR Was Less Than 70%.
NCT02495077 (44) [back to overview]The Percent of Participants With a Serum Creatinine of More Than 3 mg/dL.
NCT02495077 (44) [back to overview]Change From Baseline (Immediately After Surgery) in Serum Creatinine.
NCT02495077 (44) [back to overview]eGFR Values as Measured by CKD-EPI
NCT02495077 (44) [back to overview]eGFR Values as Measured by MDRD
NCT02495077 (44) [back to overview]Duration of Delayed Graft Function (DGF), Defined as Time From Transplantation to the Last Required Dialysis Treatment.
NCT02495077 (44) [back to overview]Days From Transplantation Until Event (ACR, AMR, or Hospitalization for Infection and/or Malignancy)
NCT02495077 (44) [back to overview]Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 5 Divided by the First Creatinine After Surgery.
NCT02495077 (44) [back to overview]Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 2 Divided by he First Creatinine After Surgery
NCT02495077 (44) [back to overview]Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by MDRD
NCT02495077 (44) [back to overview]BANFF Grades of First AMR.
NCT02495077 (44) [back to overview]Number of Dialysis Sessions.
NCT02495077 (44) [back to overview]Percent of Participants That Required at Least One Dialysis Treatment.
NCT02495077 (44) [back to overview]Percent of Participants With Any Infection Requiring Hospitalization or Resulting in Death.
NCT02495077 (44) [back to overview]eGFR Values as Measured by MDRD
NCT02495077 (44) [back to overview]Percent of Participants With BANFF Chronicity Scores > or Equal 2 on the 24 Month Biopsy.
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR)
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR).
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR.
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR)
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection.
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR).
NCT02495077 (44) [back to overview]Percent of Participants With BK Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site.
NCT02495077 (44) [back to overview]Percent of Participants With CMV Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site
NCT02495077 (44) [back to overview]Change in eGFR Between 3 Months and 24 Months as Measured by CKD-EPI
NCT02495077 (44) [back to overview]Change in eGFR Between 3 Months and 24 Months as Measured by MDRD
NCT02495077 (44) [back to overview]eGFR Values as Measured by CKD-EPI
NCT02515045 (3) [back to overview]Change From Baseline (Preoperative Exam) in Macular Thickness
NCT02515045 (3) [back to overview]Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
NCT02515045 (3) [back to overview]Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
NCT02539394 (19) [back to overview]Patients' Bazaz Dysphagia Score - Liquid
NCT02539394 (19) [back to overview]Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain
NCT02539394 (19) [back to overview]Patients' Pain Scores on the Visual Analog Scale - Neck Pain
NCT02539394 (19) [back to overview]Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain
NCT02539394 (19) [back to overview]Patients' Neck Disability
NCT02539394 (19) [back to overview]Patient Reported Swallowing Difficulty Over 1 Year
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Social)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Sleep)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Mental)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Food Selection)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Fear Swallow)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Fatigue)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Eating Duration)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Communication)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Burden)
NCT02539394 (19) [back to overview]Adverse Event
NCT02539394 (19) [back to overview]Fusion Rate
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Eating Desire)
NCT02539394 (19) [back to overview]Patients' Bazaz Dysphagia Score - Solid
NCT02550652 (22) [back to overview]Terminal Plasma Half-Life (t1/2) of Obinutuzumab
NCT02550652 (22) [back to overview]Systemic Clearance of Obinutuzumab
NCT02550652 (22) [back to overview]Percentage of Participants With First Protocol Defined Overall Response Over the Course of 52 Weeks
NCT02550652 (22) [back to overview]Percentage of Participants With First Protocol Defined CRR Over the Course of 52 Weeks
NCT02550652 (22) [back to overview]Percentage of Participants With Anti-Drug Antibody (ADA) to Obinutuzumab
NCT02550652 (22) [back to overview]Percentage of Participants Who Achieve Protocol Defined Third mCRR (mCRR3) at Week 52
NCT02550652 (22) [back to overview]Percentage of Participants With Adverse Events of Special Interest: Infusion Related Reactions, Grade 3 or Higher Infections, Drug-related Neutropenia and Drug-related Thrombocytopenia
NCT02550652 (22) [back to overview]Percentage of Participants Who Achieve Protocol Defined Second mCRR (mCRR2) at Week 52
NCT02550652 (22) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Obinutuzumab
NCT02550652 (22) [back to overview]Percentage of Participants Who Achieve Protocol Defined Partial Renal Response (PRR) at Week 52
NCT02550652 (22) [back to overview]Percentage of Participants Who Achieve Protocol Defined Overall Response (OR) at Week 52
NCT02550652 (22) [back to overview]Change From Baseline of Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Score
NCT02550652 (22) [back to overview]Area Under the Plasma Concentration Versus Time Curve (AUC) of Obinutuzumab
NCT02550652 (22) [back to overview]Volume of Distribution Under Steady State (Vss) of Obinutuzumab
NCT02550652 (22) [back to overview]Percentage of Participants Who Achieve Protocol Defined Modified CRR (mCRR1) at Week 52
NCT02550652 (22) [back to overview]Percentage of Participants Who Achieve Protocol Defined Complete Renal Response (CRR) at Week 52
NCT02550652 (22) [back to overview]Change From Baseline in Complement Component 3 (C3) Levels at Week 52
NCT02550652 (22) [back to overview]Change From Baseline in C4 Levels at Week 52
NCT02550652 (22) [back to overview]Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody Levels at Week 52
NCT02550652 (22) [back to overview]Percentage of Participants Who Achieve Protocol Defined CRR at Week 24
NCT02550652 (22) [back to overview]Percentage of Participants With Adverse Events (AEs)
NCT02550652 (22) [back to overview]Percent Change From Baseline in Circulating CD19-Positive B-Cell Levels
NCT02569437 (5) [back to overview]Visual Analog Scale
NCT02569437 (5) [back to overview]Subjective Symptom Composite Scoring
NCT02569437 (5) [back to overview]Sino-nasal Outcome Test (SNOT 22)
NCT02569437 (5) [back to overview]Middle Meatus Culture
NCT02569437 (5) [back to overview]Endoscopic Nasal Polyp Score
NCT02576249 (3) [back to overview]The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale
NCT02576249 (3) [back to overview]Pain Scale Score
NCT02576249 (3) [back to overview]Tegner Activity Level Scale
NCT02652390 (6) [back to overview]11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score
NCT02652390 (6) [back to overview]Bodily Pain Score
NCT02652390 (6) [back to overview]Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand
NCT02652390 (6) [back to overview]Satisfaction Score
NCT02652390 (6) [back to overview]Palmar Pain Score
NCT02652390 (6) [back to overview]Symptom Severity Score
NCT02790788 (22) [back to overview]Left and Right Ventricular Diastolic Area (cm^2) by Echocardiography.
NCT02790788 (22) [back to overview]Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.
NCT02790788 (22) [back to overview]Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.
NCT02790788 (22) [back to overview]Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).
NCT02790788 (22) [back to overview]Steroid-associated Complications.
NCT02790788 (22) [back to overview]Left and Right Ventricular Ejection Fraction (%) by Echocardiography.
NCT02790788 (22) [back to overview]Eccentricity Index by Echocardiography.
NCT02790788 (22) [back to overview]Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL).
NCT02790788 (22) [back to overview]Core Body Temperature in Degrees Celcius.
NCT02790788 (22) [back to overview]Cerebral Blood Flow Index by Near Infrared Spectroscopy With Indocyanine Green.
NCT02790788 (22) [back to overview]Survival to Hospital Discharge With Favorable Functional Outcome.
NCT02790788 (22) [back to overview]Organ Failure-free Days.
NCT02790788 (22) [back to overview]Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.
NCT02790788 (22) [back to overview]Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.
NCT02790788 (22) [back to overview]Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.
NCT02790788 (22) [back to overview]Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port (as Feasible).
NCT02790788 (22) [back to overview]Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.
NCT02798523 (1) [back to overview]Number of Participants Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)
NCT02828358 (5) [back to overview]Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to First Course of Azacitidine
NCT02828358 (5) [back to overview]Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of Second Course of Azacitidine
NCT02828358 (5) [back to overview]Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of First Course of Azacitidine
NCT02828358 (5) [back to overview]Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to Second Course of Azacitidine
NCT02828358 (5) [back to overview]Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R)
NCT02847494 (3) [back to overview]Medication Preference as Assessed by Self-report
NCT02847494 (3) [back to overview]Number of Participants With Sustained Headache Freedom
NCT02847494 (3) [back to overview]Headache Days as Self-reported by Participants
NCT02953678 (10) [back to overview]Failure-free Survival (FFS)
NCT02953678 (10) [back to overview]Relapse-related Mortality Rate
NCT02953678 (10) [back to overview]Percentage of Participants With Six-month Duration of Response (DOR)
NCT02953678 (10) [back to overview]Overall Survival (OS)
NCT02953678 (10) [back to overview]Percentage of Participants With Three-month DOR
NCT02953678 (10) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs
NCT02953678 (10) [back to overview]Relapse Rate
NCT02953678 (10) [back to overview]Overall Response Rate (ORR) at Day 28
NCT02953678 (10) [back to overview]Overall Response Rate (ORR)
NCT02953678 (10) [back to overview]Nonrelapse Mortality (NRM)
NCT02953873 (5) [back to overview]Dose Modifications
NCT02953873 (5) [back to overview]Number of Days to Reach Therapeutic Trough Goal
NCT02953873 (5) [back to overview]Dose-normalized Trough
NCT02953873 (5) [back to overview]Total Daily Dose
NCT02953873 (5) [back to overview]Weight-Based Dose Requirement
NCT02954198 (4) [back to overview]Self-reported Medication Adherence From Baseline to 6 Months.
NCT02954198 (4) [back to overview]Percent of Participants Who Experienced Kidney Transplant Graft Loss
NCT02954198 (4) [back to overview]Percent of Participants Experiencing Acute Allograft Rejection
NCT02954198 (4) [back to overview]Subject Specific Change on Medication Side Effect Scale
NCT02956122 (22) [back to overview]Failure-free Survival - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Graft-versus-host Disease (GvHD)-Free Survival - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Percentage of Participants Achieving Overall Response (OR) At Day 28
NCT02956122 (22) [back to overview]Number of Participants With Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs and Temporally-associated AEs
NCT02956122 (22) [back to overview]Infection-related Mortality - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Incidence of Chronic Graft-versus-host Disease (GvHD)
NCT02956122 (22) [back to overview]Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
NCT02956122 (22) [back to overview]"Area Under the Plasma Concentration Curve From Time Zero to Time t AUC(0-t) of GLASSIA"
NCT02956122 (22) [back to overview]Apparent Terminal Half-life (t1/2) of GLASSIA
NCT02956122 (22) [back to overview]Apparent Volume of Distribution at Steady State (Vss) of GLASSIA
NCT02956122 (22) [back to overview]Number of Participants With Clinically Significant Changes in Vital Signs
NCT02956122 (22) [back to overview]Maximum Observed Plasma Concentration (Cmax) of GLASSIA
NCT02956122 (22) [back to overview]Number of Participants With Recurrence of Primary Malignancies
NCT02956122 (22) [back to overview]Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
NCT02956122 (22) [back to overview]Transplant-related Mortality
NCT02956122 (22) [back to overview]Overall Survival (OS) - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Area Under the Plasma Concentration Curve (AUC0-inf) From Time Zero to Infinity
NCT02956122 (22) [back to overview]Graft-versus-host Disease (GvHD)-Related Mortality - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Percentage of Participants Achieving Overall Response at Day 56
NCT02956122 (22) [back to overview]Systemic Clearance at Steady State (CLss) of GLASSIA
NCT02956122 (22) [back to overview]All-cause Mortality - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Percentage of Participants Achieving Gastrointestinal (GI) Response at Day 28
NCT02962284 (6) [back to overview]Prostate Specific Antigen Levels
NCT02962284 (6) [back to overview]Testosterone Complete Suppression
NCT02962284 (6) [back to overview]Percentage of Subjects With Prostate Specific Antigen - 50 Response
NCT02962284 (6) [back to overview]Number of Subjects With Adverse Events
NCT02962284 (6) [back to overview]Testosterone Levels
NCT02962284 (6) [back to overview]Proportion of Subjects With Disease Progression
NCT03123614 (4) [back to overview]Best Corrected Visual Acuity at 3 Months
NCT03123614 (4) [back to overview]Number of Eyes With Corneal Haze
NCT03123614 (4) [back to overview]Uncorrected Visual Acuity
NCT03123614 (4) [back to overview]Change in Intraocular Pressure (IOP) From Baseline Through Month 3
NCT03139604 (20) [back to overview]Cmin of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Duration of Response
NCT03139604 (20) [back to overview]Failure-free Survival
NCT03139604 (20) [back to overview]Incidence Rate of aGVHD Flares
NCT03139604 (20) [back to overview]Incidence Rate of Secondary Graft Failure
NCT03139604 (20) [back to overview]Malignancy Relapse-related Mortality Rate
NCT03139604 (20) [back to overview]Number of Treatment-emergent Adverse Events With INCB39110
NCT03139604 (20) [back to overview]Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index
NCT03139604 (20) [back to overview]AUC of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]CL/F of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Nonrelapse Mortality
NCT03139604 (20) [back to overview]Proportion of Subjects Who Discontinue Immunosuppressive Medications
NCT03139604 (20) [back to overview]Proportion of Subjects Who Discontinue Corticosteroids
NCT03139604 (20) [back to overview]Objective Response Rate
NCT03139604 (20) [back to overview]Cmax of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Incidence Rate of cGVHD
NCT03139604 (20) [back to overview]Tmax of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Time to Response
NCT03139604 (20) [back to overview]Relapse Rate of Malignant and Nonmalignant Hematologic Disease
NCT03139604 (20) [back to overview]Overall Survival (OS)
NCT03229538 (7) [back to overview]Number of Participants With a Post-operative Length of Stay Greater Than 90 Days
NCT03229538 (7) [back to overview]Number of Participants With Any Other Post-operative Complications From the Start of Study Drug Administration Until Hospital Discharge.
NCT03229538 (7) [back to overview]Number of Participants With Death or Major Complication as Defined by an Outcome in One of the 7 Highest Global Ranking Categories
NCT03229538 (7) [back to overview]Number of Participants With Mortality, Including In-hospital Mortality or Mortality After Hospital Discharge But Within 30 Days of the Last Dose of Study Drug
NCT03229538 (7) [back to overview]Number of Participants With Occurrence of Any One or More of the Following STS-CHSD-defined Major Post-operative Infectious Complications: Postprocedural Infective Endocarditis, Pneumonia, Sepsis, Deep Wound Infection, Mediastinitis.
NCT03229538 (7) [back to overview]Number of Participants With Post-operative Low Cardiac Output Syndrome
NCT03229538 (7) [back to overview]Number of Participants With Prolonged Mechanical Ventilation (Greater Than 7 Days)
NCT03232749 (3) [back to overview]ASES Scores at Each Time Point
NCT03232749 (3) [back to overview]SST (Simple Shoulder Test) Scores at Each Time Point
NCT03232749 (3) [back to overview]Visual Analog Scale Scores at Each Time Point.
NCT03320434 (4) [back to overview]Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15
NCT03320434 (4) [back to overview]Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1
NCT03320434 (4) [back to overview]Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15
NCT03320434 (4) [back to overview]Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1
NCT03368664 (3) [back to overview]Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Months 4 and 8
NCT03368664 (3) [back to overview]Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Participants With New or Enlarged T2 Lesions Per MRI Scan
NCT03368664 (3) [back to overview]Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan
NCT03387046 (16) [back to overview]Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 12 and 24
NCT03387046 (16) [back to overview]Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
NCT03387046 (16) [back to overview]25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 8
NCT03387046 (16) [back to overview]Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
NCT03387046 (16) [back to overview]Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
NCT03387046 (16) [back to overview]Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
NCT03387046 (16) [back to overview]Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
NCT03387046 (16) [back to overview]Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
NCT03387046 (16) [back to overview]9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03388008 (1) [back to overview]Donor-specific HLA Antibodies, Re-transplantation, or Death
NCT03403517 (5) [back to overview]PACU Stay
NCT03403517 (5) [back to overview]Total Complication Rate
NCT03403517 (5) [back to overview]Mortality
NCT03403517 (5) [back to overview]Complications, Post-anesthesia Care Unit (PACU)
NCT03403517 (5) [back to overview]Hospital Stay
NCT03578276 (3) [back to overview]Change From Baseline (Preoperative Exam) in Macular Thickness
NCT03578276 (3) [back to overview]Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
NCT03578276 (3) [back to overview]Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
NCT03593902 (2) [back to overview]Survival of Treatment
NCT03593902 (2) [back to overview]Change in Skin Score by mRSS
NCT03640949 (3) [back to overview]Number of Participants With a Favorable Neurological Outcome at 30 Days
NCT03640949 (3) [back to overview]Number of Participants That Survived 30 Days
NCT03640949 (3) [back to overview]Number of Participants With Return of Spontaneous Circulation
NCT03704584 (3) [back to overview]Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7
NCT03704584 (3) [back to overview]Number of Patients With Subsequent Reinjection and Surgical Operation
NCT03704584 (3) [back to overview]10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
NCT03721965 (1) [back to overview]Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
NCT03797872 (1) [back to overview]Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study
NCT03817853 (8) [back to overview]Percentage of IRRs Regardless of Grade by Cycle
NCT03817853 (8) [back to overview]Percentage of Grade >=3 Infusion-Related Reactions (IRRs) During Cycle 2 in Patients Who Had Previously Received Obinutuzumab at the Standard Infusion Rate During Cycle 1 Without Experiencing a Grade 3 or 4 IRR
NCT03817853 (8) [back to overview]Duration of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle
NCT03817853 (8) [back to overview]Objective Response Rate (ORR) at the End of Induction (EOI) Therapy
NCT03817853 (8) [back to overview]Duration (In Minutes) of Obinutuzumab Administration by Cycle
NCT03817853 (8) [back to overview]Time to IRR From Infusion to Onset of the IRR During Cycle 2
NCT03817853 (8) [back to overview]Percentage of Participants With Adverse Events (AEs)
NCT03817853 (8) [back to overview]Type of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle
NCT03818737 (6) [back to overview]Change in EuroQuality of Life (EQ-5D-3L) Index Score
NCT03818737 (6) [back to overview]Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score
NCT03818737 (6) [back to overview]Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score
NCT03818737 (6) [back to overview]Overall MRI Grade of Osteoarthritis
NCT03818737 (6) [back to overview]Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score
NCT03818737 (6) [back to overview]Change in Visual Analog Pain Scale (VAS-pain) Score
NCT03852537 (14) [back to overview]Cardiovascular Dysfunction
NCT03852537 (14) [back to overview]ICU Admission
NCT03852537 (14) [back to overview]Mortality
NCT03852537 (14) [back to overview]Organ Failure
NCT03852537 (14) [back to overview]Timely Initiation of Corticosteroids and Implementation of Biomarker-titrated Corticosteroid Dosing
NCT03852537 (14) [back to overview]Need for Invasive Mechanical Ventilation
NCT03852537 (14) [back to overview]Occurrence of Delirium
NCT03852537 (14) [back to overview]Oxygen-free Days
NCT03852537 (14) [back to overview]Occurrence of Secondary Infection
NCT03852537 (14) [back to overview]Occurrence of Hyperglycemia
NCT03852537 (14) [back to overview]New Onset Cardiac Arrhythmias
NCT03852537 (14) [back to overview]Need for Noninvasive Mechanical Ventilation
NCT03852537 (14) [back to overview]Need for High Flow Nasal Cannula Oxygen
NCT03852537 (14) [back to overview]Myocardial Injury
NCT03994731 (6) [back to overview]Percentage of sUA (sUA < 6 mg/dL) Responders During Month 12
NCT03994731 (6) [back to overview]Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6
NCT03994731 (6) [back to overview]Percentage of Participants With Complete Resolution of ≥ 1 Tophi at Week 52
NCT03994731 (6) [back to overview]Mean Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52
NCT03994731 (6) [back to overview]Mean Change From Baseline in HAQ Health Score at Week 52
NCT03994731 (6) [back to overview]Mean Change From Baseline HAQ Pain Score at Week 52
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Week 24
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR), Graft Loss, Death or Loss to Follow-up (LTFU)
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Weeks 12 and 48
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR)
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Acute Rejections
NCT04046549 (7) [back to overview]Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)
NCT04046549 (7) [back to overview]Percentage of Participants With Antibody-Mediated Rejection
NCT04184999 (1) [back to overview]Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively
NCT04233164 (1) [back to overview]Number of SLE Patients That Were Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)
NCT04294459 (23) [back to overview]Duration for Achieving Target cPRA
NCT04294459 (23) [back to overview]Duration of Response (DOR)
NCT04294459 (23) [back to overview]Number of Kidney Transplant Offers
NCT04294459 (23) [back to overview]Number of Participants Achieving Target cPRA
NCT04294459 (23) [back to overview]Number of Participants With Graft Survival at 6 Months Post-Transplant
NCT04294459 (23) [back to overview]Pharmacokinetics (PK) Parameters: Concentration Observed at the End of First Intravenous Infusion (Ceoi) of Isatuximab
NCT04294459 (23) [back to overview]PK Parameters: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 168 Hours Over the Dosing Interval (AUC0-168 Hours) After First Infusion of Isatuximab
NCT04294459 (23) [back to overview]PK Parameters: Last Concentration Observed Above the Lower Limit of Quantification (Clast) After the First Infusion of Isatuximab
NCT04294459 (23) [back to overview]PK Parameters: Maximum Concentration Observed (Cmax) After the First Infusion of Isatuximab
NCT04294459 (23) [back to overview]PK Parameters: Time of Clast (Tlast) After First Infusion of Isatuximab
NCT04294459 (23) [back to overview]PK Parameters: Time Taken to Reach Cmax (Tmax) After the First Infusion of Isatuximab
NCT04294459 (23) [back to overview]PK Parameters: Trough Plasma Concentrations (Ctrough) of Isatuximab
NCT04294459 (23) [back to overview]Time to First Transplant Offer
NCT04294459 (23) [back to overview]Time to Transplant
NCT04294459 (23) [back to overview]Number of Participants With Abnormal Electrolytes Parameters
NCT04294459 (23) [back to overview]Number of Participants With Abnormal Metabolism Parameters
NCT04294459 (23) [back to overview]Number of Participants With Anti-drug Antibodies (ADA) Against Isatuximab
NCT04294459 (23) [back to overview]Number of Participants With Anti-Human Leukocyte Antigen (HLA)-Antibody Reduction
NCT04294459 (23) [back to overview]Number of Participants With Hematological Abnormalities
NCT04294459 (23) [back to overview]Number of Participants With Liver Function Abnormalities
NCT04294459 (23) [back to overview]Number of Participants With Renal Function Abnormalities
NCT04294459 (23) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)
NCT04294459 (23) [back to overview]Percentage of Participants With Response
NCT04323592 (6) [back to overview]Admission to Intensive Care Unit (ICU)
NCT04323592 (6) [back to overview]Change in C-reactive Protein (CRP)
NCT04323592 (6) [back to overview]Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28
NCT04323592 (6) [back to overview]Endotracheal Intubation (Invasive Mechanical Ventilation)
NCT04323592 (6) [back to overview]In-hospital Death Within 28 Days
NCT04323592 (6) [back to overview]Number of Days Free From Mechanical Ventilation
NCT04380857 (5) [back to overview]Patient Preference Between Groups
NCT04380857 (5) [back to overview]Mean Change in Pain
NCT04380857 (5) [back to overview]Loss of Lines in Uncorrected Visual Acuity
NCT04380857 (5) [back to overview]Post op Pain Management Per Eye
NCT04380857 (5) [back to overview]Number of Lines Lost From Best Corrected Visual Acuity
NCT04900220 (2) [back to overview]Intensity of Pain
NCT04900220 (2) [back to overview]Incidence of Pain
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Post Treatment Pain Scores
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Post Treatment Pain Scores (6 Weeks)
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Pre Treatment Pain Scores Using Knee Society Scores
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
NCT05113901 (18) [back to overview]Number of Participants With Complications Following Treatment
NCT05113901 (18) [back to overview]Adverse Events or Outcomes Outside of Manipulations Under Anesthesia
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee 6 Wks After Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment
NCT05113901 (18) [back to overview]Range of Motion in Degrees at Pre and Post Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Post Treatment Pain Scores
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment
NCT05438277 (1) [back to overview]Incidence of a Flare Reaction

Progression-free Survival

time to disease progression or death due to any cause (NCT00003270)
Timeframe: 1 year

Intervention% of participants (Number)
Arm 150

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Number of Participants With Marked Laboratory Abnormalities: Hematology Parameters

A marked reference range was predefined by Roche. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range (low or high) that also represent a defined change from Baseline were considered marked laboratory abnormalities (i.e. potentially clinically relevant). Hematology included hemoglobin, hematocrit, white blood cell count (WBC) with differential (including granulocytes or neutrophils, basophils, eosinophils, monocytes, lymphocytes), platelets, and erythrocyte count (NCT00048165)
Timeframe: Up to 12 months

,
Interventionparticipants (Number)
Hematocrit-high (n=210, 203)Hematocrit-low (n=210, 203)Hemoglobin-high (n=210, 204)Hemoglobin-low (n=210, 204)Platelets-high (n=210, 203)Platelets-low (n=210, 203)RBC-high (n=209, 203)RBC-low (n=209, 203)Basophils-high (n=199, 195)Eosinophils-high (n=199, 195)Lymphocytes-high (n=199, 198)Lymphocytes-low (n=199, 198)Monocytes-high (n=199, 198)Monocytes-low (n=199, 198)Neutrophils-low (n= 199, 198)WBC-high (n=207, 201)WBC-low (n=207, 201)
Daclizumab011601072301116402157514336143
Placebo011701121222106402157620335729

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Median Change From Baseline for Lipid Profile (Total Cholesterol, Low Density Lipoproteins, High Density Lipoproteins, and Triglycerides)

Lipid profile included total cholesterol, low density lipoproteins (LDL), high density lipoproteins (HDL), and triglycerides (all total cholesterol, LDL, HDL, and triglycerides with unit milligram per decilitre [mg/dL]), were reported. The median change from baseline (Day -2) in lipid profile values at 3 months and 6 months was reported. (NCT00048165)
Timeframe: From Baseline (Day -2) to 3 months and 6 months

,
Interventionmg/dL (Median)
Total cholesterol, change at 3 months (n=119,119)Total cholesterol, change at 6 months (n=126,130)LDL, Change at 3 months (n=92,89)LDL, Change at 6 months (n=91,99)HDL, change at 3 months (n=97, 101)HDL, change at 6 months (n=102,112)Triglycerides,change at 3 months (n=104,108)Triglycerides,change at 6 months (n=109,117)LDL/HDL ratio,change at 3 months (n=91,89)LDL/HDL ratio,change at 6 months (n=91, 99)
Daclizumab0.650.280.250.030.340.230.260.20-0.44-0.50
Placebo0.910.610.340.210.310.200.460.44-0.12-0.14

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Median Time to First Acute Rejection Episode Within the First 6 Months and 12 Months PT

The median time to first acute rejection episode within first 6 months and 12 months PT was reported. (NCT00048165)
Timeframe: Within 6 months and 12 months PT

,
Interventiondays (Median)
Within 6 months (n= 77, 104)Within 12 months (n=97, 116)
Daclizumab6196
Placebo2126

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Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT

The number of participants with 0,1, 2, 3 or 4 episodes at 6 and 12 months PT were reported. An episode of acute rejection was defined according to the date of positive biopsy of Grade IIIA or worse or the date of start of treatment for HDC, whichever came first. (NCT00048165)
Timeframe: Within 6 months and 12 months PT

,
Interventionparticipants (Number)
Within 6 months, 0 episodeWithin 6 months, 1 episodeWithin 6 months, 2 episodesWithin 6 months, 3 episodesWithin 6 months, 4 episodesWithin 12 months, 0 episodeWithin 12 months, 1 episodeWithin 12 months, 2 episodesWithin 12 months, 3 episodesWithin 12 months, 4 episodes
Daclizumab139631220119682333
Placebo114821921102901952

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Number of Participant Who Died Within 6 Months 12 Months and 3 Years PT

The survival of the graft and participants at 6,12 months and 3 years PT was reported (NCT00048165)
Timeframe: At 6 months, 12 months , 3 years PT

,
Interventionparticipants (Number)
Within 6 monthsWithin 12 monthsWithin 3 years
Daclizumab1621NA
Placebo1012NA

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Number of Participants Using Monomurab Cluster of Differentiation 3, Orthoclone Polyclonal Antithymocyte Globulin or Antilymphocyte Globulin in the First 6 Months and 12 Months PT

The number of participants who received monomurab Cluster of differentiation 3, orthoclone, polyclonal antithymocyte globulin or antilymphocyte globulin for treatment of biopsy proven rejection or HDC within 6 and 12 months PT were reported. (NCT00048165)
Timeframe: Within 6 months and 12 months PT

,
Interventionparticipants (Number)
Within 6 monthsWithin 12 months
Daclizumab1723
Placebo1921

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Number of Participants With Any Adverse Events and Any Serious Adverse Event, and Adverse Events Leading to Premature Withdrawal

An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. (NCT00048165)
Timeframe: Up to 12 months

,
Interventionparticipants (Number)
Any AEsAny SAE'sAny AEs leading to premature discontinuation
Daclizumab21410814
Placebo20710211

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Number of Participants With Malignancies and Opportunistic Infections

The opportunistic infections included infections with Cytomegalovirus, Aspergillus, Candida, Pneumocystis, Cryptococcus, Listeria, Herpes simplex, Herpes zoster. For malignancy, participants with any type of malignancy whose date of onset or diagnosis was after randomization was reported. (NCT00048165)
Timeframe: Up to 12 months

,
Interventionparticipants (Number)
Participants with malignanciesParticipants with opportunistic infections
Daclizumab1171
Placebo1180

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Number of Participants With Marked Laboratory Abnormalities: Biochemistry Parameters

A marked reference range was predefined by Roche. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range (low or high) that also represent a defined change from Baseline were considered marked laboratory abnormalities (i.e. potentially clinically relevant). Biochemistry included blood urea nitrogen, creatinine, serum glutamic oxalacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl transferase (GGT), phosphorous, total bilirubin, direct bilirubin, total protein, albumin, glucose, alkaline phosphatase, low density lipoprotein (LDH), uric acid, carbon dioxide, magnesium, sodium, potassium, chloride, calcium, LDL, HDL, total cholesterol, and triglycerides. (NCT00048165)
Timeframe: Up to 12 months

,
Interventionparticipants (Number)
SGPT-high (n=200, 200)ALP-high (n=201, 200)SGOT-high (n=201, 200)GGT-high (n=180, 175)LDH-high (n=194, 191)Total bilirubin-high (n=201, 200)BUN-high (n= 210, 200)Creatinine-high (n=211, 203)Albumin-low (n=198,197)Total protein-high (n=195,196)Total protein-low(n=195,196)Cholesterol-high (n=174, 174)Triglycerides-high (n=164, 164)Carbondioxide-high (n=206, 197)Carbondioxide-low (n=206, 197)Chloride-high (n=211, 203)Chloride-low (n=211, 203)Potassium-high (n=211, 204)Potassium-low (n=211, 204)Sodium-high (n=211, 203)Sodium-low (n=211, 203)Calcium-low (n=207, 201)Glucose fasting-high (n=210, 203)Glucose fasting-low (n=210, 203)Phosphate-high (n=199, 194)Phosphate-low (n=199,194)Uric acid high (n=191, 188)
Daclizumab4815229053289366475853352712142742839283543223
Placebo457257454209564500794302153367211144273482620

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Number of Participants With Worst ISHLT Biopsy Grade Within First 6 Months and 12 Months PT

The number of participants with Worst International Society of Heart and Lung Transplant (ISHLT) grade within first 6 months and 12 months PT were reported. ISHLT is a standardized grading method to determine the acute cellular rejection on endomyocardial biopsy ; where 0= no rejection, IA= focal (perivascular or interstitial) infiltrate without necrosis, IB= diffuse but sparse infiltrate without necrosis, II=one focus only with aggressive infiltration and/or focal myocyte damage, IIIA=multifocal aggressive infiltrates and/or myocyte damage, IIIB= diffuse inflammatory process with necrosis, IV= diffuse aggressive polymorphous and/or infiltrate and/or edema and/or hemorrhage and/or vasculitis, with necrosis (NCT00048165)
Timeframe: Within 6 months and 12 months PT

,
Interventionparticipants (Number)
Within 6 months, Grade 0Within 6 months, Grade IAWithin 6 months, Grade IBWithin 6 months, Grade IIWithin 6 months, Grade IIIAWithin 6 months, Grade IIIBWithin 6 months, Grade IVWithin 12 months, Grade 0Within 12 months, Grade IAWithin 12 months, Grade IBWithin 12 months, Grade IIWithin 12 months, Grade IIIAWithin 12 months, Grade IIIBWithin 12 months, Grade IV
Daclizumab96426554881756225163111
Placebo551283874151439214785151

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Median Change From Baseline for LDL/HDL Ratio

(NCT00048165)
Timeframe: From Baseline (Day -2) to 3 months, and 6 months

,
Interventionratio (Median)
LDL/HDL ratio,change at 3 months (n=91,89)LDL/HDL ratio,change at 6 months (n=91, 99)
Daclizumab-0.44-0.50
Placebo-0.12-0.14

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Mean Maintenance Doses of Mycophenolate Mofetil, Cyclosporine, and Cumulative Dose of Corticosteroids at 6 and 12 Months PT

The maintenance doses of mycophenolate mofetil (1.5g twice a day daily), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg oral [PO]/nasogastric [NG] within 72 hours post-operative]), and cumulative dose of corticosteroids (500-1000 mg IV methylprednisolone pre-operative switched to oral at 0.5-1 mg/kg/day. Tapered to 0.2 mg/kg/d by Day 28, 0.1-0.15 mg/kg/day from Days 36 to 90, and 0.1-0.15 mg/kg/day from Days 120 to 180)at 6 and 12 months PT were reported. Maintenance dose was calculated as total dose per day summed over all days that a participant was administered drug within the specified time interval, divided by number of days that a participant took drug within that time interval. (NCT00048165)
Timeframe: Within 6 months and 12 months PT

,
Interventionmg (Mean)
MMF dose, 6 months PT (n=193, 201)MMF dose,12 months PT (n=188, 194)IV Cyclosporine dose, 6 months PT (n=2, 1)IV Cyclosporine dose, 12 months PT (n=4, 2)PO/NG Cyclosporine dose, 6 months PT (n=184, 182)PO/NG Cyclosporine dose, 12 months PT (n=170, 170)Cumulative corticosteroids,6 months PT(n=203, 206)Cumulative corticosteroids,12 months PT(n=195,200)
Daclizumab2522.22394.186.1193.5321.9294.7848.11199.6
Placebo24502380.138.146.7331.1305.7955.41288.9

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Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT

The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months. Participants with acute rejection included participants with a biopsy histology of ISHLT Grade IIIA, IIIB, or IV and participants with hemodynamic compromise (HDC) who were treated for acute rejection (whether or not a biopsy was done and regardless of the grade of the biopsy). Participants who had treatment failure included participants who died within 6 months of transplantation before experiencing acute rejection or who were re-transplanted within 6 months of the primary transplantation and who did not experience an acute rejection or who were lost to follow-up (NCT00048165)
Timeframe: Up to 12 months PT

Interventionparticipants (Number)
Daclizumab97
Placebo116

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Number of Participants Who Developed Acute Rejection Episode Within 6 Months Post-Transplant

The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months post-transplant (PT). Participants with acute rejection included participants with a biopsy histology of International Society of Heart and Lung Transplant (ISHLT) Grade IIIA, IIIB, or IV and participants with hemodynamic compromise (HDC) who were treated for acute rejection (whether or not a biopsy was done and regardless of the grade of the biopsy). Participants who had treatment failure included participants who died within 6 months of transplantation before experiencing acute rejection or who were re-transplanted within 6 months of the primary transplantation and who did not experience an acute rejection or who were lost to follow-up. (NCT00048165)
Timeframe: Up to 6 months PT

Interventionparticipants (Number)
Daclizumab77
Placebo104

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PFS

Progression free survival defined as time from HSC infusion (day 0) until progression of disease or death due to any cause. Patients are censored if alive without disease progression through 1 year after HSC infusion (NCT00053989)
Timeframe: 1 year

Interventionpercentage of participants (Number)
All Patients27

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OS

Overall survival with events defined as death due to any cause and censored patients are alive as of 1 year post HSC infusion (NCT00053989)
Timeframe: 1 year

Interventionpercentage of participants (Number)
All Patients44

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Acute GvHD

overall grade II-IV acute GvHD (NCT00053989)
Timeframe: Day +100

InterventionParticipants (Count of Participants)
All Patients16

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Day 100 TRM

treatment related mortality within 100 days from hematopoietic stem cell (HSC) infusion on day 0 (NCT00053989)
Timeframe: from start or conditioning (day -6 or -5) through day +100 after HSC infusion

InterventionParticipants (Count of Participants)
All Patients4

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Minimal Residual Disease

The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow. Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section). (NCT00057811)
Timeframe: Not Provided

Interventionpercentage of samples analyzed (Number)
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)22
Group C (Chemotherapy, Monoclonal Antibody Therapy)70

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Response Rate

Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present.. (NCT00057811)
Timeframe: Up to 5 years

Interventionpercentage of participants analyzed (Number)
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)88
Group C (Chemotherapy, Monoclonal Antibody Therapy)83

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Grade ≥ 3 Stomatitis

The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences (NCT00057811)
Timeframe: Up to 1 year

,
Interventionparticipants (Number)
Incidence of grade ≥ 3 stomatitisNo incidence of grade ≥ 3 stomatitis
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)441
Group C (Chemotherapy, Monoclonal Antibody Therapy)634

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Toxic Death

Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death. (NCT00057811)
Timeframe: Up to 1 year

,
Interventionparticipants (Number)
Toxic deathNo toxic death
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)045
Group C (Chemotherapy, Monoclonal Antibody Therapy)238

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Event-free Survival

Alive in continuous complete remission with functioning original allograft. The Event Free Survival (EFS) will be estimated by the Kaplan-Meier method. (NCT00066469)
Timeframe: 2 years

Interventionpercentage of participants analyzed (Number)
Cyclophosphamide, Prednisone, Rituximab71

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Cluster of Differentiation 8 (CD8) + Cells

The CD8 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 194-836 u/L. (NCT00076752)
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.

Interventioncells/mL^3 (Mean)
Day 01 month3 months6 months1 year2 years
Autologous HSCT in SLE0.34138.68318.47334.91736.67674.69

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Extractable Nuclear Antigen (ENA)

Extractable nuclear antigen is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-19. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.

InterventionEU (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years3 years
Autologous HSCT in SLE66.964.861.558.551.357.260.650.626.3

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Natural Killer Cells

The natural killer cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 87-505 uL. (NCT00076752)
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.

Interventioncells/mL^3 (Mean)
Day 01 month3 months6 months1 year3 years
Autologous HSCT in SLE0.03117.06116.57123.18158.9115.18

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Platelet Count

The platelet count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 162-380 K/uL. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.

InterventionK/uL (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years3 years
Autologous HSCT in SLE251113166187170226210308272

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Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)

The SLEDAI activity index test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a SLEDAI score of ≤3; partial response is at least 50% improvement in general disease activity as measured by SLEDAI. Remission is a SLEDAI score <3 and prednisone <10mg/day. 6+ indicates active disease requiring therapy. A score of 0 indicates a better outcome and a score greater then 6+ indicates a worse outcome. (NCT00076752)
Timeframe: Day -7, day 0, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years and 3 years.

Interventionscores on a scale. (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years3 years
Autologous HSCT in SLE4.254.133.631.600000

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White Blood Cells

The white blood cell test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 3.4-9.6 K/uL. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.

InterventionK/uL (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years3 years
Autologous HSCT in SLE6.890.4710.323.844.215.815.247.176.34

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Cluster of Differentiation 4 (CD4) + Cells

The CD4 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 358-1259 uL. (NCT00076752)
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.

Interventioncells/mL^3 (Mean)
Day 01 month3 months6 months1 year2 years
Autologous HSCT in SLE2.58103.37112.8316.25702.87958.03

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Number of Participants With Adverse Events

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT00076752)
Timeframe: 18 months

Interventionparticipants (Number)
Autologous HSCT in SLE8

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Absolute Lymphocyte Count

The absolute lymphocyte count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 0.45-4.9 K/uL. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.

InterventionK/uL (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years3 years
Autologous HSCT in SLE0.540.00650.420.530.821.751.81.81.75

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Absolute Neutrophil Count

The absolute neutrophil count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 1.29-7.5 K/uL. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.

InterventionK/uL (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years3 years
Autologous HSCT in SLE5.660.459.112.722.783.442.724.043.77

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Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody

Anti-Double stranded deoxyribonucleic acid antibody is a well accepted biological clinical laboratory marker especially specific for systemic lupus. Range of normal values is 0-24 IU. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.

InterventionIU (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years3 years
Autologous HSCT in SLE17.38.80000000

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Anti-Nuclear Antibody

Anti-Nuclear antibody is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-0.9 EU. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.

InterventionEU (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years3 years 9
Autologous HSCT in SLE5.44.73.73.22.72.62.82.52.5

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Anti-Smith-Ribonuclear Protein Antibody

Anti-Smith-Ribonuclear protein antibody is a well accepted biological clinical laboratory marker of systemic lupus.Range of normal values is 0-19 EU. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months and 2 years.

InterventionEU (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years
Autologous HSCT in SLE4951.631.529.828.52016.6725.67

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Cluster of Differentiation 19 (CD19) + Cells

The CD19 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 47-409 u/L. (NCT00076752)
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.

Interventioncells/mL^3 (Mean)
Day 01 month3 months6 months1 year3 years
Autologous HSCT in SLE0.010.236.745.32142.69246.83

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Cluster of Differentiation 3 (CD3) + Cells

The CD3+Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 650-2108 uL. (NCT00076752)
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.

Interventioncells/mL^3 (Mean)
Day 01 month3 months6 months1 year2 years
Autologous HSCT in SLE2.99239.47435.97699.471493.291678.76

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Relapse-free Complete Clinical Response

Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of ≤3; prednisone ≤10mg/day at 6 months and ≤5mg/day at 12 months or later. (NCT00076752)
Timeframe: 60 months

InterventionMonths (Median)
Autologous HSCT in SLE54

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Number of Alemtuzumab Associated Adverse Events, Stratified by Sirolimus Withdrawal Status

(NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

Interventionadverse events (Number)
Alemtuzumab (Withdrawn From Sirolimus)2
Alemtuzumab (Not Withdrawn From Sirolimus)8

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Number of Deaths Stratified by Sirolimus Withdrawal Status

Participants who died during the study, all cause(s) (NCT00078559)
Timeframe: Transplantation to Death (up to four years post-transplant)

Interventiondeaths (Number)
Alemtuzumab (Withdrawn From Sirolimus)0
Alemtuzumab (Not Withdrawn From Sirolimus)0

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Number of Acute Rejections in All Enrolled Participants

"Number of acute rejections[1] in all enrolled subjects from the time of transplantation to the end of the trial (four years post-transplant)~Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Four years post-transplant

InterventionRejection Events (Number)
Alemtuzumab1

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Number of Participants Requiring Anti-lymphocyte Therapy for an Acute Rejection, Stratified by Sirolimus Withdrawal Status

"Participants who experienced acute rejection[1] during study which required anti-lymphocyte (OKT3, ATG) therapy~1] Acute rejection is defined as a biopsy-prove rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Transplantation to acute rejection (up to four years post-transplantation)

Interventionparticipants (Number)
Alemtuzumab (Withdrawn From Sirolimus)0
Alemtuzumab (Not Withdrawn From Sirolimus)0

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Number of Participants Who Experienced Graft Loss Stratified by Sirolimus Withdrawal Status

"Participants who experienced graft loss[1] during study~[1]Graft loss is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation" (NCT00078559)
Timeframe: Transplantation to Graft Loss (up to four years post-transplantation)

Interventionparticipants (Number)
Alemtuzumab (Withdrawn From Sirolimus)0
Alemtuzumab (Not Withdrawn From Sirolimus)0

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Number of Severe Acute Rejections Stratified by Sirolimus Withdrawal Status

"Participants who experienced severe acute rejections[1] during study~Severe acute rejection is defined as that which requires treatment with anti-lymphocyte antibody or is histologically evaluated as Type IIA or greater using the Banff 1997 criteria[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Transplantation to severe acute rejection (up to four years post-transplantation)

InterventionRejection Events (Number)
Alemtuzumab (Withdrawn From Sirolimus)0
Alemtuzumab (Not Withdrawn From Sirolimus)0

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Number of Side Effects of Conventional Immunosuppression, Stratified by Withdrawal Status

Side effects of conventional immunosuppression include increased body weight and hypertension (NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

Interventionside effects (Number)
Alemtuzumab (Withdrawn From Sirolimus)2
Alemtuzumab (Not Withdrawn From Sirolimus)6

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Number of Acute Rejections Between Initiation of Sirolimus Withdrawal and End of Study

"Acute rejections[1] between initiation of sirolimus withdrawal and end of study~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Initiation of sirolimus to end of study (up to four years post-transplant)

InterventionRejection Events (Number)
Alemtuzumab0

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Time From Transplantation to Acute Rejection in Participants for Whom Acute Rejection Occurred During the 1 Year Post-transplant Period

"Time (days) to acute rejection[1] for participants occurring during the year following transplantation~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Transplantation to acute rejection (up to one year post-transplant)

InterventionDays (Number)
Alemtuzumab274

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Change in Renal Function as Measured by Serum Creatinine, Stratified by Withdrawal Status

Mean change from transplantation to Month 48 in serum creatinine. Normal serum creatinine range is from 0.7 - 1.4 mg/dL. In a transplant population, starting serum creatinine is higher than normal range. A negative change indicates better renal function (NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

Interventionmg/dL (Mean)
Alemtuzumab (Withdrawn From Sirolimus)-4.2
Alemtuzumab (Not Withdrawn From Sirolimus)-5.4

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Time From Transplantation to Acute Rejection in Participants for Whom Sirolimus Withdrawal Was Not Initiated

"Time (days) to acute rejection[1] for participants where sirolimus was not initiated~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Transplantation to acute rejection (up to four years post-transplantation)

InterventionDays (Number)
Alemtuzumab274

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Number of Sirolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status

(NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

Interventionadverse events (Number)
Alemtuzumab (Withdrawn From Sirolimus)2
Alemtuzumab (Not Withdrawn From Sirolimus)7

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Number of Tacrolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status

(NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

Interventionadverse events (Number)
Alemtuzumab (Withdrawn From Sirolimus)0
Alemtuzumab (Not Withdrawn From Sirolimus)2

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Number of Acute Rejections in All Enrolled Participants Following Sirolimus Withdrawal

"Following sirolimus withdrawal, the number of acute rejections[1] in all enrolled participants~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

InterventionRejection Events (Number)
Alemtuzumab0

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Hearing Improvement

Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average. (NCT00097448)
Timeframe: 2 months

InterventiondB (Mean)
Oral Steroids30.7
IT Steroids28.7

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Number of Subjects Experiencing Serious Adverse Events

Number of subjects according to originally received treatment that experienced a serious adverse event through 18 months post-randomization or prior to being censored from analyses due to crossover, switching to open-label treatment, or best medical judgment for censor. Events are categorized by coded system organ classes (SOC). Within each SOC, a participant was counted once if the participant reported one or more events coded to that SOC. (NCT00104299)
Timeframe: Randomization to censor at Crossover, Open-label or Best Medical Judgment (up to 18 months post-randomization)

,
Interventionparticipants (Number)
# Participants with at least one SAEBlood and Lymphatic System DisordersCardiac DisordersEye DisordersGastrointestinal DisordersGeneral Disorders and Administration SiteImmune System DisordersInfections and InfestationsInjury, Poisoning, and Procedural ComplicationsInvestigationsMetabolism and Nutrition DisordersMusculoskeletal and Connective Tissue DisordersNeoplasms Benign, Malignant, and UnspecifiedNervous System DisordersPregnancy, Puerperium, and Perinatal ConditionsPsychiatric DisordersRenal and Urinary DisordersRespiratory, Thoracic, and Mediastinal DisordersVascular Disorders
Control Group375211321200232001387
Rituximab424214521222221111481

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Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups

"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 18 months post-randomization

,
InterventionDays (Number)
25% Quartile (95%CI)50% Quartile (95%CI)75% Quartile (95%CI)
Control Group2943112
Rituximab3057119

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Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups

"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and completing taper of glucocorticoid by 6 months post-randomization.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 18 months post-randomization

,
InterventionDays (Number)
25% Quartile (95%CI)50% Quartile (95%CI)75% Quartile (95%CI)
Control Group177183266
Rituximab176180189

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The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups

Duration of remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of glucocorticoid by 6 months post-randomization to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing. (NCT00104299)
Timeframe: 18 months post-randomization

,
InterventionDays (Number)
25% Quartile (95%CI)50% Quartile (95%CI)75% Quartile (95%CI)
Control Group168NANA
Rituximab246NANA

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The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups

"Duration of complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of Prednisone to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 18 months post-randomization

,
InterventionDays (Number)
25% Quartile (95%CI)50% Quartile (95%CI)75% Quartile (95%CI)
Control Group230NANA
Rituximab243NANA

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Disease Remission

A Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) score of 0 with prednisone taper successfully completed at six months. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease. (NCT00104299)
Timeframe: 6 months post-randomization

InterventionParticipants (Number)
Rituximab63
Control Group52

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Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization

"The 2-sided 95% CI of the percentage of participants who have a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and have successfully completed the glucocorticoid taper by 6 months post-randomization and the 2-sided 95% CI of the difference between two arms for assessing the superiority of rituximab to control~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 6 months post-randomization

Interventionparticipants (Number)
Rituximab62
Control Group51

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Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy

The adverse event rate for the following events considered related to vasculitis: Death; Grade 2 or higher leukopenia or thrombocytopenia; Grade 3 or higher infections; Hemorrhagic cystitis (grade 2 or lower needs confirmation by cytoscopy); Malignancy; Venous thromboembolic event (deep venous thrombosis or pulmonary embolism); Hospitalization resulting either from the disease or from a complication due to study treatment; Infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions (including cytokine release allergic reaction); Cerebrovascular accident (NCT00104299)
Timeframe: Through common close-out (defined as 18 months after the last participant is enrolled in the trial)

,
Interventionparticipants (Number)
DeathGrade 2 or Higher LeukopeniaGrade 2 or Higher ThrombocytopeniaGrade 3 or Higher InfectionsHemorrhagic Cystitis (Grade 2 or Lower)MalignancyVenous Thromboembolic EventHospitalization Resulting from the DiseaseCerebrovascular Accident (CVA)Infusion Reactions Leading to Infusion Disc.
Control Group223116128710
Rituximab274182561611

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2-year Overall Survival Rate

The overall survival rate is the percentage of patients who are alive 2 years after registration to the study. Overall survival is defined as the time between study registration and death due to any cause. (NCT00109928)
Timeframe: 0-2 years

Interventionpercentage of participants (Number)
PEGS31

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Response Rate

Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00109928)
Timeframe: up to 3 years or time of disease progression

Interventionparticipants (Number)
Complete ResponseUnconfirmed Complete ResponsePartial ResponseNo Response
PEGS62520

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2-year Progression-free Survival Rate

Progression-free survival rate is the percentage of patients who do not show signs of progression at 2 years after registration to the study, including those whose disease has either completely or partially responded to treatment, or those whose disease is stable. Progression-free survival is defined as the time between study registration and documented progression, or death if no progression was observed. (NCT00109928)
Timeframe: 0-2 years

Interventionpercentage of participants (Number)
PEGS12

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Duration of Shock and/or Pressor/Inotropic Support

Pressor/inotropic support refers to the use of adrenaline-like medications to maintain blood pressure and cardiac output. (NCT00128180)
Timeframe: 6 months

Interventiondays (Mean)
Active2.67
Placebo3.75

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Length of Time on a Ventilator

(NCT00128180)
Timeframe: 6 months

Interventiondays (Mean)
Active2.64
Placebo4.95

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Number of Participants Intubated and Placed on a Ventilator After Study Entry.

Participants (NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active6
Placebo10

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Number of Participants on Extracorporeal Membrane Oxygenation (ECMO)

number of participants (NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active0
Placebo0

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Duration of ICU Stays

(NCT00128180)
Timeframe: 6 months

Interventiondays (Mean)
Active4.48
Placebo5.83

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Development of Serum Creatinine Greater Than or Equal to 3.0 mg/dL After Study Entry

(NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active1
Placebo6

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Duration of Hospital Stay in Days

Days (NCT00128180)
Timeframe: 6 months

Interventiondays (Mean)
Active8.90
Placebo10.67

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Number of Participants With SAEs

The Number of participants with SAEs (NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active14
Placebo25

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The Proportion of Subjects Who Develop Death, PaO2/FiO2 Ratio Less Than or Equal to 55, Cardiac Index Less Than or Equal to 2.2, Pulseless Electrical Activity, Ventricular Tachycardia or Fibrillation

(NCT00128180)
Timeframe: 28 days

Interventionproportion of paticipants (Number)
Active0.27
Placebo0.47

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Number of Participants Who Developed Refractory Shock Despite Fluid Resuscitation After Study Entry

Refractory shock refers to shock that persists despite fluid resucitation. Fluid resusitation refers to administration of intravenous fluids to maintain blood pressure and cardiac output. (NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active4
Placebo6

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Percentage of Participants With an Occurrence of Biopsy Proven Acute Rejection (BPAR) During the First 3 Months Post de Novo Liver Transplantation.

A BPAR is defined when the investigator had a suspicion of an acute rejection, where the final clinical diagnosis confirmed the occurrence of an acute rejection, where a biopsy was performed that confirmed the presence of an acute rejection, and where anti-rejection treatment intervention was initiated. The efficacy measured the first rejections (clinically and biopsy proven rejections) at 3 months. (NCT00149994)
Timeframe: Month 3

InterventionPercentage of Participants (Number)
Cyclosporine A33.3
Tacrolimus32.9

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: s-ICAM

"Change is defined as Week 52 assessment - Pre-Transplant assessment.~s-ICAM= soluble-intracellular adhesion molecule" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionng/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult674.46503.71-183.96
Tacrolimus - Adult766.58590.30-227.58

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: T-bars

"Change is defined as Week 52 assessment - Pre-Transplant assessment.~T-bars = thiobarbituric acid reactive substances" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionnmol/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult3.913.14-0.77
Tacrolimus - Adult3.783.25-0.64

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Troponin T

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionug/L (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult0.280.04-0.27
Tacrolimus - Adult0.300.03-0.32

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Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria

"Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Patients may report more than one acute rejection." (NCT00157014)
Timeframe: 52 Weeks

,
InterventionRejection Episodes (Number)
Total Acute Rejection EpisodesAcute Rejection Episodes with ISHLT Grade ≥3AAcute Rejection Episodes w/ Hemodynamic Compromise
Cyclosporine - Adult872
Tacrolimus - Adult836

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Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria (Pediatric Population)

"Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Patients may report more than one rejection episode." (NCT00157014)
Timeframe: 52 Weeks

,
InterventionRejection Episodes (Number)
Total Acute Rejection EpisodesAcute Rejection Episodes with ISHLT Grade ≥3AAcute Rejection Episodes w/ Hemodynamic Compromise
Cyclosporine - Pediatric330
Tacrolimus - Pediatric330

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Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52

A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26. (NCT00157014)
Timeframe: 26 Weeks and 52 Weeks

,
InterventionPatients (Number)
Week 26Week 52
Cyclosporine - Adult1629
Tacrolimus - Adult2233

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Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52 (Pediatric Population)

A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26. (NCT00157014)
Timeframe: 26 Weeks and 52 Weeks

,
InterventionPatients (Number)
Week 26Week 52
Cyclosporine - Pediatric31
Tacrolimus - Pediatric21

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Number of Patients With Treatment Failure and Crossover for Treatment Failure

"Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first.~Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant." (NCT00157014)
Timeframe: 52 Weeks

,
InterventionPatients (Number)
Treatment FailuresCrossover for Treatment Failures
Cyclosporine - Adult118
Tacrolimus - Adult62

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Number of Patients With Treatment Failure and Crossover for Treatment Failure (Pediatric Population)

"Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first.~Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant." (NCT00157014)
Timeframe: 52 Weeks

,
InterventionPatients (Number)
Treatment FailuresCrossover for Treatment Failures
Cyclosporine - Pediatric33
Tacrolimus - Pediatric10

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The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies

"The markers assessed were p-ERK ½ (phosphorylated extracellular signal-regulated kinase), p-JNK (phosphorylated jun N-terminal kinase) and p-p38 MAPK (phosphorylated mitogen-activated protein kinase).~The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH).~Change is defined as Week 52 assessment- Week 2 assessment." (NCT00157014)
Timeframe: 2 Weeks and 52 Weeks

,
InterventionDensitometry / Densitometry of GAPDH (Mean)
p-ERK ½ - Week 2p-ERK ½ - Week 52p-ERK ½ - Change from Week 2p-JNK - Week 2p-JNK - Week 52p-JNK - Change from Week 2p-p38 MAPK - Week 2p-p38 MAPK - Week 52p-p38 MAPK - Change from Week 2
Cyclosporine - Adult0.900.79-0.051.231.460.220.540.770.23
Tacrolimus - Adult0.700.870.051.101.330.030.480.630.14

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The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies (Pediatric Population)

"The markers assessed were p-ERK ½, p-JNK and p-p38 MAPK.~The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH).~Change is defined as Week 52 assessment- Week 2 assessment." (NCT00157014)
Timeframe: 2 Weeks and 52 Weeks

,
InterventionDensitometry / Densitometry of GAPDH (Mean)
p-ERK ½ - Week 2p-ERK ½ - Week 52p-ERK ½ - Change from Week 2p-JNK - Week 2p-JNK - Week 52p-JNK - Change from Week 2p-p38 MAPK - Week 2p-p38 MAPK - Week 52p-p38 MAPK - Change from Week 2
Cyclosporine - Pediatric1.671.22-0.270.910.820.040.430.580.34
Tacrolimus - Pediatric1.740.93-0.091.170.57-0.210.830.24-0.04

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Changes in Circulating Markers of Inflammation and Oxidation: Cystatin-C (Pediatric Population)

Change is defined as Week 52 assessment - Pre-Transplant assessment (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionmg/L (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Pediatric0.770.84-0.01
Tacrolimus - Pediatric0.860.87-0.11

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Osteopontin

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionng/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult11.1410.490.20
Tacrolimus - Adult11.888.77-2.22

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Mean Cases of Acute Rejection (MCAR) Per Patient

"MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies.~Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection." (NCT00157014)
Timeframe: 52 Weeks

InterventionMCAR per patient (Mean)
Tacrolimus - Adult0.15
Cyclosporine - Adult0.17

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Mean Cases of Acute Rejection (MCAR) Per Patient (Pediatric Population)

"MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies.~Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection." (NCT00157014)
Timeframe: 52 Weeks

InterventionMCAR per patient (Mean)
Tacrolimus - Pediatric0.60
Cyclosporine - Pediatric0.50

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Number of Cardiac Rejection Episodes Requiring Treatment

The number of rejection episodes requiring treatment (medications started/ stopped, non-medication treatment, or both) regardless of biopsy grade or presence of hemodynamic compromise. (NCT00157014)
Timeframe: 52 Weeks

InterventionRejection Episodes (Number)
Tacrolimus - Adult12
Cyclosporine - Adult11

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Number of Cardiac Rejection Episodes Requiring Treatment (Pediatric Population)

A summary of rejection episodes requiring treatment regardless of biopsy grade or presence of hemodynamic compromise. (NCT00157014)
Timeframe: 52 Weeks

InterventionRejection Episodes (Number)
Tacrolimus - Pediatric3
Cyclosporine - Pediatric3

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Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection

Severe Acute Rejection is defined as rejection with ISHLT Grade 4. (NCT00157014)
Timeframe: 52 Weeks

InterventionPatients (Number)
Tacrolimus - Adult0
Cyclosporine - Adult0

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Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection (Pediatric Population)

Severe Acute Rejection was defined as rejection with ISHLT Grade 4. (NCT00157014)
Timeframe: 52 Weeks

InterventionPatients (Number)
Tacrolimus - Pediatric0
Cyclosporine - Pediatric0

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Time to First Acute Rejection Episode Following de Novo Cardiac Transplant

"Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Time to first acute rejection is defined as: date of onset - date of transplant." (NCT00157014)
Timeframe: 52 Weeks

InterventionDays (Mean)
Tacrolimus - Adult55.0
Cyclosporine - Adult35.60

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Time to First Acute Rejection Episode Following de Novo Cardiac Transplant (Pediatric Population)

"Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Time to first acute rejection is defined as: date of onset - date of transplant." (NCT00157014)
Timeframe: 52 Weeks

InterventionDays (Mean)
Tacrolimus - Pediatric56.3
Cyclosporine - Pediatric49.0

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Changes in Circulating Markers of Inflammation and Oxidation: F2 Isoprostanes (Pediatric Population)

Change is defined as Week 52 assessment - Pre-Transplant assessment (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionpg/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Pediatric104.6866.48-30.07
Tacrolimus - Pediatric106.0669.71-38.31

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Changes in Circulating Markers of Inflammation and Oxidation: hsCRP (Pediatric Population)

Change is defined as Week 52 assessment - Pre-Transplant assessment (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionmg/L (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Pediatric12.082.43-13.94
Tacrolimus - Pediatric30.4626.31-7.85

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Changes in Circulating Markers of Inflammation and Oxidation: Nitrotyrosine (Pediatric Population)

Change is defined as Week 52 assessment - Pre-Transplant assessment (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
InterventionnM (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Pediatric12701.2141147.6221514.62
Tacrolimus - Pediatric233.085462.995148.42

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: BNP

"Change is defined as Week 52 assessment - Pre-Transplant assessment.~BNP= Brain Natriuretic Peptide" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionng/L (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult4240.81856.8-1446.7
Tacrolimus - Adult4314.8670.1-4018.4

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Cystatin-C

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionmg/L (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult1.291.480.27
Tacrolimus - Adult1.211.290.06

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: E-selectin

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionng/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult98.9680.93-19.16
Tacrolimus - Adult90.4068.60-18.58

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: F2 Isoprostanes

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionpg/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult53.9450.44-3.43
Tacrolimus - Adult52.0330.08-13.29

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Fibrinogen

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventiong/L (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult4.43.8-0.5
Tacrolimus - Adult4.43.4-1.1

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: GSH/GSSG

"Change is defined as Week 52 assessment - Pre-Transplant assessment.~GSH/GSSG= ratio of reduced to oxidised glutathione" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
InterventionRatio (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult58.8353.72-5.55
Tacrolimus - Adult55.0751.69-2.07

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Homocysteine

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionμmol/L (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult15.915.80.7
Tacrolimus - Adult14.213.50.3

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: hsCRP

"Change is defined as Week 52 assessment - Pre-Transplant assessment.~hsCRP= high-sensitivity C Reactive Protein" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionmg/L (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult21.833.95-18.69
Tacrolimus - Adult32.853.01-34.32

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-18

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionpg/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult496.2427.2-71.0
Tacrolimus - Adult574.0534.65.2

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-6

"Change is defined as Week 52 assessment - Pre-Transplant assessment.~IL= Interleukin" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionpg/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult2.540.90-1.56
Tacrolimus - Adult3.360.98-2.84

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: MCP-1

"Change is defined as Week 52 assessment - Pre-Transplant assessment.~MCP-1= monocyte chemoattractant protein-1" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionpg/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult193.63180.90-16.49
Tacrolimus - Adult233.05229.9642.92

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Nitrotyrosine

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
InterventionnM (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult482.43368.95-99.79
Tacrolimus - Adult422.63451.8871.44

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Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant

GVHD grading system goes from 0-4 where grade 4 is the most severe. Grade 0 and 1 do not require systemic treatment, Grade 2-4 require treatment. This trial evaluated the risk of developing acute GVHD grades 2-4 within 90 days of transplant. (NCT00185692)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
Transplantation of CD34+ Cells1

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Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning

number achieving donor cell engraftment (>95%) by day 90 after transplant. (NCT00185692)
Timeframe: 100 days

InterventionParticipants (Count of Participants)
Transplantation of CD34+ Cells4

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Mortality

Number of participants who died within 100 days and within 1 year, non-relapse and associated with relapse. (NCT00186628)
Timeframe: Day 100 and 1 year

InterventionParticipants (Number)
Mortality within 100 days, all causesNonrelapse mortality within 1 yearRelapse + mortality within 1 year
Prophylactic Rituximab012

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Overall Survival

(NCT00186628)
Timeframe: 4 years

InterventionPercentage of participants by disease (Number)
Prophylactic Rituximab (CLL Patients)73
Prophylactic Rituximab (MCL Patients)69

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Incidence of Relapse

Subjects who Relapsed following after Allogeneic HSCT (NCT00186628)
Timeframe: 4 years

InterventionParticipants (Count of Participants)
Prophylactic Rituximab18

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Chronic Graft-vs-Host Disease (cGvHD)

The cumulative percentage of participants who develop chronic graft-vs-host disease (cGvHD). Chronic cGvHD was defined as at least one instance of a clinically-accepted marker for cGvHD (see Filipovich, et al. Biology of Blood and Marrow Transplantation. 2005;11:945-955) (NCT00186628)
Timeframe: 4 years

Interventionpercentage of participants (Number)
Prophylactic Rituximab20

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Number of Participants With American College of Rheumatology (ACR) Major Clinical Response and/or Remission

"Major clinical response is an ACR70 response defined as improvement from baseline: ≥70% in tender joint count; ≥70% in swollen joint count; ≥70% in 3 of the following: Patient Pain Assessment, Patient Global Assessment, Physician Global Assessment, Patient Self-Assessed Disability, ESR or CRP for ≥169 consecutive days.~Remission: ≥5 requirements fulfilled for ≥2 consecutive months: Duration of morning stiffness <15 minutes, No fatigue, No joint pain, No joint tenderness or pain on motion, No soft tissue swelling in joints or tendon sheaths, ESR <30 mm/hour for women and <20 mm/hour for men." (NCT00243412)
Timeframe: 24 months

InterventionParticipants (Number)
Arm A: 500 mg Rituximab1
Arm B: 1000 mg Rituximab0

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DAS28-4 Erythrocyte Sedimentation Rate(ESR)

The DAS28-4(ESR) score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10, where a score of less than or equal to 3.2 implies well controlled disease and greater than or equal to 5.1 implies active disease In this trial, CRP rather than ESR was used, unless the CRP value was missing at both Day 1 and screening, in which case ESR value was used. (NCT00243412)
Timeframe: 24 Months

InterventionScores on a scale (Mean)
Arm A: 500 mg Rituximab4.25
Arm B: 1000 mg Rituximab4.32

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Change From Baseline in Short Form 36 (SF 36) Summary and Subscale Scores

The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning (PF), Role Physical (RP), Bodily Pain(BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE),Mental Health (MH). Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. (NCT00243412)
Timeframe: Baseline, 24 Months

,
InterventionUnits on a Scale (Mean)
Summary Score: Mental Component ScoreSummary Score: Physical Component ScoreSubscale: Bodily PainSubscale: General HealthSubscale: Mental HealthSubscale: Physical FunctionSubscale: Role EmotionalSubscale: Role PhysicalSubscale: Social FunctioningSubscale: Vitality
Arm A: 500 mg Rituximab7.699.8826.6413.8620.0021.6216.6734.0921.5910.61
Arm B: 1000 mg Rituximab2.284.938.0018.402.5015.728.33-1.257.508.13

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Number of Participants With European League Against Rheumatism (EULAR) Response and Remission Using Disease Activity Score 28-4 (DAS28-4)C-reactive Protein (CRP)

"EULAR remission = DAS28-4(CRP) < 2.6 (Fransen et al. 2004.~EULAR response categories (van Gestel et al. 1999):~Good response = final DAS28-4(CRP) < 3.2 and decreased > 1.2 points from baseline Moderate response = final DAS28-4(CRP) ≥ 3.2 but ≤ 5.1 and decreased > 0.6 points from baseline or final DAS28-4(CRP) > 5.1 and decreased > 1.2 from baseline." (NCT00243412)
Timeframe: Baseline, 24 months

,
InterventionParticipants (Number)
No ResponseModerate ResponseGood ResponseEular Remission
Arm A: 500 mg Rituximab0253
Arm B: 1000 mg Rituximab0643

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Number of Participants With Either an Infection or a Grade III or IV Adverse Event (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI CTCAE], Version 3.0)

"A Grade III Adverse Event (AE) is severe; defined as considerable interference with the subject's daily activities, medical intervention/therapy required and hospitalization possible.~A Grade IV AE is life-threatening; defined as extreme limitation in activity, significant medical intervention/therapy required, hospitalization probable.~Because of the small sample size and the small number of subjects who completed Week 104, the analysis were limited to descriptive statistics only." (NCT00243412)
Timeframe: 24 months

,
InterventionParticipants (Number)
InfectionsAdverse Events (Grade 3 or 4)
Arm A: 500 mg Rituximab145
Arm B: 1000 mg Rituximab114

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Change From Baseline in Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F)

FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status. (NCT00243412)
Timeframe: Baseline, 24 Months

InterventionScores on a scale (Mean)
Arm A: 500 mg Rituximab9.64
Arm B: 1000 mg Rituximab8.80

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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)

The Stanford HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The questionnaire was provided in a certified translation of the local languages at the participating sites and was scored based on the instructions from the Stanford University Medical Center.The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. (NCT00243412)
Timeframe: Baseline, 24 Months

InterventionScores on a scale (Mean)
Arm A: 500 mg Rituximab-0.60
Arm B: 1000 mg Rituximab-0.45

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Number of Participants With American College of Rheumatology Responses (ACR20, ACR50, and ACR70)

"ACR20 response was defined as satisfying the following 3 criteria improvement from baseline: ≥ 20% in tender joint count; ≥ 20% in swollen joint count; ≥ 20% improvement from baseline in 3 of the following 5 criteria:~Subject's Global Assessment of Pain Subject's Global Assessment of Disease Activity Physician's Global Assessment Subject's Self-Assessment Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) Note: The definitions of ACR50 and ACR70 are the same as ACR20, except that the 20% value in the above definition is replaced by 50% and 70% values, respectively." (NCT00243412)
Timeframe: Baseline, 24 months

,
InterventionParticipants (Number)
ACR20 RespondersACR50 RespondersACR70 Responders
Arm A: 500 mg Rituximab744
Arm B: 1000 mg Rituximab653

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Change From Baseline in Rheumatoid Factor (RF)

Serum levels of rheumatoid factor at baseline, month 24 and change from baseline to month 24. (NCT00243412)
Timeframe: Baseline, 24 Months

,
InterventionIU/mL (Mean)
BaselineMonth 24Change from Baseline to Month 24
Arm A: 500 mg Rituximab542.843.0-499.8
Arm B: 1000 mg Rituximab243.741.4-202.3

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Change From Baseline in Disease Activity Score 28-4 C-reactive Protein (DAS28-4(CRP))

The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. Change from baseline at 24 months was analyzed for DAS28-4 (CRP). (NCT00243412)
Timeframe: Baseline, 24 months

,
InterventionScores on a scale (Mean)
BaselineMonth 24Change from baseline
Arm A: 500 mg Rituximab6.534.03-2.49
Arm B: 1000 mg Rituximab6.333.77-2.56

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Number of Participants Alive at 3 Years

The intent was to measure Median Overall Survival at 3 years, however only one participant was analyzable at this time point. Therefore, the number of participants who survived is reported instead. (NCT00248534)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
IV Rituximab1

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1 Year Overall Survival Rate

(NCT00248534)
Timeframe: 1 year

Interventionpercentage of participants (Number)
IV Rituximab71

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6-month Progression-free Survival

"Scan at 6 months~Complete response: Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable or improving neurological exam minimum of 4 wks~Partial response: Greater than or equal 50% reduction in tumor size on MRI, on sable or decreasing glucocorticoids with stable or improving neurological exam for a minimum of 4 wks.~Progressive disease: Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.~Stable disease: Clinical status and MRI does not qualify for complete response, partial response or progression" (NCT00248534)
Timeframe: 6 months

Interventionpercentage of participants (Number)
IV Rituximab13

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Percentage of Participants With Objective Response

Objective response rate of the combination of Rituximab and TMZ (NCT00248534)
Timeframe: 2 months

Interventionpercent of participants (Number)
IV Rituximab14

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Time Measured From the Administration of the Loading Dose of Prednisolone (2mg/kg up to Max 60mg) in the Emergency Department (ED) Until the Home Dose of Albuterol is Administered

(NCT00257933)
Timeframe: Median time from loading dose to home dose of albuterol

InterventionHours (Median)
High Dose Prednisolone35
Lower Dose Prednisolone33

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Number of Participants Experiencing Acute Graft-Versus-Host Disease

Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. (NCT00258427)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Marrow Isolex0
USB Arm1
Marrow Clinimacs0
Sibling withoutCliniMACS0

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Number of Participants Experiencing Chronic Graft-Versus-Host Disease

Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cellsinto a foreign host. (NCT00258427)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Marrow Isolex0
USB Arm0
Marrow Clinimacs0
Sibling withoutCliniMACS0

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Number of Participants Experiencing Acute Graft-Versus-Host Disease

Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. (NCT00258427)
Timeframe: Day 42

InterventionParticipants (Count of Participants)
Marrow Isolex0
USB Arm0
Marrow Clinimacs0
Sibling withoutCliniMACS0

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Number of Participants Experiencing Relapse

Patients with leukemia will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. (NCT00258427)
Timeframe: 1 Year

InterventionParticipants (Count of Participants)
Marrow Isolex0
USB Arm2
Marrow Clinimacs1
Sibling withoutCliniMACS0

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Number of Participants Experiencing Chronic Graft-Versus-Host Disease

Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cellsinto a foreign host. (NCT00258427)
Timeframe: Day 42

InterventionParticipants (Count of Participants)
Marrow Isolex0
USB Arm0
Marrow Clinimacs0
Sibling withoutCliniMACS0

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Number of Participants Experiencing Graft Failure

Graft failure is defined as absolute neutrophil count( ANC ) <5 x 10^8/L by day 30. (NCT00258427)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
Marrow Isolex1
USB Arm0
Marrow Clinimacs0
Sibling withoutCliniMACS0

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Number of Participants Experiencing Major Infections

Number of participants experiencing Major Infections by the end of treatment (NCT00258427)
Timeframe: Day 1 through 1 year post-transplant

InterventionParticipants (Count of Participants)
Marrow Isolex3
USB Arm8
Marrow Clinimacs2
Sibling withoutCliniMACS1

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Number of Participants Experiencing Overall Survival

Overall Survival - Number of patients alive at 1 year post transplant (NCT00258427)
Timeframe: 1 Year

InterventionParticipants (Count of Participants)
Marrow Isolex1
USB Arm4
Marrow Clinimacs1
Sibling withoutCliniMACS1

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Survival

Survival (NCT00278564)
Timeframe: up to 5 years

InterventionParticipants (Count of Participants)
Hematopoietic Stem Cell Transplantation7

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Percentage of Participants Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52

A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5. (NCT00282347)
Timeframe: Week 24 to Week 52

InterventionPercentage of participants (Number)
Rituximab1.4
Placebo6.9

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Percentage of Participants Who Achieved a Complete Renal Response at Week 52

A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5. (NCT00282347)
Timeframe: Week 52

InterventionPercentage of participants (Number)
Rituximab26.4
Placebo30.6

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Percentage of Participants With a Baseline Urine Protein to Creatinine Ratio of > 3.0 Who Achieved a Urine Protein to Creatinine Ratio of < 1.0 at Week 52

(NCT00282347)
Timeframe: Baseline to Week 52

InterventionPercentage of participants (Number)
Rituximab47.4
Placebo53.7

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Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52

A participant had a CRR if they met the following 3 criteria: (1) Normalization of serum creatinine (SC) as evidenced by a SC level ≤ the upper limit of the normal range of central laboratory values or a SC level ≤ 15% greater than Baseline, if Baseline SC was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field (RBCs/HPF) and absence of red cell casts; (3) Urinary protein (UP) to creatinine ratio (CR) < 0.5. A participant had a PRR if they met the following 3 criteria: (1) A SC level ≤ 15% above Baseline; (2) RBCs/HPF ≤ 50% above Baseline and no RBC casts; (3) 50% improvement in the UP to CR, with 1 of the following conditions met: If the Baseline UP to CR was ≤ 3.0, then a UP to CR of < 1.0 or if the Baseline UP to CR was > 3.0, then a UP to CR of ≤ 3.0. A participant had a NRR if they did not achieve either a CRR or PRR. (NCT00282347)
Timeframe: Week 52

,
InterventionPercentage of participants (Number)
CRRPRRNRR
Placebo30.615.354.2
Rituximab26.430.643.1

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Time to Achieve a Complete Renal Response

(NCT00282347)
Timeframe: Baseline to Week 52

InterventionWeeks (Median)
Rituximab11.99
Placebo12.12

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Change From Baseline in C3 and C4 Complement Levels at Week 52

(NCT00282347)
Timeframe: Baseline to Week 52

,
Interventionmg/dL (Mean)
C3 ComplementC4 Complement
Placebo25.96.6
Rituximab37.59.9

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British Isles Lupus Assessment Group (BILAG) Index Score Over 52 Weeks

The BILAG Index assesses 86 clinical signs and symptoms and laboratory measures of systemic lupus erythematosus in 8 organ system domains: General, mucocutaneous, neurological, musculoskeletal, cardiorespiratory, vasculitis, renal, and hematologic. Most of the 86 items are rated on the following scale: 0=Not present, 1=Improving, 2=Same, 3=Worse, 4=New. Some items are rated as either Yes or No. A single alphabetic score of A (very active) through E (not or never active) for each of the 8 domains is determined from the rating of the individual items in each domain. The total BILAG score is the sum of the scores of the 8 domains where A=9, B=3, C=1, D=0, and E=0. The total score ranges from 0 to 72 with a higher score indicating greater lupus activity. To calculate a BILAG score over the 52 week treatment period of the study, the area under the response-time curve of BILAG scores assessed every 4 weeks was divided by the number of days in the time curve minus the Baseline BILAG score. (NCT00282347)
Timeframe: Baseline to Week 52

InterventionUnits on a scale (Mean)
Rituximab-8.49
Placebo-8.58

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Change From Baseline in Anti-double-stranded DNA at Week 52

(NCT00282347)
Timeframe: Baseline to Week 52

InterventionIU/mL (Mean)
Rituximab0.45
Placebo1.06

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Change From Baseline in the Systemic Lupus Erythematosus Expanded Health Survey Physical Function Score at Week 52

The systemic lupus erythematosus Expanded Health Survey is based on the Short Form 36 Health survey with additional questions specific to lupus. The physical function component score of the survey can range from 0-100. A higher score indicates better health. A positive change score indicates improvement. (NCT00282347)
Timeframe: Baseline to Week 52

InterventionUnits on a scale (Mean)
Rituximab4.8
Placebo5.7

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Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable

Improvement in Numerical Rating Scale between the time of the emergency department visit and the one month telephone call is rated on an 11-point scale ranging from 0-10 with 0 indicating no pain and 10 indicating worse pain imaginable. (NCT00290589)
Timeframe: 1 month

Interventionunits on a scale (Mean)
Intramuscular Methylprednisolone Acetate7.1
Placebo5.8

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Number of Patients Using Analgesics

Use of analgesics for low back pain (within the previous 24 hours) (NCT00290589)
Timeframe: Assessed at 1 month

InterventionParticipants (Count of Participants)
Intramuscular Methylprednisolone Acetate8
Placebo17

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Functional Disability Scales

The low back pain functional disability scale is the Roland Morris Disability questionnaire score (RMDQ). The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment. (NCT00290589)
Timeframe: 1 month

Interventionunits on a scale (Median)
Intramuscular Methylprednisolone Acetate0
Placebo0

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Weight Z-Score

weight for age Z-score (in subjects without ascites) over the course of the study (NCT00294684)
Timeframe: HPE until 24 months of age

InterventionZ-score (Mean)
Corticosteroids-0.8
Placebo-0.8

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Total Bilirubin Concentration at 24 Months of Age

(NCT00294684)
Timeframe: At 24 Months of Age

Interventionmg/dL (Mean)
Corticosteroids1.3
Placebo1.6

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The Percentage of Patients With Serum Total Bilirubin <1.5 mg/dL and With Native Liver at 6 Months After Portoenterostomy

(NCT00294684)
Timeframe: Measurements will be made at 6 months after portoenterostomy

Interventionpercentage of participants (Number)
Corticosteroids58.6
Placebo48.6

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Survival With Native Liver at 24 Months of Age

(NCT00294684)
Timeframe: Measurements will be made at 24 months of age

Interventionpercentage of participants (Number)
Corticosteroids58.7
Placebo59.4

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Serum Total Bilirubin Concentration

(NCT00294684)
Timeframe: Measurements will be made at 3 months after portoenterostomy

Interventionmg/dL (Mean)
Corticosteroids3.5
Placebo5.1

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Presence of Ascites at 24 Months

(NCT00294684)
Timeframe: 24 Months

Interventionparticipants (Number)
Corticosteroids1
Placebo3

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Presence of Ascites at 12 Months

(NCT00294684)
Timeframe: 12 Months

Interventionparticipants (Number)
Corticosteroids5
Placebo3

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Height Z-Score

Height by Age Z-score over the course of the study (NCT00294684)
Timeframe: HPE to age 24 Months

InterventionZ-score (Mean)
Corticosteroids-0.7
Placebo-0.6

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Total Bilirubin Concentration at 12 Months

(NCT00294684)
Timeframe: 12 Months post HPE

Interventionmg/dL (Mean)
Corticosteroids1.7
Placebo3.7

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New-onset Diabetes Mellitus (NODM) as Secondary Outcome

The incidence of new-onset Diabetes mellitus (NODM, based on percentage of previously non-diabetic patients who developed DM post-transplantation, was similar between the 2 groups. (NCT00296244)
Timeframe: 6 months

InterventionPercentage of participants (Number)
Control Group40
Study Group42

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Infection as an Adverse Effect of Steroids

Incidence of bacterial infection was similar in the control group as well as study group, 4 patients in both groups had infection (NCT00296244)
Timeframe: 3 months post-transplant

InterventionPercentage of participants (Number)
Control Group20
Study Group21

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Acute Rejection Rate

Biopsy proven acute rejection defined by biochemical and histological changes as well as the need for temporary steroid use occurred in 1 patient in each group both of which were steroid responsive (NCT00296244)
Timeframe: 6 months post-transplant

InterventionPercentage of participants (Number)
Control Group5
Study Group5

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Incidence and Severity of HCV Recurrence Post-OLT

The incidence and severity of HCV recurrence based on Hepatitis C PCR levels and protocol liver biopsy findings were found to be similar between the 2 groups. (NCT00296244)
Timeframe: 6 months post-transplant

InterventionPercentage of participants (Number)
Control Group27
Study Group29

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Patient Survival Rate

Percentage of recipients who are still alive at the end of 1 and 2 years. (NCT00296244)
Timeframe: 1 and 2 years

,
InterventionPercentage of participants (Number)
1-year patient survival rate2-year patient survival rate
Control Group10090
Study Group94.784

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Graft Survival Rate

Percentage of recipients whose liver grafts are still working at the end of 1 and 2 years. (NCT00296244)
Timeframe: 1 and 2 years

,
Interventionpercentage of participants (Number)
1-year graft survival rate2-year graft survival rate
Control Group10090
Study Group94.784

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Proportion of Participants With at Least One Serious Infection Through Week 24

An infection was considered serious if it required intravenous (IV) antibiotics or met the regulatory definition of a serious adverse event (SAE). An SAE was any event that resulted in death, resulted in a congenital anomaly in a child of a participant in the study, caused or prolonged an inpatient hospitalization, resulted in significant or persistent disability, or was considered by the investigator to be an important medical event that may have required intervention to prevent any of the above-listed outcomes. (NCT00298272)
Timeframe: Through Week 24

Interventionproportion of participants (Number)
Rituximab0.03
Placebo0.00

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Week 24

An AE was any sign (including an abnormal laboratory result that the investigator determined to be clinically significant), symptom, or diagnosis/disease that is unfavorable or unintended, that was new, or if pre-existing, worsened in a participant and that did not necessarily have a causal relationship with the treatment. An SAE was any event that resulted in death, resulted in a congenital anomaly in a child of a participant in the study, caused or prolonged an inpatient hospitalization, resulted in significant or persistent disability, or was considered by the investigator to be an important medical event that may have required intervention to prevent any of the above-listed outcomes. (NCT00298272)
Timeframe: Through Week 24

,
Interventionparticipants (Number)
Any AEAny SAE
Double-blind Placebo/Open Label Rituximab150
Double-blind/Open Label Rituximab312

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Number of Participants With Any Infections or Any Grade 3/4 Infections Through Week 24

"Infections were defined as adverse events that map to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of infections and infestations and also included other infectious events that do not map to this SOC (e.g., cholecystitis, pleurisy, conjunctivitis, acne, tongue ulceration). Participants with multiple infections were calculated only once. The severity of all reported adverse events, including infections, was graded and reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events. This scale defines the severity of an adverse event as follows: Grade 1 = a mild adverse event, Grade 2 = a moderate adverse event, Grade 3 = a severe adverse event, and Grade 4 = a life-threatening or disabling adverse event." (NCT00298272)
Timeframe: Through Week 24

,
Interventionparticipants (Number)
Any InfectionAny Grade 3/4 Infection
Double-blind Placebo/Open Label Rituximab110
Double-blind/Open Label Rituximab183

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Proportion of Participants Achieving an American College of Rheumatology 70 (ACR70) Response at Week 24

An ACR70 response is defined as a 70% reduction in the number of both swollen and tender joints, and a 70% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate. (NCT00298272)
Timeframe: Week 24

Interventionproportion of participants (Number)
Rituximab0.00
Placebo0.00

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Proportion of Participants Achieving an American College of Rheumatology 50 (ACR50) Response at Week 24

An ACR50 response is defined as a 50% reduction in the number of both swollen and tender joints, and a 50% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate. (NCT00298272)
Timeframe: Week 24

Interventionproportion of participants (Number)
Rituximab0.12
Placebo0.06

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Proportion of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 24

An ACR20 response is defined as a 20% reduction in the number of both swollen and tender joints, and a 20% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate. (NCT00298272)
Timeframe: Week 24

Interventionproportion of participants (Number)
Rituximab0.30
Placebo0.17

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Number of Participants With Clinically Significant Immunological and Laboratory Assessment Findings

The following immunological assessments were conducted: autoantibody concentrations for RF, anti-cyclic-citrullinated peptide (CCP) antibody concentrations, quantitative immunoglobulin levels, and lymphocyte assessments of T- and B-cell populations, determined using whole blood expanded fluorescent-activated cell sorter (FACS) analysis. The following laboratory assessments were performed: hemoglobin, hematocrit, red blood cells (RBC), white blood cells (WBC) with differential, and platelet counts; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total protein, albumin, total bilirubin, blood urea nitrogen (BUN), uric acid, creatinine, random glucose, potassium, sodium, chloride, calcium, and phosphorous; blood, protein, and glucose (microscopic examination, if abnormal and applicable). (NCT00298272)
Timeframe: Through Week 24

Interventionparticipants (Number)
Double-blind/Open Label Rituximab0
Double-blind Placebo/Open Label Rituximab0

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Maximum Duration of Infections Through Week 24

"Infections were defined as adverse events that map to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of infections and infestations and also included other infectious events that do not map to this SOC (e.g., cholecystitis, pleurisy, conjunctivitis, acne, tongue ulceration). For participants with multiple infections, only the infection with the longest duration was included in this analysis." (NCT00298272)
Timeframe: Week 24

Interventiondays (Mean)
Double-blind/Open Label Rituximab12.6
Double-blind Placebo/Open Label Rituximab14.5

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The Percentage of Participants With Major Clinical Response at Week 52

"Major clinical response is defined as a continuous six-month period of success by the ACR70.~ACR70= 70% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 70% improvement in 3 of five additional measurements from:~the physician's global assessment of disease activity~patient's global assessment of disease activity~patient's assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)" (NCT00299104)
Timeframe: Week 52

InterventionPercentage of Participants (Number)
Placebo + Methotrexate8.4
Rituximab (0.5 g x 2) + Methotrexate18.1
Rituximab (1.0 g x 2) + Methotrexate21.2

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Change From Baseline in the SF-36 Mental Health Component Summary Score at Week 52 and Week 104

"The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.~Means are adjusted for baseline value, Rheumatoid Factor status and region." (NCT00299104)
Timeframe: Baseline, Weeks 52, Week 104

,,
InterventionScore on a scale (Mean)
Week 52 (n=239,236,241)Week 104 (n= 240,236,242)
Placebo + Methotrexate6.6896.295
Rituximab (0.5 g x 2) + Methotrexate7.7187.617
Rituximab (1.0 g x 2) + Methotrexate8.1679.066

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Change From Baseline in the SF-36 Physical Health Component Summary Score at Week 52 and Week 104

"The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.~Means are adjusted for baseline value, Rheumatoid Factor status and region." (NCT00299104)
Timeframe: Baseline, Week 52, Week 104

,,
InterventionScore on a scale (Mean)
Week 52 (n=239,236,241)Week 104 (n=240,236,242)
Placebo + Methotrexate8.9538.617
Rituximab (0.5 g x 2) + Methotrexate11.02211.032
Rituximab (1.0 g x 2) + Methotrexate12.20512.649

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Percentage of Participants With Categorical Change in Health Assessment Questionnaire- Disability Index (HAQ-DI) From Baseline at Week 52

"The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has at least two component questions. There are four possible responses for each component on a scale of 0 (without difficulty) to 3 (unable to do). Higher scores=greater dysfunction.~Improved:HAQ-DI score change <=-0.22 Unchanged:HAQ-DI score change -0.22 to 0.22 Worsened:HAQ score => 0.22" (NCT00299104)
Timeframe: Baseline, Week 52

,,
InterventionPercentage of participants (Number)
ImprovedUnchangedWorsenedNot Assessable
Placebo + Methotrexate77.114.18.40.4
Rituximab (0.5 g x 2) + Methotrexate86.78.83.60.8
Rituximab (1.0 g x 2) + Methotrexate86.88.04.40.8

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Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Week 52

European League Against Rheumatism (EULAR) criteria reflects an improvement in disease activity and an attainment of a lower degree of disease activity. A good response is defined as an improvement in the DAS28-ESR of > 1.2 compared with baseline, and attainment of a DAS28-ESR of < 3.2. (NCT00299104)
Timeframe: Baseline, Week 52

InterventionPercentage of Participants (Number)
Placebo + Methotrexate18.1
Rituximab (0.5 g x 2) + Methotrexate39.0
Rituximab (1.0 g x 2) + Methotrexate41.6

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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 104

The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement. (NCT00299104)
Timeframe: Baseline, Week 104

InterventionScore on a scale (Mean)
Placebo + Methotrexate-0.806
Rituximab (0.5 g x 2) + Methotrexate-1038
Rituximab (1.0 g x 2) + Methotrexate-1.055

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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52

The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip,and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement. (NCT00299104)
Timeframe: Baseline, Week 52

InterventionScore on a scale (Mean)
Placebo + Methotrexate-0.800
Rituximab (0.5 g x 2) + Methotrexate-1.038
Rituximab (1.0 g x 2) + Methotrexate-1.023

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Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 24

Joint Space Narrowing is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing. (NCT00299104)
Timeframe: Baseline, Week 24

InterventionScore on a scale (Mean)
Placebo + Methotrexate0.210
Rituximab (0.5 g x 2) + Methotrexate0.176
Rituximab (1.0 g x 2) + Methotrexate0.108

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Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 52

Rate of progression in structural joint damage (PJD) by change in modified joint space narrowing (JSN) from screening to Week 52. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing. (NCT00299104)
Timeframe: Baseline and week 52

InterventionScore on a scale (Mean)
Placebo + Methotrexate0.341
Rituximab (0.5 g x 2) + Methotrexate0.193
Rituximab (1.0 g x 2) + Methotrexate0.126

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Change From Baseline in Modified Sharp Erosion Score at Week 52

Rate of progression in structural joint damage (PJD) by change in modified Sharp erosion score from screening to Week 52. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions. (NCT00299104)
Timeframe: Baseline and week 52

InterventionScore on a scale (Mean)
Placebo + Methotrexate0.738
Rituximab (0.5 g x 2) + Methotrexate0.453
Rituximab (1.0 g x 2) + Methotrexate0.233

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Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52

Rate of progression in structural joint damage (PJD) by change in Total Modified Sharp Score (TMSS) from screening to Week 52 in the modified intent-to-treat (MITT) population. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing. (NCT00299104)
Timeframe: Baseline and week 52

InterventionScore on a scale (Mean)
Placebo + Methotrexate1.079
Rituximab (0.5 g x 2) + Methotrexate0.646
Rituximab (1.0 g x 2) + Methotrexate0.359

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Change From Baseline in the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 52

"DAS28-ESR is calculated from the following formula:~(0.56 * TJC) + (0.28 * SJC) + (0.70 * ln ESR) + (0.014 * GH) TJC = tender joint count, based on 28 joints SJC = swollen joint count, based on 28 joints ESR = erythrocyte sedimentation rate in mm/h GH = patient's global assessment of disease activity A DAS28-ESR score of 5.1 or above is considered to indicate high disease activity. Patients can also be defined as having low disease activity (DAS28-ESR ≤ 3.2) or remission (DAS28-ESR < 2.6)." (NCT00299104)
Timeframe: Baseline, Week 52

InterventionScore on a scale (Mean)
Placebo + Methotrexate-2.33
Rituximab (0.5 g x 2) + Methotrexate-3.35
Rituximab (1.0 g x 2) + Methotrexate-3.46

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Change From Baseline in the Modified Total Sharp Score at Week 104

The modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing. (NCT00299104)
Timeframe: Baseline, Week 104

InterventionScore on a scale (Mean)
Placebo + Methotrexate1.948
Rituximab (0.5 g x 2) + Methotrexate0.761
Rituximab (1.0 g x 2) + Methotrexate0.406

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Change From Baseline in the Modified Total Sharp Score at Week 24

The modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing. (NCT00299104)
Timeframe: Baseline, Week 24

InterventionScore on a scale (Mean)
Placebo + Methotrexate0.701
Rituximab (0.5 g x 2) + Methotrexate0.508
Rituximab (1.0 g x 2) + Methotrexate0.328

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Change From Baseline in the Total Erosion Score at Week 104

Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The change from the score at baseline to week 104 is calculated. (NCT00299104)
Timeframe: Baseline, Week 104

InterventionScore on a scale (Mean)
Placebo + Methotrexate1.315
Rituximab (0.5 g x 2) + Methotrexate0.499
Rituximab (1.0 g x 2) + Methotrexate0.227

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Change From Baseline in the Total Erosion Score at Week 24

Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The Total Erosion Score at Week 24 - Total Erosion Score at baseline is calculated. (NCT00299104)
Timeframe: Baseline, Week 24

InterventionScore on a scale (Mean)
Placebo + Methotrexate0.491
Rituximab (0.5 g x 2) + Methotrexate0.404
Rituximab (1.0 g x 2) + Methotrexate0.220

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Change in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score From Baseline at Week 52

FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status. (NCT00299104)
Timeframe: Baseline, Week 52

InterventionScore on a scale (Mean)
Placebo + Methotrexate10.154
Rituximab (0.5 g x 2) + Methotrexate11.833
Rituximab (1.0 g x 2) + Methotrexate12.426

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Percentage of Participants With American College of Rheumatology (ACR) ACR20 Response at Week 52

"To achieve an ACR20 response requires at least a 20% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 20% improvement in three of five additional measurements from:~the physician's global assessment of disease activity~patient's global assessment of disease activity~patient's assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)" (NCT00299104)
Timeframe: Baseline, Week 52

InterventionPercentage of Participants (Number)
Placebo + Methotrexate64.3
Rituximab (0.5 g x 2) + Methotrexate76.7
Rituximab (1.0 g x 2) + Methotrexate80.0

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Percentage of Participants With American College of Rheumatology (ACR) ACR50 Response at Week 52

"To achieve an ACR50 response requires at least a 50% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 50% improvement in three of five additional measurements from:~the physician's global assessment of disease activity~patient's global assessment of disease activity~patient's assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)" (NCT00299104)
Timeframe: Week 52

InterventionPercentage of Participants (Number)
Placebo + Methotrexate41.8
Rituximab (0.5 g x 2) + Methotrexate59.4
Rituximab (1.0 g x 2) + Methotrexate64.8

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Percentage of Participants With American College of Rheumatology (ACR) ACR70 Response at Week 52

"To achieve an ACR70 response requires at least a 70% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 70% improvement in three of five additional measurements from:~the physician's global assessment of disease activity~patient's global assessment of disease activity~patient's assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)" (NCT00299104)
Timeframe: Baseline, Week 52

InterventionPercentage of Participants (Number)
Placebo + Methotrexate24.9
Rituximab (0.5 g x 2) + Methotrexate42.2
Rituximab (1.0 g x 2) + Methotrexate46.8

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Percentage of Participants With American College of Rheumatology (ACR) ACR90 Response at Week 52

"To achieve an ACR90 response requires at least a 90% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 90% improvement in three of five additional measurements from:~the physician's global assessment of disease activity~patient's global assessment of disease activity~patient's assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)" (NCT00299104)
Timeframe: Baseline, Week 52

InterventionPercentage of Participants (Number)
Placebo + Methotrexate9.2
Rituximab (0.5 g x 2) + Methotrexate17.3
Rituximab (1.0 g x 2) + Methotrexate16.4

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Percentage of Participants With DAS28-ESR Low Disease Activity at Week 52

"The DAS28-4(ESR) score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10.~Low disease activity is defined as achieving a DAS28-ESR score of less than or equal to 3.2" (NCT00299104)
Timeframe: Week 52

InterventionPercentage of Participants (Number)
Placebo + Methotrexate19.8
Rituximab (0.5 g x 2) + Methotrexate40.3
Rituximab (1.0 g x 2) + Methotrexate43.0

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Percentage of Participants With DAS28-ESR Remission at Week 52

"The DAS28-4(ESR) score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10.~Remission is defined as achieving a DAS28-ESR score of less than 2.6" (NCT00299104)
Timeframe: Week 52

InterventionPercentage of Participants (Number)
Placebo + Methotrexate12.6
Rituximab (0.5 g x 2) + Methotrexate25.4
Rituximab (1.0 g x 2) + Methotrexate30.5

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Percentage of Participants Without Radiographic Progression at Week 104

Percentage of patients without radiographic progression at Week 104, defined as change in total modified Sharp score (TMSS) ≤ 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change. (NCT00299104)
Timeframe: Baseline, Week 104

InterventionPercentage of Participants (Number)
Placebo + Methotrexate37.3
Rituximab (0.5 g x 2) + Methotrexate49.4
Rituximab (1.0 g x 2) + Methotrexate56.6

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Percentage of Participants Without Radiographic Progression at Week 24

Percentage of patients without radiographic progression at Week 24 defined as change in total modified Sharp score (TMSS) ≤ 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change. (NCT00299104)
Timeframe: Baseline, Week 24

InterventionPercentage of Participants (Number)
Placebo + Methotrexate59.7
Rituximab (0.5 g x 2) + Methotrexate65.3
Rituximab (1.0 g x 2) + Methotrexate71.7

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Percentage of Participants Without Radiographic Progression in the Total Erosion Score at Week 104

"Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The score at baseline is compared to the score at week 104.~No progression is defined as a change from score at screening to week 104 ≤0." (NCT00299104)
Timeframe: Week 104

InterventionPercentage of Participants (Number)
Placebo + Methotrexate38.2
Rituximab (0.5 g x 2) + Methotrexate52.7
Rituximab (1.0 g x 2) + Methotrexate58.6

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Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Mental Health Component Score at Week 52

"MCID is defined as a change from baseline in SF-36 Mental Health Component Score of >6.33.~SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement." (NCT00299104)
Timeframe: Baseline, Week 52

InterventionPercentage of Participants (Number)
Placebo + Methotrexate49.0
Rituximab (0.5 g x 2) + Methotrexate50.8
Rituximab (1.0 g x 2) + Methotrexate57.0

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Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Physical Health Component Score at Week 52

"MCID is defined as a change from baseline in SF-36 Physical Health Component Score of >5.42.~SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement." (NCT00299104)
Timeframe: Baseline, Week 52

InterventionPercentage of Participants (Number)
Placebo + Methotrexate63.2
Rituximab (0.5 g x 2) + Methotrexate69.9
Rituximab (1.0 g x 2) + Methotrexate76.4

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Percentage of Patients Without Radiographic Progression at Week 52

Percentage of patients without radiographic progression at Week 52, defined as change in total modified Sharp score (TMSS) <= 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change. (NCT00299104)
Timeframe: Baseline, Week 52

InterventionPercentage (Number)
Placebo + Methotrexate53.4
Rituximab (0.5 g x 2) + Methotrexate57.7
Rituximab (1.0 g x 2) + Methotrexate63.5

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Percentage of Patients Without Radiographic Progression in Total Erosion Score at Week 52

No radiographic progression is defined as a change in the total erosion score at Week 52 of less than or equal to zero. (NCT00299104)
Timeframe: Baseline, Week 52

InterventionPercentage of Participants (Number)
Placebo + Methotrexate54.7
Rituximab (0.5 g x 2) + Methotrexate59.0
Rituximab (1.0 g x 2) + Methotrexate66.8

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Percent Change From Baseline in Erythrocyte Sedimentation Rate

"Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionpercent change (Mean)
Week 24 [N=172, 166, 169]Week 48 [N=172, 166, 169]
Placebo + MTX8.0-14.5
Rituximab 2 x 0.5 g + MTX-28.0-31.3
Rituximab 2 x 1.0 g + MTX-29.2-36.7

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Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24

"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2.~No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1." (NCT00299130)
Timeframe: Baseline and Week 24

,,
Interventionpercentage of participants (Number)
No ResponseModerate ResponseGood Response
Placebo + MTX66.329.14.7
Rituximab 2 x 0.5 g + MTX33.549.117.4
Rituximab 2 x 1.0 g + MTX37.151.211.8

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Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 48

"The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity.~Low disease activity is defined by a DAS28 score less than or equal to 3.2. Remission is defined by a DAS28 score less than 2.6." (NCT00299130)
Timeframe: Week 48

,,
Interventionpercentage of participants (Number)
Low Disease ActivityClinical Remission
Placebo + MTX18.17.0
Rituximab 2 x 0.5 g + MTX20.09.1
Rituximab 2 x 1.0 g + MTX24.311.2

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Change From Baseline in Short Form 36 Health Survey (SF-36) Social Functioning Domain Score

"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionscores on a scale (Mean)
Week 24 [N=138, 154, 156]Week 48 [N=137, 148, 147]
Placebo + MTX2.5296.569
Rituximab 2 x 0.5 g + MTX5.9857.112
Rituximab 2 x 1.0 g + MTX6.4686.159

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Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Role Limitations Domain Score

"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionscores on a scale (Mean)
Week 24 [N=136, 153, 156]Week 48 [N=137, 148, 147]
Placebo + MTX2.7136.423
Rituximab 2 x 0.5 g + MTX5.6186.812
Rituximab 2 x 1.0 g + MTX5.1756.497

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Percentage of Participants With an ACR70 Response at Week 48

"To achieve an ACR70 required at least a 70% improvement compared with baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 70% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to Week 48, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders." (NCT00299130)
Timeframe: Baseline and Week 48

Interventionpercentage of participants (Number)
Placebo + MTX9.3
Rituximab 2 x 0.5 g + MTX12.6
Rituximab 2 x 1.0 g + MTX13.5

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Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score

"The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionpercent change (Mean)
Week 24 [N=172, 165, 170]Week 48 [N=172, 165, 170]
Placebo + MTX-14.7-22.6
Rituximab 2 x 0.5 g + MTX-26.9-30.2
Rituximab 2 x 1.0 g + MTX-23.4-30.6

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Change From Baseline in Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score

"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionscores on a scale (Mean)
Week 24 [N=138, 152, 156]Week 48 [N=137, 147, 147]
Placebo + MTX3.3048.449
Rituximab 2 x 0.5 g + MTX6.9318.079
Rituximab 2 x 1.0 g + MTX7.6048.964

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Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scores

"The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions using a value in the range of 0 (not at all) to 4 (very much). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.~A positive change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionscores on a scale (Mean)
Week 24 [N=170, 165, 168]Week 48 [N=170, 165, 169]
Placebo + MTX2.6615.506
Rituximab 2 x 0.5 g + MTX5.5646.269
Rituximab 2 x 1.0 g + MTX6.3986.203

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Time to Repletion of Peripheral CD19+ B-cells

Peripheral CD19+ B-cell repletion was defined as a CD19+ B-cell count that returned to the Baseline value or returned to ≥ the lower limit of normal, whichever was lower. (NCT00299130)
Timeframe: Beginning of the first infusion (Day 1) in the last treatment cycle until repletion or the end of the study (approximately 6.5 years)

InterventionWeeks (Median)
Rituximab 2 x 0.5 g + MTX110.3
Rituximab 2 x 1.0 g + MTX109.6

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Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 24

"The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity.~Low disease activity is defined by a DAS28 score less than or equal to 3.2. Remission is defined by a DAS28 score less than 2.6." (NCT00299130)
Timeframe: Week 24

,,
Interventionpercentage of participants (Number)
Low Disease ActivityClinical Remission
Placebo + MTX4.72.3
Rituximab 2 x 0.5 g + MTX17.59.6
Rituximab 2 x 1.0 g + MTX12.49.4

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Percentage of Participants With an ACR70 Response at Week 24

"To achieve an ACR70 required at least a 70% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 70% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders." (NCT00299130)
Timeframe: Baseline and Week 24

Interventionpercentage of participants (Number)
Placebo + MTX5.2
Rituximab 2 x 0.5 g + MTX9.0
Rituximab 2 x 1.0 g + MTX10.0

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Percentage of Participants With an ACR50 Response at Week 48

"To achieve an ACR50 required at least a 50% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to week 48, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders." (NCT00299130)
Timeframe: Baseline and Week 48

Interventionpercentage of participants (Number)
Placebo + MTX18.6
Rituximab 2 x 0.5 g + MTX32.9
Rituximab 2 x 1.0 g + MTX34.1

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Percentage of Participants With an ACR50 Response at Week 24

"To achieve an ACR50 required at least a 50% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders." (NCT00299130)
Timeframe: Baseline and Week 24

Interventionpercentage of participants (Number)
Placebo + MTX9.3
Rituximab 2 x 0.5 g + MTX26.3
Rituximab 2 x 1.0 g + MTX25.9

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Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24

"To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders." (NCT00299130)
Timeframe: Baseline and Week 24

Interventionpercentage of participants (Number)
Placebo + MTX23.3
Rituximab 2 x 0.5 g + MTX54.5
Rituximab 2 x 1.0 g + MTX50.6

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Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24

"The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6." (NCT00299130)
Timeframe: Baseline and Week 24

Interventionscores on a scale (Mean)
Placebo + MTX-0.76
Rituximab 2 x 0.5 g + MTX-1.71
Rituximab 2 x 1.0 g + MTX-1.68

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Percent Change From Baseline in Patient's Global Assessment of Disease Activity

"The participant's overall assessment of their current disease activity measured on a 100 mm horizontal visual analog scale (VAS). The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity).~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionpercent change (Mean)
Week 24 [N=171, 166, 169]Week 48 [N=171, 166, 169]
Placebo + MTX-14.0-28.0
Rituximab 2 x 0.5 g + MTX-31.5-39.7
Rituximab 2 x 1.0 g + MTX-29.1-36.6

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Percent Change From Baseline in Patient's Pain Assessment

"The participant's assessment of their current level of pain on a 100 mm horizontal visual analog scale (VAS), where the left-hand extreme of the line (0 mm) was described as no pain and the right-hand extreme (100 mm) as unbearable pain.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionpercent change (Mean)
Week 24 [N=171, 166, 169]Week 48 [N=171, 166, 169]
Placebo + MTX-9.7-24.4
Rituximab 2 x 0.5 g + MTX-25.7-35.5
Rituximab 2 x 1.0 g + MTX-29.1-36.3

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Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score

"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionscores on a scale (Mean)
Week 24 [N=138, 154, 154]Week 48 [N=137, 148, 146]
Placebo + MTX3.5536.212
Rituximab 2 x 0.5 g + MTX5.4606.778
Rituximab 2 x 1.0 g + MTX5.6536.854

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Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Health Domain Score

"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionscores on a scale (Mean)
Week 24 [N=137, 153, 156]Week 48 [N=135, 147, 147]
Placebo + MTX3.2783.890
Rituximab 2 x 0.5 g + MTX2.7704.583
Rituximab 2 x 1.0 g + MTX4.4864.224

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Change From Baseline in Short Form 36 Health Survey (SF-36) General Health Domain Score

"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionscores on a scale (Mean)
Week 24 [N=138, 154, 155]Week 48 [N=137, 148, 147]
Placebo + MTX2.0784.214
Rituximab 2 x 0.5 g + MTX3.5324.165
Rituximab 2 x 1.0 g + MTX3.8664.362

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Change From Baseline in Short Form 36 Health Survey (SF-36) Emotional Role Limitations Domain Score

"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionscores on a scale (Mean)
Week 24 [N=136, 151, 155]Week 48 [N=137, 146, 146]
Placebo + MTX1.8294.724
Rituximab 2 x 0.5 g + MTX4.6346.257
Rituximab 2 x 1.0 g + MTX4.4644.446

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Change From Baseline in Short Form 36 Health Survey (SF-36) Vitality Domain Score

"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionscores on a scale (Mean)
Week 24 [N=137, 154, 156]Week 48 [N=135, 147, 147]
Placebo + MTX3.6316.853
Rituximab 2 x 0.5 g + MTX4.2305.925
Rituximab 2 x 1.0 g + MTX5.9105.869

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Percent Change From Baseline in Physician's Global Assessment of Disease Activity

"The physician's assessment of the participant's current disease activity on a 100 mm horizontal VAS, where the left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as maximum disease activity.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionpercent change (Mean)
Week 24 [N=172, 166, 170]Week 48 [N=172, 166, 170]
Placebo + MTX-25.3-39.4
Rituximab 2 x 0.5 g + MTX-36.9-40.5
Rituximab 2 x 1.0 g + MTX-35.4-49.0

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Percent Change From Baseline in Short Form 36 Health Survey (SF-36) Summary Scores (Physical and Mental Components)

"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions split into two major components: physical health and mental health. Under physical health are the following four domains: physical health, bodily pain, physical functioning and physical role limitations. Under the mental health domain there are four domains; mental health, vitality, social functioning, and emotional role limitation. The individual domain scores are aggregated to derive a physical-component summary score and a mental-component summary score which range from 0 to 100, with higher scores indicating a better level of functioning.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A positive percentage change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionpercent change (Mean)
Physical Component: Week 24 [N=147, 152, 155]Physical Component: Week 48 [N=154, 154, 162]Mental Component: Week 24 [N=147, 152, 155]Mental Component: Week 48 [N=154, 154, 162]
Placebo + MTX11.121.38.412.7
Rituximab 2 x 0.5 g + MTX23.726.412.618.4
Rituximab 2 x 1.0 g + MTX22.827.419.618.7

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Percent Change From Baseline in Tender Joint Count

"Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionpercent change (Mean)
Week 24 [N=172, 166, 170]Week 48 [N=172, 166, 170]
Placebo + MTX-14.2-37.1
Rituximab 2 x 0.5 g + MTX-42.5-50.2
Rituximab 2 x 1.0 g + MTX-31.5-45.1

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Percent Change From Baseline in C-Reactive Protein

"C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionpercent change (Mean)
Week 24 [N=172, 166, 170]Week 48 [N=172, 166, 170]
Placebo + MTX58.140.1
Rituximab 2 x 0.5 g + MTX-27.5-37.3
Rituximab 2 x 1.0 g + MTX-23.1-34.9

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Percent Change From Baseline in Swollen Joint Count

"Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement." (NCT00299130)
Timeframe: Baseline, Week 24 and Week 48

,,
Interventionpercent change (Mean)
Week 24 [N=172, 166, 170]Week 48 [N=172, 166, 170]
Placebo + MTX-21.6-38.9
Rituximab 2 x 0.5 g + MTX-47.4-54.0
Rituximab 2 x 1.0 g + MTX-49.1-59.3

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Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 48

"The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from baseline score indicates an improvement.~Improved HAQ-DI is defined as a change from Baseline score less than or equal to -0.22.~An Unchanged HAQ-DI is defined as a change from Baseline score greater than -0.22 and less than 0.22.~A worsened HAQ-DI score is defined as a change from Baseline score of greater than or equal to 0.22." (NCT00299130)
Timeframe: Baseline and Week 48

,,
Interventionpercentage of participants (Number)
ImprovedNo changeWorsened
Placebo + MTX54.729.116.3
Rituximab 2 x 0.5 g + MTX73.317.09.7
Rituximab 2 x 1.0 g + MTX68.825.35.9

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Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 24

"The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from baseline score indicates an improvement.~Improved HAQ-DI is defined as a change from Baseline score less than or equal to -0.22.~An Unchanged HAQ-DI is defined as a change from Baseline score greater than -0.22 and less than 0.22.~A worsened HAQ-DI score is defined as a change from Baseline score of greater than or equal to 0.22." (NCT00299130)
Timeframe: Baseline and Week 24

,,
Interventionpercentage of participants (Number)
ImprovedNo changeWorsened
Placebo + MTX47.732.619.8
Rituximab 2 x 0.5 g + MTX66.123.610.3
Rituximab 2 x 1.0 g + MTX58.232.49.4

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Percentage of Participants With Low Immunoglobulin Concentrations Pre- and Post-Rituximab Treatment

A low immunoglobulin concentration was defined as a concentration below the lower level of normal. (NCT00299130)
Timeframe: Baseline (pre-rituximab), Beginning of the safety follow-up period to the end of the study (approximately 6 years) (post-rituximab)

InterventionPercentage of participants (Number)
Pre-Rituximab (N=490)Post-Rituximab (N=491)
Rituximab + MTX0.25.1

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Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 48

"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.~No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of 5.1 or higher." (NCT00299130)
Timeframe: Baseline and Week 48

,,
Interventionpercentage of participants (Number)
No ResponseModerate ResponseGood Response
Placebo + MTX41.341.916.9
Rituximab 2 x 0.5 g + MTX26.953.319.8
Rituximab 2 x 1.0 g + MTX31.847.620.6

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Number of Participants Achieving Durable Engraftment (Presence of Donor Cells) at 6 Weeks Post Transplantation

Peripheral blood chimerism studies were performed by quantitative real time polymerase chain reaction (qPCR) evaluation of differential short tandem repeat DNA sequences (NCT00301834)
Timeframe: 6 weeks post-transplant

Interventionparticipants (Number)
Single Arm - Transplant Pre-conditioning Per Study Protocol31

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Cytomegalovirus (CMV) Viral Infection and Disease Symptoms

polymerase chain reaction testing for presence of CMV weekly until at least day +100 then every 2 weeks until T-cell reconstitution as defined by cluster of differentiation 4 (CD4) > 200 cells/mm3. Median time to T-cell reconstitution was 6 months. (NCT00301834)
Timeframe: Up to one year post-transplant

,
Interventionparticipants (Number)
Positive CMV Viral Load AssaySymptomatic CMV disease
CMV Seronegative Participants10
CMV Seropositive Participants120

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Toxicity Grade ≥ 3 From Start of Conditioning Through the First Year Post Transplantation

(NCT00301834)
Timeframe: 1 year post-transplantation

Interventionparticipants (Number)
Grade 3-4 acute Graft-Versus-Host DiseaseGrade 3-4 mucositis
Single Arm216

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Treatment-related Mortality at 100 Days and 1 Year Post Transplantation

(NCT00301834)
Timeframe: 100 days and 1 year

Interventionparticipants (Number)
Transplantation-related mortality 0-100 daysTransplantation-related mortality 100-365 days
Single Arm - Transplant Pre-conditioning Per Study Protocol21

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Disease-free Survival With Correction of Disease at One Year Post Transplantation

"Patients deemed alive and well at follow-up timepoint later than 1-year post-transplantation" (NCT00301834)
Timeframe: 1 year post-transplantation

Interventionparticipants (Number)
Single Arm - Transplant Pre-conditioning Per Study Protocol22

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Survival Rate

Estimated Day 56 survival rate following initiation of etanercept + corticosteroid therapy for patients with IPS. (NCT00309907)
Timeframe: Up to day 56

Interventionpercentage of participants (Number)
Etanercept and Corticosteroid Therapy75

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Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0

Grade 3-5 organ toxicities attributable to etanercept. (NCT00309907)
Timeframe: Up to 56 days

InterventionPatients (Number)
Etanercept and Corticosteroid Therapy0

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Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy

Pulmonary response is defined as alive & come off of oxygen . (NCT00309907)
Timeframe: up to day 56

Interventionpercentage of participants (Number)
Etanercept and Corticosteroid Therapy74

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Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.

Response to therapy is defined as survival to Day 28 of study, PLUS complete discontinuation all supplemental oxygen support by Day 28 of study. Subjects must be able to remain off all supplemental oxygen support for > 72 consecutive hours. Subjects who discontinue supplemental oxygen within the last 72 hours of the observation period will be followed until they have completed 72 consecutive hours off oxygen or failed prior to assessing response. (NCT00309907)
Timeframe: At day 28

Interventionparticipants (Number)
With ResponseWithout Response
Etanercept and Corticosteroid Therapy208

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Plasma Cytokine IL6 Level

Estimated mean and standard error of IL6 level (NCT00309907)
Timeframe: From baseline to days 7 and 28

Interventionpg/ml (Mean)
BaselineDay 7Day 28
Etanercept and Corticosteroid Therapy205.228.823.1

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C-reactive Protein Levels

Estimated mean and standard deviation (NCT00309907)
Timeframe: From baseline to days 7, 14, 21, and 28

Interventionmg/dL (Mean)
BaselineDay 7 Non RespondersDay 7 RespondersDay 14 Non RespondersDay 14 RespondersDay 21 Non RespondersDay 21 RespondersDay 28 Non RespondersDay 28 Responders
Etanercept and Corticosteroid Therapy28.15.41.84.9110.71.619.65.3

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Participant's Quality of Life Using the Edmonton Scale

The Edmonton Scale consisted of 9 items: pain, activity, nausea, depression, anxiety, fatigue, appetite, sensation of well-being and dyspnea (difficult or labored breathing). Participants rated these items on a scale of 0 to 10, with 10 being the worse. (NCT00332696)
Timeframe: Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3

,
InterventionScores on a scale (Mean)
Day 1 (n=30,29)Day 7 (n=24,26)Day 14 (n=20,14)Month 1 (n=11,13)Month 2 (n=7,4)Month 3 (n=2,2)
Octreotide4.124.234.304.183.460.05
Placebo4.123.373.854.493.231.60

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Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14

The mean number of vomiting episodes per a 24 hour period is presented for Day 1, Day 7 and Day 14. (NCT00332696)
Timeframe: Day 1, Day 7 and Day 14

,
InterventionVomiting episodes (Mean)
Day 1Day 7 (n=31,31)Day 14 (n=28,27)
Octreotide1.20.30.3
Placebo0.60.40.5

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Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1

Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 1. (NCT00332696)
Timeframe: Day 1

,
InterventionParticipants (Number)
Score=0Score=1Score=2Score=3
Octreotide16178
Placebo13298

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Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14

Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 14. (NCT00332696)
Timeframe: Day 14

,
InterventionParticipants (Number)
Score=0Score=1Score=2Score=3
Octreotide22222
Placebo22311

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Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7

Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 7. (NCT00332696)
Timeframe: Day 7

,
InterventionParticipants (Number)
Score=0Score=1Score=2Score=3
Octreotide21253
Placebo15961

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Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1

Recurrence of bowel obstruction was confirmed by abdominal X-ray. (NCT00332696)
Timeframe: 1 Month

,
InterventionParticipants (Number)
Recurrence at Month 1No Recurrence at Month 1
Octreotide113
Placebo213

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Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2

Recurrence of bowel obstruction was confirmed by abdominal X-ray. (NCT00332696)
Timeframe: Month 2

,
InterventionParticipants (Number)
Recurrence at Month 2No Recurrence at Month 2
Octreotide26
Placebo25

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Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3

Recurrence of bowel obstruction was confirmed by abdominal X-ray. (NCT00332696)
Timeframe: Month 3

,
InterventionParticipants (Number)
Recurrence at Month 3No Recurrence at Month 3
Octreotide03
Placebo02

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Number of Participants With Relief From Obstruction at Day 7 and Day 14

Relief from obstruction is defined by combining restart of stools for at least the previous 3 days, less than 2 episodes of vomiting on average for the previous 4 days and the restarting of flatus (gas generated in the stomach or bowels) for at least the previous 12 hours. (NCT00332696)
Timeframe: Day 7 and Day 14

,
InterventionParticipants (Number)
Relief from Obstruction: Day 7No Relief from Obstruction: Day 7Relief from Obstruction: Day 14No Relief from Obstruction: Day 14
Octreotide9201110
Placebo1512105

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Number of Participants With Treatment Success From Day 10 to Day 13

"Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 [from Day 10 to Day 13] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14.~Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause." (NCT00332696)
Timeframe: Day 10 to Day 13

,
InterventionParticipants (Number)
TREATMENT SUCCESSVomiting episodes <2 (per day)Vomiting episodes ≥2 (per day)No Nasogastric Tube since Day 10Nasogastric Tube used since Day 10No Anticholinergic agentsAnticholinergic agents takenPremature discontinuation/missing data, failure
Octreotide1219214718311
Placebo913213211417

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Number of Participants With Treatment Success From Day 5 to Day 7

Day 7 treatment success was defined as improvement of symptoms in the previous 2 days (average number of vomiting episodes less than 2 from Day 5, no Nasogastric Tube (NGT) since Day 5 and no anticholinergic agent or withdrawal from trial). (NCT00332696)
Timeframe: Day 5 to Day 7

,
InterventionParticipants (Number)
TREATMENT SUCCESSVomiting episodes <2 (per day) since Day 5Vomiting episodes ≥2 (per day) since Day 5No Nasogastric Tube since Day 5Nasogastric Tube used since Day 5No Anticholinergic agentsAnticholinergic agents takenPremature discontinuation/missing data
Octreotide222812272633
Placebo202522432525

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Worst Toxicity Grade by Patient

graded by National Cancer Institute Common Toxicity Criteria of Adverse Event version 3.0 (NCT00336583)
Timeframe: up to 24 weeks

Interventionparticipants (Number)
Grade 1 neutropeniaGrade 2 neutropeniaGrade 3 neutropeniaGrade 4 neutropeniaGrade 1 thrombocytopeniaGrade 2 thrombocytopeniaGrade 3 thrombocytopeniaGrade 4 thrombocytopenia
ESHAOx332134336

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Overall Response Rate

The Overall Response Rate was measured by the number of patients per the total treatment population who partially or completely responded to treatment. Response was evaluated according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. (NCT00336583)
Timeframe: up to 24 weeks

Interventionpariticipants (Number)
ESHAOx17

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Percent Change in Flare at Resolution

(NCT00345046)
Timeframe: 2 months

InterventionPercent change in flare (Mean)
Pred Forte 1%64.8
Econo Pred Plus 1%68.3
Predisolone Acetate 1%65.7

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Acute Rejection at 12-Months

"Incidence of acute rejection[1] at 12 months post-transplant~Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00346151)
Timeframe: 12 months post-transplant

InterventionParticipants (Number)
Immunosuppression Withdrawal4

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Acute Rejection at 6-Months

"Cumulative incidence of acute rejection[1] at 6 months post-transplant based on local pathology biopsy reads~Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00346151)
Timeframe: 6 months post-transplant

InterventionParticipants (Number)
Immunosuppression Withdrawal3

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Graft Survival at 12 Months Post-transplant

(NCT00346151)
Timeframe: 12 months post-transplant

InterventionParticipants (Number)
Immunosuppression Withdrawal4

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Participant Survival at 12 Months Post-Transplant

(NCT00346151)
Timeframe: 12 months post-transplant

InterventionParticipants (Number)
Immunosuppression Withdrawal4

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Proportion of Participants Requiring Antilymphocyte Therapy for Acute Rejection

"Proportion of participants who experienced acute rejection[1] requiring antilymphocyte therapy~Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00346151)
Timeframe: Participants followed from transplantation until completion of study (up to four years post-transplantation)

InterventionParticipants (Number)
Immunosuppression Withdrawal0

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Proportion of Participants With a Sirolimus Associated Adverse Event

(NCT00346151)
Timeframe: Participants followed from transplantation until completion of study (up to four years post-transplantation)

InterventionParticipants (Number)
Immunosuppression Withdrawal5

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Proportion of Participants With Chronic Allograft Nephropathy

(NCT00346151)
Timeframe: Participants followed from transplantation until completion of study (up to four years post-transplantation)

InterventionParticipants (Number)
Immunosuppression Withdrawal0

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Proportion of Participants With Delayed Graft Function

(NCT00346151)
Timeframe: Participants followed from transplantation until completion of study (up to four years post-transplantation)

InterventionParticipants (Number)
Immunosuppression Withdrawal0

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Proportion of Participants With Malignancies

(NCT00346151)
Timeframe: Participants followed from transplantation until completion of study (up to four years post-transplantation)

InterventionParticipants (Number)
Immunosuppression Withdrawal0

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Proportion of Participants With Post-transplant Diabetes Mellitus

(NCT00346151)
Timeframe: Participants followed from transplantation until completion of study (up to four years post-transplantation)

InterventionParticipants (Number)
Immunosuppression Withdrawal1

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Proportion of Participants With Post-transplant Infections

Proportion of participants who experienced infections post-transplant. Participants were checked for any type of opportunistic infection at all study visits post-transplantation (up to 4 years post-transplantation) (NCT00346151)
Timeframe: Participants followed from transplantation until completion of study (up to four years post-transplantation)

InterventionParticipants (Number)
Immunosuppression Withdrawal4

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Proportion of Participants With Wound Complications

(NCT00346151)
Timeframe: Start of study to end of study

InterventionParticipants (Number)
Immunosuppression Withdrawal0

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Renal Function as Measured by Glomerular Filtration Rate (GFR) at 24 Weeks

"GFR utilizing clearance of iothalamate.~GFR is an index of level of kidney function. A higher value means better kidney function." (NCT00346151)
Timeframe: 24 weeks post-transplant

InterventionmL/min/1.73m^2 (Mean)
Immunosuppression Withdrawal62.0

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Time From Transplant to Acute Rejection

"Time (days) from transplant to occurrence of acute rejection[1]~Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00346151)
Timeframe: Transplantation until rejection occurs (participants followed up to four years post-transplantation)

InterventionDays (Median)
Immunosuppression Withdrawal15

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Tolerance Induction

Time from transplantation to initiation of sirolimus withdrawal. (NCT00346151)
Timeframe: 48 months

InterventionDays (Number)
Immunosuppression Withdrawal391

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Number of Participants (Patients) Who Experienced Relapse by 12 Months

Number of patients who experienced recurrence or progression of disease from the time of transplant. (NCT00354172)
Timeframe: 1 Year Post Transplant

InterventionParticipants (Number)
Evaluable Patients10

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Number of Participants (Patients) Who Attained Neutrophil Engraftment

"Defined as absolute neutrophils (ANC) > 5 x 10^8/Liter for 3 consecutive days.~ANC is the real number of white blood cells (WBCs) that are neutrophils. The absolute neutrophil count is commonly called the ANC. The ANC is not measured directly. It is derived by multiplying the WBC count times the percent of neutrophils in the differential WBC count. The percent of neutrophils consists of the segmented (fully mature) neutrophils) + the bands (almost mature neutrophils). The normal range for the ANC = 1.5 to 8.0 (1,500 to 8,000/mm3)." (NCT00354172)
Timeframe: Day 42 Post Transplant

InterventionParticipants (Number)
Evaluable Patients13

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Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months

Number of patients who were alive and free of disease (malignancy) at 6 months after transplant. (NCT00354172)
Timeframe: 6 Months Post Transplant

InterventionParticipants (Number)
Evaluable Patients2

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Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months

Number of patients who were alive and free of disease (malignancy) at 12 months after transplant. (NCT00354172)
Timeframe: 12 Months Post transplant

InterventionParticipants (Number)
Evaluable Patients1

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Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV

Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. (NCT00354172)
Timeframe: Day 100 Post Transplant

InterventionParticipants (Number)
Evaluable Patients6

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Number of Participants (Patients) Who Experienced Relapse by 24 Months

Number of patients who experienced recurrence or progression of disease from the time of transplant. (NCT00354172)
Timeframe: 2 Years Post transplant

InterventionParticipants (Number)
Evaluable Patients11

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Chimerism After Double Umbilical Cord Blood Transplant (UCBT)

Calculation of Median (range) of percentage of donor cells engrafted (present) in the recipient (patient). (NCT00354172)
Timeframe: Day 21, Day 100, 6 Months

InterventionPercentage of Engrafted Cells (Median)
Day 21Day 1006 Months
Evaluable Patients9210096.5

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Number of Patients Who Were Disease-free and Alive at 24 Months

Number of patients who were alive and free of disease (malignancy) at 24 months after transplant. (NCT00354172)
Timeframe: 24 Months Post transplant

InterventionParticipants (Number)
Evaluable Patients0

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Number of Participants (Patients) With Chronic Graft-Versus-Host Disease

The chronic form of graft-versus-host-disease (cGVHD) normally occurs after 100 days. The appearance of moderate to severe cases of cGVHD adversely influences long-term survival. (NCT00354172)
Timeframe: Day 100 through 1 Year Post Transplant

InterventionParticipants (Number)
Evaluable Patients1

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Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV

Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. (NCT00354172)
Timeframe: Day 100 post transplant

InterventionParticipants (Number)
Evaluable Patients1

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Number of Participants (Patients) Who Attained Platelet Engraftment

Platelet engraftment is defined as platelet counts > 50 x 10^9/Liter for 3 consecutive days. (NCT00354172)
Timeframe: 1 Year Post Transplant

InterventionParticipants (Number)
Evaluable Patients5

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Number of Participants (Patients) With Successful Natural Killer Cell Expansion

Defined by an absolute circulating donor-derived natural killer cell count of >100 cells/microliter 10-13 days after infusion with <5% donor T and B cells in the mononuclear population (NCT00354172)
Timeframe: 10-13 Days Post Infusion

InterventionParticipants (Number)
Evaluable Patients3

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Number of Participants (Patients) Who Died by 12 Months

Number of patients who died after receiving treatment within 12 months post transplant. (NCT00354172)
Timeframe: 1 year Post Transplant

InterventionParticipants (Number)
Evaluable Patients14

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Number of Participants (Patients) Who Died by 24 Months

Number of patients who died after receiving treatment within 24 months post transplant. (NCT00354172)
Timeframe: 2 years post-transplant

InterventionParticipants (Number)
Evaluable Patients15

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Number of Participants (Patients) Who Died Due to Transplant.

Patients who had transplant-related mortality (TRM). TRM = adverse event(s) that occur(s) after the patient has received a transplant, the principal investigator decides it is related to the procedure and the patient dies within 6 months. (NCT00354172)
Timeframe: 6 Months Post Transplant

InterventionParticipants (Number)
Evaluable Patients4

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Percentage of Participants With at Least 1 Serious Adverse Event

A serious adverse event is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator. (NCT00381810)
Timeframe: Baseline to the end of the study (up to 52 weeks)

InterventionPercentage of participants (Number)
Rituximab 1000 mg35.5

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Serious Adverse Events

Serious Adverse Events (NCT00393367)
Timeframe: 0-5 days

,
Interventionparticipants (Number)
Return within 5 days with hosptial admissionIncreased level of care
Budesonide Inhalation Suspension (BIS)21
Placebo (Saline)20

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Number of Participants With Adverse Events (Non-serious).

(NCT00393367)
Timeframe: within 30 days of the ED visit

,
InterventionParticipants (Number)
RhinorrheaHeadacheDiarrheaSore throatCoughHyperglycemia
Budesonide Inhalation Suspension (BIS)653422
Placebo (Normal Saline)1197330

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Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category

Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the moderate category (Asthma Severity score 8-11) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. (NCT00393367)
Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)22
Placebo (Normal Saline)11

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Median Change in Asthma Score 2 Hours After Intervention

The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator. (NCT00393367)
Timeframe: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator

InterventionUnits on a scale (Median)
Budesonide Inhalation Suspension (BIS)-3
Placebo (Normal Saline)-3

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Mean Change in Respiratory Rate.

Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator. (NCT00393367)
Timeframe: Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator

InterventionBreaths per minute (Mean)
Budesonide Inhalation Suspension (BIS)-6
Placebo (Normal Saline)-6

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Mean Change in Asthma Score at 2 Hours

The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator. (NCT00393367)
Timeframe: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator

InterventionUnits on a scale (Mean)
Budesonide Inhalation Suspension (BIS)-2.9
Placebo (Normal Saline)-3.0

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Change in Mean Heart Rate

Mean of heart rate in beats per minute before treatment minus mean of heart rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol (NCT00393367)
Timeframe: From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

InterventionBeats per minute (Mean)
Budesonide Inhalation Suspension (BIS)12
Placebo (Normal Saline)13

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Oxygen Saturation.

Mean oxygen saturation (non-invasive pulse-oximetry, % hemoglobin saturation) 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator minus mean oxygen saturation before treatment. (NCT00393367)
Timeframe: 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator

InterventionPercent Hemoglobin Saturation (Mean)
Budesonide Inhalation Suspension (BIS)1.0
Placebo (Normal Saline)1.0

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Number of Subjects Moving From the Severe Asthma to Mild Asthma Category

Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the mild category (Asthma Severity score 5-7) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. (NCT00393367)
Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)8
Placebo (Normal Saline)10

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Number of Patients Hospitalized

The number of patients requiring hospital admission 4 hours after budesonide/albuterol intervention or saline/albuterol comparator. All hospitalization decisions are made at the discretion of the attending physician. (NCT00393367)
Timeframe: within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)56
Placebo (Saline)55

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Number of Subjects Remaining in the Severe Asthma Category

Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who remained in this category 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. (NCT00393367)
Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)4
Placebo (Normal Saline)4

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Relapse / Readmission Numbers.

Participants admitted to the hospital within 5 days of the ED visit (NCT00393367)
Timeframe: within 5 days of ED visit

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)2
Placebo (Normal Saline)2

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Post-Induction Nadir Serum Asparaginase Activity Level

Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. (NCT00400946)
Timeframe: Samples for nadir serum asparaginase activity analyses were obtained before doses administered at weeks 5, 11, 17, 23 and 29 of post-induction asparaginase treatment.

,
InterventionIU/mL (Mean)
Week 5 NSAA LevelWeek 11 NSAA LevelWeek 17 NSAA LevelWeek 23 NSAA LevelWeek 29 NSAA Level
Intramuscular Native E Coli L-asparaginase (IM-EC)0.1290.1430.1590.1800.123
Intravenous PEG-asparaginase (IV-PEG)0.7260.7730.7870.7570.806

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Induction Therapeutic Nadir Serum Asparaginase Activity Rate

Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. Induction therapeutic NSAA rate is defined as the percentage of patients achieving a NSAA level above 0.1 IU/mL at a given timepoint. (NCT00400946)
Timeframe: Samples for serum asparaginase activity analyses were obtained days 4, 11, 18 and 25 post one-dose of IV-PEG on day 7 of the induction phase.

Interventionpercentage of participants (Number)
Day 4 NSAA RateDay 11 NSAA RateDay 18 NSAA RateDay 25 NSAA Rate
Overall97968712

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Induction Serum Asparaginase Activity Level

Serum asparaginase activity (NSAA) levels were estimated based on established methods. (NCT00400946)
Timeframe: Samples for serum asparaginase activity analyses were obtained days 4, 11, 18 and 25 post one-dose of IV-PEG on day 7 of the induction phase.

InterventionIU/mL (Median)
Day 4 NSAA LevelDay 11 NSAA LevelDay 18 NSAA LevelDay 25 NSAA Level
Overall.694.505.211.048

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Post-Induction Therapeutic Nadir Serum Asparaginase Activity Rate

Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. Post-Induction therapeutic NSAA rate is defined as the percentage of patients achieving a NSAA level above 0.1 IU/mL ever during post-induction therapy. (NCT00400946)
Timeframe: Samples for nadir serum asparaginase activity analyses were obtained before doses administered at weeks 5, 11, 17, 23 and 29 of post-induction asparaginase treatment.

Interventionpercentage of participants (Number)
Intramuscular Native E Coli L-asparaginase (IM-EC)71
Intravenous PEG-asparaginase (IV-PEG)99

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5-Year Disease-Free Survival by MRD Day 32 Status

Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. (NCT00400946)
Timeframe: Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.

Interventionprobability (Number)
Low Day 32 MRD Level.79
High Day 32 MRD Level.90

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5-year Disease-Free Survival by CNS Directed Treatment Group

Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. (NCT00400946)
Timeframe: Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.

Interventionprobability (Number)
CNS-1.89
CNS-2.89
CNS-31.00
Traumatic Tap With Blasts.84
Traumatic Tap Without Blasts.87

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Induction Infection Toxicity Rate

Infection toxicity rate is defined as the percentage of patients who experience bacterial or fungal infection of grade 3 or higher with treatment attribution of possibly, probably or definite based on CTCAEv3 during remission induction phase of combination chemotherapy. (NCT00400946)
Timeframe: Assessed daily during remission induction days 4-32.

Interventionpercentage of participants (Number)
Overall26

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5-Year Disease-Free Survival

Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. (NCT00400946)
Timeframe: Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.

Interventionprobability (Number)
Intramuscular Native E Coli L-asparaginase (IM-EC).89
Intravenous PEG-asparaginase (IV-PEG).90

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5-Year Disease-Free Survival by Bone Marrow Day 18 Status

Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. (NCT00400946)
Timeframe: Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.

Interventionprobability (Number)
M1 Day 18 Bone Marrow Status.89
M2/M3 Day 18 Bone Marrow Status.78
Hypocellular Day 18 Bone Marrow Status.88

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Discontinuation of Supplemental Oxygen

"The time required to discontinue supplemental oxygen will be measured in the number of days from study entry." (NCT00421174)
Timeframe: Day 56

Interventiondays (Median)
Etanercept9
Placebo7

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Overall Mortality

(NCT00421174)
Timeframe: Year 2

Interventionparticipants (Number)
Etanercept13
Placebo15

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Incidence of Relapse

Percentage of patients who experience relapse. Deaths without relapse are considered as a competing risk. (NCT00421174)
Timeframe: Year 1

InterventionParticipants (Count of Participants)
Etanercept3
Placebo2

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Incidence of Infection

(NCT00421174)
Timeframe: Day 56

,
InterventionInfections (Number)
Bacterial infectionViral infectionFungal infection
Etanercept974
Placebo21102

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Incidence of Graft-vs-Host-Disease (GVHD)

(NCT00421174)
Timeframe: Year 1

,
Interventionpercentage of participants (Number)
Acute GVHDGVHDChronic GVHD
Etanercept31.225.012.5
Placebo44.427.80

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Corticosteroid Dose

Patients were treated with systemic corticosteroids with methylprednisolone at 2 mg/kg/day on day 0, with taper allowed after day 7. (NCT00421174)
Timeframe: Day 14 and 28

,
Interventionmg/kg/day (Median)
Day 14Day 28
Etanercept0.940.57
Placebo1.000.49

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Response to Therapy

Response will be defined as the ability to survive to Day 56 of study, plus the ability to completely discontinue all supplemental oxygen support for > 72 consecutive hours during this time period. (NCT00421174)
Timeframe: Day 56

Interventionpercentage of participants (Number)
Etanercept56.3
Placebo50.0

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Response Rate

Response will be defined as survival to Day 28 of study, plus discontinuation of all supplemental oxygen support for more than 72 consecutive hours by Day 28. (NCT00421174)
Timeframe: Day 28

Interventionpercentage of participants (Number)
Etanercept62.5
Placebo66.7

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Incidence of Toxicity

(NCT00421174)
Timeframe: Day 56

,
InterventionToxcities (Number)
RenalHepaticCardiacCentral nervous system
Etanercept4712
Placebo31426

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Overall Survival

Percentage of patients that survived after one year (NCT00421174)
Timeframe: Year 1

Interventionpercentage of participants (Number)
Etanercept18.8
Placebo16.7

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Number of Patients With Complete Remission

Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal value. (NCT00423098)
Timeframe: 12 Weeks

,
Interventionparticipants (Number)
YesNo
Low Dose534
Standard Dose933

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Number of Patients With Moderate to Severe Flares

A moderate to severe flare was defined as the occurrence of increased lupus activity after partial or complete remission, based on the presence of 1 BILAG A score or >=3 BILAG B scores. British Isles Lupus Assessment Group (BILAG) index divides lupus activity in 8 organs/systems which are each given a score of A to E. A=disease sufficiently active to need disease modifying treatment; B=problems requiring symptomatic treatment; C=mild stable disease; D=previously affected but currently inactive system; E=the system or organ has never been involved. BILAG score: A=9, B=3, C=1, D/E=0; range(0-72) (NCT00423098)
Timeframe: 12 and 24 weeks

,
Interventionparticipants (Number)
At week 12 - YesAt week 12 - NoAt week 24 - YesAt week 24 - No
Low Dose039039
Standard Dose042141

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Number of Patients With Partial Remission

Partial remission was defined as urine protein/creatinine ratio reduced by at least 50% from baseline and stable serum creatinine within 10% of baseline value) or improved. (NCT00423098)
Timeframe: Baseline to 12 and 24 weeks

,
InterventionParticipants (Number)
At 12 weeks - YesAt 12 weeks - NoAt 24 weeks - YesAt 24 weeks - No
Low Dose11281425
Standard Dose16262022

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Number of Patients With Treatment Failure

Treatment failure was defined as no therapeutic response (without complete or partial remission) or premature discontinuation during the first 24 weeks from study medication or the study for any reason except complete or partial remission. (NCT00423098)
Timeframe: 12 Weeks and 24 Weeks

,
Interventionparticipants (Number)
At 12 weeks - YesAt 12 weeks - NoAt 24 weeks - YesAt 24 weeks - No
Low Dose25142217
Standard Dose23192121

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Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)

Corticosteroid use was measured as cumulative dose until 12 and 24 weeks of treatment as well as daily doses at baseline, 12 and 24 weeks. (NCT00423098)
Timeframe: 12 Weeks and 24 Weeks

,
Interventionmg/kg (Mean)
Week 12Week 24
Low Dose68.273.0
Standard Dose106.1114.2

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Number of Patients With Adverse Events and Infections

Safety assessments included collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. (NCT00423098)
Timeframe: 24 weeks

,
Interventionparticipants (Number)
At least one adverse eventAny severe adverse eventAny drug related adverse eventAny serious adverse eventAny infectionAny severe infectionAny drug related infectionAny serious infection
Low Dose30316417161
Standard Dose357188253104

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Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)

SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index and was a well established global score index based on assessment of 24 items measuring a disease activity in the 10-day period prior to the assessment. SLEDAI item weights range from 1 for fever to 8 for seizures. A maximum theoretical score is 105. Total score range from 1 to 105. A flare has been defined as a SLEDAI score increase of 3 or more to a level of 8 or higher. During flares SLEDAI scores of 25 to 30 are common. (NCT00423098)
Timeframe: From Baseline to week 4, week 12 and week 24

,
InterventionUnits on a scale (Mean)
Change from Baseline to Week 4: (N= 39, 37)Change from Baseline to Week 12: (N= 41, 35)Change from Baseline to Week 24: (N= 39, 34)
Low Dose-7.7-10.3-9.8
Standard Dose-7.4-9.7-10.3

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Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)

BILAG (British Isles Lupus Assessment Group) index divides lupus activity into 8 organs/systems and was based on the principle of the physician's intention to treat, assessing activity in the previous one month. Each organ or system was given a score of A to E, where A = disease that is sufficiently active to require disease modifying treatment; a B = problems requiring symptomatic treatment; C = stable mild disease; D = previously affected but currently inactive system; and E = the system or organ has never been involved. [A=9, B=3, C=1, D/E=0 the score range for each patient will be 0-72]. (NCT00423098)
Timeframe: From Baseline to week 4, week 12 and week 24

,
InterventionUnits on a scale (Mean)
Change from baseline Week 4: (N= 40, 37)Change from baseline Week 12: (N= 41, 35)Change from baseline Week 24: (N= 40, 34)
Low Dose-5.5-8.7-9.4
Standard Dose-4.8-8.6-8.6

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Duration of Exposure to Study Medication

The duration of exposure was calculated as the date of the last Mycophenolate sodium dose minus the date of the last Mycophenolate sodium dose +1. (NCT00423098)
Timeframe: 24 weeks

Interventiondays (Mean)
Standard Dose164.5
Low Dose157.7

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Number of Patients With Complete Remission

Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal range according to local lab. (NCT00423098)
Timeframe: 24 Weeks

,
InterventionParticipants (Number)
YesNo
Low Dose831
Standard Dose834

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Survival

Survival (NCT00424489)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Hematopoietic Stem Cell Transplantation6

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Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events

(NCT00443430)
Timeframe: Over 12 months maximum study participation per subject

Interventionevents (Number)
Methotrexate Arm1
Methotrexate-Prednisolone-Etanercept Arm2

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Proportion of Participants Who Attain Inactive Disease by 6 Months

(NCT00443430)
Timeframe: 6 months after initiation of study intervention

Interventionparticipants (Number)
Methotrexate Arm10
Methotrexate-Prednisolone-Etanercept Arm17

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Clinical Remission on Medication

6 months of clinical inactive disease (NCT00443430)
Timeframe: 12 months or end of study

Interventionparticipants (Number)
Methotrexate Arm3
Methotrexate-Prednisolone-Etanercept Arm9

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Overall Survival

Overall survival is defined as time from date of transplant to date of death or censored at the date of last documented contact for patients still alive. (NCT00455312)
Timeframe: 1 Year

InterventionParticipants (Count of Participants)
Patients With DC12
Patients With SAA19

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Neutrophil Engraftment

Defined as an absolute neutrophil count (ANC) >5 x 10^8/L (first of three consecutive laboratory measurements on different days) with at least 10% donor cells by day 100. Demonstrate sustained engraftment after a fludarabine based preparative regimen in patients with dyskeratosis congenita followed by hematopoietic cell transplantation. (NCT00455312)
Timeframe: Day 100

InterventionParticipants (Count of Participants)
Patients With DC15
Patients With SAA20

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Incidence of Pulmonary Complications

Defined as patients who exhibit a pulmonary (lung) adverse event. (NCT00455312)
Timeframe: 6 Months

InterventionParticipants (Count of Participants)
Patients With DC3
Patients With SAA3

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Incidence of Grade 3-4 Acute Graft Versus Host Disease (GVHD)

Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. (NCT00455312)
Timeframe: Day 100

InterventionParticipants (Count of Participants)
Patients With DC0
Patients With SAA0

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Incidence of Late Secondary Malignancies

Defined as patients who have a secondary malignancy (cancer) occurring. (NCT00455312)
Timeframe: 1 Year

InterventionParticipants (Count of Participants)
Patients With DC0
Patients With SAA4

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Incidence of Grade 2-4 Acute Graft Versus Host Disease (GVHD)

Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. (NCT00455312)
Timeframe: Day 100

InterventionParticipants (Count of Participants)
Patients With DC1
Patients With SAA0

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Incidence of Chronic GVHD

Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. (NCT00455312)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Patients With DC0
Patients With SAA0

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Incidence of Chronic GVHD

Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. (NCT00455312)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Patients With DC1
Patients With SAA2

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Overall Survival

Overall survival is defined as time from date of transplant to date of death or censored at the date of last documented contact for patients still alive. (NCT00455312)
Timeframe: Day 100

InterventionParticipants (Count of Participants)
Patients With DC14
Patients With SAA19

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Percentage of Participants Reaching Overall Survival

Overall survival from diagnosis (NCT00458848)
Timeframe: At 60 months

Interventionpercentage of patients (Number)
Philadelphia Positive, Imatinib Only in Induction Therapy48.8

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Number of Patients Reaching Complete Hematological Response After Induction Therapy

(NCT00458848)
Timeframe: At the end of induction, day +50

Interventionparticipants (Number)
Philadelphia Positive, Imatinib Only in Induction Therapy49

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Percentage of Participants Reaching Disease Free Survival

(NCT00458848)
Timeframe: At 60 months

Interventionpercentage of participants (Number)
Philadelphia Positive, Imatinib Only in Induction Therapy45.8

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Relapse Rate

Relapse rate (disease recurrence) 3 years after transplant, for participants who received both transplants, as determined by Kaplan-Meier estimation. (NCT00481832)
Timeframe: 3 years

Interventionpercentage of participants (Number)
T & B Cell Mobilization Auto & Allo HCT27

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Incidence of Chemotherapy-associated Pneumonitis

Interstitial pneumonitis (IP) is a risk associated with high-dose carmustine (BCNU) or other chemotherapy drugs used for transplantation. IP is diagnosed by 1) a decrease of >25% in DLCO compared with pre-transplant PFT DLCO values or 2) a drop of 7% or more in oxygen saturation after exertion. (NCT00481832)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
T & B Cell Mobilization Auto & Allo HCT16

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Incidence of Acute Graft Versus Host Disease (GvHD)

The development of GvHD in vaccinated patients of any grade and at 6 months. (NCT00481832)
Timeframe: 6 Months

InterventionParticipants (Count of Participants)
T & B Cell Mobilization Auto & Allo HCT3

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Achieving Full Donor Chimerism

Achieving full donor chimerism (donor T cells >95%): Blood was sent for donor cell percentage measured by short tandem repeat (STR) at post-transplant Day 30; Day 60; Day 90; Day 120; Day 180; Day 270; and Day 360. Full donor chimerism is defined as donor CD3+ cells > 95%. (NCT00481832)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
T & B Cell Mobilization Auto & Allo HCT10

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Event-free Survival (EFS)

"Event-free survival (EFS) as determined for participants who receive both planned transplants, for a minimum of 3 years.~Events are defined as disease progression/relapse and death of all causes." (NCT00481832)
Timeframe: 3 years

Interventionpercentage of participants (Number)
T & B Cell Mobilization Auto & Allo HCT35

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Incidence of Chronic Graft Versus Host Disease (GvHD)

The development of GvHD in vaccinated patients of any grade at 6 months. (NCT00481832)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
T & B Cell Mobilization Auto & Allo HCT3

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Overall Mortality Rate

Overall mortality is determined by Kaplan-Meier estimation. The overall morality rate is expressed as the percentage of patients who died for any reason, including disease-related death. (NCT00481832)
Timeframe: 3 years

Interventionpercentage of participants (Number)
T & B Cell Mobilization Auto & Allo HCT56

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Median Time to Platelet Engraftment

Complete blood counts were measured daily after allogeneic transplant. Time to platelet engraftment is defined as the number of days it takes to reach platelet count >20,000, counting from the day of transplant. (NCT00481832)
Timeframe: Up to 45 days

InterventionDays (Median)
T & B Cell Mobilization Auto & Allo HCT11

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Median Time to Neutrophile Engraftment

Complete blood counts were measured daily after allogeneic transplant. Time to neutrophil engraftment is defined as the number of days it takes to reach an absolute neutrophils count (ANC) >500, counting from the day of transplant. (NCT00481832)
Timeframe: up to 45 days

InterventionDays (Median)
T & B Cell Mobilization Auto & Allo HCT17

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Overall Survival (OS)

Overall Survival (OS) 3 years after transplant, for participants who received both transplants, as determined by Kaplan-Meier estimation. (NCT00481832)
Timeframe: 3 years

Interventionpercentage of participants (Number)
T & B Cell Mobilization Auto & Allo HCT57

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Median Time to Platelet Engraftment After Allogeneic Transplant

Reported as platelet engraftment after allogeneic transplant, defined as platelet count > 20,000/µL, counting from the day of transplant. (NCT00482053)
Timeframe: within 1 month

InterventionDays (Median)
Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL10

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Overall Survival (OS)

To evaluate the overall and transplant related mortality rate, reported as the number of subjects remaining alive 3 years after transplant. (NCT00482053)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL2

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Median Time to Platelet Engraftment After Autologous Transplant

Reported as platelet engraftment after autologous transplant, defined as platelet count > 20,000/µL, counting from the day of transplant. (NCT00482053)
Timeframe: within 1 month

InterventionDays (Median)
Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL19

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Median Time to Neutrophil Engraftment After Autologous Transplant

Reported as neutrophil engraftment after autologous transplant, defined as absolute neutrophil count (ANC) > 500/µL, counting from the day of transplant. (NCT00482053)
Timeframe: within 1 month

InterventionDays (Median)
Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL11

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Median Time to Neutrophil Engraftment After Allogeneic Transplant

Reported as neutrophil engraftment after allogeneic transplant, defined as absolute neutrophil count (ANC) > 500/µL, counting from the day of transplant. (NCT00482053)
Timeframe: within 1 month

InterventionDays (Median)
Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL10.5

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Incidence of Chronic Graft vs Host Disease (GvHD)

The incidence of chronic graft vs host disease (GvHD) is reported as any events within 3 years. Note that GvHD was assessed per investigator judgement. There was no protocol-specified criteria of GvHD. (NCT00482053)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL0

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Event-free Survival (EFS) Per Protocol

Event-free survival (EFS) through 4 years, as assessed in participants with poor-risk recurrent or primary refractory DLBCL treated with TLI and ATG followed by matched allogeneic hematopoietic cell transplantation as a consolidation to HCT. Event is defined as tumor progression or death. (NCT00482053)
Timeframe: 48 months

Interventionmonths (Median)
Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL48

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Amount of Pain Medication Taken Per Day

(NCT00492973)
Timeframe: Average of 3 days after surgery

Interventionmg/day morphine equivalant (Mean)
Control Group47.8
Corticosteroid46.0

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Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.

(NCT00492973)
Timeframe: any point during the first postoperative year

InterventionNumber of participants with complication (Number)
Control Group0
Corticosteroid3

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Knee Range of Motion

(NCT00492973)
Timeframe: 3 months

Interventiondegrees (Mean)
Control Group112.5
Corticosteroid112.4

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Length of Hospital Stay

(NCT00492973)
Timeframe: days after surgery

Interventiondays (Mean)
Control Group3.5
Corticosteroid2.6

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Knee Society Scores

The Knee Society Score is on a scale of 0 to 100, with 0 being the worst possible score, and 100 being the best possible score. The Knee Society Score takes into account subjective patient reports of pain and functional ability as well as clinical measures of passive knee range of motion. (NCT00492973)
Timeframe: 3 months postoperative

Interventionunits on a scale (Mean)
Control Group87.1
Corticosteroid83.3

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Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart.

improvement with combination of niacin and topical prednisolone acetate (NCT00493064)
Timeframe: one year

InterventionParticipants (Count of Participants)
Prospective Active Treatment63

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Change From Baseline to Day 98 Using the WOMAC Pain Question #1

"The WOMAC Index is a validated, 24-question self-administered assessment of three dimensions of pain, stiffness, and physical function for subjects with knee or hip OA. The WOMAC pain question #1 asks subjects to think about the pain you felt in your (study joint) caused by your arthritis during the last 48 hours when walking on a flat surface. This is a visual analog scale (VAS) where the subject indicates pain severity by making a mark through a 100 mm horizontal line with No Pain on the left (0 mm) and Extreme Pain on the right (100 mm). The distance between the left end of the scale and the subject's mark is measured in millimeters. Lower values represent a better outcome." (NCT00521989)
Timeframe: Baseline to Day 98

Interventionmillimeters (Mean)
CRx-102 (2.7/90 mg)-32.4
CRx-102 (2.7/180 mg)-33.2
CRx-102 (2.7/360 mg)-37.3
Prednisolone-40.4
Placebo-34.6

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Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population

Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated. (NCT00551707)
Timeframe: baseline to day 98

Interventionpercentage of change from baseline (Median)
CRx-102 (2.7/180)-29.90
CRx-102 (2.7/360)-40.84
Prednisolone15.92
Dipyridamole-33.67
Placebo-27.64

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Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population

Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated. (NCT00551707)
Timeframe: Day 98

Interventionmg/L (Median)
CRx-102 (2.7/180)12.85
CRx-102 (2.7/360)14.25
Prednisolone21.85
Dipyridamole16.60
Placebo2.68

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Cumulative Incidence of NK Cell Reconstitution

Cumulative incidence of successful reconstitution to donor level is calculated. (NCT00553202)
Timeframe: At 5 years from HSCT date

InterventionPercentage of participants (Number)
Treatment (Chemotherapy and Allogeneic SCT)48.1

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Overall Survival (OS)

OS - Time from HSCT until death (NCT00553202)
Timeframe: At 5 years from HSCT date

InterventionPercentage of participants (Number)
Treatment (Chemotherapy and Allogeneic SCT)45.9

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Toxicity to Medications

"Adverse events were closely monitored and recorded at weekly visits during treatment period and for two years after treatment ceased. Laboratory values were taken every other week during the treatment period.~Please see Adverse Events module for more details." (NCT00555464)
Timeframe: Initial visit, 2, 4, 6, 10 and 12 weeks of therapy

,
Interventionparticipants (Number)
Patients with Serious Adverse EventsPatients with Other Adverse Events
Oral Steroid Treatment Group00
Vincristine Treatment Group03

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Response of Hemangioma (IH) to Treatment

"Response of IH not confined to the dermis will be coded using the following criteria: Progressive disease: >40% increase in volume by MRI, Partial response: >65% reduction in volume by MRI, Complete response: no visual or radiographic evidence of disease, Stable disease: none of the above or <40% increase or <65% decrease in volume by MRI.~Response of superficial IH will be coded using the following criteria (based on RECIST): Progressive disease: >30% increase in IH size, Partial response: >30% reduction in size, Complete response: no evidence of disease, Stable disease: none of the above.~Our first 3 patients showed limits to using MRI volume to measure IH size/response to therapy. Unlike other solid tumors, the superficial distribution of some IH made getting volume by MRI difficult, resulting in smaller tumor estimation compared to clinical assessment. Based on these observations, we amended the protocol to report response based on RECIST criteria instead of change in IH volume." (NCT00555464)
Timeframe: 6 weeks

,
Interventionparticipants (Number)
Progressive DiseasePartial ResponseComplete ResponseStable Disease
Oral Steroid Treatment Group1002
Vincristine Treatment Group0202

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Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in available Arm C relapse samples (NCT00557193)
Timeframe: At relapse (up to 3 years)

InterventionqPCR fold expression ratio (Mean)
Arm C (Safety/Efficacy Dose Level 2)5.73

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Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in samples which have acquired resistance to lestaurtinib (NCT00557193)
Timeframe: At relapse (up to 3 years)

InterventionProportion of cells that are viable (Mean)
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)0.69

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Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2

Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years.

Interventionpercent probability (Number)
Arm B (IR/HR MLL-R Chemotherapy)38.89
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)35.82

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Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm

Three-year EFS estimates and 90% CI will be reported by treatment arm and end-induction MRD status. (NCT00557193)
Timeframe: 3 Years from end of Induction)

Interventionpercent probability (Number)
Arm A (MRD Negative)86.05
Arm A (MRD Positive)87.5
Arm B (MRD Negative)47.37
Arm B (MRD Positive)22.73
Arm C (MRD Negative)51.85
Arm C (MRD Positive)27.03

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Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy

Summarized with mean and standard deviation for those with available data in Arm C (NCT00557193)
Timeframe: Sampled between weeks 6-12 from start of induction

InterventionActivity percentage (Mean)
Arm C (Safety/Efficacy Dose Level 2)69.00

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Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)

EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years

Interventionpercentage probability (Number)
Arm C (Safety/Efficacy Dose Level 2)35.82

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Percent Probability for Event-free Survival (EFS) for Patients on Arm A

EFS time is defined as time from treatment assignment to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years

Interventionpercentage probability (Number)
Arm A (Standard Risk MLL-G)86.67

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Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts

Described via mean and standard deviation by group. (NCT00557193)
Timeframe: Sampled at the start of induction

InterventionqPCR fold expression ratio (Mean)
Arm A (Standard Risk MLL-G)1.25
Arm B (IR/HR MLL-R Chemotherapy)7.85
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)5.83

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Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in samples which have primary resistance to lestaurtinib (NCT00557193)
Timeframe: Sampled at the start of induction

InterventionProportion of cells that are viable (Median)
Arm A (Standard Risk MLL-G)0.75
Arm B (IR/HR MLL-R Chemotherapy)0.48
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)0.47

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Relapse Rate

Relapse will be determined as ≥ 5% blast cells in the bone marrow, not secondary to regeneration after myelosuppressive therapy; OR emergence of extramedullary leukemia; OR the re-emergence of blasts in the peripheral blood. The outcome will be reported as the number and percentage of participants that meet these criteria (a number without dispersion). (NCT00568633)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Allo-HSCT + TLI + ATG20
Best Standard Care24

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Complete Donor Hematopoietic Cell Chimerism

Complete donor hematopoietic cell chimerism was evaluated in transplant recipients. Complete donor chimerism will be assessed as the presence of > 95% donor T-cells (CD3+) in the blood. The outcome is reported as the percentage of participants that achieve complete donor chimerism, a number without dispersion. (NCT00568633)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Allo-HSCT + TLI + ATG56

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Disease-free Survival (DFS)

Disease-free survival is defined as the time interval between the date of attaining a first complete remission (CR) and the date of relapse. Disease free survival (DFS) will compared to conventional therapy vs Non-myeloablative Host Conditioning (NMA HCT). The outcome is reported as the number of participants which never experienced disease relapse (without dispersion). (NCT00568633)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Allo-HSCT + TLI + ATG5
Best Standard Care9

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Non-relapse Mortality

Non-relapse mortality is defined as death that occurs after therapy, from any cause except a cause associated with relapse. This will be reported as the number of participants experiencing non-relapse mortality (a number without dispersion). (NCT00568633)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Allo-HSCT + TLI + ATG1
Best Standard Care2

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Overall Survival (OS)

Overall survival defined as the time interval between the date of attaining a first complete remission (CR) and the date of death from any cause. The outcome is reported as the number of participants alive (without dispersion). (NCT00568633)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Allo-HSCT + TLI + ATG9
Best Standard Care13

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Patients Completing the Intended Therapy in Both Arms

The assessment for completion of the intended therapy (in both arms) will be reported as the percentage of participants, a number without dispersion (NCT00568633)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Allo-HSCT + TLI + ATG100
Best Standard Care81.8

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Early Graft Loss

Early graft loss means a failure to achieve donor T-cell chimerism of > 5% at any time after transplant. The outcome is reported as the percentage of participants that experience early graft loss, a number without dispersion. (NCT00568633)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Allo-HSCT + TLI + ATG4

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Part 2: Progression-Free Survival

Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first. (NCT00574288)
Timeframe: Up to Week 27

Interventionmonths (Median)
Daratumumab 8 mg/kg2.4
Daratumumab 16 mg/kg5.6

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Part 1: Time to Response

Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment. Kaplan-Meier method was used to estimate the distribution of time to response and time to best response. (NCT00574288)
Timeframe: Up to Week 28

,,,
Interventionmonths (Median)
Time to first responseTime to best response
Daratumumab 16 mg/kg8.48.4
Daratumumab 8 mg/kgNANA
Part 1: Daratumumab 4 mg/kgNANA
Part 1:Daratumumab 24 mg/kg1.91.9

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Part 2: Overall Survival

Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method. (NCT00574288)
Timeframe: Approximately 3 years

Interventionmonths (Median)
Daratumumab 8 mg/kg18.2
Daratumumab 16 mg/kg34.3

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Part 2: Duration of Response as Assessed Using the Method of Kaplan-Meier

Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the International Myeloma Working Group (IMWG) criteria. (NCT00574288)
Timeframe: Up to Week 27

Interventionmonths (Median)
Daratumumab 8 mg/kg6.9
Daratumumab 16 mg/kgNA

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Overall Response Rate

Overall response defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). Per IMWG criteria, sCR: is defined as normal free light chain (FLC) ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5 % plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein plus urine M-protein level < 100mg/24 hours; PR: >= 50 % reduction of serum M-protein and reduction in 24 hour urinary M-protein by >= 90% or to <200 mg/24 hours; if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. (NCT00574288)
Timeframe: Up to Week 28 (for Part 1) and Week 27 (for Part 2)

Interventionpercentage of participants (Number)
Part 1: Daratumumab 4 mg/kg33.3
Part 1:Daratumumab 8 mg/kg0
Part 1: Daratumumab 16 mg/kg33.3
Part 1:Daratumumab 24 mg/kg66.7
Part 2: Daratumumab 8 mg/kg10.0
Part 2: Daratumumab 16 mg/kg35.7

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Number of Participants With Adverse Events

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. (NCT00574288)
Timeframe: Up to Week 28 (for Part 1) and up to approximately 2.5 years (for Part 2)

Interventionparticipants (Number)
Part 1: Daratumumab Less Than (<) 4 mg/kg19
Part 1: Daratumumab 4 mg/kg3
Part 1:Daratumumab 8 mg/kg3
Part 1: Daratumumab 16 mg/kg3
Part 1:Daratumumab 24 mg/kg3
Part 2: Daratumumab 8 mg/kg30
Part 2: Daratumumab 16 mg/kg41

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Part 2: Time to Response

Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment. Time to VGPR (very good partial response) was defined as the time from the date of first dose of daratumumab to the date of initial documentation of VGPR response. The Kaplan-Meier method was used to estimate time to response. (NCT00574288)
Timeframe: Up to Week 27

Interventionmonths (Mean)
Time to first responseTime to best responseTime to VGPR or better response
Daratumumab 16 mg/kg1.332.460.49

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Part 2: Time to Response

Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment. Time to VGPR (very good partial response) was defined as the time from the date of first dose of daratumumab to the date of initial documentation of VGPR response. The Kaplan-Meier method was used to estimate time to response. (NCT00574288)
Timeframe: Up to Week 27

Interventionmonths (Mean)
Time to first responseTime to best response
Daratumumab 8 mg/kg1.361.36

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Part 2: Time to Progression (TTP)

TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression. Disease progression (IMWG criteria): increase of 25 percent (%) from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 g/dL); urine M-component and/or (the absolute increase must be >=200 mg/24 hour; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase must be >10 mg/dL); Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Median TTP was estimated by using the Kaplan-Meier method. (NCT00574288)
Timeframe: Up to Week 27

Interventionmonths (Median)
Daratumumab 8 mg/kg2.4
Daratumumab 16 mg/kg5.6

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Number of Participants With Progression Free Survival (10 Years) by Treatment

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00577993)
Timeframe: 10 years

InterventionParticipants (Count of Participants)
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab59
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)58

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Number of Participants With Overall Survival (10 Years) by Treatment

Overall Survival is the time from date of treatment start until date of death due to any cause or last Follow-up within 10 years. (NCT00577993)
Timeframe: 10 Years

InterventionParticipants (Count of Participants)
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab59
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)58

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Percentage of Participants Achieving a Major Clinical Response at Week 52

"A major clinical response was defined as an improvement of at least 70% in the American College of Rheumatology score from Baseline at Week 52. Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate participant and physician assessments of participant disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line no disease activity [symptom-free and no arthritis symptoms] and the extreme right end maximum disease activity); participant assessment of pain in previous the 24 hours on a VAS (extreme left end of the line no pain and the extreme right end unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein level." (NCT00578305)
Timeframe: Baseline to Week 52

InterventionPercentage of participants (Number)
Rituximab 500 mg6.5
Rituximab 1000 mg6.7
Placebo1.6

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Percentage of Participants With an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Weeks 24 and 52

Improvement must be seen in tender and swollen joint counts (28 assessed joints; Joints were evaluated and classified as swollen or not swollen and tender or not tender based on pressure and joint manipulation upon physical examination) and in at least 3 (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionPercentage of participants (Number)
Week 24 - ACR20 responseWeek 24 - ACR50 responseWeek 24 - ACR70 responseWeek 52 - ACR20 responseWeek 52 - ACR50 responseWeek 52 - ACR70 response
Placebo28.611.11.628.614.36.3
Rituximab 1000 mg51.726.78.368.335.016.7
Rituximab 500 mg51.624.211.367.737.117.7

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Percentage of Participants With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 24 and 52

Change of the DAS28 score from Baseline was used to determine the EULAR responses. For a post-Baseline score ≤ 3.2, a change from Baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-Baseline score > 3.2 to ≤ 5.1, a change from Baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-Baseline score > 5.1, a change from Baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-Baseline scores > 3.2. DAS28=(0.56×√(TJC28))+(0.28×√(SJC28))+(0.7×log(CRP))+(0.014×GH), where TJC28=tender joint count (JC) and SJC28=swollen JC (28 joints), GH=a participant's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end=no disease activity, right end=maximum disease activity), and CRP=C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionPercentage of participants (Number)
Week 24 - No responseWeek 24 - Moderate responseWeek 24 - Good responseWeek 52 (n = 63, 62, 59) - No responseWeek 52 (n = 63, 62, 59) - Moderate responseWeek 52 (n = 63, 62, 59) - Good response
Placebo58.722.219.060.331.77.9
Rituximab 1000 mg22.042.435.613.649.237.3
Rituximab 500 mg33.937.129.021.045.233.9

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Percentage of Participants With Improvement in Osteitis at Weeks 24 and 52

There were 2 definitions of improvement in osteitis. A participant met the criterion for definition 1 when there was a drop in the magnetic resonance imaging osteitis score from Baseline > 0.5. A participant met the criterion for definition 2 when there was a drop in the magnetic resonance imaging osteitis score from Baseline > than the smallest detectable change. The osteitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI (RAMRIS) scoring system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionPercentage of participants (Number)
Week 24 (Definition 1)Week 24 (Definition 2)Week 52 (Definition 1)Week 52 (Definition 2)
Placebo22.222.227.027.0
Rituximab 1000 mg51.751.751.751.7
Rituximab 500 mg50.050.058.158.1

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Change From Baseline in the Disease Activity Score 28 (DAS28) at Weeks 24 and 52

The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, C-reactive protein level (CRP), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionUnits on a scale (Mean)
Week 24 (n = 63, 62, 59)Week 52 (n = 63, 62, 59)
Placebo-0.752-0.747
Rituximab 1000 mg-1.683-1.801
Rituximab 500 mg-1.714-2.055

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Percentage of Participants With Improvement in Synovitis at Weeks 24 and 52

There were 2 definitions of improvement in synovitis. A participant met the criterion for definition 1 when there was a drop in the magnetic resonance imaging synovitis score from Baseline > 0.5. A participant met the criterion for definition 2 when there was a drop in the magnetic resonance imaging synovitis score from Baseline > than the smallest detectable change. The synovitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI (RAMRIS) scoring system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionPercentage of participants (Number)
Week 24 (Definition 1)Week 24 (Definition 2)Week 52 (Definition 1)Week 52 (Definition 2)
Placebo22.222.225.425.4
Rituximab 1000 mg56.756.760.060.0
Rituximab 500 mg41.941.954.854.8

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Percentage of Participants With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Weeks 24 and 52

The percentage of participants who had low rheumatic arthritis disease activity at Weeks 24 and 52, as measured by a DAS28 score ≤ 3.2, is reported. DAS28 is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]), and CRP = C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionPercentage of participants (Number)
Week 24Week 52
Placebo19.09.5
Rituximab 1000 mg36.738.3
Rituximab 500 mg33.937.1

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Percentage of Participants With no Newly Eroded Joints at Weeks 24 and 52

No newly eroded joints was defined as no new erosions in joints which were scored 0 at baseline. The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionPercentage of participants (Number)
Week 24Week 52
Placebo55.560.3
Rituximab 1000 mg73.340
Rituximab 500 mg77.477.4

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Percentage of Participants With no Progression/no Worsening in Bone Erosion at Weeks 24 and 52

There were 2 definitions of no progression/no worsening in bone erosion. A participant met the criterion for definition 1 when there was a change in the magnetic resonance imaging erosion score ≤ 0. A participant met the criteria for definition 2 when there was either (1) no change from Baseline in the MRI erosion score, (2) an increase in erosion score and the size of the increase in score was smaller than the smallest detectable change, or (3) a drop in the erosion score. The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionPercentage of participants (Number)
Week 24 (Definition 1)Week 24 (Definition 2)Week 52 (Definition 1)Week 52 (Definition 2)
Placebo33.381.027.055.6
Rituximab 1000 mg51.796.755.093.3
Rituximab 500 mg50.088.748.485.5

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Change in Magnetic Resonance Imaging (MRI) Osteitis Score From Baseline to Weeks 12, 24, and Week 52

The osteitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Each location was scored in 0.5 increments from 0 to 3 with each integer unit increment representing a 33% increase in the volume of the peripheral 1 cm of original (eroded + residual) articular bone using the following scale: 0.0=normal, no osteitis; 0.5=1-17% involvement of original articular bone; 1.0=18-33%; 1.5=34-50%; 2.0=51-67%; 2.5=68-83%; 3.0=84-100% involvement of original articular bone. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more synovitis. A negative change score indicates improvement. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionUnits on a scale (Mean)
Week 12 (n = 58, 58, 56)Week 24 (n = 61, 59, 59)Week 52 (n = 61, 59, 59)
Placebo-0.140.07-0.22
Rituximab 1000 mg-1.88-2.86-3.83
Rituximab 500 mg-2.11-2.91-4.75

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Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 24 and 52

The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionUnits on a scale (Mean)
Week 24 (n = 63, 62, 59)Week 52 (n = 63, 62, 59)
Placebo-0.194-0.177
Rituximab 1000 mg-0.439-0.417
Rituximab 500 mg-0.425-0.520

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Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Week 24

The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more erosion. A negative change score indicates improvement. (NCT00578305)
Timeframe: Baseline to Week 24

InterventionUnits on a scale (Mean)
Rituximab 500 mg0.13
Rituximab 1000 mg0.39
Placebo1.33

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Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Weeks 12 and 52

The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more erosion. A negative change score indicates improvement. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionUnits on a scale (Mean)
Week 12 (n = 58, 58, 56)Week 52 (n = 56, 57, 58)
Placebo0.333.02
Rituximab 1000 mg0.13-0.30
Rituximab 500 mg0.420.11

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Change in Magnetic Resonance Imaging (MRI) Synovitis Score From Baseline to Weeks 12, 24, and Week 52

The synovitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images of 3 wrist regions and 5 metacarpophalangeal joints in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 3 with each integer unit increment representing a 33% enhancement of the maximum volume of enhancing tissue in the synovial compartment using the following scale: 0.0=normal, no synovitis; 0.5=1-17% estimated volume of enhancement; 1.0=18-33%; 1.5=34-50%; 2.0=51-67%; 2.5=68-83%; 3.0=84-100% estimated volume of enhancement. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more synovitis. A negative change score indicates improvement. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionUnits on a scale (Mean)
Week 12 (n = 58, 58, 56)Week 24 (n = 61, 59, 59)Week 52 (n = 61, 59, 59)
Placebo-0.220.20-0.01
Rituximab 1000 mg-1.15-1.81-2.73
Rituximab 500 mg-0.50-1.14-2.03

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Correlation of Magnetic Resonance Imaging Assessments and Clinical Outcome Measures

Correlation coefficients of magnetic resonance imaging erosion, synovitis, and osteitis scores and clinical outcome measures of swollen joint count (SJC), tender joint count (TJC), C-reactive protein level (CRP), erythrocyte sedimentation rate (ESR), a participant's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (GH), Disease Activity Score 28-C-reactive protein (DAS28-CRP), and Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) are reported. Not all of these variables were specified as primary or secondary Outcome Measures in the study protocol and were not individually analyzed. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionCorrelation coefficient (Number)
Erosion score and SJC - Week 24Erosion score and SJC - Week 52Synovitis score and SJC - Week 24Synovitis score and SJC - Week 52Osteitis score and SJC - Week 24Osteitis score and SJC - Week 52Erosion score and TJC - Week 24Erosion score and TJC - Week 52Synovitis score and TJC - Week 24Synovitis score and TJC - Week 52Osteitis score and TJC - Week 24Osteitis score and TJC - Week 52Erosion score and CRP - Week 24Erosion score and CRP - Week 52Synovitis score and CRP - Week 24Synovitis score and CRP - Week 52Osteitis score and CRP - Week 24Osteitis score and CRP - Week 52Erosion score and ESR - Week 24Erosion score and ESR - Week 52Synovitis score and ESR - Week 24Synovitis score and ESR - Week 52Osteitis score and ESR - Week 24Osteitis score and ESR - Week 52Erosion score and GH - Week 24Erosion score and GH - Week 52Synovitis score and GH - Week 24Synovitis score and GH - Week 52Osteitis score and GH - Week 24Osteitis score and GH - Week 52Erosion score and DAS28-CRP - Week 24Erosion score and DAS28-CRP - Week 52Synovitis score and DAS28-CRP - Week 24Synovitis score and DAS28-CRP - Week 52Osteitis score and DAS28-CRP - Week 24Osteitis score and DAS28-CRP - Week 52Erosion score and DAS28-ESR - Week 24Erosion score and DAS28-ESR - Week 52Synovitis score and DAS28-ESR - Week 24Synovitis score and DAS28-ESR - Week 52Osteitis score and DAS28-ESR - Week 24Osteitis score and DAS28-ESR - Week 52
Placebo0.4460.3550.5660.5740.3700.3980.2980.4250.2820.4210.2880.3710.0060.3520.1920.3110.0400.1190.1970.3140.3580.3600.1480.2050.3260.3160.2060.2860.2050.1360.4570.4980.4370.5000.3510.3560.4390.4730.4380.5140.3530.356
Rituximab 1000 mg0.4250.2340.3890.1880.3540.1920.1150.0670.1740.0360.1180.048-0.0240.0980.0900.085-0.057-0.0100.1360.1880.2140.2480.0430.1160.043-0.0090.221-0.0370.1220.0520.1980.1270.3490.1500.2090.1430.2550.1800.3320.1470.2310.172
Rituximab 500 mg0.3410.2870.3290.1680.4070.2650.3640.2750.3360.1420.3550.2450.1850.0550.030-0.077-0.0310.0050.3210.1270.1820.1850.044-0.0410.2060.0630.186-0.0260.2740.1060.4200.2380.3930.1490.3800.1390.4290.2440.3980.1980.3530.108

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Percentage of Participants in Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Weeks 24 and 52

The percentage of participants in remission of their rheumatic arthritis at Weeks 24 and 52, as measured by a DAS28 score < 2.6, is reported. DAS28 is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]), and CRP = C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionPercentage of participants (Number)
Week 24Week 52
Placebo12.77.9
Rituximab 1000 mg28.325.0
Rituximab 500 mg21.025.8

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Immune Reconstitution Efficacy - Naive CD4 T Cells

The development of total naive CD4 T cells at one year as measured using flow cytometry (NCT00579527)
Timeframe: 1 year post-CTTI

Interventioncells/mm3 (Median)
Cultured Thymus Tissue Implantation With Immunosuppression156

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Immune Reconstitution Efficacy - Naive CD8 T Cells

The development of total naive CD8 T cells at one year as measured using flow cytometry (NCT00579527)
Timeframe: 1 year post-CTTI

Interventioncells/mm3 (Median)
Cultured Thymus Tissue Implantation With Immunosuppression37

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Immune Reconstitution Efficacy - Total CD8 T Cells

The development of total CD8 T cells at one year as measured using flow cytometry (NCT00579527)
Timeframe: 1 year post-CTTI

Interventioncells/mm3 (Median)
Cultured Thymus Tissue Implantation With Immunosuppression145

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Survival at 2 Years Post-CTTI

Survival at 2 years post cultured thymus tissue implantation was assessed using the Kaplan Meier Estimated Survival. This mathematical function estimates the survival for a certain length of time. (NCT00579527)
Timeframe: 2 years post-CTTI

Intervention% of participants who survive to 2 years (Number)
Cultured Thymus Tissue Implantation With Immunosuppression71

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Survival at 1 Year Post-CTTI

Survival at 1 year post cultured thymus tissue implantation was assessed using the Kaplan Meier Estimated Survival. This mathematical function estimates the survival for a certain length of time. (NCT00579527)
Timeframe: 1 year post-CTTI

Intervention% of participants who survive to 1 year (Number)
Cultured Thymus Tissue With Immunosuppression71

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Immune Reconstitution Efficacy - Response to Mitogens

Measurement of the T cell proliferative response to the mitogen phytohemagglutin (PHA). (NCT00579527)
Timeframe: 1 year post-CTTI

Interventioncounts per minute (cpm) (Median)
Cultured Thymus Tissue Implantation With Immunosuppression139189

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Immune Reconstitution Efficacy - Total CD4 T Cells

The development of total CD4 T cells at one year as measured using flow cytometry (NCT00579527)
Timeframe: 1 year post-CTTI

Interventioncells/mm3 (Median)
Cultured Thymus Tissue Implantation With Immunosuppression593

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Immune Reconstitution Efficacy - Total CD3 T Cells

The development of total CD3 T cells at one year as measured using flow cytometry (NCT00579527)
Timeframe: 1 year post-CTTI

Interventioncells/mm3 (Median)
Cultured Thymus Tissue Implantation With Immunosuppression726

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Failure Rate

The failure rate was defined as a composite variable of CAS decrease of < 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease. (NCT00595335)
Timeframe: 6 months after first infusion, 12 months after first infusion

,
Interventionpercentage of participants (Number)
Failure rate at 6 monthsFailure rate at 12 months
Placebo7550
Rituximab6946

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Graves' Ophthalmopathy Quality of Life Score Using the Short Form-12 (SF-12) Health Survey

Quality of life (QoL) was measured by the SF-12 questionnaire. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Physical and Mental Health Composite Scores are computed (combined, scored, and weighted) using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Improvement was defined as a change of ≥ 6 points. (NCT00595335)
Timeframe: baseline, 6 months after first infusion, 12 months after first infusion

,
Interventionunits on a scale (Median)
Baseline QoL physicalBaseline QoL mental6 months QoL physical6 months QoL mental12 months QoL physical12 months QoL mental
Placebo39.946.140.346.146.749.4
Rituximab53.244.345.952.851.856.1

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Change in Disease Severity

Disease severity was measured by the NOSPECS Score. This classification scheme of the eye changes in thyroid eye disease was introduced by the American Thyroid Association. It separates patients into seven classes of disease (class 0-6), with 0 being no signs or symptoms and 6 being sight loss. (The acronym is based on the first letter of the defining characteristic of each class, the classification is known as: 'no signs or symptoms; only signs; soft tissue; proptosis; extraocular muscle; cornea; sight loss' (NOSPECS) ). (NCT00595335)
Timeframe: baseline, 6 months after first infusion

,
Interventionparticipants (Number)
Improvement by 1 classImprovement by 2 classesDeteriorationNo change
Placebo8202
Rituximab6223

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Failure Rate at One Year

The failure rate was defined as a composite variable of CAS decrease of < 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease. (NCT00595335)
Timeframe: one year

Interventionpercentage of participants (Number)
Rituximab46
Placebo50

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Change in Lid Fissure

"The palpebral fissure is the elliptic space between the medial and lateral canthi of the two open eye lids. In adults, this measures about 10mm vertically and 30mm horizontally. The fissure may be increased in vertical height in Graves' disease.~Improvement was defined as a decrease in lid aperture width by ≥3 mm." (NCT00595335)
Timeframe: baseline, 6 months after first infusion

,
Interventionmm (Median)
Lid fissure right eyeLid fissure left eye
Placebo00.5
Rituximab00

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Change in Clinical Activity Score (CAS)

The clinical activity score (CAS), for Grave's ophthalmopathy has become a widely accepted tool to assess disease activity and help decide the management of the condition. The CAS, which is based on classical signs of inflammation (pain, redness, and swelling), consists of 7 equally weighted items. The total CAS (as used in this study) may range from 0 to 7. The higher the CAS, the greater degree of inflammation is present. A drop in CAS of 2 or more points suggests an improvement in the inflammatory components of the disease. A CAS ≥3 implies active disease. (NCT00595335)
Timeframe: baseline, 6 months after the first infusion

Interventionunits on a scale (Mean)
Rituximab-1.2
Placebo-1.5

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Change in Proptosis

Eye proptosis is a condition resulting in forward displacement of the globe from its normal position within the orbit. It is measured by computed tomography. Improvement in proptosis was defined as a decrease in proptosis by ≥2 mm. (NCT00595335)
Timeframe: baseline, 12 months after first infusion

,
Interventionmm (Mean)
Proptosis right eyeProptosis left eye
Placebo0.800.0
Rituximab0.820.1

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Change in Extraocular Motility

"Change extraocular motility was assessed using the Gorman diplopia score. Diplopia, commonly known as double vision, is the simultaneous perception of two images of a single object that may be displaced horizontally, vertically, or diagonally (i.e., both vertically and horizontally) in relation to each other. It is usually the result of impaired function of the extraocular muscles, where both eyes are still functional but they cannot converge to target the desired object.~The Gorman diplopia score includes four categories: 1) no diplopia (absent), 2) diplopia when the patient is tired or awakening (intermittent), 3) diplopia at extremes of gaze (inconstant), and 4) continuous diplopia in the primary or reading position (constant)." (NCT00595335)
Timeframe: baseline, 6 months after first infusion, 12 months after first infusion

,
Interventionunits on a scale (Median)
Change baseline-6 monthsChange baseline-12 months
Placebo2.51.5
Rituximab32

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Number of Subjects With All-cause Mortality

Death from any cause at 100 days (NCT00608517)
Timeframe: at 100 days

Interventionparticipants (Number)
Pediatric Myeloablative Conditioning1
Adult Myeloablative Conditioning0
Reduced-intensity Conditioning0

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Overall Survival

Overall survival at 1 year (NCT00608517)
Timeframe: 1 year

Interventionparticipants (Number)
Pediatric Myeloablative Conditioning1
Adult Myeloablative Conditioning3
Reduced-intensity Conditioning1

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Number of Participants With 100-day Non-relapse Mortality

Evaluate the safety (as determined by the day 100 non-relapse mortality) and feasibility of single or double umbilical cord blood (UCB)stem cell transplant (SCT) in adult or pediatric patients with hematologic malignancies receiving graft-versus-host disease (GVHD) prophylaxis with tacrolimus and mycophenolate mofetil (MMF). (NCT00608517)
Timeframe: 100 days

Interventionparticipants (Number)
Pediatric Myeloablative Conditioning1
Adult Myeloablative Conditioning0
Reduced-intensity Conditioning0

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Number of Participants With Acute Graft-versus-host Disease (GVHD)

Participants who exhibit acute GVHD. (NCT00608517)
Timeframe: 100 days

Interventionparticipants (Number)
Pediatric Myeloablative Conditioning0
Adult Myeloablative Conditioning1
Reduced-intensity Conditioning0

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Number of Participants With Chronic Graft Versus Host Disease (GVHD)

As opposed to acute GVHD, which is characterized by rash, cholestasis, and enteritis, chronic GVHD is characterized by nausea, anorexia, ocular and oral sicca, and other organ involvement (NCT00608517)
Timeframe: 100 days

Interventionparticipants (Number)
Pediatric Myeloablative Conditioning0
Adult Myeloablative Conditioning0
Reduced-intensity Conditioning0

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Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells

Recovery of the neutrophil portion of white blood cells and showing complete donor cells. (NCT00608517)
Timeframe: 42 days

Interventionparticipants (Number)
Pediatric Myeloablative Conditioning1
Adult Myeloablative Conditioning1

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Number of Participants Who Relapsed at 1 Year

(NCT00608517)
Timeframe: 1 year

Interventionparticipants (Number)
Pediatric Myeloablative Conditioning0
Adult Myeloablative Conditioning0
Reduced-intensity Conditioning0

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Percentage of Participants Alive, In Remission & Without GVHD Progression Day 28 & Day 56

Percentage meeting steroid milestone who were alive, in remission and did not have GVHD progression before Day 28 or Day 56. (NCT00609609)
Timeframe: Up to day 56

,
Interventionpercentage of participants (Number)
Day 28 Steroid dose Day 56 steroid dose < 0.1mg/kg
Corticosteroids1030
ECP + Corticosteroids23.543

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Non-relapse Mortality (NRM) at 6 Months

Percentage of participants at 6 months whose deaths were without relapse/recurrence. (NCT00609609)
Timeframe: 6 months

Interventionpercentage of participants (Number)
Corticosteroids19.6
ECP + Corticosteroids20.0

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Day 56 Treatment Success

Definition of Treatment Failure: No Response according to the following: A) Skin: 1) No change in GVHD stage by day 14; 2) Gut: No change in GVHD stage by Day 7; 3) Liver: No change in GVHD stage by Day 21. B) Progressive Disease (PD): 1) Skin/Gut: Increase in Stage by 72 hours from the start of therapy; 2) Liver: Increase in Stage by Day 14; 3) Initiation of 2nd line treatment at any time for acute GVHD: 4) Any new organ involvement by acute GVHD. C) Inability to Taper: 1) Patient still on >1 mg/kg/d of methylprednisolone equivalent at 1 month. 2) Patient still on > 0.5 mg/kg/d of methylprednisolone equivalent at 2 months; 3) Death from GVHD. Definition of Treatment Success: Participants not defined above in Treatment Failure definition. Baseline biopsy with Acute GVHD assessed weekly until last ECP procedure (anticipated Day 63). At 6 months follow up with a phone call for survival and GVHD status. (NCT00609609)
Timeframe: Day 1 to Day 63 (approximately 9 weeks), Acute GVHD scored weekly.

,
Interventionpercentage of participants (Number)
Skin-onlyVisceral InvolvementTotal
Corticosteroids574353
ECP + Corticosteroids724765

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Disease-free Survival

Number of patients who were free of disease and alive at 1 year. (NCT00609739)
Timeframe: 1 year

InterventionParticipants (Number)
Cytarabine + Mitoxantrone0

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Patients Who Relapsed

Number of patients whose disease relapsed. (NCT00609739)
Timeframe: 1 Year

Interventionparticipants (Number)
Cytarabine + Mitoxantrone1

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Patients With Graft-Versus-Host-Disease

Number of patients who exhibited acute and/or chronic graft-versus-host disease. (NCT00609739)
Timeframe: Up to 30 Days Post Study Treatment

Interventionparticipants (Number)
Cytarabine + Mitoxantrone1

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Overall Survival (OS)

OS is defined as the time from date of first dose of study drug until the date of death. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those missing a recorded last date of contact will be censored at the last date the patient was known to be alive. (NCT00623766)
Timeframe: From first dose to 24 months

InterventionMonths (Median)
Ipilimumab, 10 mg/kg, IV in Corticosteroid-free Patients6.97
Ipilimumab, 10 mg/kg, IV in Corticosteroid-dependent Patients3.75

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Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria

Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) (global, in brain, or outside of brain) based on mWHO criteria divided by the number of patients who received treatment. By mWHO criteria: CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the 2 largest perpendicular diameters of all index lesions. SD=does not meet criteria for CR or PR, in the absence of progressive disease (PD). Patients with PR or CR not confirmed after at least 4 weeks are scored as SD unless they have new primary lesions. PD=at least 25% increase in the sum of the diameters of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesions. CNS=central nervous system. (NCT00623766)
Timeframe: From Day 1, first dose to end of Week 12

,
InterventionPercentage of participants (Number)
Global disease control rateDisease control rate in brain
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients4.89.5
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients17.623.5

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Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)

OS is defined as the time from the first dose of study drug until the date of death. Overall survival rate is the percentage of participants known to be alive at a timepoint. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those with a missing recorded last date of contact will be censored at the last date the patient was known to be alive. The survival rate at a specified time-point is the probability that a patient is alive at that time following randomization. The rate is calculated for each treatment group using the Kaplan-Meier product-limit method. A corresponding 2-sided 95% bootstrap confidence interval will be calculated. (NCT00623766)
Timeframe: From first dose to Months 6, 12, 18, 24, and 36 months

,
InterventionProbability of being alive (Number)
At 6 monthsAt 12 monthsAt 18 monthsAt 24 monthsAt 36 months
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients0.380.190.190.100.10
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients0.550.310.260.260.26

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Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)

BORR is defined as the number of patients whose global best overall response (BOR) was complete (CR) or partial response (PR), divided by the total number of participants who received treatment. CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index lesions. The global BOR is the best overall response (OR) designation over the study as a whole for an individual in the study based on overall tumor burden. Both central nervous system (CNS) (brain lesions) and non-CNS compartments (lesions outside the brain) are considered for the global BOR. For the analysis of global BOR of CR or PR (by both modified WHO criteria and immune-related response criteria [irRC]), the OR assessment must be confirmed by a second (confirmatory) evaluation meeting the criteria for response and must be performed no less than 4 weeks after the criteria for response are first met. (NCT00623766)
Timeframe: From Day 1, first dose until the last tumor assessment, Week 12

,
InterventionPercentage of participants (Number)
Global BORR (mWHO criteria)BORR in brain (mWHO criteria)BORR in non-CNS compartment (mWHO criteria)Global BORR (irRC)BORR in brain (irRC)BORR in non-CNS compartment (irRC criteria )
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients4.84.84.84.84.84.8
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients9.815.713.79.815.713.7

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The Number of Lipoma Increased in Volume.

(NCT00624416)
Timeframe: After four weeks of treatment up to one year.

InterventionLipomas (Number)
Prednisolone and Isoproteronol9

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The Number of Subjects Elected to Have the Lipoma Removed.

(NCT00624416)
Timeframe: After four weeks up to one year.

Interventionparticipants (Number)
Prednisolone and Isoproteronol8

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The Average Percent Volume Reduction in the Lipoma.

(NCT00624416)
Timeframe: Baseline and 4 weeks

InterventionPercent Volume reduction (cc^3) (Mean)
Prednisolone and Isoproteronol50

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Number of Participants With Chronic Graft-Versus-Host Disease (GVHD)

Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. (NCT00630253)
Timeframe: 1 Year

InterventionParticipants (Count of Participants)
Marrow Isolex2
UCB Arm0
Marrow Clinimax0

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Number of Participants With Acute Graft-Versus-Host Disease (GVHD)

Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. (NCT00630253)
Timeframe: Day 42

InterventionParticipants (Count of Participants)
Marrow Isolex0
UCB Arm0
Marrow Clinimax0

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Number of Participants Experiencing Overall Survival

"The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.~Overall survival will be defined as time from enrollment to date of death or censored at the date of last documented contact for patients still alive." (NCT00630253)
Timeframe: 1 Year

InterventionParticipants (Count of Participants)
Marrow Isolex15
UCB Arm8
Marrow Clinimax5

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Number of Participants Experiencing Graft Failure

graft failure = absolute neutrophil count (ANC) <5 x 10^8/L and an acellular bone marrow aspirate/biopsy (NCT00630253)
Timeframe: From Day 1 to event, assessed up to100 days

InterventionParticipants (Count of Participants)
Marrow Isolex0
UCB Arm0
Marrow Clinimax0

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Visual Analogue Scale for Pain (VAS-pain)

100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionmm (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo65.453.053.656.454.351.151.149.2
TRU-015 Induction Dose61.649.649.047.044.840.839.143.9
TRU-015 Single Dose62.547.748.945.842.339.339.539.2

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Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28

The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionpercentage of participants (Number)
Week 2: good responseWeek 2: moderate responseWeek 2: no responseWeek 4: good responseWeek 4: moderate responseWeek 4: no responseWeek 8: good responseWeek 8: moderate responseWeek 8: no responseWeek 12: good responseWeek 12: moderate responseWeek 12: no responseWeek 16: good responseWeek 16: moderate responseWeek 16: no responseWeek 20: good responseWeek 20: moderate responseWeek 20: no responseWeek 24: good responseWeek 24: moderate responseWeek 24: no response
Placebo1.433.864.95.439.255.48.144.647.39.539.251.418.940.540.517.637.844.614.944.640.5
TRU-015 Induction Dose2.739.757.58.245.246.612.353.434.216.452.131.520.556.223.326.054.819.230.150.719.2
TRU-015 Single Dose6.738.754.714.741.344.014.744.041.321.353.325.334.741.324.029.352.018.726.746.726.7

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Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response

ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo0.01.41.41.46.82.72.7
TRU-015 Induction Dose1.40.01.42.76.86.89.6
TRU-015 Single Dose1.31.32.72.78.06.79.3

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Health Assessment Questionnaire Disability Index (HAQ-DI)

HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The overall disability index computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionunits on a scale (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo1.81.51.41.51.51.41.41.4
TRU-015 Induction Dose1.61.31.31.21.11.11.01.0
TRU-015 Single Dose1.71.41.41.31.31.21.21.2

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Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24

ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP). (NCT00634933)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Placebo16.2
TRU-015 Single Dose29.3
TRU-015 Induction Dose27.4

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Disease Activity Score Based on 28-joints Count (DAS28)

DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's general health visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionunits on a scale (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo6.15.45.25.15.04.74.74.7
TRU-015 Induction Dose6.15.35.04.74.64.34.14.0
TRU-015 Single Dose5.85.14.94.64.33.94.04.1

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Number of Swollen Joints

The number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. (NCT00634933)
Timeframe: Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionswollen joints (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo12.29.57.87.07.66.16.06.2
TRU-015 Induction Dose13.910.29.07.77.15.95.15.0
TRU-015 Single Dose12.39.08.56.96.05.14.84.7

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Number of Tender Joints

The number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventiontender joints (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo17.013.611.911.711.09.49.09.4
TRU-015 Induction Dose17.713.011.610.19.68.47.67.6
TRU-015 Single Dose16.811.910.79.88.87.37.68.1

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Patient Global Assessment (PtGA) of Disease Activity

Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionunits on a scale (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo7.36.26.06.25.96.65.55.3
TRU-015 Induction Dose7.05.65.65.35.24.64.54.7
TRU-015 Single Dose6.95.65.45.24.84.44.54.6

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Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response

ACR20 response: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo17.631.131.131.141.947.343.2
TRU-015 Induction Dose26.034.242.549.361.664.467.1
TRU-015 Single Dose21.334.744.052.064.062.761.3

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Physician Global Assessment (PGA) of Disease Activity

Physician Global Assessment of Disease Activity was measured on a 0 to 10 point scale, where 0 = no disease activity and 10 = extreme disease activity. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionunits on a scale (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo6.85.55.05.04.84.64.44.3
TRU-015 Induction Dose6.65.24.94.44.33.63.63.6
TRU-015 Single Dose6.45.15.04.14.13.73.83.7

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Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response

ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52

,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20
Placebo0.06.812.214.916.216.2
TRU-015 Induction Dose6.86.88.213.731.528.8
TRU-015 Single Dose8.08.010.716.030.728.0

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Number of Participants With a Response

Response - Complete remission (CR): Normalization peripheral blood & bone marrow 5% or & platelet count >100x10^9/L; CR with incomplete platelet recovery (CRp): CR but platelet count <100x10^9/L. CR with incomplete recovery (CRi): CR but platelet count <100x10^9/L or absolute neutrophil count < 1x10^9/L. Partial response (PR): As above except for presence of 6-25% marrow blasts. Lymphoblastic lymphoma (& ALL subtypes with extramedullary disease): CR - disappearance all known disease. PR - >50% decrease in tumor size using sum of product, includes 50% volume decrease in lesions measurable in 3 dimensions. No Response (NR) - No significant change (includes stable disease). Lesions decreased size but <50% or lesions with slight enlargement <25% increase in size. Progressive Disease (PD): Appearance new lesions, 25% or > increase in size existing lesions (>50% if 1 lesion & <2). (NCT00671658)
Timeframe: Response assessed following first 21 day course up to end of treatment with 8 cycles, up to 210 days

InterventionParticipants (Number)
Complete Response (CR)Complete Response without Platelet RecoveryPartial Response (PR)
HYPER-CVAD19834

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Change in Serum Cortisol

Cortisol levels were measured over 28 days. Outcome represents mean change in cortisol level between baseline visit and day 28. (NCT00682357)
Timeframe: Change from Baseline Visit to Day 28

Interventionmcg/dL (Mean)
Group 1 - Standard Dose-1.16
Group 2 - Low Dose0.65
Group 3 - Placebo1.30

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Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)

Outcome represents the mean change in serum biomarkers of bone breakdown (TRACP-5b) from baseline visit to day 28. (NCT00682357)
Timeframe: Change from Baseline Visit to Day 28

InterventionU/L (Mean)
Group 1 - Standard Dose-0.153
Group 2 - Low Dose-0.295
Group 3 - Placebo-0.148

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Change in Testosterone

Outcome represents the mean change in testosterone level from baseline visit to day 28. (NCT00682357)
Timeframe: Change from Baseline Visit to Day 28

Interventionng/dL (Mean)
Group 1 - Standard Dose0.08

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Change in Serum Osteocalcin

Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28. (NCT00682357)
Timeframe: Change from Baseline Visit to Day 28

Interventionng/mL (Mean)
Group 1 - Standard Dose-2.18
Group 2 - Low Dose-0.45
Group 3 - Placebo-1.10

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Ocular Itching at Day 7

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 7. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.092.031.88
Pred Forte2.112.111.97
Pred Mild2.282.692.75
Tears Naturale2.031.941.72

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Ocular Redness at Day 7

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 7. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.591.591.47
Pred Forte2.081.831.72
Pred Mild1.531.691.78
Tears Naturale1.591.661.5

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Ocular Redness at Day 6

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.842.132.03
Pred Forte21.972
Pred Mild2.222.412.31
Tears Naturale2.112.282.17

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Ocular Redness at Day 28

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.691.691.69
Pred Forte1.581.811.5
Pred Mild1.962.111.86
Tears Naturale1.811.941.72

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Ocular Redness at Day 27

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 27. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.441.631.53
Pred Forte1.721.721.53
Pred Mild2.142.111.89
Tears Naturale1.561.721.72

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Ocular Redness at Baseline (Day 0)

A baseline CAC was performed on Day 0. Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.862.112
Pred Forte2.112.332.22
Pred Mild2.112.312.28
Tears Naturale2.082.252.06

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Ocular Itching at Day 6

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.062.412.31
Pred Forte2.172.442.17
Pred Mild2.192.592.72
Tears Naturale2.332.532.14

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Ocular Itching at Day 28

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.0321.78
Pred Forte1.831.971.89
Pred Mild2.252.642.71
Tears Naturale1.751.781.56

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Ocular Itching at Day 27

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 27. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex1.752.092
Pred Forte2.142.172.03
Pred Mild2.432.642.64
Tears Naturale2.031.841.72

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Ocular Itching at Baseline (Day 0)

A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.613.063.08
Pred Forte2.532.923.03
Pred Mild3.083.473.44
Tears Naturale2.52.752.83

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Mean Aqueous Humor Prednisolone Acetate Concentration

(NCT00699803)
Timeframe: 4 hours

Interventionng/mL (Mean)
T-Pred102.5
Pred Forte127.5

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Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation

A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used. (NCT00720109)
Timeframe: At end of consolidation (at 11 weeks)

InterventionPercentage of participants (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)10.5
Standard-risk0
High-risk66.7

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Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)

An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death. (NCT00720109)
Timeframe: From the time entry on study to first event or date of last follow-up, assessed up to 7 years

Interventionpercentage of patients (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)79.8
Standard-risk83.2
High-risk66.7

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Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy

Percent of patients MRD Positive (MRD > 0.01%) at End of Induction. (NCT00720109)
Timeframe: At the end of induction therapy (at 5 weeks)

InterventionPercentage of participants (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)40.7
Standard-risk29.2
High-risk100.0

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Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy

Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed. (NCT00720109)
Timeframe: At 3 years

InterventionPercent probability (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)79.8
Standard-risk83.2
High-risk66.7

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Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events

Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay) (NCT00720109)
Timeframe: Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)

InterventionPts with DLTs (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)1

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Complete Response Rate

To evaluate the complete (CR) response rate with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy (NCT00732498)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
ESHAP Followed by Zevalin and Rituximab10

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Median Time to Progression

To evaluate the median TTP of patients with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy. (NCT00732498)
Timeframe: 5 years

Interventionmonths (Median)
ESHAP Followed by Zevalin and Rituximab10

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Overall Response Rate

To evaluate the overall (ORR) response rate with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy. Descriptive and summary statistics for demographic and clinical variables obtained. The incidences of reported adverse events (AEs) tabulated. Kaplan-Meier survival analysis for PFS and OS performed on TPP. All the analyses were performed using Stata [12]. (NCT00732498)
Timeframe: 5 years

Interventionpercentage of participants (Number)
ESHAP Followed by Zevalin and Rituximab77.3

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Progression-free Survival at 1 Year

To evaluate the 1-year progression-free survival (PFS) of patients with relapsed follicular non-Hodgkin's lymphoma (NHL) treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy. (NCT00732498)
Timeframe: 1 year

Interventionpercentage of participants (Number)
ESHAP Followed by Zevalin and Rituximab38

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Oswestry Disability Score

0-100%. 0= no disability, 100% is complete disability (NCT00733096)
Timeframe: 1 month

Interventionpercentage of disability out of 100% (Mean)
Steroid22.4
Etanercept40.26
Saline30.00

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Numerical Rating Leg Pain Score

0-10 pain score. 0= no pain, 10= worst imaginable pain. (NCT00733096)
Timeframe: 1 month

Interventionunits on a scale (Mean)
Steroid2.54
Etanercept3.56
Saline3.78

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Medication Reduction

Number of people who reduced medications (NCT00733096)
Timeframe: 1 month

Interventionparticipants (Number)
Steroid17
Etanercept9
Saline14

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Global Perceived Effect

Satisfaction. Number of participants with positive perceived global satisfaction. (NCT00733096)
Timeframe: 1 month

Interventionparticipants (Number)
Steroid23
Etanercept15
Saline17

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Renal Allograft Survival

(NCT00771875)
Timeframe: 1 year after rejection treatment

Interventionparticipants (Number)
Rabbit Antithymocyte Globulin (RATG)7
RATG/Rituximab7
RATG/Bortezomib10

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Number of Patients With Allografts With C4d Focal Positive Pretreatment Biopsy

(NCT00771875)
Timeframe: Day 1

Interventionparticipants (Number)
Rabbit Antithymocyte Globulin (RATG)2
RATG/Rituximab2
RATG/Bortezomib4

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Number of Patients With Allografts With C4d Diffuse Positive Pretreatment Biopsy

(NCT00771875)
Timeframe: 90 days

Interventionparticipants (Number)
Rabbit Antithymocyte Globulin (RATG)3
RATG/Rituximab3
RATG/Bortezomib5

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Mean Serum Creatinine

Renal allograft function as determined by change (∆) in Calculated creatinine clearance by Cockcroft-Gault at 7, 14, 28, 60, and 90 days and 1 year post therapy initiation (NCT00771875)
Timeframe: 7, 14, 28, 60, 90 days and 1 year post therapy initiation

,,
Interventionmg/dL (Mean)
7 days14 days28 days60 days90 days1 year
Rabbit Antithymocyte Globulin (RATG)3.043.252.92.622.482.19
RATG/Bortezomib2.312.202.182.382.132.87
RATG/Rituximab2.322.352.352.322.122.07

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Incidence of Death

(NCT00771875)
Timeframe: 90 days

Interventionparticipants (Number)
Rabbit Antithymocyte Globulin (RATG)0
RATG/Rituximab0
RATG/Bortezomib0

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Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)

(NCT00771875)
Timeframe: 1 year

Interventionparticipants (Number)
Rabbit Antithymocyte Globulin (RATG)0
RATG/Rituximab0
RATG/Bortezomib0

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Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection

"Rejection Reversal is a return of serum creatinine to within 115% of the baseline value, or histologic reversal occurring within 14 days of initiation of treatment.~Recurrent Rejection is histologic evidence of rejection noted on a biopsy specimen obtained up to 3 months after documented rejection reversal." (NCT00771875)
Timeframe: 1 year

,,
Interventionparticipants (Number)
Rejection RecurrenceRejection Reversal
Rabbit Antithymocyte Globulin (RATG)02
RATG/Bortezomib01
RATG/Rituximab01

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Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).

BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study. (NCT00782717)
Timeframe: From Day 7 to Day 90 (or Early Exit)

InterventionPercentage of patients (Number)
NEVANAC6
Nepafenac Vehicle12

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Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery

Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT). (NCT00782717)
Timeframe: 3 Months

InterventionPercentage of patients (Number)
NEVANAC3
Nepafenac Vehicle17

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Survival

survival rate will be evaluated at 6 months,1 year, 2 year, 3 year, 4 year, 5 year after the transplant (NCT00787722)
Timeframe: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant

InterventionParticipants (Count of Participants)
6 months survival1 year survival2 year survival3 year survival4 year survival5 year survival
Hematopoietic Stem Cell Transplantation131212111111

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Post HSCT Immune -Modulating Medication and Relapse

Number of immune - modulating medication and relapse evaluated 5 year - after the transplant (NCT00787722)
Timeframe: Pre transplant and 6 months, 1 year, 2 year, 3 year, 4 year and 5 year after transplant

InterventionParticipants (Count of Participants)
Pre HSCT - Immunosuppression/Relapse Rate6 Mos Post HSCT Immunosuppression/ Relapse Rate1 Year Post HSCT Immunosuppression/Relapse Rate2 Year Post HSCT Immunosuppression/Relapse Rate3 Year Post HSCT Immunosuppression/Relapse Rate4 Year Post HSCT Immunosuppression/Relapse Rate5 Year Post HSCT Immunosuppression Relapse Rate
Hematopoietic Stem Cell Transplantation (HSCT)12113011

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Quality of Life (QOL) Short Form - 36 (SF-36)

SF- 36 is a self-administered quality of life exam. The evaluation of the results was done by attributing scores to each question, which were then transformed into a scale ranging from 0 to 100, where 0 corresponds to the worst quality of life and 100 to the best. (NCT00787722)
Timeframe: pre-transplant 12mo and 5 years

Interventionscore on a scale (Median)
Pretransplant1 Year Post Transplant5 Year Post Transplant
Hematopoietic Stem Cell Transplantation30.8352.6961.63

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Disability Score: Expanded Disability Status Scale (EDSS)

"Disability scores (disease improvement defined by at least a 1 point increase in the Expanded Disability Status Scale (EDSS) on consecutive evaluations at least three months apart.~The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability." (NCT00787722)
Timeframe: pretransplant 6 month, 5 year

Interventionscore on a scale (Mean)
Pretransplant Disability Score (EDSS)1 Year Post Transplant Disability Score (EDSS)5 Year Post Transplant Disability Score (EDSS)
Hematopoietic Stem Cell Transplantation4.42.83.3

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NMO-IgG Aquaporin- 4 Autoantibody Titer

NMO-IgG aquaporin- 4 autoantibody titer will be tested pretransplant and post transplant. (NCT00787722)
Timeframe: Pretransplant and 5 year Post Transplant

InterventionParticipants (Count of Participants)
Pretransplant NMO ASSAY positive5 year post transplant NMO Assay positive
Hematopoietic Stem Cell Transplantation112

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Number of Patients Who Require No Device Assistance for Ambulation

No Device Assistance Needed for Ambulation evaluated at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant (NCT00787722)
Timeframe: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant

InterventionParticipants (Count of Participants)
Pre HSCT- No Assistive Required6 Mos Post HSCT- No Assistive Device Required1 Year Post HSCT- No Assistive Device Required2 Year Post HSCT- No Assistive Device Required3 Year Post HSCT- No Assistive Device Required4 Year Post HSCT- No Assistive Device Required5 Year Post HSCT- No Assistive Device Required
Hematopoietic Stem Cell Transplantation69109889

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Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation

Will be estimated using the method of Kaplan-Meier. (NCT00792948)
Timeframe: 12 months

InterventionProbability of 12-month RFS (Number)
Treatment0.83

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Overall Survival (OS)

OS will be estimated using the method of Kaplan-Meier. (NCT00792948)
Timeframe: From the date of initial registration on the study until death from any cause, assessed up to 5 years

InterventionProbability of surviving 12 months (Number)
Treatment0.88

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Continuous Complete Remission (CCR) Rate

Will be testing using an exact binomial test (NCT00792948)
Timeframe: 18 months

Interventionpercentage of participants (Number)
Treatment57

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Change in Renal Function

Change in renal function as seen in serum creatinine values from baseline until study completion or participant termination. Baseline is defined as the lowest serum creatinine collected during stabilization period or in the four weeks following the end of the stabilization period. The stabilization period is defined as four consecutive creatinine values close in value (not differing more than 0.3 mg/dL). Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (up to five years)

Interventionmg/dL (Mean)
Baseline Serum CreatinineStudy Termination/CompletionChange from Baseline
MEDI-5071.93.21.2

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Time to Platelet Recovery Following Transplant

Time (in days) until platelet recovery following transplant. Platelet recovery is defined as a platelet count >20,000 /mm^3 and where no transfusion is required. Time to recovery is time from transplantation until platelet value recovers. (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (participants followed up to five years)

Interventiondays (Mean)
MEDI-5071.0

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Percentage of Participants With Graft Survival Through 156 Weeks

The percentage of participants with graft survival from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded. Graft survival is defined as the time to week 156 or graft loss. Graft loss is defined as the day on which a graft is deemed irreversibly nonfunctional and dialysis is begun, a transplantectomy is performed, or the participant is re-transplanted, whichever comes first. Six consecutive weeks of dialysis are required for the diagnosis of graft loss, though the date of graft loss will be defined as the date of first dialysis. (NCT00801632)
Timeframe: Transplantation until week 156

InterventionPercentage of Participants (Number)
MEDI-50780

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Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks

A participant was considered a success if they were off immunosuppressive therapy for 104 consecutive weeks leading up to study week 208 (48 months post-transplant) or study termination, whichever occurred first. (NCT00801632)
Timeframe: 48 months post-transplant

Interventionparticipants (Number)
MEDI-5073

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Percentage of Participants Experiencing a Clinically Significant Invasive or Resistant Opportunistic Infection

Clinically significant invasive or resistant opportunistic infections include cytomegalovirus, herpes zoster, and candida. (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (participants followed up to five years)

InterventionPercentage of Participants (Number)
MEDI-5070

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Percentage of Participants Experiencing Acute Rejection

"The percentage of participants who experience an acute rejection. Acute rejection is defined as a biopsy with findings of Banff score of grade IA or higher. The Banff classification is as follows: grade IA is >25% of parenchyma affected and foci of moderate tubulitis; Grade IB is >25% of parenchyma affected and foci of severe tubulitis; Grade IIA is mild to moderate intimal arteritis; Grade IIB is severe intimal arteritis comprising >25% of the luminal area; Grade III is transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation." (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (up to five years)

InterventionPercentage of Participants (Number)
MEDI-50740

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Time to Neutrophil Recovery Following Transplant

Time (in days) until neutrophil recovery following transplant. Neutrophil recovery is defined as an absolute neutrophil count (ANC) > 500/mm^3 at three consecutive assessments on different days post-transplant. Time to recovery is time from transplantation until the first assessment date used to confirm the recovery. (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (participants followed up to five years)

Interventiondays (Mean)
MEDI-50714.0

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Percentage of Participants Surviving Through 156 Weeks

The percentage of participants who survived from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded. (NCT00801632)
Timeframe: Transplantation until week 156

InterventionPercentage of Participants (Number)
MEDI-507100

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Vertigo Attacks

The number of vertigo attacks between 18-24months follow-up were taken retrospectively during a face-to-face appointment at 24 months follow-up and compared to 6 month pre-enrollment baseline (as per Committee on Hearing and Equilibrium guidelines). (NCT00802529)
Timeframe: 6month pre-enrollment baseline, 18-24 months after initial treatment

,
InterventionVertigo Attacks (Mean)
Baseline18-24months
Gentamicin19.932.5
Steroid (Methylprednisolone)16.41.6

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Change in Speech Discrimination

"Speech discrimination was measured at Baseline, 1month, 2months, 6months, 12month and 24 months follow-up.~Speech discrimination was assessed by means of ipsilesional suprathreshold word recognition (%). Arthur Boothroyd's isophonemic word lists (AB wordlists, Guymark, Southampton) comprising sets of 10 words were played to the ipsilesional ear at the low-frequency pure-tone threshold of 0·5, 1 and 2 kHz +30dB with masking sound in the contralesional ear if necessary. The formula for masking level was: low-frequency pure-tone threshold in ipsilesional ear - bone conduction mean threshold (0·5, 1 and 2KHz) in contralesional ear - 40dB. Speech loudness and masking were rounded to the nearest 5dB. Step increments and decrements of 10dB for speech loudness and masking were used to attain the maximum speech discrimination score." (NCT00802529)
Timeframe: Baseline, 1,2,6,12 and 24months after initial treatment

,
InterventionPercentage correct (Mean)
Baseline1month2months6months12months24months
Gentamicin72.1069.4374.3176.3571.5864.99
Steroid (Methylprednisolone)64.9771.7876.1075.6373.4376.32

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Change in Hearing

Hearing was measured as ipsilesional pure-tone threshold at Baseline, 1month, 2months, 6months, 12month, 18months and 24 months follow-up. Hearing level was taken as the average threshold across 0.5, 1, 2 and 3KHz. (NCT00802529)
Timeframe: Baseline, 1,2,6,12,18 and 24months after initial treatment

,
InterventiondB (Mean)
Baseline1month2months6months12months18months24months
Gentamicin51.552.1848.9945.4847.3444.8249.1
Steroid (Methylprednisolone)53.2549.2949.8346.6747.0248.4446.9

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Overall Response

Complete response (CR) was defined as normalization of peripheral blood and bone marrow with <5% blasts, a peripheral absolute neutrophil count (ANC) >/= 1 * 10^9/l, hemoglobin >/= 100g/l, and a platelet count >/= * 10^9/l, Partial Response (PR) was defined as transfusion independence with a peripheral blood ANC >=/ 0.05 * 10^9/l, a platelet count >/= 20 * 10^9/l, and a hemoglobin >/= 40 g/l. Hematologic improvement was defined as a clinically relevant increase in hemoglobin, platelets or absolute neutrophil count. (NCT00806598)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed first at 3 months on study, continuing monthly up to 3 years.

Interventionparticipants (Number)
Complete ResponsePartial ResponseHematological Improvement
Thymoglobulin + Cyclosporin884

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Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks

Clinically significant atrial arrhythmias include ER, urgent care, or hospitalization for atrial fibrillation, cardioversion for atrial fibrillation, or atrial fibrillation requiring an increase in anti-arrhythmia medication (NCT00807586)
Timeframe: 6 weeks

InterventionParticipants (Count of Participants)
Steroid4
Placebo12

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Repeat Intervention

Need for repeat ablation (NCT00807586)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Steroid2
Placebo8

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Cardiac Pain Assessment

Perception of cardiac pain assessed by a numerical pain scale (0= no pain; 10=worst pain imaginable) (NCT00807586)
Timeframe: one day and one week

,
Interventionunits on a scale (Mean)
Pain Scale Day 1Pain Scale Week 1
Placebo1.50.6
Steroid0.90.8

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Percentage of Participants With Adverse Events (AEs)

(NCT00808210)
Timeframe: Baseline up to 30 months

InterventionPercentage of Participants (Number)
Ocrelizumab 200mg78.9
Infliximab 5mg/kg76.9

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Means Aqueous Humor Prednisolone Acetate Concentration

(NCT00854061)
Timeframe: 35 days

Interventionng/mL (Mean)
T-Pred100.02
Pred Forte131.65

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Number of Patients Whose Cytotoxic Panel Reactive Antibody (PRA) is Decreased by 50%

Number of patients on the waiting list whose cytotoxic PRA is decreased by 50%. (NCT00908583)
Timeframe: 46 days

Interventionparticipants (Number)
All Study Participants6

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Number of Living Donor Transplant Candidates That Are Transplanted

Number of living donor transplant candidates who convert to a negative flow T- and B-cell crossmatch via desensitization and are subsequently transplanted (NCT00908583)
Timeframe: 1 year post baseline

Interventionparticipants (Number)
All Study Participants19

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Acute Rejection Rate

Acute rejection rate at 6 months of all desensitized and transplanted patients (NCT00908583)
Timeframe: 6 months post transplant

Interventionparticipants (Number)
All Transplanted Participants3

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Overall Safety of Bortezomib

Incidence of grade 3 and above non-hematologic toxicities. Incidence of grade 4 hematologic toxicities. Incidence of all grades of peripheral neuropathy. Incidence of Cytomegalovirus (CMV), Polyomavirus Allograft Nephropathy (PVN), and Posttransplant Lymphoproliferative Disorder (PTLD). (NCT00908583)
Timeframe: Study Day 62

,,,,,,,
Interventionparticipants (Number)
Incidence of CTCAE Grade 3 Anemia (<8.0-6.5 g/dL)Incidence of CTCAE Grade 4 Anemia (<6.5g/dL)Incidence of CTCAE Grade 3 ThrombocytopeniaIncidence of CTCAE Grade 4 ThrombocytopeniaIncidence of CTCAE Grade 3 NeutropeniaIncidence of CTCAE Grade 4 NeutropeniaIncidence of new onset level 1 PNIncidence of new onset level 2 PNIncidence of new onset level 3 PNIncidence of new onset level 4 PNIncidence of new onset level 5 PNCMV D+/R- StatusCMV Viremia or Invasive DiseasePolyomavirus Allograft Nephropathy (PVN)Malignancy
Phase 1 Cycle 2202010033100000
Phase 1, Cycle 1101000151010000
Phase 2 Cycle 2000000230000000
Phase 2, Cycle 1100000320100000
Phase 3, Cycle 1001000021000000
Phase 3, Cycle 2001000110010000
Phase 4, Single Stage000000000000000
Phase 5, Single Stage100000100000000

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Mean Frequency of Days With a Migraine

(NCT00915473)
Timeframe: 4 weeks post-injection

,
Interventiondays per 4 weeks (Mean)
SevereAt Least ModerateAt Least Mild
Active Injection3.47.09.3
Placebo Injection2.97.810.4

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Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period

The baseline frequency will be the number of calendar days with moderate or severe migraine during the 4 week period prior to injection, and the follow-up frequency will be the number of calendar days with migraine during the 4 week period following injection. (NCT00915473)
Timeframe: 4 weeks pre-injection baseline, 4 weeks post-injection

Interventionparticipants (Number)
Active Injection10
Placebo Injection9

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Mean Number of Hours With Moderate or Severe Migraine

(NCT00915473)
Timeframe: 4 weeks post-injection

Interventionhours per 4 weeks (Mean)
Active Injection60
Placebo Injection58

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Mean Number of Days With Acute Medication Use

"Acute medication use meant the consumption of a drug to abort or terminate a headache." (NCT00915473)
Timeframe: 4 weeks post-injection

Interventiondays per 4 weeks (Mean)
Active Injection6.7
Placebo Injection7.7

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Chronic Extensive GVHD

Percentage of patients with chronic extensive GVHD, estimated by cumulative incidence methods (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy

Interventionpercentage of participants (Number)
Group A (Low-dose)47
Group B (Standard-dose)54

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Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)

The total number of invasive infections (bacterial, fungal and viral) occurring in patients in each group were collected. (NCT00929695)
Timeframe: Baseline and through 100 days of treatment

Interventionpercentage of participants (Number)
Group A (Low-dose)52
Group B (Standard-dose)53

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Prednisone-associated Toxicity as Assessed by Myopathy

Assessed by mean change from baseline to day 42 using Manual Muscle Testing measure. The degree of resistance against pressure applied by tester was measured on a 5-point scale. A score of 5 indicates the patient can hold the position against maximum to strong resistance. A score of 0 indicates the patient has no resistance against pressure. Testing included upper and lower extremities: shoulder (deltoid at 90 degrees), and hip and knee in a sitting position. (NCT00929695)
Timeframe: Baseline and then weekly until 42 days after starting treatment

Interventionunits on a scale (Mean)
Group A (Low-dose)-0.18
Group B (Standard-dose)-0.18

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Prednisone-associated Toxicity as Assessed by Hypertension

The number of different anti-hypertensive medications administered to control hypertension were collected. The mean change in the number of medications from baseline to day 42 was measured. (NCT00929695)
Timeframe: Baseline and then through 42 days after starting treatment

Interventionmedications (Mean)
Group A (Low-dose)-0.29
Group B (Standard-dose)-0.24

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Prednisone-associated Toxicity as Assessed by Hyperglycemia

Impact on blood glucose (BG) control will be assessed by comparing average BG and BG-variability between patients given standard-dose and low-dose prednisone. (NCT00929695)
Timeframe: Baseline and then through 42 days after starting treatment

Interventionmg/dL (Mean)
Group A (Low-dose)140
Group B (Standard-dose)142

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Overall Survival

Percentage of patients surviving as estimated by Kaplan-Meier. (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy

Interventionpercentage of participants (Number)
Group A (Low-dose)77
Group B (Standard-dose)77

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Non-relapse Mortality

Non-relapse mortality (NRM) is defined as death due to any cause in the absence of documented relapse/progression. (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy

Interventionpercentage of participants (Number)
Group A (Low-dose)15
Group B (Standard-dose)16

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Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment

The total cumulative dose of prednisone (milligrams/kilogram) was calculated starting from the start of therapy through study day 42. (NCT00929695)
Timeframe: At day 42 after initiation of treatment

Interventionmilligrams per kilogram (Mean)
Grade IIa GVHD; 0.5 mg/kg/d Prednisone22.2
Grade IIa GVHD; 1.0 mg/kg/d Prednisone27.1
Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone38.4
Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone41.3

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Prednisone-associated Toxicity as Assessed by Quality of Life

Patients completed the MD Anderson Symptom Inventory (MDASI), which is a quality of life questionnaire validated for oncology/transplant patients. On a 1-10 point scale, patients scored the degree of severity of symptoms or the degree of interference in feelings or function due to symptoms at baseline or in the previous week. A score of 1 indicates symptom is not present or does not interfere with feelings or function. A score of 10 indicates the symptom is as bad as you can imagine or interferes completely with feelings or function. The mean change in score from baseline to day 42 was measured. (NCT00929695)
Timeframe: Baseline and then every other week until 42 days after starting treatment

Interventionunits on a scale (Mean)
Group A (Low-dose)-2.3
Group B (Standard-dose)-1.9

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Progression to Grade III-IV Acute GVHD

Diagnosed and graded according to standard established criteria. Measure is percent of patients with baseline scores of IIa (Group A) or IIb (Group B) who progressed to more severe GVHD (Grade III/IV). Percentage estimated by cumulative incidence methods. (NCT00929695)
Timeframe: At approximately 100 days after transplant

Interventionpercentage of participants (Number)
Group A (Low-dose)6
Group B (Standard-dose)13

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Recurrent or Progressive Malignancy

Percentage of relapse estimated by cumulative incidence methods (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy

Interventionpercentage of participants (Number)
Group A (Low-dose)21
Group B (Standard-dose)21

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Secondary Therapy for Acute GVHD Beyond Prednisone

This includes any intervention intended to control acute GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not given previously. This does not include topical therapy, an increase in the dose of glucocorticoids or the resumption of treatment after previous discontinuation or any increase in the dose of immunosuppressive medication previously administered for GVHD prophylaxis, or reinstatement of GVHD prophylaxis previously discontinued. A change in treatment from cyclosporine to tacrolimus or vice versa because of drug toxicity is not considered secondary therapy, but any change made because of uncontrolled GVHD is considered secondary therapy. Percentage is estimated by cumulative incidence methods. (NCT00929695)
Timeframe: At approximately 100 days after transplant

Interventionpercentage of participants (Number)
Group A (Low-dose)23
Group B (Standard-dose)7

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Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits

Participant-rated clinical severity score of lesions rated the severity of all symptoms in the past 24 hours on an 11-point Numerical Rating Scale (NRS) where 0 = No lesions and 10 = Most severe possible lesions. (NCT00929981)
Timeframe: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)

InterventionUnits on a scale (Mean)
BaselineChange at first follow-upChange at second follow-upChange at third follow-upChange at final follow-up
Medrol6.8-4.1-6.2-6.7-6.8

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Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits

Investigator-rated total signs and symptoms score of CD included pruritus, erythema, induration, vesiculation, edema or other specific sign or symptom rated on a 5 point scale of 0 - 4 (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme) with a total score of 0 - 20 (lower score was preferred). (NCT00929981)
Timeframe: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)

InterventionUnits on a scale (Mean)
BaselineChange at first follow-upChange at second follow-upChange at third follow-upChange at final follow-up
Medrol9.2-5.6-8.3-9.0-9.1

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Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit

"The signs and symptoms of CD were rated on Physician's Global Assessment (PGA) 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4." (NCT00929981)
Timeframe: Second follow-up visit (Day 5-28)

InterventionPercentage of Participants (Number)
SuccessFailure
Medrol93.86.30

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Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits

Participant-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 = no pruritus and 10 = most severe possible pruritus. (NCT00929981)
Timeframe: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)

InterventionUnits on a scale (Mean)
BaselineChange at first follow-upChange at second follow-upChange at third follow-upChange at final follow-up
Medrol7.3-4.2-6.3-7.1-7.2

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Treatment Status (Success/Failure) of CD at the Final Follow-up Visit

"The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4." (NCT00929981)
Timeframe: Final follow-up visit (between Day 25 to 35 after EOT)

InterventionPercentage of Participants (Number)
SuccessFailure
Medrol100.000

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Treatment Status (Success/Failure) of CD at the First Follow-up Visit

"The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4." (NCT00929981)
Timeframe: First follow-up visit (between Day 6 to 10 after start of treatment)

InterventionPercentage of Participants (Number)
SuccessFailure
Medrol52.5047.50

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Treatment Status (Success/Failure) of CD at the Third Follow-up Visit

"The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4." (NCT00929981)
Timeframe: Third follow-up visit (between Day 6 to 10 after EOT)

InterventionPercentage of Participants (Number)
SuccessFailure
Medrol100.000

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Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery

Number of participants who died of any cause between 36 hours and 30 days following cardiac surgery (NCT00934843)
Timeframe: at 36 hours and 30 days

Interventionparticipants (Number)
MP Single Dose1
MP Two Dose0

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Inotropic Score

The inotropic score was calculated by the equation using drug dosages in micrograms/kg/min, (dopamine+dobutamine) + (milrinonex10) + (epinephrinex100) and recorded hourly upon arrival to the ICUthrough 36 hours postoperatively. The highest score during this timeframe was recorded. This score converts dosages of commonly used inotropic medications into a score. The higher the score the more inotropic medications required. The minimum score would be zero indicating no inotropic medications were used. There is no maximum score. (NCT00934843)
Timeframe: over the first 36 hours after surgery

InterventionScores on a scale (Mean)
MP Single Dose14.4
MP Two Dose15.0

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Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery.

The presence of low cardiac output syndrome (LCOS) was defined by the same definition used in the PRIMACORP study (Hoffman TM.et.al. Circulation 2003 107:996-1002). Specifically, if there were clinical signs and symptoms of low cardiac output (e.g., tachycardia, oliguria, cold extremities, cardiac arrest, etc.) which required one or more of the following interventions: mechanical circulatory support, the escalation of existing pharmacological circulatory support to >100% over baseline, or the initiation of new pharmacological circulatory support. (NCT00934843)
Timeframe: 36 hours

Interventionparticipants (Number)
MP Single Dose17
MP Two Dose15

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Total Intake/Output of Fluid

Total amount of all fluids in and out during the first 36 hours postoperatively in mL. (NCT00934843)
Timeframe: over 36 hours

,
InterventionmL (Mean)
Total Fluid in at 36 hrTotal Fluid out at 36 hr
MP Single Dose575600
MP Two Dose586558

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Urine Output

Total urine output in mL over the first 36 hours after cardiac surgery (NCT00934843)
Timeframe: over 36 hours

InterventionmL (Mean)
MP Single Dose498
MP Two Dose453

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Pain(at 6 Months): Nirschl Staging

"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain" (NCT00947765)
Timeframe: 6 months

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group0.366
Local Corticosteroid Injection Group1.233

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Pain(at 12 Weeks): Nirschl Staging

"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain" (NCT00947765)
Timeframe: 12 weeks

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group0.433
Local Corticosteroid Injection Group1.03

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Pain(at 1 Week): Nirschl Staging (0 to 7)

"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain" (NCT00947765)
Timeframe: 1 week

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group5.1
Local Corticosteroid Injection Group3.06

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Pain (at 1 Week): Visual Analogue Scale(0 to 10)

"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1___2___3___4___5___6___7___8___9___10 worst pain ever." (NCT00947765)
Timeframe: 1 week

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group7.166
Local Corticosteroid Injection Group4.5

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Pain(at 4 Weeks): Nirschl Staging

"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain" (NCT00947765)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group2.2
Local Corticosteroid Injection Group1.03

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Pain(at 6 Months): Visual Analogue Scale

"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever." (NCT00947765)
Timeframe: 6 months

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group0.533
Local Corticosteroid Injection Group1.833

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Pain(at 12 Weeks): Visual Analogue Scale

"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever." (NCT00947765)
Timeframe: 12 weeks

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group0.6
Local Corticosteroid Injection Group1.5

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Pain(at 4 Weeks): Visual Analogue Scale

"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever." (NCT00947765)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group3.2
Local Corticosteroid Injection Group1.533

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Serum Estradiol Measured on Treatment Day 1 (Baseline Study)

Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL. (NCT00957801)
Timeframe: treatment day 1

Interventionpg/mL (Mean)
Testosterone Injection22.86
Testosterone Gel33.69
Medrol 6 Day Dose Pack36.33
Testosterone Injection and Medrol 6 Day Dose Pack34.71

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Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)

Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL. (NCT00957801)
Timeframe: treatment day 8

Interventionng/mL (Mean)
Testosterone Injection1.98
Testosterone Gel2.32
Medrol 6 Day Dose Pack1.78
Testosterone Injection and Medrol 6 Day Dose Pack2.07

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Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)

Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL. (NCT00957801)
Timeframe: treatment day 1

Interventionng/mL (Mean)
Testosterone Injection1.92
Testosterone Gel2.33
Medrol 6 Day Dose Pack1.85
Testosterone Injection and Medrol 6 Day Dose Pack1.83

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Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)

Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection104.0
Testosterone Gel94.57
Medrol 6 Day Dose Pack87.5
Testosterone Injection and Medrol 6 Day Dose Pack75.14

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Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)

Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection103.0
Testosterone Gel93.57
Medrol 6 Day Dose Pack96.83
Testosterone Injection and Medrol 6 Day Dose Pack90.71

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Insulin Measured on Treatment Day 8 (Post Study)

Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL. (NCT00957801)
Timeframe: treatment day 8

InterventionuIu/mL (Mean)
Testosterone Injection7.47
Testosterone Gel10.58
Medrol 6 Day Dose Pack3.92
Testosterone Injection and Medrol 6 Day Dose Pack3.89

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Insulin Measured on Treatment Day 1 (Baseline Study)

Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL. (NCT00957801)
Timeframe: treatment day 1

InterventionuIu/mL (Mean)
Testosterone Injection8.53
Testosterone Gel10.28
Medrol 6 Day Dose Pack4.09
Testosterone Injection and Medrol 6 Day Dose Pack9.89

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Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)

Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL. (NCT00957801)
Timeframe: treatment day 1

Interventionng/mL (Mean)
Testosterone Injection71.77
Testosterone Gel69.2
Medrol 6 Day Dose Pack61.42
Testosterone Injection and Medrol 6 Day Dose Pack90.74

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High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)

High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection41.29
Testosterone Gel36.71
Medrol 6 Day Dose Pack47.67
Testosterone Injection and Medrol 6 Day Dose Pack43.43

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High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)

High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection40.29
Testosterone Gel38.86
Medrol 6 Day Dose Pack46.50
Testosterone Injection and Medrol 6 Day Dose Pack42.14

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Hematocrit Measured on Treatment Day 8 (Post Study)

Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%. (NCT00957801)
Timeframe: treatment day 8

Interventionpercent (Mean)
Testosterone Injection38.74
Testosterone Gel37.23
Medrol 6 Day Dose Pack40.53
Testosterone Injection and Medrol 6 Day Dose Pack39.24

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Hematocrit Measured on Treatment Day 1 (Baseline Study)

Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%. (NCT00957801)
Timeframe: treatment day 1

Interventionpercent (Mean)
Testosterone Injection39.17
Testosterone Gel38.4
Medrol 6 Day Dose Pack40.45
Testosterone Injection and Medrol 6 Day Dose Pack39.86

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Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week

"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions.~This data is presented as the pre-treatment week average of study days -7 to -1." (NCT00957801)
Timeframe: Study days -7 to -1 (Pre - treatment)

Interventionunits on a scale (Mean)
Testosterone Injection2.25
Testosterone Gel1.47
Medrol 6 Day Dose Pack2.26
Testosterone Injection and Medrol 6 Day Dose Pack1.86

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Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week

"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions.~This data is presented as the treatment week average of study days 1-8." (NCT00957801)
Timeframe: Study days 1-7 (treatment week)

Interventionunits on a scale (Mean)
Testosterone Injection1.84
Testosterone Gel1.79
Medrol 6 Day Dose Pack2.19
Testosterone Injection and Medrol 6 Day Dose Pack1.57

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Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)

Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionug/dL (Mean)
Testosterone Injection37.96
Testosterone Gel35.54
Medrol 6 Day Dose Pack34.74
Testosterone Injection and Medrol 6 Day Dose Pack36.07

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Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)

Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionug/dL (Mean)
Testosterone Injection46.34
Testosterone Gel34.16
Medrol 6 Day Dose Pack62.55
Testosterone Injection and Medrol 6 Day Dose Pack46.07

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Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol

Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. (NCT00957801)
Timeframe: treatment day 8 - before exercise

Interventionug/dL (Mean)
Testosterone Injection7.84
Testosterone Gel5.97
Medrol 6 Day Dose Pack6.28
Testosterone Injection and Medrol 6 Day Dose Pack5.19

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Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol

Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. (NCT00957801)
Timeframe: treatment day 8 - after exercise

Interventionug/dL (Mean)
Testosterone Injection7.05
Testosterone Gel6.28
Medrol 6 Day Dose Pack4.40
Testosterone Injection and Medrol 6 Day Dose Pack5.78

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Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol

Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. (NCT00957801)
Timeframe: treatment day 1 - before exercise

Interventionug/dL (Mean)
Testosterone Injection7.25
Testosterone Gel6.00
Medrol 6 Day Dose Pack6.64
Testosterone Injection and Medrol 6 Day Dose Pack6.28

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Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol

Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. (NCT00957801)
Timeframe: treatment day 1 - after exercise

Interventionug/dL (Mean)
Testosterone Injection7.71
Testosterone Gel7.20
Medrol 6 Day Dose Pack4.76
Testosterone Injection and Medrol 6 Day Dose Pack4.15

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C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)

C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection0.47
Testosterone Gel0.31
Medrol 6 Day Dose Pack0.32
Testosterone Injection and Medrol 6 Day Dose Pack0.3

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C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)

C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection0.47
Testosterone Gel0.33
Medrol 6 Day Dose Pack0.32
Testosterone Injection and Medrol 6 Day Dose Pack0.4

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Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)

Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL. (NCT00957801)
Timeframe: treatment day 8

Interventionng/mL (Mean)
Testosterone Injection80.16
Testosterone Gel72.11
Medrol 6 Day Dose Pack69.17
Testosterone Injection and Medrol 6 Day Dose Pack54.86

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Triglycerides Measured on Treatment Day 8 (Post Study)

Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection112.57
Testosterone Gel160.0
Medrol 6 Day Dose Pack155.17
Testosterone Injection and Medrol 6 Day Dose Pack116.28

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Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)

Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection26.71
Testosterone Gel29.29
Medrol 6 Day Dose Pack31.0
Testosterone Injection and Medrol 6 Day Dose Pack24.71

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Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)

Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection28
Testosterone Gel33.14
Medrol 6 Day Dose Pack24.67
Testosterone Injection and Medrol 6 Day Dose Pack23.86

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Triglycerides Measured on Treatment Day 1 (Baseline Study)

Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection140.42
Testosterone Gel164.0
Medrol 6 Day Dose Pack122.5
Testosterone Injection and Medrol 6 Day Dose Pack119.71

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Total Cholesterol Measured on Treatment Day 8 (Post Study)

Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection172
Testosterone Gel162.86
Medrol 6 Day Dose Pack166.17
Testosterone Injection and Medrol 6 Day Dose Pack141.86

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Total Cholesterol Measured on Treatment Day 1 (Baseline Study)

Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection171.29
Testosterone Gel165.57
Medrol 6 Day Dose Pack168.00
Testosterone Injection and Medrol 6 Day Dose Pack156.71

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Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)

Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L. (NCT00957801)
Timeframe: treatment day 8

Interventionnmol/L (Mean)
Testosterone Injection17.62
Testosterone Gel20.13
Medrol 6 Day Dose Pack19.22
Testosterone Injection and Medrol 6 Day Dose Pack14.57

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Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)

Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L. (NCT00957801)
Timeframe: treatment day 1

Interventionnmol/L (Mean)
Testosterone Injection21.78
Testosterone Gel19.86
Medrol 6 Day Dose Pack25.66
Testosterone Injection and Medrol 6 Day Dose Pack24.70

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Serum Total Testosterone Measured on Treatment Day 8 (Post Study)

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 8

Interventionng/dL (Mean)
Testosterone Injection454.29
Testosterone Gel435.14
Medrol 6 Day Dose Pack340.17
Testosterone Injection and Medrol 6 Day Dose Pack481.14

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Serum Total Testosterone Measured on Treatment Day 7

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 7

Interventionng/dL (Mean)
Testosterone Injection578.29
Testosterone Gel485.86
Medrol 6 Day Dose Pack320.0
Testosterone Injection and Medrol 6 Day Dose Pack579.57

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Serum Total Testosterone Measured on Treatment Day 6

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 6

Interventionng/dL (Mean)
Testosterone Injection629.0
Testosterone Gel536.43
Medrol 6 Day Dose Pack284.5
Testosterone Injection and Medrol 6 Day Dose Pack645.14

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Serum Total Testosterone Measured on Treatment Day 5

"TesTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 5

Interventionng/dL (Mean)
Testosterone Injection722.0
Testosterone Gel460.14
Medrol 6 Day Dose Pack246.33
Testosterone Injection and Medrol 6 Day Dose Pack669.71

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Serum Total Testosterone Measured on Treatment Day 4

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 4

Interventionng/dL (Mean)
Testosterone Injection779.57
Testosterone Gel441.71
Medrol 6 Day Dose Pack271.6
Testosterone Injection and Medrol 6 Day Dose Pack734.57

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Serum Total Testosterone Measured on Treatment Day 3

"TTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 3

Interventionng/dL (Mean)
Testosterone Injection828.71
Testosterone Gel527.43
Medrol 6 Day Dose Pack206.0
Testosterone Injection and Medrol 6 Day Dose Pack673.29

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Serum Total Testosterone Measured on Treatment Day 2

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 2

Interventionng/dL (Mean)
Testosterone Injection980.86
Testosterone Gel526.71
Medrol 6 Day Dose Pack191.87
Testosterone Injection and Medrol 6 Day Dose Pack675.86

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Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 1

Interventionng/dL (Mean)
Testosterone Injection307.57
Testosterone Gel363.43
Medrol 6 Day Dose Pack408.17
Testosterone Injection and Medrol 6 Day Dose Pack318.68

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Serum Estradiol Measured on Treatment Day 8 (Post Study)

Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL. (NCT00957801)
Timeframe: treatment day 8

Interventionpg/mL (Mean)
Testosterone Injection48.29
Testosterone Gel33.43
Medrol 6 Day Dose Pack30.83
Testosterone Injection and Medrol 6 Day Dose Pack47.14

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Overall Response Rate (OR) Where OR = CR + CRp + CRi

Number of participants out of total treated who experienced a complete response response according to RECIST criteria either (CR + CRp) CR Without Platelet Recovery. Response (CR + CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl. (NCT00968253)
Timeframe: 8 courses of treatment, up to 24 weeks

Interventionpercentage of participants (Number)
Phase I: RAD001 5 mg + Combination Chemo33
Phase I: RAD001 10 mg + Combination Chemo33
Phase II: MTD RAD001 + Combination Chemo33

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Participant Responses by Daily Dose Level Assignment (RAD001 5 mg, 10 mg and MTD 5 mg)

Response defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl. Partial remission (PR): Peripheral blood count recovery as for CR, with decrease in marrow blasts by > 50% from pretreatment values with no more than 25% leukemia/lymphoma cells in the marrow. Nonresponder, Other: All other responses will be considered failures. (NCT00968253)
Timeframe: Up to 20 cycles of study drugs (21 day cycles) or till disease progression

,,
Interventionparticipants (Number)
Complete RemissionComplete Remission without platelet recoveryCR with incomplete blood count recoveryPartial RemissionNonresponder
Phase I: RAD001 10 mg + Combination Chemo20115
Phase I: RAD001 5 mg + Combination Chemo10011
Phase II: MTD RAD001 + Combination Chemo31008

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Maximum Tolerated Dose [MTD] Determination by Number of Participants With Dose Limiting Toxicity (DLT)

"The Maximum tolerated dose (MTD) was the highest dose level at which fewer than 2 of 6 patients developed a dose limiting toxicity (DLT) in the first two cycles of therapy. A 3 by 3 design was used for dose escalation in the phase I portion of the study.~A dose-limiting toxic effect (DLT) was defined as a clinically significant adverse event or abnormal laboratory value directly attributable to everolimus and assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, occurring during the first or second cycle of therapy, that met any of the following criteria: CTCAE version 3.0 grade 3 increased AST or ALT for 7 days, CTCAE grade 4 increased AST or ALT of any duration, or any other clinically significant CTCAE grade 3 or 4 toxic effect. Electrolyte abnormalities (changes in glucose, chemistries, liver enzymes, pancreatic enzymes) correctable by optimal therapy and without clinical impact were not considered DLTs." (NCT00968253)
Timeframe: Following first two dose cycles (21 days/each), up to 42 days

InterventionParticipants (Count of Participants)
Phase I: RAD001 5 mg + Combination Chemo0
Phase I: RAD001 10 mg + Combination Chemo1

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Time to Flare Comparing Patients With Moderate vs Severe Disease Activity at Baseline

Group A only: patients on immunosuppressive treatments had them withdrawn at baseline. All patients were allowed up to 160 mg depomedrol at baseline which could be repeated within two weeks up to a total of 4 shots maximum or until satisfactory improvement. Time to flare was calculated from baseline. moderate disease at baseline was defined as up to 3 BILAG B (moderate disease) organ scores, no BILAG A (severe disease) score and a SLEDAI 3 BILAG B, OR at least one BILAG A OR SLEDAI > 10 or meeting criteria for a severe flare on the SELENA SLEDAI flare index. At baseline 25 patients with moderate disease. 16 patients had severe disease. Note: severe rash with A on BILAG is only SLEDAI=2, explaining some discrepancies in measures (NCT00987831)
Timeframe: 12 months

Interventiondays to flare (Median)
Severe Disease Activity at Baseline45
Moderate Disease Activity at Baseline71

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Time to Flare Comparing Patients With (at Baseline) British Isles Lupus Assessment Group Index (BILAG) >/= 17 (Severe Disease) to Those With BILAG < 17 (Moderate Disease Activity).

(NCT00987831)
Timeframe: 12 months

Interventiondays to flare (Median)
Severe Disease Activity at Baseline40
Moderate Disease Activity at Baseline72.5

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Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24

The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: [VAS] 0 equals (=) no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Scores less than (<) 2.6 indicate best disease control and scores greater than or equal to (≥) 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. The average improvement at each visit to the group score is equal to the formula (Previous DAS28 minus [-] current DAS 28)/ Previous DAS 28 x 100. Negative percentages indicate that the participant has worsened in comparison to last evaluation, and positive percentages indicate improvement of its DAS28 score and correlated with a bettering of clinical situation. (NCT01000610)
Timeframe: Baseline and Week 24

Interventionpercentage change from baseline (Mean)
Rituximab-1.7

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Change in Bone Density (in Participants Untreated With Bisphosphonates)

Bone mineral density test was performed using x-ray radiation and the values of bone density were provided directly by the apparatus as grams per square centimeter (g/cm^2) . T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. (NCT01000610)
Timeframe: Screening and Week 84

Interventiont-score (Number)
ScreeningWeek 84
Rituximab-1.82-1.6

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Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24

The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [VAS: 0 = no disease activity to 100 = maximum disease activity] and the ESR for a total possible score of 0 to 10. Scores < 2.6 indicate best disease control and scores ≥ 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. An improvement of >1.2 was considered to be clinically significant improvement. (NCT01000610)
Timeframe: Baseline and Week 24

Interventionpercentage of participants (Number)
Rituximab75.0

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Number of Participants Reporting Adverse Events (AEs)

(NCT01000610)
Timeframe: Days 1 and 15, every 8 weeks up to Week 24 and and then every 3 months up to 18 months for a total of 104 weeks

Interventionnumber of participants (Number)
Participants who experienced an AEParticipants who experienced more than 1 AE
Rituximab117

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Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria.

MRI rescue criteria were the presence of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size, according to the central MRI reader. (NCT01071083)
Timeframe: 28 Weeks

InterventionPercentage of subjects meeting criteria (Number)
Natalizumab0.0
Intravenous Placebo52.5
Interferon β-1a8.3
Glatiramer Acetate49.7
Methylprednisolone46.1

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Time Course to Return of Radiological and/or Clinical Evidence of Multiple Sclerosis Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) and/or Clinical Relapse Rescue Criteria.

Rescue criteria were: 1) central reader MRI finding of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size 2) clinical relapse. Clinical relapse was new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, as defined by: an increase of ≥1 grade in ≥2 functional scales of the Expanded Disability Status Scale (EDSS); an increase of ≥2 grades in 1 functional scale of the EDSS; or an increase of >0.5 in EDSS if the previous EDSS was ≤5.5, or ≥0.5 if the previous EDSS was >5.5 (NCT01071083)
Timeframe: 28 Weeks

InterventionPercentage of subjects meeting criteria (Number)
Natalizumab4.7
Intravenous Placebo60.5
Interferon β-1a28.6
Glatiramer Acetate53.3
Methylprednisolone54.8

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Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24

Estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease (MDRD) formula. (NCT01085097)
Timeframe: Baseline, Week 24

Interventionpercent change (Mean)
Placebo12.1
Laquinimod 0.5 mg18.0
Laquinimod 1 mg24.3

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Number of Participants With Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. (NCT01085097)
Timeframe: Baseline up to Week 28

Interventionparticipants (Number)
Placebo14
Laquinimod 0.5 mg15
Laquinimod 1 mg15

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Time to the Change or Addition of New Pulmonary Arterial Hypertension (PAH) Therapeutic Medications

Per protocol, from the time of study entry, participants were to remain on background PAH medical therapy with either a single agent or a combination of prostanoid, endothelin receptor antagonist, PDE-5 inhibitor, and/or guanylate cyclase stimulators as per the entry criteria. Doses should have remained stable through the Week 24 primary outcome/endpoint visit. If a dose of a background PAH medication was changed or a new PAH medication was added during the course of the trial, the date of the first dose change or additional medication was recorded. Time to the addition or modification of PAH medications was defined in study days as: date of the first time a PAH medication was modified or added minus (-) date of randomization. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 48

InterventionWeeks (Mean)
Rituximab21.2
Placebo26.7

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Change From Baseline in Quality of Life as Measured by the Short Form Health Survey (SF-36): Physical Component Summary Score

The SF-36 measures health-related quality of life. It has 36 items and 2 component scores, the Physical Component Score and the Mental Component Score. The SF-36 Physical component summary score is comprised of the Physical Functioning Scale, the Role-Physical Scale, the Bodily Pain Scale, and the General Health Scale. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 is equivalent to no disability. A negative value indicates a decrease in quality of life from Baseline. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 48

,
InterventionUnits on a Scale (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo1.73.5
Rituximab0.61.3

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Percent Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization

"During a right heart catheterization, a catheter is guided to the right side of the heart and then into the pulmonary artery; blood flow through the heart is observed and is used to measure pressures in a participant's heart and lungs. Pulmonary vascular resistance (PVR) is measured in Woods Units. Higher PVR values indicate worse disease status.~Change in PVR is determined by Baseline value minus (-) Week 24 value." (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24

InterventionPercent Change (Least Squares Mean)
Rituximab-4.6
Placebo3.2

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Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization at Week 24

During a right heart catheterization, a catheter is guided to the right side of the heart and then into the pulmonary artery; blood flow through the heart is observed and is used to measure pressures in a participant's heart and lungs. The calculation of Pulmonary Vascular Resistance (PVR) is measured in Woods Units. Change is derived by measuring the difference between Baseline and Week 24 PVR (Week 24 minus Baseline). Higher PVR values indicate worse disease status. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24

InterventionWoods Units (Least Squares Mean)
Rituximab-0.5
Placebo0.1

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Change From Baseline in Distance Walked During a Six Minute Walk Test

The six minute walk test measures the distance a participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the participant to walk as far as possible in six minutes. The participant is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The total distance walked, in meters, was recorded for each participant. Longer distances indicate better outcomes. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24

InterventionMeters (Least Squares Mean)
Rituximab23.6
Placebo0.5

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All-Cause Mortality: From Treatment Initiation to Week 48

Death from any cause occurring after randomization and ≤ Week 48. (NCT01086540)
Timeframe: Day 0 (Treatment Randomization) to Week 48

InterventionParticipants (Count of Participants)
Rituximab4
Placebo1

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All-Cause Mortality: From Treatment Initiation to Week 104

Death from any cause occurring after randomization and ≤ Week 104. (NCT01086540)
Timeframe: Day 0 (Treatment Randomization) to Week 104

InterventionParticipants (Count of Participants)
Rituximab8
Placebo5

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Change From Baseline in Quality of Life as Measured by the Short Form Health Survey (SF-36): Mental Component Summary Score

The SF-36 measures health-related quality of life. It has 36 items and 2 component scores, the Physical Component Score and the Mental Component Score. The SF-36 Mental Health component summary score is comprised of the Vitality Scale, the Social Functioning Scale, the Role-Emotional Scale, and the Mental Health Scale. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 is equivalent to no disability. A negative value indicates a decrease in quality of life from Baseline. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionUnits on a Scale (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo0.40.9
Rituximab0.10.2

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Change From Baseline in Distance Walked During a Six Minute Walk Test at Week 24 and Week 48

The six minute walk test measures the distance a participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the participant to walk as far as possible in six minutes. The participant is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The total distance walked, in meters, was recorded for each participant. Longer distances indicate better outcomes. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionMeters (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo0.4-7.0
Rituximab25.59.5

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Time to Clinical Worsening

"Assessment of time to clinical worsening, censored at Week 48, defined as the first occurrence of any of the following:~death,~hospitalization for Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH),~lung transplantation,~atrial septostomy,~addition of other Pulmonary Arterial Hypertension (PAH) therapeutic agents, or~worsening of the six minute walk distance by > 20% and an increase in New York Heart Association functional class.~Time to clinical worsening was defined as the first date that met any of the above criteria and was calculated in study days as: date of first event minus (-) date of treatment randomization. If a participant did not experience any of the referenced events by Week 48 or, if the date of death was after the 48 week follow-up period, time to clinical worsening was equal to the participant's duration of follow-up in the study." (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 48

InterventionWeeks (Mean)
Rituximab21.2
Placebo26.2

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Number of New Digital Ulcers

The total number of digital ulcers present on the dorsal and palmar surfaces for both the left and right fingers were captured at the Baseline study visit. The number of new digital ulcers since the last study visit (including any ulcers that had appeared and healed since the last study visit) on the dorsal and palmar surfaces for both the left and right fingers were captured at the post-Baseline study visits. The total number of digital ulcers on both hands was summed from the number present on the dorsal and palmar surfaces for both the left and right fingers. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionNew Ulcers (Mean)
Total Ulcer Count at BaselineNew Ulcers at Week 24New Ulcers at Week 48
Placebo0.40.10.2
Rituximab0.60.00.1

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Oxygen Saturation Levels at Week 24 and Week 48

Oxygen saturation is the amount of oxygen that is in your bloodstream and is measured as the percentage of blood hemoglobin that is carrying oxygen. Normal oxygen saturation levels are considered to be 95-100 percent; low oxygen saturation values indicate worse disease. Room air oxygen saturation by pulse oximetry and/or amount of supplemental oxygen used, if saturation <90%, were recorded. (NCT01086540)
Timeframe: Week 24 , Week 48

,
InterventionPercent Oxygen Saturation (Mean)
O2 Sat Level: Week 24O2 Sat Level: Week 48
Placebo96.196.2
Rituximab96.597.7

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Number of Grade 3 or Higher Adverse Events (AEs) Through Week 48

Total number of Grade 3, 4, and 5 AEs. Ref: National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 48

,
InterventionEvents (Number)
Grade 3 AEsGrade 4 AEsGrade 5 AEs
Placebo1921
Rituximab2863

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Change in Severity of Raynaud's Phenomenon

"Severity of Raynaud's phenomenon was measured by a Visual Analog Scale (VAS) of the Scleroderma Health Assessment Questionnaire (SHAQ). The SHAQ VAS includes a question asking, In the past week, how much has your Raynaud's Phenomenon interfered with your activities? Participants were asked to place a mark on a 15 cm line, scaled from 0 (does not interfere) to 100 (very severe limitation), to describe the severity of their Raynaud's phenomenon in the past week. The distance from the left edge of the line to the vertical line placed by the participant was measured in centimeters; VAS scores were converted to a 0 to 100 scale." (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionScore on a Scale (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo0.10.1
Rituximab-2.2-4.4

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Change in Quality of Life as Measured by the Disability Index of the Scleroderma Health Assessment Questionnaire (HAQ-DI)

The HAQ-DI is a self-reported questionnaire of functionality that includes questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities) and addresses scleroderma related manifestations that contribute to disability. The final score ranges from 0 to 3, where a higher HAQ-DI score indicates a worse outcome. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionUnits on a Scale (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo0.00.0
Rituximab0.00.0

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Change in Carbon Monoxide Diffusing Capacity (DLCO)

"Carbon Monoxide Diffusing Capacity (DLCO) is a measure of lung function. Predicted values for DLCO were computed according to the Global Lung Function Initiative (GLI) all-age reference values and corrected for hemoglobin. Lower DLCO values indicate worse disease activity.~DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)" (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionPercent Predicted Value (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo0.40.7
Rituximab-0.3-0.5

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Recurrence or Relapse

Number of subjects that had disease recurrence (NCT01093586)
Timeframe: one year in patients post UCBT

InterventionParticipants (Count of Participants)
Arm I2

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Recurrence or Relapse

Number of subjects that had disease recurrence (NCT01093586)
Timeframe: two years post transplant

InterventionParticipants (Count of Participants)
Arm I2

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Occurrence of Serious Infections

Number of participants that had infections (NCT01093586)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Arm I13

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Disease Free

Number of participants that were disease free (NCT01093586)
Timeframe: At 1 year

InterventionParticipants (Count of Participants)
Arm I4

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Overall Survival

Number of participants that were alive. (NCT01093586)
Timeframe: At 2 years

InterventionParticipants (Count of Participants)
Arm I4

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Disease Free

Number of participants that were disease free (NCT01093586)
Timeframe: At 2 years

InterventionParticipants (Count of Participants)
Arm I4

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Overall Survival

Number of participants that were alive. (NCT01093586)
Timeframe: At 1 year

InterventionParticipants (Count of Participants)
Arm I6

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Overall Survival

Number of participants alive at 180 days post engraftment. (NCT01093586)
Timeframe: On day +180

InterventionParticipants (Count of Participants)
Arm I8

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Incidence of Chronic GVHD

Number of participants that have chronic GVHD. Chronic GVHD will be diagnosed and graded on clinical and histological criteria from the Center for International Blood and Marrow Transplant Research (CIBMTR) (NCT01093586)
Timeframe: At 1 year

InterventionParticipants (Count of Participants)
Arm I1

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Hematologic Engraftment

Number of participants that were able to complete engraftment by day 42. (NCT01093586)
Timeframe: On day +42

InterventionParticipants (Count of Participants)
Arm I10

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Incidence of Acute Graft-versus-host Disease (GVHD)

Number of participants that had acute GVHD (NCT01093586)
Timeframe: At 100 days

InterventionParticipants (Count of Participants)
Arm I11

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Number of Participants With Progressive Disease at One Year

(NCT01105650)
Timeframe: 1 Year

InterventionParticipants (Count of Participants)
Arm 1: CsA2
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-21
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-25

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Overall Survival

Number of participants alive at 1 year. (NCT01105650)
Timeframe: 1 Year

Interventionparticipants (Number)
Arm 1: CsA0
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-21
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-23

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Response Rate

Response includes Complete Response (CR), Partial Response (PR), and Stable Disease (SD) as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI. Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease. (NCT01105650)
Timeframe: Month 3

Interventionparticipants (Number)
Arm 1: CsA1
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-22
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-24

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Time to Disease Progression

Time from study entry until progressive disease or data collection cutoff. (NCT01105650)
Timeframe: 1 Year

Interventiondays (Median)
Arm 1: CsA52
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-298
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2100

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Number of Participants With Thyroid Function Assessment, Hormone and Glucose Assay Abnormalities Meeting the Criteria for PCC

The following laboratory parameters were analyzed: thyroid function assessment (thyroid stimulating hormone [TSH], thyroid peroxidase antibody, thyrotropin receptor antibodies (TSH-R-Abs) or TSH-binding inhibiting immunoglobulin (TBII), free thyroxine [fT4], free triiodothyronine [fT3]; hormone and glucose assays (cortisol, adrenocorticotrophic hormone [ACTH], insulin-like growth factor [IgF-1] and plasma glucose. Thyroid function tests were done at Day 1 (pre-dose) and Week 4-24. Hormone and glucose assays were done at Day 1 (pre-dose) and Week 2-24. (NCT01114503)
Timeframe: Up to Week 24

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With an Epstein Barr Virus (EBV) Viral Load Abnormalities Meeting the Criteria for PCC

The PCC range for EBV viral load was > 10,000 copies of deoxyribonucleic acid (DNA) per million lymphocytes. The assessments were done at Week 2, Week 4, Week 8 and Week 12. (NCT01114503)
Timeframe: Week 2 to Week 12

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With Electrocardiogram (ECG) Abnormalities Meeting the Criteria for PCC

ECG parameters included pulse rate (PR) interval, QRS interval, QT interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval <110 and >220 milliseconds (msec); QRS interval <75 and >110 msec; QTc interval >480 to <= 500 msec, increase from baseline QTc >30 to <= 60 msec. (NCT01114503)
Timeframe: Screening (Day -35 to Day -1)

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With Laboratory Clinical Chemistry Abnormalities Meeting the Criteria for Potential Clinical Concern (PCC)

The PCC range for clinical chemistry parameters included albumin, <30 gram per liter (g/L); calcium, low- < 2.0 millimole (mmol)/L: high->2.75 mmol/L; creatinine, high- > 1.3x ULN mmol/L or > 159 micromole (μmol)/L or > 44 μmol/L change from Baseline; glucose, low- < 3.0 mmol/L, high- > 9.0 0 mmol/L; magnesium, low- < 0.5 mmol/L, high- > 1.23 mmol/L, phosphorus, low- < 0.8 mmol/L, high- > 1.6 mmol/L; potassium, Low- < 3.0 mmol/L, high- > 5.5 mmol/L; sodium, low- < 130 mmol/L, high- > 150 mmol/L; bicarbonate, low- < 18 mmol/L, high- > 32 mmol/L; alanine aminotransferase, high->= 2x ULN, where the normal range was (NR) 0 - 39 international units (IU)/L; aspartate aminotransferase, high- >= 2x ULN, where NR was 0 - 39 IU/L; alkaline phosphatase, high- >= 1.5x ULN, where NR was 35 - 120 IU/L; total bilirubin- >= 1.5x ULN, where NR was 0 - 18 μmol/L.The assessments were done at Day 1 (pre dose), Day 8, Week 2-24 and Month 12 and 24. (NCT01114503)
Timeframe: Up to Month 24 (Long term follow-up)

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With Laboratory Hematology Abnormalities Meeting the Criteria for PCC

The PCC range for hematology parameters included white blood cell count, low- < 3 giga cells (GI)/L, high- > 20 GI/L; neutrophil count, low- < 1.5 GI/L; hemoglobin, low- > 25 g/L change from baseline, high- 180 g/L; hematocrit, low- > 0.075 L change from baseline, high- 0.54 L; platelet count, low- < 100 GI/L, high- >550 GI/L and lymphocytes, low < 0.8 GI/L. The assessments were done at Day 1 (pre dose), Day 8, Week 2-24, Month 12 and 24. (NCT01114503)
Timeframe: Upto Month 24 (Long term follow-up)

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With Laboratory Urinalysis Abnormalities Meeting the Criteria for PCC

The urinalysis parameters included pH, glucose, protein, blood and ketones by dipstic and microscopy (if urine dipstick was positive for blood or protein). The assessments were done at Day 1 (pre dose), Day 8, Week 2-24, Month 12 and 24. (NCT01114503)
Timeframe: Up to Month 24 (Long term follow-up)

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With Vital Signs Abnormalities Meeting the Criteria for PCC

Vital signs assessment included pulse rate, blood pressure, temperature and respiratory rate. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate <40 or >110 beats per minute (bpm), >= 15 increase from baseline and >= 30 decrease from baseline; systolic blood pressure (SBP) < 85 and > 160 millimeters of mercury (mm Hg), >= 20 mmHg increase from baseline and >= 40 mmHg decrease from baseline; diastolic blood pressure (DBP) < 45 and > 100 mm Hg, >= 10 mmHg increase from baseline and >= 20 mmHg decrease from baseline. (NCT01114503)
Timeframe: Up to Month 24 (Long term follow-up)

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Global Assessment Score of Postoperative Inflammation by Visit

A Global Assessment Score (GAS) was assigned by the Investigator based on the clinical evidence of postoperative inflammation: 0=clear, 1=improving satisfactorily; 2=not improving or worsening, withdrawal from study indicated to allow appropriate alternative therapy to be instituted. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 29: Grade 0Day 29: Grade 1Day 29: Grade 21 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 2Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2
DUREZOL30.869.20.048.748.72.656.443.60.079.520.50.089.77.72.692.35.12.6
PRED FORTE17.582.50.025.070.05.050.050.00.072.525.02.590.07.52.592.57.50.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis

Vitritis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Vitritis (accumulation of inflammatory cells or exudates in the vitreous humor, the fluid that fills the middle chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE97.52.50.00.097.50.02.50.097.50.02.50.097.50.02.50.097.50.02.50.097.50.02.50.0

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Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days

Anterior cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. (NCT01124045)
Timeframe: Day 15 ± 2 days

InterventionPercentage of patients (Number)
DUREZOL78.9
PRED FORTE77.5

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade

Anterior chamber cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 1: Grade 4Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 8: Grade 4Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 15: Grade 4Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 3Day 29: Grade 41 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 31 Week After Last Dose: Grade 4Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3Month 3: Grade 4
DUREZOL23.757.915.82.60.055.336.85.32.60.078.918.40.02.60.089.510.50.00.00.097.42.60.00.00.094.75.30.00.00.0
PRED FORTE40.030.027.50.02.557.532.510.00.00.077.517.55.00.00.095.02.52.50.00.095.02.52.50.00.097.50.02.50.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation

Lacrimation was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Excessive lacrimation (tear production and secretion, 1-3) is a symptom of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL64.130.85.10.094.95.10.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE72.522.55.00.097.52.50.00.095.05.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity

Corneal clarity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of corneal clarity (1-3) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL92.37.70.00.094.95.10.00.094.95.10.00.097.42.60.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE87.512.50.00.090.07.52.50.090.010.00.00.097.52.50.00.097.52.50.00.097.52.50.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon

Hypopyon was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Hypopyon (pus in the anterior chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity

Wound integrity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of wound integrity (healing, 1-3) is a sign of inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 1: Grade 0Month 1: Grade 1Month 1: Grade 2Month 1: Grade 3
DUREZOL100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection

Conjunctival injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Conjunctival injection (redness of the white sclera of the eye) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL46.248.72.62.679.520.50.00.089.710.30.00.097.42.60.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE25.065.010.00.077.522.50.00.092.57.50.00.095.05.00.00.0100.00.00.00.0100.00.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection

Ciliary/limbal injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Ciliary/limbal injection (redness of the white sclera of the eye near the limbal ring) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL69.228.20.02.689.710.30.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE57.540.02.50.090.010.00.00.0100.00.00.00.097.52.50.00.0100.00.00.00.0100.00.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis

Chemosis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Chemosis (swelling of the conjunctiva) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL82.115.40.02.697.42.60.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE85.015.00.00.0100.00.00.00.097.52.50.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade

Anterior chamber flare was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL41.051.37.70.061.535.92.60.074.417.97.70.087.212.80.00.094.92.62.60.092.35.12.60.0
PRED FORTE45.037.512.55.052.540.05.02.570.027.52.50.092.57.50.00.092.57.50.00.095.05.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia

Photophobia was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Photophobia (abnormal intolerance to visual perception of light) is a symptom of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL71.820.57.70.089.710.30.00.097.42.60.00.097.42.60.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE60.035.05.00.087.510.02.50.095.05.00.00.092.55.00.02.597.52.50.00.0100.00.00.00.0

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Change in Joint Effusions From Day 0 to Day 56 Target Knee

"Outcome calculated based on Physician observation of joint swelling from 0-3. A score of 0 = no effusion,1 = positive bulge, 2 = moderate effusion, 3 = tense effusion. The outcome represents the change in means between the two time points." (NCT01144143)
Timeframe: Change from Day 0 to Day 56

Interventionunits on a scale (Mean)
Infliximab0.3
Salt Water0.0
Methylprednisolone Acetate0.0

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Change in Levels of Serum IL-6

(NCT01144143)
Timeframe: Change from Day 0 to Day 56

Interventionpg/ml (Mean)
Infliximab-0.4
Salt Water8.1
Methylprednisolone Acetate5.5

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Change in Serum CRP Day 0 to Day 56

Serum measure of systemic inflammation (NCT01144143)
Timeframe: Day 0 to Day 56

Interventionmg/dl (Mean)
Infliximab-0.18
Salt Water-0.15
Methylprednisolone Acetate0.08

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Change in Serum SAA Levels Day 0 to Day 56

Serum Amyloid A (NCT01144143)
Timeframe: Day 0 to Day 56

Interventionug/ml (Mean)
Infliximab-1.0
Salt Water-715.6
Methylprednisolone Acetate-1580.2

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Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score Target Knee

The WOMAC questionnaire is used to evaluate the condition of patients with osteoarthritis. Patients answer questions based on how they are feeling. The questionnaire has a total of 24 questions which deal with pain, stiffness and physical function. Participants are asked to respond to how difficult it is for them to do/complete an activity. There is a total possible score of 96. A score of 0 equals no difficulty completing any of the 24 activities. A score of 96 would indicate extreme difficulty with all activities. (NCT01144143)
Timeframe: Change from Day 0 to Day 56

Interventionunits on a scale (Mean)
Infliximab-25.9
Normal Saline-9.3
Methylprednisolone Acetate2.0

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Serious Adverse Events

Number of participants experiencing serious adverse events that occur during study. Adverse event collection for the purposes of this study will focus on targeted adverse events and unexpected adverse events at specific time points in relation to the NK cell infusion and post infusion IL2 injections. (NCT01181258)
Timeframe: Day 1 through Month 12

InterventionParticipants (Count of Participants)
Patients Receiving NK Cell Infusion15

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Patients With Expansion of NK Cells

Number of patients who experience in vivo expansion of allogeneic donor natural killer (NK) cells. (NCT01181258)
Timeframe: Day 14

InterventionParticipants (Count of Participants)
Patients Receiving NK Cell Infusion0

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Time to Disease Progression

Cumulative incidence will be used to determine time to disease progression. (NCT01181258)
Timeframe: Day 1 through Month 12

Interventiondays (Median)
Patients Receiving NK Cell Infusion38

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Number of Patients With an Objective Response

The number of patients with a partial response (PR) or complete response (CR). For patients with non-hodgkin's lymphoma: CR - complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR - at least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses. For patients with chronic lymphocytic leukemia: CR - disappearance of all palpable disease, normalization of the blood counts without transfusions, bone marrow aspirate lymphocyte percentage < 30%, and no evidence of disease on bone marrow biopsy. PR - 50% or more reduction in palpable disease as well as one or more of the remaining features: neutrophils >= 1.5 × 109/L or 50% improvement over baseline, platelets more than 100 × 109/L or 50% improvement over baseline, and hemoglobin more than 11.0 g/dL or 50% improvement over baseline without transfusions. (NCT01181258)
Timeframe: Month 2 Post Infusion

InterventionParticipants (Count of Participants)
Patients Receiving NK Cell Infusion4

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Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol13.041.378.382.680.482.680.4
Pred Forte14.940.461.776.676.676.678.7

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Proportion of Subjects With Anterior Chamber Cell Grade ≤1

As assessed by the investigator during slit lamp examination. Anterior chamber cell grade was graded on a 5-point scale, with 0 = no cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = more than 50 cells. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol50.087.093.593.593.593.591.3
Pred Forte57.480.985.189.487.285.185.1

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Proportion of Subjects Who Discontinued Due to Lack of Efficacy

Lack of efficacy was defined as those subjects who discontinued study participation either due to treatment failure or an adverse event with a preferred term of iridocyclitis, iritis, uveitis, or vitritis. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Time to Event

InterventionPercentage of subjects (Number)
Durezol0
Pred Forte14.9

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Proportion of Subjects With Anterior Chamber Cell Count of 0

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Proportion is reported as a percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol13.021.752.273.973.969.669.6
Pred Forte2.121.338.348.963.863.868.1

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Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. (NCT01201798)
Timeframe: Baseline (Day 0), Day 14

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 14
Durezol2.6-2.2
Pred Forte2.6-2.0

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Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points

Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol2.2-1.1-1.6-2.0-2.0-2.0-2.0-2.0
Pred Forte2.3-1.2-1.6-1.9-2.0-2.0-2.0-2.0

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Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits

The following signs were each graded on a 0 - 3 scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe): posterior synechia, hypopyon, limbal injection, and keratic precipitates. Peripheral synechia was graded by the combined number of clock hours affected (0 = absent; 1 = < 3 hrs; 2 = 3-6 hours; 3 = > 6 hours). The total sign score was calculated as the sum of the 5 individual sign scores, the anterior chamber cell grade and the anterior chamber flare grade. The minimum/best total sign score was 0, and the maximum/worst total sign score was 23. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol7.1-3.5-5.2-6.1-6.5-6.4-6.3-6.2
Pred Forte7.3-3.6-5.0-5.8-6.2-6.2-6.2-6.3

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Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points

The following symptoms were each graded by the subject according to a 0-100 visual analog scale (VAS) using a mark on a 100 mm line (0 = absent, 100 = maximal): eye pain, photophobia, blurred vision, and lacrimation. The total symptom score was calculated as the sum of the 4 individual symptom scores. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol186.7-88.4-108.2-133.3-138.8-140.1-143.9-146.2
Pred Forte203.2-88.4-123.8-137.4-149.5-152.4-147.3-155.5

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Proportion of Subjects With Anterior Chamber Cell Grade of 0

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol15.234.865.284.880.478.376.1
Pred Forte6.425.555.363.870.270.274.5

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Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 21Day 28Day 35Day 42
Durezol2.6-1.1-1.8-2.4-2.3-2.3-2.3
Pred Forte2.6-1.0-1.6-2.1-2.1-2.1-2.1

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Number of Participants Who Survived at 6 Months Following Completion of Plasma Exchange (PLEX)

Following the completion of rapid removal of natalizumab using PLEX or equivalent. (NCT01211665)
Timeframe: 6 months

Interventionparticipants (Number)
Pulsed IVMP1
IVMP With Oral Prednisolone Taper1

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Severity of AEs and SAEs

AEs and SAEs were categorized as mild, moderate or severe according to the following criteria: Mild=barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptom(s) but may be given because of personality of participant. Moderate=of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptom(s) may be needed. Severe=symptoms cause severe discomfort; symptoms cause incapacity or significant impact on participant's daily life; severity may cause cessation of treatment with study treatment; treatment for symptom(s) may be given and/or participant hospitalized. Please see Outcome Measure 3 for AE and SAE definitions. (NCT01211665)
Timeframe: from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period

,
Interventionevents (Number)
Mild SAEModerate SAESevere SAEMild AEModerate AESevere AE
IVMP With Oral Prednisolone Taper110510
Pulsed IVMP112330

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE=any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. (NCT01211665)
Timeframe: from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period

,
Interventionparticipants (Number)
AEsSAEs
IVMP With Oral Prednisolone Taper11
Pulsed IVMP22

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Short-Form 36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS) During the Interventional Phase

"36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined." (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
MCS V3 (n=37)MCS CV (n=26)MCS: Change from V3 to CV (n=22)PCS V3 (n=36)PCS CV (n=26)PCS: Change from V3 to CV (n=22)
Tocilizumab47.046.2-4.442.541.8-2.1

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SJC and TJC During the Interventional Phase

TJC and SJC were assessed for 28 joints. An assessment of 28 joints for swelling and tenderness was made. Joints were assessed and classified as swollen (1)/not swollen (0) and tender (1)/not tender (0) by pressure and joint manipulation on physical examination for a total score range of 0-28. Higher scores indicated greater disease activity (tenderness/swelling). V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionjoints (Mean)
SJC V3 (n=43)SJC CV (n=29)SJC Change from V3 to CV (n=29)TJC V3 (n=43)TJC CV (n=29)TJC Change from V3 to CV (n=29)
Tocilizumab0.90.4-0.30.91.81.0

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Type of GC Taken at the End of the Noninterventional Phase

During the noninterventional phase of the study participants received GC as prescribed by the physician. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
MPPrednisolonePrednisone
Tocilizumab70.028.02.0

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VAS for Pain (VAS-Pain) During the Interventional Phase

Participants were asked to mark the line corresponding to the intensity of their pain on a 100-mm VAS, where 0=no pain and 100=worst possible pain. The distance from the left edge was measured. Change = V3 mean minus CV mean. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionmm (Mean)
V3 (n=43)CV (n=28)Change from V3 to CV (n=28)
Tocilizumab19.924.96.9

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VAS-Physician's Global Assessment of Disease Activity (GDA) During the Interventional Phase

Physician's were asked to determine the overall GDA for each participant using a 100-mm VAS, where 0=no disease activity and 100=maximum disease activity. The physician marked the line corresponding to their assessment and the distance from the left edge was measured. V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionmm (Mean)
V3 (n=40)CV (n=28)Change from V3 to CV (n=26)
Tocilizumab16.616.73.1

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Median Dose of Tocilizumab During the Noninterventional Phase

(NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionmg/kg (Median)
Tocilizumab8.0

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Median Time Interval Between V1 and V2

The noninterventional phase was planned to last for a maximum of 6 months per participant. The time between V1 and V2 was measured in months. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionmonths (Median)
Tocilizumab2.3

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Number of Participants With Changes in Tocilizumab Dose During the Noninterventional Phase

The dose of tocilizumab could have been reduced from the recommended 8 mg/kg to 4 mg/kg in participants in the case of adverse events. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionparticipants (Number)
Tocilizumab1

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Number of Participants With GC Switches During the Noninterventional Phase

During the noninterventional phase of the study, once LDA was achieved, GC was switched to MP tablets. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionparticipants (Number)
Tocilizumab0

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Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional Phase

DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP and Patient's Global Assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day= LDA. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
Tocilizumab72.1

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Percentage of Participants Able to Discontinue GCs During the Interventional Phase by V9

(NCT01219933)
Timeframe: V9 (24 weeks after V3)

Interventionpercentage of participants (Number)
Tocilizumab3.3

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Percentage of Participants Able to Reduce Oral GCs by ≥50 Percent (%) During the Interventional Phase by V9

(NCT01219933)
Timeframe: V9 (24 weeks after V3)

Interventionpercentage of participants (Number)
Tocilizumab93.3

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Percentage of Participants Able to Start the GC Reduction Phase at V3

All participants who maintained LDA (defined as DAS28-CRP ≤3.2) from V2 to V3 were included in the interventional phase for reduction of GC. (NCT01219933)
Timeframe: V3 (7 months)

Interventionpercentage of participants (Number)
Tocilizumab87.8

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Percentage of Participants Acheiving Remission Assessed Using DAS28 While Receiving Oral GC on Background TocilizumabTreatment During the Noninterventional Phase

DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <2.6 = remission. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
Tocilizumab41.2

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Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks

The percentage of participants with rheumatoid arthritis (RA) with LDA was defined as DAS28 ≤3.2, able to discontinue oral GC within 20 weeks and at the latest at V8, confirmed at the Consolidation Visit without loss of clinical response defined as DAS28 (CRP) >3.2. (NCT01219933)
Timeframe: Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), and 8 (12 months)

Interventionpercentage of participants (Number)
Tocilizumab58.1

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Percentage of Participants With Changes in RA Treatment During the Noninterventional Phase

(NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
Tocilizumab15.2

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Time-Averaged GC Dose Changes During the Interventional Phase

"Area Under the Curve (AUC) of GC dose during the interventional phase was determined using the trapezoidal method and was calculated as:~AUC = sigma(Ti+1 - Ti) x [(Di+1+Di)/2]~With Di=dosage at time Ti~It corresponds to the total GC dose received between Baseline (visit 3) and visit 9 and has been calculated only for the 30 patients achieving visit 9." (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionmg (Mean)
Tocilizumab341.8

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CDAI Score During the Interventional Phase

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-100 mm VAS; higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity. V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
V3 (n=40)CV (n=27)Change from V3 to CV (n=25)
Tocilizumab5.66.51.4

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Clinical Disease Activity Index (CDAI) During the Noninterventional Phase

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and Physician Global Assessment (PGA) of disease assessed on 0-100 mm Visual analog scale (VAS); higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionunits on a scale (Mean)
V1 (n=62)V2 (n=52)Change from V1 to V2 (n=50)
Tocilizumab33.814.6-20.4

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DAS28-CRP During the Interventional Phase

DAS28-CRP was calculated from the SJC and TJC using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP) ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. DAS28-CRP values indicated in the CRF were recalculated by the data manager. The cumulative DAS28 (CRP) value (AUC method) was performed using the calculated DAS28. The recalculated values were used in the statistical analyses. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
V3 (n=42)CV (n=27)Change from V3 to CV (n=27)
Tocilizumab2.22.30.2

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DAS28-CRP During the Noninterventional Phase

DAS28-CRP was calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-CRP values indicated in the Case Report Form (CRF) were recalculated by the data manager. The recalculated values were used in the statistical analyses. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionunits on a scale (Mean)
V1 (n=67)V2 (n=66)Change from V1 to V2 (n=65)
Tocilizumab5.42.9-2.5

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DAS28-ESR During the Noninterventional Phase

DAS28-ESR was calculated from the SJC and TJC using the 28 joints count and ESR (millimeters per hour [mm/hr]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-ESR ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-ESR <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-ESR values indicated in the CRF were recalculated by the data manager. The recalculated values were used in the statistical analyses. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionunits on a scale (Mean)
V1 (n=62)V2 (n=52)Change from V1 to V2 (n=50)
Tocilizumab5.83.3-2.7

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Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score During the Interventional Phase

FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
V3 (n=37)CV (n=26)Change from V3 to CV (n=22)
Tocilizumab37.535.68.8

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HAQ-DI During the Interventional Phase

HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: Visit 3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
V3 (n=41)CV (n=28)Change from V3 to CV (n=26)
Tocilizumab1.00.80.0

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Health Assessment Questionnaire Disability Index (HAQ-DI) During the Noninterventional Phase

HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. Timepoint was V2, or before V2 for participants withdrawn before V2. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionunits on a scale (Mean)
V1 (n=66)V2 (n=61)Change from V1 to V2 (n=60)
Tocilizumab1.71.2-0.5

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Median GC Dose Taken During the Noninterventional Phase

During the noninterventional phase of the study participants received GC as prescribed by the physician. Doses of all GC administered are expressed as MP equivalents. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionmg (Median)
Start dose V1 (n=68)Start dose (V1) for Interventional phase (n=50)Stop dose (V2; n=50)Change from start to stop (n=50)Cumulative dose from V1 to V2 (n=45)
Tocilizumab6640320

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Number of Erosions During the NonInterventional Phase

In RA, the presence, number, and size of bone erosions and the number of joints with erosions on CRs are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionerosions (Mean)
V1 (n=11)Between V1 and V2 (n=6)
Tocilizumab5.13.2

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Percentage of Participants Positive for Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody During the Noninterventional Phase

Anti-CCP antibodies are important markers of bone erosion in RA. Anti-CCP antibodies were classified as positive if >7 U/mL. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
V1 (n=20)Between V1 and V2 (n=6)
Tocilizumab75.083.3

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Percentage of Participants Positive for Rheumatoid Factor (RF) During the Noninterventional Phase

RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
V1 (n=39)Between V1 and V2 (n=21)
Tocilizumab56.452.4

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Percentage of Participants With Erosions During the NonInterventional Phase

In RA, the presence, number and size of bone erosions and the number of joints with erosions on conventional radiographs (CRs) are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
V1 (n=57)Between V1 and V2 (n=36)
Tocilizumab47.441.7

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Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using CDAI

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-100 mm VAS; higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission and >2.8 to 10=LDA. (NCT01219933)
Timeframe: Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), and 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionpercentage of participants (Number)
V3 LDA (n=40)V3 Remission (n=40)V4 LDA (n=41)V4 Remission (n=41)V5 LDA (n=38)V5 Remission (n=38)V6 LDA (n=35)V6 Remission (n=35)V7 LDA (n=33)V7 Remission (n=33)V8 LDA (n=31)V8 Remission (n=31)V9 LDA (n=29)V9 Remission (n=29)CV LDA (n=27)CV Remission (n=27)
Tocilizumab85.027.582.939.081.647.471.437.175.833.380.638.769.031.077.833.3

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Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using DAS28-CRP

DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joint count, the CRP and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-CRP ≤3.2 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day=LDA; DAS28 <2.6 = remission. (NCT01219933)
Timeframe: Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionpercentage of participants (Number)
V3 LDA (n=42)V3 Remission (n=42)V4 LDA (n=41)V4 Remission (n=41)V5 LDA (n=35)V5 Remission (n=35)V6 LDA (n=35)V6 Remission (n=35)V7 LDA (n=33)V7 Remission (n=33)V8 LDA (n=32)V8 Remission (n=32)V9 LDA (n=30)V9 Remission (n=30)CV LDA (n=27)CV Remission (n=27)
Tocilizumab90.573.885.473.288.671.482.962.990.957.687.562.573.356.788.959.3

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SF-36 Subscale Scores During the Interventional Phase

"SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined." (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
Physical functioning V3 (n=36)Physical functioning CV (n=26)Change in physical functioning V3 to CV (n=22)Physical sub-score V3 (n=37)Physical sub-score CV (n=26)Change in physical sub-score V3 to CV (n=22)Bodily pain V3 (n=37)Bodily pain CV (n=26)Change in bodily pain V3 to CV (n=22)General health V3 (n=37)General health CV (n=26)Change in general health V3 to CV (n=22)Vitality V3 (n=37)Vitality CV (n=26)Change in vitality V3 to CV (n=22)Social functioning V3 (n=37)Social functioning CV (n=26)Change in social functioning V3 to CV (n=22)Emotional sub-score V3 (n=37)Emotional sub-score CV (n=26)Change in emotional sub-score V3 to CV (n=22)Mental health V3 (n=37)Mental health CV (n=26)Change in Mental health V3 to CV (n=22)
Tocilizumab41.5241.92-1.8040.6139.85-2.7945.8844.65-3.2143.1140.82-3.7850.5148.91-4.3745.4245.58-2.7340.5940.37-2.4547.1445.94-5.47

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Maximum Observed Plasma Concentration (Cmax)

(NCT01267201)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

Interventionng/mL (Geometric Mean)
Methylprednisolone 32 mg Tablet289.00
Methylprednisolone 32 mg Micronized API279.10
Methylprednisolone 32 mg Sieve Cut API246.20

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). (NCT01267201)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose

Interventionng*hr/mL (Geometric Mean)
Methylprednisolone 32 mg Tablet1286.00
Methylprednisolone 32 mg Micronized API1204.00
Methylprednisolone 32 mg Sieve Cut API1180.00

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Time to Reach Maximum Observed Plasma Concentration (Tmax)

(NCT01267201)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

Interventionhr (Median)
Methylprednisolone 32 mg Tablet2.00
Methylprednisolone 32 mg Micronized API1.00
Methylprednisolone 32 mg Sieve Cut API2.00

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Plasma Decay Half-life (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT01267201)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

Interventionhr (Mean)
Methylprednisolone 32 mg Tablet2.43
Methylprednisolone 32 mg Micronized API2.42
Methylprednisolone 32 mg Sieve Cut API2.45

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Urgent Care Visits, ED Visits and Hospitalizations

Number of participants who had urgent care visits, ED visits, and/or hospitalizations for respiratory symptoms. (NCT01272635)
Timeframe: 14 days after initiation of therapy

Interventionparticipants (Number)
Azythromycin20
Placebo38

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Progression to Clinically Significant Lower Respiratory Tract Symptoms

Progression to clinically significant lower respiratory tract symptoms defined by: (1) having symptoms that were more than mild after 3 albuterol administrations over 1 hour, or (2) requiring albuterol administrations more often than once every 4 hours, or (3) requiring more than 6 albuterol treatments over a 24-hour period, or (4) having moderate to severe cough or wheeze for 5 or more days since study medication was initiated. (NCT01272635)
Timeframe: 14 days after initiation of APRIL therapy

Interventionparticipants (Number)
Azythromycin35
Placebo57

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OCELOT: Pediatric Respiratory Assessment Measure

The Pediatric Respiratory Assessment Measure (PRAM) is a composite outcome with scores ranging from 0-12 with higher numbers representing worse symptoms. The score is calculated as the sum total of the follow five elements: (1) scalene retractions, (2) suprasternal retractions, (3) wheezing, (4) air entry, (5) oxygen saturation. A complete description can be found in: Ducharme FM, Chalut D, Plotnick L, et al. The Pediatric Respiratory Assessment Measure: a valid clinical score for assessing acute asthma severity from toddlers to teenagers. J Pediatr 2008;152:476-80. (NCT01272635)
Timeframe: 36-72 hours after initiation of OCELOT therapy

InterventionPRAM score (Mean)
Prednisone0.82
Placebo1.00

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60-day Mortality

The primary outcome is all-cause mortality at 60 days, defined by whether the patient has died by the end of study day 60. (NCT01283009)
Timeframe: 60-day

InterventionParticipants (Count of Participants)
Died on or prior to study day 6072325123Died on or prior to study day 6072325124On Mechanical Ventilation at Study Entry72325123On Mechanical Ventilation at Study Entry72325124Not on Mechanical Ventilation72325123Not on Mechanical Ventilation72325124
YesNoUnknown
Arm 1: Inactive Substance50
Arm 2: Methylprednisolone47
Arm 1: Inactive Substance227
Arm 2: Methylprednisolone239
Arm 1: Inactive Substance10
Arm 2: Methylprednisolone11
Arm 1: Inactive Substance24
Arm 2: Methylprednisolone22
Arm 1: Inactive Substance70
Arm 2: Methylprednisolone72
Arm 1: Inactive Substance2
Arm 2: Methylprednisolone3
Arm 1: Inactive Substance26
Arm 2: Methylprednisolone25
Arm 1: Inactive Substance157
Arm 2: Methylprednisolone167
Arm 1: Inactive Substance8
Arm 2: Methylprednisolone8

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Complete Response Duration

The complete remission (CR) is the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine. CR was defined as the presence of 1x10^9/L neutrophils, >100x10^9/L platelets in the perpherial blood, and no extramedullary disease. Response date to loss of response or last follow up. Remission duration will be measured by the estimated median remission duration computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative remission duration drops below 50%, if present. If not present then median remission duration is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis.. (NCT01319981)
Timeframe: Up to 7 years, 8 months

InterventionMonths (Median)
Hyper-CMAD + RituximabNA
Hyper-CMADNA

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Overall Survival

Time from date of treatment start until date of death due to any cause or last Follow-up. Survival will be measured by the estimated median survival computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative survival drops below 50%, if present. If not present then the median Overall Survival is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis. (NCT01319981)
Timeframe: Up to 7 years, 8 months

InterventionMonths (Median)
Hyper-CMAD + RituximabNA
Hyper-CMADNA

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Number of Patients With Complete Remission at One Year

The complete remission (CR) is the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine. CR was defined as the presence of 1x10^9/L neutrophils, >100x10^9/L platelets in the perpherial blood, and no extramedullary disease. (NCT01319981)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Hyper-CMAD + Rituximab12
Hyper-CMAD13

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Change From Baseline in DAS28-CRP at 12 Weeks

"The primary efficacy endpoint was the mean change in Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12.~The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤3.2 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores." (NCT01369745)
Timeframe: baseline to week 12

Interventionunits on a scale (Mean)
Prednisolone-1.147
Dipyridamole-0.813
Prednisone-1.237
Z102-0.907
Placebo-0.538

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Overall Survival (OS)

OS was calculated as the time from randomization to death from any cause. (NCT01381874)
Timeframe: Approximately 3 years

InterventionMonths (Median)
ExemestaneNA
Abiraterone Acetate + Prednisone26.41
Abiraterone Acetate + Exemestane + PrednisoneNA

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Overall Response Rate (ORR)

Overall response rate was defined as the percentage of participants with measurable disease achieving a best overall response of either complete response (CR) or partial response (PR) based on RECIST. CR: disappearance of all target lesions and non-target lesions. PR: at least a 30 percent (%) decrease in the sum of longest diameter (LD) of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. (NCT01381874)
Timeframe: Approximately 2 years

InterventionPercentage of participants (Number)
Exemestane6.3
Abiraterone Acetate + Prednisone5.8
Abiraterone Acetate + Exemestane + Prednisone12.1

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Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment

Change from baseline in serum endocrine biomarkers (estradiol and estrone) was summarized by treatment at end of treatment. (NCT01381874)
Timeframe: Baseline and End of treatment (approximately 2 years)

,,
InterventionPicomoles Per Liter (Pmol/L) (Mean)
EstradiolEstrone
Abiraterone Acetate + Exemestane + Prednisone-1.04-30.60
Abiraterone Acetate + Prednisone-3.35-28.09
Exemestane1.53-34.20

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Duration of Response

Duration of objective response was measured from the first time that the CR or PR was achieved to the first observation of disease progression (either radiographic or clinical) based on the RECIST criteria. (NCT01381874)
Timeframe: Approximately 2 years

Interventionmonths (Median)
Exemestane6.47
Abiraterone Acetate + Prednisone4.86
Abiraterone Acetate + Exemestane + Prednisone6.93

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Clinical Benefit Rate

Clinical benefit rate was defined as the percentage of participants with measurable disease achieving a best overall response of a CR, PR, or stable disease (SD) for at least 6 months based on RECIST. Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits. (NCT01381874)
Timeframe: Approximately 2 years

InterventionPercentage of participants (Number)
Exemestane12.7
Abiraterone Acetate + Prednisone9.6
Abiraterone Acetate + Exemestane + Prednisone22.7

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Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment

Change from baseline in serum endocrine biomarkers (Progesterone and Testosterone) was summarized by treatment at end of treatment. (NCT01381874)
Timeframe: Baseline and End of treatment (approximately 2 years)

,,
InterventionNanomoles Per Liter (nmol/L) (Mean)
ProgesteroneTestosterone
Abiraterone Acetate + Exemestane + Prednisone12.34-0.48
Abiraterone Acetate + Prednisone8.98-0.51
Exemestane-4.80-0.09

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Progression-Free Survival (PFS)

Progression-free survival was defined as the time from randomization to first occurrence of disease progression (either radiographic or clinical), or death from any cause. PFS was determined using radiographic progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) on measurable lesions captured by computed tomography (CT) or magnetic resonance imaging (MRI). Clinical disease progression was considered only when disease progression could not be confirmed by CT or MRI, such as when the disease site is skin, bone marrow, or central nervous system. (NCT01381874)
Timeframe: Approximately 2 years

InterventionMonths (Median)
Exemestane3.68
Abiraterone Acetate + Prednisone3.65
Abiraterone Acetate + Exemestane + Prednisone4.47

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Percentage of Participants Experiencing Any Serious IRR (SIRR) Associated With the Second Rituximab Infusion

A serious infusion-related reaction (SIRR) is an IRR that meets the definition of a serious adverse event. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. (NCT01382940)
Timeframe: Within 24 hours of beginning infusion on Day 15

Interventionpercentage of participants (Number)
Rituximab0.0

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Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Third Rituximab Infusion

"The intensity of AEs experienced within 24 hours of beginning infusion were graded on NCI's CTCAE (v. 4.0) intensity scale from Grade 1 (Mild) to Grade 5 (Death). Grade 3 AEs are Severe and Grade 4 AEs are Life-threatening, Disabling." (NCT01382940)
Timeframe: Within 24 hours of beginning infusion on Day 168

Interventionpercentage of participants (Number)
Rituximab0.0

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Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Second Rituximab Infusion

"The intensity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0), where Grade 1 indicates Mild severity and Grade 5 indicates Death. The CTCAE defines Grades 3 and 4 as follows: - Grade 3 means Severe, indicating considerable interference with the patient's daily activities; medical intervention/therapy required; and hospitalization possible. - Grade 4 means Life-threatening, Disabling, based on extreme limitation in activity; significant medical intervention/therapy required, and hospitalization probable." (NCT01382940)
Timeframe: Within 24 hours of beginning infusion on Day 15

Interventionpercentage of participants (Number)
Rituximab0.6

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Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Third Rituximab Infusion

"Participants who experienced a moderate or serious IRR had their infusion interrupted immediately and received aggressive symptomatic treatment. The CTCAE includes the following severity descriptions: - Moderate means mild to moderate interference with the patient's daily activities, no or minimal medical intervention/therapy required; - Severe means considerable interference with the patient's daily activities, medical intervention/therapy required, hospitalization possible. If the IRR was moderate, the infusion was not to be restarted before all the symptoms disappeared, and then at half the rate. If the participant tolerated the reduced rate for 30 minutes, the infusion rate was increased to the next rate on the protocol-specified infusion schedule. If the symptoms did not resolve with treatment, the participant was withdrawn from the treatment period of the study. Participants who experienced a severe IRR to rituximab treatment were discontinued from the study." (NCT01382940)
Timeframe: During the infusion (a 2-hour period) on Day 168

Interventionpercentage of participants (Number)
Rituximab6.6

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Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Second Rituximab Infusion

"Participants who experienced a moderate or serious IRR had their infusion interrupted immediately and received aggressive symptomatic treatment. The CTCAE includes the following severity descriptions: - Moderate means mild to moderate interference with the patient's daily activities, no or minimal medical intervention/therapy required; - Severe means considerable interference with the patient's daily activities, medical intervention/therapy required, hospitalization possible. If the IRR was moderate, the infusion was not to be restarted before all the symptoms disappeared, and then at half the rate. If the participant tolerated the reduced rate for 30 minutes, the infusion rate was increased to the next rate on the protocol-specified infusion schedule. If the symptoms did not resolve with treatment, the participant was withdrawn from the treatment period of the study. Participants who experienced a severe IRR to rituximab treatment were discontinued from the study." (NCT01382940)
Timeframe: During the infusion (a 2-hour period) on Day 15

Interventionpercentage of participants (Number)
Rituximab3.9

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Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion

IRRs are AEs that occurred within 24 hours of beginning infusion that were included on a pre-specified list of MedDRA preferred terms, and an SIRR is an IRR that suggests a significant hazard, contraindication, side effect or precaution. (NCT01382940)
Timeframe: Within 24 hours of beginning infusion on Day 168

Interventionpercentage of participants (Number)
Any IRRAny SIRR
Rituximab5.90.0

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Part A: Area Under the Concentration-time Curve From Day 0 to Day 84 (AUC0-84day) After a Single Course of Treatment

AUC is a measure of the amount of drug in the plasma over time; samples are collected at intervals from pre-dose up to 84 days after the dose. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E6. (NCT01390441)
Timeframe: Day 1 (pre- and post-dose), Day 3, Day 5, Day 8, Day 15, Day 17, Day 19, Day 22, Day 29, Day 43, Day 57, Day 85

Interventionhr*mg/mL (Geometric Mean)
Part A: MK-8808 500 mg/m^2110.56
Part A: MabThera® 500 mg/m^2110.12

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Number of Participants Who Discontinued Study Drug Due to Adverse Events

Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. (NCT01390441)
Timeframe: Parts A and B: Up to Week 28; Extension A and B: Up to 82 weeks

InterventionParticipants (Number)
Part A: MK-8808 500 mg/m^22
Part A: MabThera® 500 mg/m^22
Part B: MK-8808 1000 mg1
Part B: MabThera® 1000 mg1
Part B: Rituxan® 1000 mg2
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg0
Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg0
Extension B: MK-8808 1000 mg /MK-8808 1000 mg0
Extension B: MabThera® 1000 mg /MK-8808 1000 mg0
Extension B: Rituxan® 1000 mg/MK-8808 1000 mg0

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Number of Participants Who Experienced at Least One Adverse Event

An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. (NCT01390441)
Timeframe: Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks

InterventionParticipants (Number)
Part A: MK-8808 500 mg/m^218
Part A: MabThera 500 mg/m^221
Part B: MK-8808 1000 mg12
Part B: MabThera 1000 mg16
Part B: Rituxan 1000 mg13
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg2
Extension A: MabThera 500 mg/m^2 /MK-8808 1000 mg2
Extension B: MK-8808 1000 mg /MK-8808 1000 mg0
Extension B: MabThera 1000 mg /MK-8808 1000 mg0
Extension B: Rituxan1000 mg/MK-8808 1000 mg0

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Part A: Maximum Concentration (Cmax) After the Second Infusion of a Single Course of Treatment

Cmax is a measure of the maximum plasma concentration of drug; samples are collected on Day 15 after the second infusion of the first course of treatment. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E3. (NCT01390441)
Timeframe: Day 15

Interventionng/mL (Geometric Mean)
Part A: MK-8808 500 mg/m^2326.49
Part A: MabThera® 500 mg/m^2332.39

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Change From Baseline in Disease Activity in 28 Joints C-Reactive Protein Score (DAS28-CRP) by Time-point

The DAS28-CRP is a combination scoring method for function using the European League against Rheumatism (EULAR) 28 joint count and the CRP value. The DAS28-CRP scores range from 2.0 to 10.0 with higher values indicating a higher disease activity. A DAS28-CRP below the score of 2.6 is interpreted as Remission. CRP values below lower limit of quantification (LLQ) (<0.4 mg/dL) were set to 0.2 mg/dL in the calculation of DAS28-CRP. (NCT01390441)
Timeframe: Baseline, Week 6, Week 12

,
InterventionScore (Mean)
Week 6 (n=22, n=20)Week 12 (n=21, n=21)
Part A: MabThera® 500 mg/m^2-1.16-2.04
Part A: MK-8808 500 mg/m^2-1.39-1.68

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Part A: Number of ACR20, ACR50, and ACR70 Responders at Week 24

"American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-no pain; right hand marker-extreme pain HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do" (NCT01390441)
Timeframe: Week 24

,
InterventionParticipants (Number)
ACR20ACR50ACR70
Part A: MabThera® 500 mg/m^220154
Part A: MK-8808 500 mg/m^223164

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Part B: Number of ACR20, ACR50, and ACR70 Responders at Week 24

"American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-no pain; right hand marker-extreme pain HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do" (NCT01390441)
Timeframe: Week 24

,,
InterventionParticipants (Number)
ACR20ACR50ACR70
Part B: MabThera® 1000 mg17121
Part B: MK-8808 1000 mg16122
Part B: Rituxan® 1000 mg15131

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Count of Participants With Estimated Glomerular Filtration Rate (GFR) < 60 mL/Min/1.73 m^2 by CKD EPI

GFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI). A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure. This measure specifically looked at participants with scores less than 60. (NCT01436305)
Timeframe: Week 52, Week 104, and Week 156

,,
InterventionParticipants (Count of Participants)
Week 52Week 104Week 156
Induction: Alemtuzumab, Maintenance: MMF + Belatacept211
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus322
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac432

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Count of Participants With Infections Requiring Hospitalization or Systemic Therapy Reported as Serious Adverse Events

Infections of certain types (i.e., excluding those identified in the protocol as occurring commonly in this study population) were required to be reported as a serious adverse event if they required either inpatient hospitalization of prolongation of a current hospitalization. (NCT01436305)
Timeframe: Transplantation through last study visit (up to week 156)

InterventionParticipants (Count of Participants)
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus2
Induction: Alemtuzumab, Maintenance: MMF + Belatacept2
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac1

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Number of All Adverse Events (AEs) and Serious Adverse Events (SAEs)

Adverse events were collected systematically from enrollment through last study visit. Displayed below are counts of all adverse events per treatment group (including both serious and non-serious adverse events). Separately counts of all adverse events determined to be serious are displayed per treatment group. More detail about adverse events for this trial is displayed in the 'Adverse Event' section. (NCT01436305)
Timeframe: Enrollment through last study visit (up to week 156)

,,
InterventionEvents (Number)
All Adverse EventsSerious Adverse Events
Induction: Alemtuzumab, Maintenance: MMF + Belatacept2511
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus216
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac407

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Total Daily Prescribed Pill Number at Days 28 and 84, and Wks 24, 36, 52, 72, 104 and 156

This is a measure of the total number of pills a participant was prescribed on a given day (NCT01436305)
Timeframe: Day 28, Day 84, Week 24, Week 36, Week 52, Week 72, Week 104, Week 156

InterventionNumber of pills (Mean)
Day 28Day 84Week 24Week 36Week 52Week 72Week 104Week 156
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac27.321.316.617.017.816.014.812.7

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Type of Treatment of Rejection

"Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of biopsy findings and corresponding treatment are presented here for each instance of treatment for rejection. Acronyms and abbreviations are defined below.~ACR=Acute Cellular Rejection ATG=Anti-thymocyte globulin therapy Chr. AMR=Chronic Antibody Mediated Rejection Gd.=Grade IFTA=Interstitial Fibrosis and Tubular Atrophy IVIG=Intravenous Immunoglobulin therapy.~Only 'for cause' biopsies were performed post-transplant; thus, it is possible for a participant to be included in the analysis population and not have a biopsy for this outcome measure." (NCT01436305)
Timeframe: Transplantation through last study visit (up to week 156)

,,
InterventionBiopsy (Number)
Borderline rejection; IVIG and plasmapheresisACR Gd. IA + Chr. AMR + IFTA Gd. I; Pulse SteroidsACR Gd. IA + IFTA Gd. II; Pulse SteroidsACR Gd. IIB; ATG and Pulse SteroidsBorderline + IFTA Gd. I; with Pulse SteroidsACR Gd. IA + IFTA Gd. I; Pulse SteroidsACR Gd. IIA; Pulse SteroidsACR Gd. IIA + IFTA Gd. I; ATG and Pulse SteroidsACR Gd. IIB + IFTA Gd. I; ATG and Pulse Steroids
Induction: Alemtuzumab, Maintenance: MMF + Belatacept011100000
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus100000000
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac000011121

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Count of Participants With Rejection

The number of participants who were treated by their local physician for any type of rejection including, but not limited to cellular rejection and antibody- mediated rejection of the transplanted kidney regardless of the presence of a biopsy. (NCT01436305)
Timeframe: Transplantation through last study visit (up to week 156)

InterventionParticipants (Count of Participants)
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus1
Induction: Alemtuzumab, Maintenance: MMF + Belatacept3
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac5

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Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156

"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are detailed below.~Total cholesterol: 75-169 mg/dL if age ≤ 20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease" (NCT01436305)
Timeframe: Baseline, Week 24, Week 52, Week 104, Week 156

,,
Interventionmg/dL (Mean)
Tot. Chol. BaselineTot. Chol. W24Tot. Chol. W52Tot. Chol. W104Tot. Chol. W156Non-HDL BaselineNon-HDL W24Non-HDL W52Non-HDL W104Non-HDL W156LDL BaselineLDL W24LDL W52LDL W104LDL W156HDL BaselineHDL W24HDL W52HDL W104HDL W156Triglyc. BaselineTriglyc. W24Triglyc. W52Triglyc. W104Triglyc. W156
Induction: Alemtuzumab, Maintenance: MMF + Belatacept160.2159.0187.0142.5133.5118.8129.3151.0110.5102.586.686.6114.058.055.541.329.736.032.031.0307.8249.7187.0220.0228.0
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus141.2171.6156.0170.5183.5108.2128.0117.5129.5138.576.776.769.5100.5116.033.043.638.541.045.0158.7161.0319.3146.0115.0
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac165.6185.6157.5189.0181.7122.3129.061.0135.6136.083.483.449.0101.4106.043.356.659.053.445.7206.9115.958.0172.8156.5

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Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90mm Hg Within 24 Hours of Onset of Transplant Procedure

Temperature of >39 degrees Celsius would be an indication of fever most often in response to an infection or illness. Systolic blood pressure <90mm Hg would be an indication of low blood pressure. (NCT01436305)
Timeframe: 24 hours after transplantation

,,
InterventionParticipants (Count of Participants)
Fever >39 degreesSystolic BP <90
Induction: Alemtuzumab, Maintenance: MMF + Belatacept01
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus00
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac00

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HbA1c Measured at Days 28 & 84, and Weeks 24, 36, 52, 72, 104 and 156

Hemoglobin A1c (HbA1c) measures the average blood glucose levels over 8-12 weeks, thus acting as a useful long-term gauge of blood glucose control. A value below 6.0% reflects normal levels, 6.0% to 6.4% reflects prediabetes, and a value of ≥ 6.5% reflects diabetes. (NCT01436305)
Timeframe: Day 28, Day 84, Week 24, Week 36, Week 52, Week 72, Week 104, Week 156

Interventionpercent (Mean)
Day 28Day 84Week 24Week 36Week 52Week 72Week 104Week 156
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac5.85.96.57.27.68.16.67.8

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Count of Participants With Use of Lipid Lowering Medications at Baseline and Wks 24, 52, 104 and 156

Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood (NCT01436305)
Timeframe: Baseline, Week 24, Week 52, Week 104, Week 156

,,
InterventionParticipants (Count of Participants)
BaselineWeek 24Week 52Week 104Week 156
Induction: Alemtuzumab, Maintenance: MMF + Belatacept11111
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus54333
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac22233

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Count of Participants by Severity of First Acute Cellular Rejection by Wk 52

"Acute cellular rejection is when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade ≥ IA by Banff 2007 criteria. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection. Originally, this endpoint was worded as The severity of first and highest acute cellular rejection within the first 52 weeks. But since the highest grade for each subject coincided with the first ACR episode for each subject, only a summary of severity of the first episode is presented here." (NCT01436305)
Timeframe: Transplantation through Week 52

,,
InterventionParticipants (Count of Participants)
Grade IAGrade IBGrade IIAGrade IIBGrade III
Induction: Alemtuzumab, Maintenance: MMF + Belatacept10010
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus00000
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac10210

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Mean Calculated eGFR Using MDRD 4 Variable Model

The estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease equation (MDRD). A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure. (NCT01436305)
Timeframe: Week 52, Week 104, and Week 156

,,
InterventionmL/min/1.73m^2 (Mean)
Week 52Week 104Week 156
Induction: Alemtuzumab, Maintenance: MMF + Belatacept47.869.365.5
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus52.454.249.0
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac55.760.461.5

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Standardized Blood Pressure Measurement at Wk 52

A blood pressure measurement consists of two numbers: the systolic and diastolic pressures. Systolic pressure measures the pressure in blood vessels when the heart beats. Diastolic pressure measures the pressure in blood vessels between beats of the heart. Systolic measures of <120 and diastolic measures of <80 are considered normal. Systolic measures of 120-139 and diastolic measures of 80-89 are considered at risk (or pre-hypertension). Systolic measures of ≥140 and diastolic measures of ≥90 are considered high. (NCT01436305)
Timeframe: Week 52

,,
InterventionmmHg (Mean)
Systolic Blood Pressure at Week 52Diastolic Blood Pressure at Week 52
Induction: Alemtuzumab, Maintenance: MMF + Belatacept146.792.7
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus147.580.8
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac139.979.3

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Count of Participants With Treated Diabetes Between Day 14 and Wk 52

Treated diabetes is defined as the receipt of oral medication or insulin for >14 days between 14 days and 52 weeks post-transplant (NCT01436305)
Timeframe: Day 14 to Week 52

InterventionParticipants (Count of Participants)
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus1
Induction: Alemtuzumab, Maintenance: MMF + Belatacept0
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac1

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Count of Participants With Use of Anti-hypertensive Medications at Wk 52

Anti-hypertensive medications are a class of drugs that are used to treat hypertension. The medications seek to prevent the complications of high blood pressure, such as stoke and myocardial infarction. (NCT01436305)
Timeframe: Week 52

InterventionParticipants (Count of Participants)
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus3
Induction: Alemtuzumab, Maintenance: MMF + Belatacept3
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac7

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Mean Glomerular Filtration Rate (GFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52

GFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI). A score of ≥ 90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure. (NCT01436305)
Timeframe: Week 52

InterventionmL/min/1.73m^2 (Mean)
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus55.9
Induction: Alemtuzumab, Maintenance: MMF + Belatacept51.6
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac58.3

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The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine

The estimated Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI). A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure. An estimate of the slope, or change over time, in eGFR was produced using standard statistical linear modeling procedures. The estimate was then re-scaled so that it can be interpreted as a change in eGFR per month. Positive numbers indicate increasing kidney function. Larger numbers indicate greater change in kidney function. (NCT01436305)
Timeframe: Week 52, Week 104, and Week 156

,,
InterventionChange in eGFR (mL/min/1.73m^2) by month (Mean)
Week 52Week 104Week 156
Induction: Alemtuzumab, Maintenance: MMF + Belatacept0.620.620.69
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus1.291.271.33
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac1.070.680.48

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Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Wk 52 Based on Criteria Specified by the ADA and WHO

"New onset diabetes is the development of diabetes post-kidney transplant. It was identified by the clinical sites caring for each participant and reported directly in the clinical database. Impaired fasting glucose (IFG) is a determination made by referencing glucose measurements obtained from a standard chemistry panel. Any fasting glucose measure that is between 110 and 125 mg/dL is classified as IFG.~Acronyms: American Diabetes Association (ADA); World Health Organization (WHO)." (NCT01436305)
Timeframe: Week 52

,,
InterventionParticipants (Count of Participants)
New onset diabetes during first 52 weeksImpaired fasting glucose at week 52
Induction: Alemtuzumab, Maintenance: MMF + Belatacept00
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus01
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac00

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Count of Participants With CKD Stage 4 or 5

"The stages of Chronic Kidney Disease are defined using the participant's GFR value as indicated below.~Stage 1 if GFR value is ≥90; Stage 2 if 60 ≤ GFR < 90; Stage 3A if 45 ≤ GFR < 60; Stage 3B if 30 ≤ GFR < 45; Stage 4 if 15 ≤ GFR < 30; Stage 5 if GFR < 15.~Stage 1 means kidney function is normal. Stage 2 indicates mildly reduced kidney function, pointing to kidney disease. Stages 3A abd 3B indicate moderately reduced kidney function. Stage 4 indicates severely reduced kidney function. Stage 5 indicates very severe or end stage kidney failure." (NCT01436305)
Timeframe: Week 52, Week 104, and Week 156

,,
InterventionParticipants (Count of Participants)
Week 52Week 104Week 156
Induction: Alemtuzumab, Maintenance: MMF + Belatacept100
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus000
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac000

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Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant

"The stages of Chronic Kidney Disease are defined using the participant's GFR value as indicated below:~Stage 1 if GFR value is ≥90; Stage 2 if GFR value is ≥60 and < 90; Stage 3A if 45 ≤GFR < 60; Stage 3B if 30 ≤ GFR < 45; Stage 4 if 15 ≤GFR < 30;l Stage 5 if GFR < 15.~Stage 1 means kidney function is normal. Stage 2 indicates mildly reduced kidney function, pointing to kidney disease. Stages 3A and 3B indicate moderately reduced kidney function. Stage 4 indicates severely reduced kidney function. Stage 5 indicates very severe or end stage kidney failure." (NCT01436305)
Timeframe: Week 52, Week 104, and Week 156

,,
InterventionParticipants (Count of Participants)
Week 52 - Stage 1Week 52 - Stage 2Week 52 - Stage 3AWeek 52 - Stage 3BWeek 52 - Stage 4Week 104 - Stage 1Week 104 - Stage 2Week 104 - Stage 3AWeek 104 - Stage 3BWeek 104 - Stage 4Week 156 - Stage 1Week 156 - Stage 2Week 156 - Stage 3AWeek 156 - Stage 3BWeek 156 - Stage 4
Induction: Alemtuzumab, Maintenance: MMF + Belatacept011011010001100
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus013000111001110
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac033101321005110

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Count of Participants With BKV and CMV Viremia (Local Center Monitoring) Reported as Adverse Events

"Viral infections following renal transplantation is significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during this study using participant blood samples.~Acronyms: BK Polyoma Virus (BKV); Cytomegalovirus (CMV)." (NCT01436305)
Timeframe: Transplantation through last study visit (up to week 156)

,,
InterventionParticipants (Count of Participants)
BKVCMV
Induction: Alemtuzumab, Maintenance: MMF + Belatacept00
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus01
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac20

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Count of Participants With EBV Infection as Reported on the Case Report Form as Adverse Events

"Viral infections following renal transplantation is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during this study using participant blood samples.~Acronym: Epstein-Barr virus (EBV)" (NCT01436305)
Timeframe: Transplantation through last study visit (up to week 156)

InterventionParticipants (Count of Participants)
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus0
Induction: Alemtuzumab, Maintenance: MMF + Belatacept0
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac0

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Count of Participants With Delayed Graft Function Post-Transplant

Delayed graft function is defined as dialysis in the first week on one or more occasions for any indication other than the treatment of acute hyperkalemia in the setting of otherwise acceptable renal function (NCT01436305)
Timeframe: Any time within the first week post-transplant

InterventionParticipants (Count of Participants)
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus0
Induction: Alemtuzumab, Maintenance: MMF + Belatacept2
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac0

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Number of Events of Death or Graft Loss

This measure counts deaths and graft loss occurring at any point post transplantation. Graft loss is defined as need for dialysis for greater than 30 days duration, allograft nephrectomy, or retransplantation. (NCT01436305)
Timeframe: Transplantation through last study visit (up to week 156)

InterventionEvents (Number)
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus2
Induction: Alemtuzumab, Maintenance: MMF + Belatacept3
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac0

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HbA1c Measured at Days 28 & 84, and Weeks 24, 36, 52, 72, 104 and 156

Hemoglobin A1c (HbA1c) measures the average blood glucose levels over 8-12 weeks, thus acting as a useful long-term gauge of blood glucose control. A value below 6.0% reflects normal levels, 6.0% to 6.4% reflects prediabetes, and a value of ≥ 6.5% reflects diabetes. (NCT01436305)
Timeframe: Day 28, Day 84, Week 24, Week 36, Week 52, Week 72, Week 104, Week 156

,
Interventionpercent (Mean)
Day 28Day 84Week 24Week 36Week 52Week 104Week 156
Induction: Alemtuzumab, Maintenance: MMF + Belatacept5.15.05.15.34.85.25.2
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus5.35.76.96.77.05.75.6

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Count of Participants With CAN/IFTA Grade I, II or III at Any Time Post-transplant

CAN/IFTA grades were determined per local pathology interpretations of biopsy tissue. These grades reflect the severity of interstitial fibrosis and tubular atrophy present in the tissue obtained during a kidney biopsy. Higher grades indicate greater severity in interstitial fibrosis and tubular atrophy present the kidney biopsy tissue. (NCT01436305)
Timeframe: Transplantation through last study visit (up to week 156)

InterventionParticipants (Count of Participants)
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus1
Induction: Alemtuzumab, Maintenance: MMF + Belatacept3
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac5

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Count of Participants With Biopsy Proven Acute Rejection at Any Time Post-Transplant

Biopsy proven acute rejection was defined as histologic evidence of borderline or higher cellular rejection per local pathologist. (NCT01436305)
Timeframe: Transplantation through last study visit (up to week 156)

InterventionParticipants (Count of Participants)
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus3
Induction: Alemtuzumab, Maintenance: MMF + Belatacept2
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac5

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Count of Participants With Antibody Mediated Rejection

Antibody mediated rejection (AMR) is defined as diffusely positive staining for C4d, presence of circulating anti-donor antibodies and morphologic evidence of acute tissue injury. (NCT01436305)
Timeframe: Transplantation through last study visit (up to week 156)

InterventionParticipants (Count of Participants)
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus0
Induction: Alemtuzumab, Maintenance: MMF + Belatacept1
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac0

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Count of Participants With Acute Cellular Rejection Grade Equal to or Greater Than IA, by the Banff 2007 Criteria

Acute cellular rejection is when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade ≥ IA by Banff 2007 criteria. (NCT01436305)
Timeframe: Transplantation through last study visit (up to week 156)

InterventionParticipants (Count of Participants)
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus0
Induction: Alemtuzumab, Maintenance: MMF + Belatacept2
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac4

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Total Daily Prescribed Pill Number at Days 28 and 84, and Wks 24, 36, 52, 72, 104 and 156

This is a measure of the total number of pills a participant was prescribed on a given day (NCT01436305)
Timeframe: Day 28, Day 84, Week 24, Week 36, Week 52, Week 72, Week 104, Week 156

,
InterventionNumber of pills (Mean)
Day 28Day 84Week 24Week 36Week 52Week 104Week 156
Induction: Alemtuzumab, Maintenance: MMF + Belatacept15.813.58.314.014.315.515.0
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus28.822.214.813.014.615.314.0

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Count of Participants With de Novo Anti-donor HLA Antibodies at Wk 52

The presence of antibodies reactive to Histocompatibility Antigen (HLA) molecules expressed on the renal allograft have been associated with both acute and chronic injury to the transplanted kidney. The development of de novo anti- donor HLA antibodies may mean a person is more likely to reject the graft. (NCT01436305)
Timeframe: Week 52

InterventionParticipants (Count of Participants)
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus0
Induction: Alemtuzumab, Maintenance: MMF + Belatacept0
Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac0

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Number of Participants With Treatment Failure

"Treatment failure will not occur until a minimum of 12 months after treatment at which time failure is defined as:~Increase of skin score (if > 14 on enrollment) by > 25% above enrollment value and must be documented on 2 occasions at least 6 months apart~Deterioration in percent predicted FVC by 10% below enrollment level, due to systemic sclerosis, and documented on 2 occasion at least 6 months apart" (NCT01445821)
Timeframe: up to and post 12 months of treatment

InterventionParticipants (Count of Participants)
Cyclophosphamide rATG/HSCT2
Cyclophosphamide rATG/Fludarabine/HSCT2

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Survival of Treatment

Survival of Hematopoietic Stem Cell Transplant. (NCT01445821)
Timeframe: up to 12 months post treatment

InterventionParticipants (Count of Participants)
Cyclophosphamide rATG/HSCT22
Cyclophosphamide rATG/Fludarabine/HSCT21

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Number of Eyes With Intraocular Pressure (IOP) Elevation

Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading. (NCT01448213)
Timeframe: one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK

Interventioneyes (Number)
Fluorometholone 0.1% Solution9
Prednisolone Acetate 1% Solution32

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Number of Eyes With Immunologic Graft Rejection Episodes

(NCT01448213)
Timeframe: Within 1 year

Interventioneyes (Number)
Fluorometholone 0.1% Solution2
Prednisolone Acetate 1% Solution0

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3-Year Progression-Free Survival (PFS) Probability

3-year PFS is the probability of participants remaining alive and progression-free at 3 years from study entry estimated using Kaplan-Meier methods. Disease progression (PD) per International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008) is: the appearance of any new lesion (enlarged lymph node minimum >1.5 centimeters); an increase by 50% in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by 50% or more or the de novo appearance of hepatomegaly, splenomegaly; a 50% increase of blood lymphocytes (over baseline with level at least 5,000/microliter); occurrence of cytopenia secondary to CLL at least 3 months post treatment including a 50% or greater decrease from baseline in platelet count (or level <100,000/microliter) or a hemoglobin decrease of >2 grams/deciliter (or level <10 grams/deciliter); and transformation to a more aggressive histology. (NCT01465334)
Timeframe: Disease was evaluated on treatment after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C as well as off-treatment every 3 months up to 5 years.

Interventionpercentage probability (Number)
Treatment Naive53
Relapsed/Refractory25

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Induction Overall Response Rate (ORR)

Induction ORR is the percentage of participants achieving a minimum of partial response (PR) over induction treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level >100,000/micro liter), hemoglobin (or level >11 grams/deciliter), neutrophils (or level >1500/microliter). (NCT01465334)
Timeframe: Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B.

Interventionpercentage of participants (Number)
Treatment Naive73
Relapsed/Refractory60

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3-year Overall Survival (OS) Probability

3-year OS is the probability of participants remaining alive at 3 years from study entry estimated using Kaplan-Meier methods. (NCT01465334)
Timeframe: Median survival follow-up was 45 months (range 31-58 months) in this study cohort.

Interventionpercentage probability (Number)
Treatment Naive66
Relapsed/Refractory53

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Overall MRD Negative Rate

Overall MRD negative rate is the percentage of participants classified as MRD negative by four color flow cytometry. The assay has a sensitivity of 1 in 10,000 leukocytes. (NCT01465334)
Timeframe: MRD was assessed after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.

Interventionpercentage of participants (Number)
Treatment Naive80
Relapsed/Refractory53

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Overall Objective Response Rate (ORR)

Overall ORR is the percentage of participants achieving a minimum of partial response (PR) over induction and maintenance treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level >100,000/micro liter), hemoglobin (or level >11 grams/deciliter), neutrophils (or level >1500/microliter). (NCT01465334)
Timeframe: Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.

Interventionpercentage of participants (Number)
Treatment Naive80
Relapsed/Refractory67

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Transplant Rate

Percentage of participants eligible for allogeneic hematopoietic stem cell transplantation (alloHSCT) that are able and willing to proceed to alloHSCT. (NCT01465334)
Timeframe: Evaluated up to 36 cycles (approximately 2.75 years) of treatment (Parts A, B and C)

Interventionpercentage of participants (Number)
Treatment Naive43
Relapsed/Refractory43

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Number of Participants Completing Part A Treatment

Participants counted as completing Part A with either 2 or 4 cycles of treatment per protocol. (NCT01465334)
Timeframe: Evaluated up to 4 cycles/16 weeks.

Interventionparticipants (Number)
Treatment Naive12
Relapsed/Refractory15

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Number of Participants With Overall CR

CR overall (induction and maintenance treatment) was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes<4000/microliter, normocellular for age marrow with <30% lymphocytes, no B-lymphoid nodules and platelet>100,000/micro liter, hemoglobin>11 grams/deciliter, neutrophils>1500/microliter. (NCT01465334)
Timeframe: Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.

Interventionparticipants (Number)
Treatment Naive2
Relapsed/Refractory0

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Number of Participants Completing Only 2 Cycles of Part A Treatment

Participants counted if only completed 2 cycles of Part A treatment per protocol. (NCT01465334)
Timeframe: Evaluated after 2 cycles/8 weeks of Part A therapy.

Interventionparticipants (Number)
Treatment Naive0
Relapsed/Refractory0

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Number of Participants Achieving Induction Complete Response (CR)

CR over induction treatment was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes<4000/microliter, normocellular for age marrow with <30% lymphocytes, no B-lymphoid nodules and platelet>100,000/micro liter, hemoglobin>11 grams/deciliter, neutrophils>1500/microliter. (NCT01465334)
Timeframe: Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B.

Interventionparticipants (Number)
Treatment Naive0
Relapsed/Refractory0

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Anterior Chamber Cells & Flare

"Anterior Chamber Flare (for those subjects that could be examined with a slit lamp):~Assessed scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0 = None No Tyndall effect~= Mild Tyndall effect barely discernible~= Moderate Tyndall effect in anterior chamber is moderately intense. Iris pattern is seen clearly~= Severe Tyndall effect in anterior chamber is severely intense. Iris pattern cannot be seen clearly~= Very severe Tyndall effect is very severely intense. The aqueous has a white and milky appearance" (NCT01475643)
Timeframe: Over all visits 42 days

InterventionGrade of anterior chamber flare (Mean)
Loteprednol Etabonate.192
Prednisolones Acetate.341

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Anterior Chamber Inflammation

"Anterior Chamber Inflammation (for subjects that could only be examined with a pen light and a 20D [g20 Diopter] magnifying lens): 0 = None Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal~= Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal~= Moderate Moderate anterior chamber clouding~= Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished~= Very severe Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished" (NCT01475643)
Timeframe: Postoperative Day 29

Interventiongrade of anterior chamber cells (Mean)
Loteprednol Etabonate.913
Prednisolones Acetate.783

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Rate of Progression/Relapse Free Survival (PFS)

Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier. (NCT01496976)
Timeframe: Up to 56 months

Interventionmonths (Median)
Immunotherapy54.4

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Number of Participants With Overall Survival (OS)

Overall survival will be summarized with the Kaplan-Meier curve. (NCT01496976)
Timeframe: 36 Months

Interventionparticipants (Number)
Immunotherapy24

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Number of Participants With Complete Response (CR)

Number of participants with complete response, the disappearance of all signs of cancer in response to treatment. (NCT01496976)
Timeframe: 3 Months

InterventionParticipants (Count of Participants)
Immunotherapy1

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Number of Participants With Partial Response (PR)

The primary endpoint for this trial is the combined complete and partial response rate to the protocol therapy at 3 months, which is also the end of Cycle 3. The objective response (CR+PR) rate will be summarized using both a point estimate and its exact confidence interval based on the binomial distribution. (NCT01496976)
Timeframe: 3 Months

Interventionparticipants (Number)
Immunotherapy33

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Objective Response Rate (ORR)

ORR at 3 months. Assessment for response will be made following the National Cancer Institute Working Group (NCIWG) 2008 Chronic Lymphocytic Leukemia (CLL) criteria for response. Objective response = Complete Response (disappearance of all target lesions) + Partial Response (>=30% decrease in the sum of the longest diameter of target lesions) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) (NCT01497496)
Timeframe: 3 Months

Interventionpercentage of participants (Number)
Immunotherapy48.3

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Ocular Itching Change From Baseline to Day 11

Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching). (NCT01534195)
Timeframe: 5 minutes post-CAC

Interventionunits on a scale (Mean)
Prednisolone-1.1
Placebo-0.45

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Episcleral Redness Change From Baseline to Day 6

Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness). (NCT01534195)
Timeframe: 7 minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-1.0
Placebo0.45

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Conjunctival Redness Change From Baseline to Day 11

Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness) (NCT01534195)
Timeframe: 7 Minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-0.69
Placebo0.40

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Ciliary Redness Change From Baseline to Day 6

Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness). (NCT01534195)
Timeframe: 7 minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-0.94
Placebo0.30

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Orthostatic Hypotension

(NCT01559675)
Timeframe: Postoperative Day 1

Interventionparticipants (Number)
High Dose Steroid2
Low Dose Steroid2

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Neurodevelopmental Outcome

Bayley Scales of Infant and Toddler Development version 3 at 1 year. Cognitive, language, and motor composite scores will be used. The general population has a mean of 100 with a standard deviation of 15 for each composite score. Higher scores are better. The minimum composite score is 46 and maximum 154. (NCT01579513)
Timeframe: 1 year

,
Interventionscore on a scale (Mean)
Cognitive DomainLanguage DomainMotor Domain
Intraoperative Methylprednisone10510190
Placebo10410091

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Number of Participants With a Clinically Derived Composite Morbidity-mortality Outcome

The composite morbidity-mortality outcome will be met if any of the following occur after surgery but before hospital discharge: death, cardiac arrest, extracorporeal membrane oxygenation, renal insufficiency (creatinine more than two times normal), hepatic insufficiency (aspartate aminotransferase or alanine aminotransferase more than two times normal), or rising lactic acidosis (>5mmol/L). This outcome was choosen because death rarely occurs in this population. We have found this endpoint to be highly associated with other important clinical outcomes in this population. (NCT01579513)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

InterventionParticipants (Count of Participants)
Intraoperative Methylprednisone27
Placebo40

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Intensive Care Unit Stay

Amount of time in the intensive care unit following cardiac surgery (NCT01579513)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

InterventionDays (Mean)
Intraoperative Methylprednisone11
Placebo11

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Hospital Stay

Total duration of hospital stay following cardiac surgery (NCT01579513)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

InterventionDays (Mean)
Intraoperative Methylprednisone20
Placebo22

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Duration of Mechanical Ventilation Post Cardiac Surgery.

Amount of time on mechanical ventilation following cardiac surgery (NCT01579513)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

InterventionDays (Median)
Intraoperative Methylprednisone4
Placebo5

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Number of Participants With a Treatment Response

The primary outcome of the trial was the treatment response rate at two months. The definitions of response and progressive disease were based on both the radiographic changes and clinical symptoms. We defined response as both (1)a reduction in edema volume on FLAIR images by ≥25% and (2)no deteriorating symptoms. Progressive disease was defined as either (1)larger than 10% increase in the volume of the lesions; (2)appearance of any new lesion/site; or (3)clear clinical worsening. (NCT01621880)
Timeframe: At 2 months.

InterventionParticipants (Count of Participants)
Bevacizumab38
Corticosteroid17

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Percentage Change in Radiological Measures of Lesion Volume

T1 post-gadolinium imaging was used to measure the enhancement and T2-weighted FLAIR to measure the edema. For lesion measurements, radiologists used manual and semiautomatic approaches to identify the outline of the lesion, and the total volume was estimated with Volume Viewer 2 software(GE Healthcare, AW Suite2.0 6.5.1.z). (NCT01621880)
Timeframe: Change from baseline to evaluation at 2 months.

,
Interventionpercentage (Mean)
Percentage Change in FLAIRPercentage Change in enhancement
Bevacizumab-51.8-25.5
Corticosteroid-19.3-5.0

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Reduction of Pain Severity Expressed as Percentage Change in VAS Score

"VAS score~VAS score is a 10 -cm graduated scale with scores ranging from 0 (no pain) to 10 (unbearable pain) self- reported by patients~Reference: Langley GB and Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int 1985;5(4):145-148." (NCT01652495)
Timeframe: 180 days after treatment

Interventionpercentage of pain reduction (Mean)
Methylprednisolone Acetate Group82
Triamcinolone Acetonide Group96

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Functional Improvement Measured According to Percentage Change in Constant Score

"Patients will be evaluated clinically by Constant Score~Constant score: range 0 (total shoulder impairment) to 100 (non impaired shoulder). The score is obtained from two subjective (pain and relation between pain and daily-life activities) - and two objective physician-assessed (strength and range of motion) measurements~Reference: Constant CR and Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4." (NCT01652495)
Timeframe: 180 days after treatment

Interventionpercentage of improvement Constant score (Mean)
Methylprednisolone Acetate Group99
Triamcinolone Acetonide Group95

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Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis

"Evaluation of blood cortisol and ACTH, free urinary cortisol, urinary levels of methylprednisolone or triamcinolone (depending on the administered drug) by RIA immunoassay and tandem mass assays~Persistent suppression of the HPA axis at the end of the follow up is based on the evidence of ACTH, plasmatic and urinary cortisol levels under reference values" (NCT01652495)
Timeframe: 45 days after treatment

Intervention% of patients with HPA suppression (Number)
Methylprednisolone Acetate Group0
Triamcinolone Acetonide Group15

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BPAR (Biopsy-proven Acute Rejection) Incidence During the First 12 Months Post-transplant

BPAR (biopsy-proven acute rejection) incidence during the first 12 months post-transplant. Grading is determined using standard Banff criteria. (NCT01680861)
Timeframe: 1 year

Interventionparticipants (Number)
Tacrolimus/Everolimus1
Tacrolimus/EC-MPS3

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Discontinuance of Any Study Medication (Tacrolimus, Everolimus, or EC-MPS)

(NCT01680861)
Timeframe: during the first 12 months post-transplant

Interventionparticipants (Number)
Tacrolimus/Everolimus0
Tacrolimus/EC-MPS1

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eGFR (Renal Function) at Month 3 Post-transplant

Renal function as determined by the estimated glomerular filtration rate (eGFR) at 3 months post-transplant, using the abbreviated MDRD formula. (NCT01680861)
Timeframe: at 3 months post-transplant

Interventionml/min per 1.73 m^2 (Mean)
Tacrolimus/Everolimus75.7
Tacrolimus/EC-MPS65.6

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Graft Loss (Return to Permanent Dialysis or Death)

(NCT01680861)
Timeframe: during the first 12 months post-transplant

Interventionparticipants (Number)
Tacrolimus/Everolimus0
Tacrolimus/EC-MPS0

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Incidence of Chronic Allograft Nephropathy (CAI) at 12 Months Post-transplant

Incidence of (biopsy-proven) chronic allograft nephropathy (CAI) [interstitial fibrosis and tubular atrophy, using standard Banff criteria] at 12 months post-transplant. (NCT01680861)
Timeframe: 1 year

Interventionparticipants (Number)
Tacrolimus/Everolimus3
Tacrolimus/EC-MPS3

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eGFR (Calculated Glomerular Filtration Rate), i.e., Renal Function, at 1 Month Post-transplant.

using the abbreviated MDRD formula. (NCT01680861)
Timeframe: at 1 month post-transplant

Interventionml/min per 1.73 m2 (Mean)
Tacrolimus/Everolimus82.1
Tacrolimus/EC-MPS62.1

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eGFR (Renal Function) at 6 Months Post-transplant

using the abbreviated MDRD formula. (NCT01680861)
Timeframe: at 6 months post-transplant

Interventionml/min per 1.73 m2 (Mean)
Tacrolimus/Everolimus66.7
Tacrolimus/EC-MPS63.7

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Progression-free Survival (PFS)

PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes <= 1.0 × <= 1.0 cm would not be considered as abnormal for PD. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

Interventionmonths (Median)
Arm ANA
Arm BNA

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Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])

Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion (NCT01724021)
Timeframe: Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)

Interventionminutes (Median)
Rituximab Intravenous (IV)840
Rituximab Subcutaneous (SC)22

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Cancer Therapy Satisfaction Questionnaire (CTSQ) Score

CTSQ is a validated 16-item questionnaire that measures three domains related to participants' satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. (NCT01724021)
Timeframe: During Cycle 4, 8 of treatment (Up to 32 weeks)

,
Interventionunits on a scale (Mean)
Expectations of therapy domainFeelings about side effects domainSatisfaction with therapy domain
Rituximab Intravenous (IV)80.8860.6384.59
Rituximab Subcutaneous (SC)82.0761.6485.42

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Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time

(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

,
Interventionpercentage of participants (Number)
Cycle 1Cycle 2Cycle 3Cycle 4Interim stagingCycle 5Cycle 6Cycle 7Cycle 8Final stagingFollow-up, 6 monthsFollow-up, 12 monthsEnd of study/early treatment termination
Arm A11.47.07.17.09.012.516.023.813.310.06.57.73.5
Arm B15.618.223.514.79.710.211.610.911.012.613.48.76.3

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Percentage of Participants With Anti-Rituximab Antibodies Over Time

(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

,
Interventionpercentage of participants (Number)
Cycle 1Cycle 2Cycle 3Cycle 4Interim stagingCycle 5Cycle 6Cycle 7Cycle 8Final stagingFollow-up, 6 monthsFollow-up, 12 monthsEnd of study/early treatment termination
Arm A2.02.10.300000001.82.10.6
Arm B3.02.20.90.300000000.60.6

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Rituximab Administration Satisfaction Questionnaire (RASQ) Score

The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. (NCT01724021)
Timeframe: During Cycle 4, 8 of treatment (Up to 32 weeks)

,
Interventionunits on a scale (Mean)
Physical impact domainPsychological Impact domainImpact on activitiesf daily livingConvenience domainSatisfaction domain
Rituximab Intravenous (IV)82.1477.7359.4959.0574.88
Rituximab Subcutaneous (SC)82.0884.0081.8681.0587.26

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Summary of Observed Serum Rituximab Concentration

(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

,
Interventionmicrogram per milliter (Mean)
Cycle 1Cycle 2Cycle 3Cycle 4Interim stagingCycle 5Cycle 6Cycle 7Cycle 8Final stagingFollow-up, 6 monthsFollow-up, 12 monthsEnd of study/early treatment termination
Arm A3355.925053.162977.087956.6117273.6108030.9100927.795614.0104873.086806.67802.92380.19302.0
Arm B970.124541.146093.959485.577665.370387.398679.7117172.0137048.1120995.78042.91685.39553.9

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Complete Response (CR) Rate

CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study. (NCT01724021)
Timeframe: 28 days (± 3 days) after Day 1 of the last dose of induction treatment

Interventionpercentage of participants (Number)
Arm A49.2
Arm B52.7

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Disease-free Survival (DFS)

DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

Interventionmonths (Median)
Arm ANA
Arm BNA

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Event-free Survival (EFS)

EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (<=) 1.0 × <= 1.0 cm would not be considered as abnormal for PD. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

Interventionmonths (Median)
Arm ANA
Arm BNA

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Number of Participants With Treatment Emergent Adverse Events (AEs)

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT01724021)
Timeframe: Randomization of first participant to clinical cutoff date (Up to 4 years)

Interventionparticipants (Number)
Arm A352
Arm B347

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Overall Survival (OS)

OS was defined as the time from randomization to death from any cause. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

Interventionmonths (Median)
Arm ANA
Arm BNA

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Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6

Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6. (NCT01724021)
Timeframe: Cycle 6 (Up to 24 weeks)

Interventionpercentage of participants (Number)
Arm A79.1
Arm B80.6

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Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8

Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing Cycle 8. (NCT01724021)
Timeframe: Cycle 8 (Up to 32 weeks)

Interventionpercentage of participants (Number)
Arm A77.1
Arm B84.2

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Ocular Redness Change From Baseline to Day 6

Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness). (NCT01730872)
Timeframe: 7 minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-1.1
Placebo0.31

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Inflammation Change From Baseline to Day 6

Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation). (NCT01730872)
Timeframe: 90 minutes post CAC

Interventionscore on a scale (Mean)
Prednisolone-1.2
Placebo-0.19

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Ocular Itching Change From Baseline to Day 6

Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC (NCT01730872)
Timeframe: 7 minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-1.1
Placebo-1.0

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Number of Participants With Change/Improvement Visual Acuity From the Beseline

Best corrected visual acuity will measure at 1,2,3 days, 1 week, 2 weeks and 1 month and at least 3 months after treatment. Improvement is defined based on 1) mean logMAR[12], 2) 0.3 change in logMAR (improvement, deterioration, and no change) [12,16] , 3) mean improvement percentage which is calculated as: improvement%= (logMar ( of VA after treatment)-logMar ( of initial VA))/(logMar(20/13)˟-logMar ( of initial VA) 4) percentage of patients at different ordinal categorization of the BCVA as no light perception (NLP), light perception (LP)and hand motion (HM), count fingers (CF), and ≥ 20/200. (NCT01783847)
Timeframe: Change from baseline at least 3 months after treatment

InterventionParticipants (Count of Participants)
Recombinant Human Erythropoietin (EPO)28
Methylprednisolone3
Observation5

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Number of Participants With Relative Afferent Papillary Defect (RAPD) Grade +4

A positive RAPD means there are differences between the two eyes in the afferent pathway due to retinal or optic nerve disease. Graded from +1 to +4. The higher one is a better grade (NCT01783847)
Timeframe: Change from baseline at least 3 months after treatment

InterventionParticipants (Count of Participants)
Recombinant Human Erythropoietin (EPO)26
Methylprednisolone7
Observation8

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Type of Treatment(s) Participants Received for Biopsy-Proven Pancreatic Allograft Rejection During the First 52 Weeks Post-Transplant

"Participants are stratified by kidney biopsy results/treatment received.~Upon having a for-cause biopsy performed, persons often receive treatment for rejection based on the biopsy results, which may or may not reveal signs of rejection. Details of biopsy findings and corresponding treatment are provided for each instance of treatment for rejection.~Results summary format: biopsy results; treatment.~Acronyms and abbreviations:~ACR=Acute Cellular Rejection~IFTA=Interstitial Fibrosis and Tubular Atrophy~ATG=Anti-thymocyte globulin therapy~IVIG=Intravenous Immunoglobulin therapy~Gd =Grade~PO=Orally~QD=Daily" (NCT01790594)
Timeframe: Transplant through Week 52

,
InterventionParticipants (Count of Participants)
ACR-Gd. I/ATGACR-Gd. I/ATG, Pulse SteroidsACR-Gd. I/ATG, Pulse Steroids, IVIGACR-Gd. I, IFTA-Gd. I/Pulse Steroids, Solumedrol,ACR-Gd. II/ATG, Pulse SteroidsNo grade reported/None
Control000010
Investigational111111

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Count of Participants With Full Pancreatic Graft Function (Insulin Independent) at Wk 52 Post-Transplant

Participants with full pancreatic graft functions are defined as those that no longer require exogenous insulin therapy. (NCT01790594)
Timeframe: Week 52 Post-Transplant

InterventionParticipants (Count of Participants)
Investigational19
Control21

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Count of Participants With Evidence of Partial Pancreatic Graft Function at Week 52 Post-Transplant

C-peptide is a measure of pancreatic function. The definition of partial pancreatic graft function: a fasting C-peptide levels >0.3ng.mL (0.1nmol.L) plus the participant's continued requirement for exogenous insulin or oral hypoglycemic agent(s). (NCT01790594)
Timeframe: Week 52 Post-Transplant

InterventionParticipants (Count of Participants)
Investigational1
Control0

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Count of Participants With Evidence of Pancreatic Loss at Week 52 Post-Transplant

C-peptide is a measure of pancreatic function. The definition of pancreatic loss: a C-peptide value of <0.3 ng/mL. (NCT01790594)
Timeframe: Week 52 Post-Transplant

InterventionParticipants (Count of Participants)
Investigational1
Control0

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Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant

"eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or end stage kidney failure." (NCT01790594)
Timeframe: Week 52 Post-Transplant

InterventionParticipants (Count of Participants)
Investigational5
Control5

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Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant

"The stages of Chronic Kidney Disease (CKD) are defined using the participant's GFR value:~Stage 1 if GFR value is ≥ 90 (kidney function is normal)~Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease)~Stage 3A if 45 <= GFR < 60*~Stage 3B if 30 <= GFR < 45*~Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function)~Stage 5 if GFR < 15 (severe or end stage kidney failure).~Stages 3A abd 3B indicate moderately reduced kidney function.*" (NCT01790594)
Timeframe: Week 52 Post-Transplant

InterventionParticipants (Count of Participants)
Investigational0
Control0

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Count of Participants With an Infectious Disease Serious Adverse Event(s) Requiring Hospitalization or Systemic Therapy

Infections were required to be reported as a serious adverse event if they required either inpatient hospitalization or prolongation of a current hospitalization. Displayed are counts of all participants who experienced infection(s) as an adverse event, by treatment group. (NCT01790594)
Timeframe: Transplant through Week 52 Post-Transplant

InterventionParticipants (Count of Participants)
Investigational11
Control11

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Count of Participants Diagnosed With Malignancy as an Adverse Event

An increased risk/incidence of malignancy is a recognized complication of immunosuppression in recipients of organ transplants. In Phase 3 clinical trials, overall malignancy rates were similar across all treatment groups, with the exception of posttransplant lymphoproliferative disease (PTLD).Displayed are counts of all participants who experienced malignancy reported as an adverse event. (NCT01790594)
Timeframe: Transplant through Week 52 Post-Transplant

InterventionParticipants (Count of Participants)
Investigational0
Control0

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Count of Participants Diagnosed With Epstein-Barr Virus (EBV) Infection as an Adverse Event

Viral infections following renal transplantation is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during this study using participant blood samples. Displayed are counts of all participants diagnosed with EBV infection as an adverse event by EBV test(s), diagnosed by test results from the local clinical pathology laboratory. (NCT01790594)
Timeframe: Transplant through Week 52 Post-Transplant

InterventionParticipants (Count of Participants)
Investigational0
Control0

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Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant

Delayed grafted function is defined as dialysis in the first week on one or more occasions for any indication other than the treatment of acute hyperkalemia in the setting of otherwise acceptable renal function. (NCT01790594)
Timeframe: Transplant through Week 52 Post-Transplant

InterventionParticipants (Count of Participants)
Investigational1
Control1

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Fasting Lipid Profile at Baseline (Pre-Transplant)

"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease." (NCT01790594)
Timeframe: Baseline (Pre-Transplant)

,
Interventionmg/dL (Mean)
Tot. Chol. BaselineNon-HDL BaselineLDL BaselineHDL BaselineTriglyc. Baseline
Control140.582.460.758.1107.5
Investigational142.891.066.551.8120.9

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Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant

"Participants are stratified by kidney biopsy results/treatment received.~In the event of a for cause renal (kidney) biopsy:~-The diagnosis of acute cellular rejection (ACR) using the Banff 2007 renal allograft pathology criteria. These criteria for renal allograft biopsies is an international histopathological classification standard. ACR is defined by a renal biopsy demonstrating a Banff 2007 classification of Grade IA or greater, with higher scores indicating more severe rejection. (Ref: Solez K, Colvin RB et al. Banff 07 classification of renal allograft pathology: updates and future directions. Am J Transplant 2008 8(4): 753-60).~Acronyms and abbreviations:~ACR=Acute Cellular Rejection*~Normal*~Borderline* (criteria for ACR not fulfilled)~Gd.=Grade*~IFTA=Interstitial Fibrosis and Tubular Atrophy*~ATG=Anti-thymocyte globulin therapy~IVIG=Intravenous Immunoglobulin therapy~PO=Orally~QD=Daily *Banff 2007 renal allograft pathology criteria" (NCT01790594)
Timeframe: Transplant through Week 52

,
InterventionParticipants (Count of Participants)
Borderline/NoneBorderline/Pulse SteroidsBorderline, IFTA-Gd. I/Pulse Steroids, IVIGACR-Gd. IA/ATG, Pulse SteroidsACR-Gd. IB/ATG, Pulse SteroidsACR-Gd. IIA/ATG, Pulse SteroidsACR-Gd. IIB/ATG, Pulse SteroidsIFTA-Gd. I/NoneIFTA-Gd. I/Potassium citrateNormal/Steroids QDNo grade reported/IVIGNo grade reported/NoneNormal/None
Control0111010001042
Investigational1000101120113

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Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant

"A blood pressure measurement consists of two numbers: the systolic and diastolic pressures. Systolic pressure measures the pressure in blood vessels when the heart beats. Diastolic pressure measures the pressure in blood vessels between beats of the heart.~Systolic measures of <120 and diastolic measures of <80 are considered normal.~Systolic measures of 120-139 and diastolic measures of 80-89 are considered at risk (or pre-hypertension).~Systolic measures of ≥140 and diastolic measures of ≥90 are considered high." (NCT01790594)
Timeframe: Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52

,
InterventionmmHg (Mean)
Systolic BP at BaselineSystolic BP at Day 28Systolic BP at Day 84Systolic BP at Week 28Systolic BP at Week 36Systolic BP at Week 52Diastolic BP at BaselineDiastolic BP at Day 28Diastolic BP at Day 84Diastolic BP at Week 28Diastolic BP at Week 36Diastolic BP at Week 52
Control158.3112.0123.8126.2126.7127.085.265.473.473.376.877.0
Investigational161.3116.9126.3136.1133.5132.082.767.072.876.676.574.2

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Severity Grade of First Biopsy-Proven Acute Rejection (AR) During the First 52 Weeks Post-Transplant

"AR grading using standard Banff* criteria. For both kidney and pancreas, AR is defined as a grade ≥1.~AR for the kidney: Banff 2007 criteria. Severity of AR is graded by as IA, IB, IIA, IIB, or III, with IA defined as the mildest form of AR and III being the most severe.~AR for the pancreas: Banff 2011 Criteria. Severity of AR is graded is I, II, or III, with I defined as the mildest form of AR and III being the most severe." (NCT01790594)
Timeframe: Transplant through Week 52

,
InterventionParticipants (Number)
Kidney First Grade IAKidney First Grade IBKidney First Grade IIAKidney First Grade IIBPancreas First Grade IPancreas First Grade II
Control101001
Investigational010141

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Lipid Profile at Wk 52 Post-Transplant

"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤ 20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease." (NCT01790594)
Timeframe: Week 52 Post-Transplant

,
Interventionmg/dL (Mean)
Tot. Chol. Week 52Non-HDL Week 52LDL Week 52HDL Week 52Triglyc. Week 52
Control162.8112.392.747.395.4
Investigational164.2115.796.948.588.6

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HbA1c at Baseline (Pre-Transplant) Through Wk 52 Post-Transplant

"Hemoglobin A1c (HbA1c) measures the average blood glucose levels over 8-12 weeks, thus acting as a useful long-term gauge of blood glucose control:~A value below 6.0% reflects normal levels,~6.0% to 6.4% reflects prediabetes, and~a value of ≥ 6.5% reflects diabetes." (NCT01790594)
Timeframe: Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52

,
Interventionpercent (Mean)
BaselineDay 28Day 84Week 28Week 36Week 52
Control8.56.14.95.25.15.3
Investigational8.66.04.85.35.35.5

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Fasting Lipid Profile at Wk 28 Post-Transplant

"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease." (NCT01790594)
Timeframe: Week 28 Post-Transplant

,
Interventionmg/dL (Mean)
Tot. Chol. Week 28Non-HDL Week 28LDL Week 28HDL Week 28Triglyc. Week 28
Control149.297.481.251.887.8
Investigational159.9112.693.147.393.2

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Fasting Blood Sugar (FBS) From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant

"Fasting blood sugar (e.g., glucose) test is used to help diagnose diabetes, prediabetes, and gestational diabetes.~Reference fasting blood sugar (glucose) values:~70 to 99 mg/dL is normal~100 to 125 mg/dL is considered prediabetes~126 mg/dL or higher on two separate tests is considered diabetes." (NCT01790594)
Timeframe: Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52

,
Interventionmg/dL (Mean)
BaselineDay 28Day 84Week 28Week 36Week 52
Control217.3100.989.796.287.291.5
Investigational183.3100.096.0106.596.098.6

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Count of Participants With Use of Lipid Lowering Medications at Baseline, Wk 28 and Wk 52 Post-Transplant

Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood (NCT01790594)
Timeframe: Baseline (Pre-Transplant), Week 28, and Week 52

,
Interventionparticipants (Number)
BaselineWeek 28Week 52
Control181616
Investigational181919

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Count of Participants With Use of Anti-hypertensive Medication From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant

Anti-hypertensive medications are a class of drugs that are used to treat hypertension. The medications seek to prevent the complications of high blood pressure, such as stoke and myocardial infarction. (NCT01790594)
Timeframe: Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52

,
InterventionCount of Participants (Number)
BaselineDay 28Day 84Week 28Week 36Week 52
Control19107111111
Investigational181411131313

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Count of Participants With the Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

"Adverse events were collected systematically. Counts of all participants who experienced at least one adverse event (AEs, SAEs) by assigned treatment group.~Refer to the Serious Adverse Events and Other Adverse Events tables for more detail." (NCT01790594)
Timeframe: From Enrollment (Pre-Transplant) to Week 52 Post-Transplant

,
InterventionCount of Participants (Number)
All Adverse EventsSerious Adverse Events
Control2119
Investigational2220

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Count of Participants With Event of Death, Graft Loss, or Undetectable C-peptide

"This measure counts death, graft loss, or undetectable C-peptide value (e.g., C-peptide <0.3 ng/mL) occurring at any point post-transplant and independent of each other.~Kidney Graft Loss was defined as 90 consecutive days of dialysis dependency.~Pancreas graft loss was defined as returning to exogenous insulin therapy or initiation of oral hypoglycemic agents for greater than 30 days.~Factitious hypoglycemia due to surreptitious insulin administration results in elevated serum insulin levels and low or undetectable C-peptide levels." (NCT01790594)
Timeframe: Transplant through Week 52 Post-Transplant

,
InterventionParticipants (Count of Participants)
DeathKidney Graft LossPancreas Graft LossUndetectable C-peptide
Control0000
Investigational1010

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Count of Participants With De Novo Anti-Donor Antibodies or Anti-Human Leukocyte Antigen (HLA) Antibodies During the First 52 Weeks Post-Transplant

"The de novo development of donor-specific antibody (DSA) is associated with an increased risk of graft rejection.~The presence of anti-Histocompatibility Antigen (HLA) antibodies (alloantibodies) is associated with increased risk of acute and chronic injury to the transplant allograft." (NCT01790594)
Timeframe: Transplant through Week 52

,
InterventionCount of Participants (Number)
De novo DSAAnti-HLA
Control01
Investigational02

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Count of Participants With Biopsy-Proven Humoral Rejection During the First 52 Weeks Post-Transplant

"Humoral rejection (i.e., antibody mediated rejection) of:~the kidney as defined by diffusely positive staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury determined by local pathology and,~the pancreas as defined by the presence of circulating anti-donor antibodies, and histopathological data including morphologic evidence of microvascular tissue injury and C4d staining in interacinar capillaries determined by local pathology." (NCT01790594)
Timeframe: Transplant through Week 52

,
InterventionCount of Participants (Number)
KidneyPancreas
Control00
Investigational00

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Count of Participants With Acute Rejection (AR) of Kidney or Pancreatic Transplant During the First 52 Wks Post-Transplant

"Biopsy-proven acute rejection (AR) of the kidney (renal) or pancreas during the first 52 weeks post-transplant. AR grading using standard Banff* criteria. For both kidney and pancreas, AR is defined as a grade ≥1.~AR for the kidney: Banff 2007 criteria. Severity of AR is graded by as IA, IB, IIA, IIB, or III, with IA defined as the mildest form of AR and III being the most severe.~AR for the pancreas: Banff 2011 Criteria. Severity of AR is graded as I, II, or III, with I defined as the mildest form of AR and III being the most severe." (NCT01790594)
Timeframe: Transplant through Week 52

,
InterventionCount of Participants (Number)
KidneyPancreas
Control21
Investigational25

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Count of Participant Diagnosed With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia As Adverse Events

"Viral infections following renal transplantation is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss.~Specific viruses were monitored during this study using participant blood samples. Displayed are counts of participants who experienced BKV and CMV viremia as adverse events, diagnosed by test results from the local clinical pathology laboratory." (NCT01790594)
Timeframe: Transplant through Week 52 Post-Transplant

,
InterventionCount of Participants (Number)
BK ViremiaCMV Viremia
Control33
Investigational85

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The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant

"The estimated Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥ 90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or endstage kidney failure.~An estimate of the slope, or change over time, in eGFR was produced using standard statistical linear modeling procedures. The estimate was then re-scaled so that it could be interpreted as a change in eGFR per month. Positive numbers indicate increasing kidney function.~Larger numbers indicate greater change in kidney function." (NCT01790594)
Timeframe: Day 28 through Week 52 Post-Transplant

InterventioneGFR change over time (by month) (Mean)
Investigational0.1
Control-0.1

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Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant

"eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or end stage kidney failure." (NCT01790594)
Timeframe: Week 52 Post-Transplant

InterventionmL/min/1.73m^2 (Mean)
Investigational77.0
Control74.6

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Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant

"The estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease equation (MDRD):~A score of ≥ 90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate severe or endstage kidney failure." (NCT01790594)
Timeframe: Week 52 Post-Transplant

InterventionmL/min/1.73m^2 (Mean)
Investigational68.7
Control67.0

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Count of Participants With Successful Discontinuation of Tacrolimus in Recipients Randomized to the Investigational Arm

Participants achieved successful discontinuation if they were able to discontinue (e.g., off tacrolimus therapy completely) over a 4-8 weeks after tacrolimus withdrawal was initiated at week 40. (NCT01790594)
Timeframe: Week 40 through week 48 Post-Transplant

InterventionParticipants (Count of Participants)
Investigational5

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MELD Score at 180 Days

"Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome.~The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure." (NCT01809132)
Timeframe: 180 Days

Interventionscore on a scale (Mean)
Anakinra & Pentoxifylline & Zinc Sulfate15.81
Methylprednisolone11.85

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180 Days Mortality

Death at 180 days (NCT01809132)
Timeframe: Time to event up to 6 months

InterventionParticipants (Count of Participants)
Anakinra & Pentoxifylline & Zinc Sulfate17
Methylprednisolone22
Observational0

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MELD Score at 28 Days

"Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome.~The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure." (NCT01809132)
Timeframe: 28 days

Interventionscore on a scale (Mean)
Anakinra & Pentoxifylline & Zinc Sulfate22.57
Methylprednisolone20.95

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MELD Score at 90 Days

"Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome.~The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure." (NCT01809132)
Timeframe: 90 Days

Interventionscore on a scale (Mean)
Anakinra & Pentoxifylline & Zinc Sulfate15.50
Methylprednisolone16.38

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Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90

BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis. (NCT01853072)
Timeframe: Baseline to Day 14, and maintained through Day 90

InterventionPercentage of participants (Number)
Nepafenac61.7
Vehicle43.0

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Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit

(NCT01853072)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac9.1
Vehicle15.3

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Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60

(NCT01853072)
Timeframe: Baseline to Day 60

InterventionPercentage of participants (Number)
Nepafenac76.2
Vehicle64.7

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Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]

(NCT01853072)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac15.4
Vehicle27.3

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Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)

Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis. (NCT01853072)
Timeframe: Day 0 to Day 90

InterventionPercentage of participants (Number)
Nepafenac2.3
Vehicle17.3

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Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90

(NCT01853072)
Timeframe: Baseline to Day 90

InterventionPercentage of participants (Number)
Nepafenac77.2
Vehicle67.7

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Immunologic Graft Rejection Episode

Rejection episodes were assessed by slit lamp examination and categorized as definite when an endothelial rejection line was detected in a previously clear graft, probable when inflammation (stromal infiltrate, keratic precipitates, cells in the anterior chamber, or ciliary injection) was detected in a previously clear graft without an endothelial rejection line, and possible if central corneal pachymetry increased by 30 microns or more, even if the cornea was clear and no inflammation was detected by slit lamp examination. (NCT01853696)
Timeframe: within first year after cornea transplantation

Interventioneyes (Number)
Loteprednol0
Prednisolone Acetate0

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Intraocular Pressure

Number of eyes in which the absolute intraocular pressure equaled or exceeded 24 mm Hg OR in which there was a relative increase of at least 10 mm Hg over the baseline preoperative reading. (NCT01853696)
Timeframe: from 1 to 12 months after transplant

Interventioneyes (Number)
Loteprednol11
Prednisolone Acetate27

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Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies

"Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of local biopsy findings are presented here for rejection. Acronyms and abbreviations are defined as follows:~ACR= Acute T-Cell Mediated rejection~AMR= Acute Antibody-mediated rejection~Chr. AMR=Chronic Antibody Mediated Rejection~Gd.=Grade~IFTA=Interstitial Fibrosis and Tubular Atrophy" (NCT01856257)
Timeframe: Transplantation through Week 52

,,
InterventionBiopsy (Number)
BorderlineBorderline, AMR-Gd. I (ATN-Like)Borderline, AMR-Gd.I (ATN-Like), Chr.AMR, IFTA-Gd1Borderline, AMR-Gd. I (ATN-Like), IFTA-Gd. IBorderline, Chr.AMR, IFTA-Gd. IBorderline, IFTA-Gd. IBorderline, IFTA- Gd. IIACR-Gd. IAACR-Gd. IA, IFTA-Gd. IACR-Gd. IA, IFTA-Gd. IIACR-Gd. IBACR-Gd. IB, IFTA-Gd. IACR-Gd. IB, IFTA-Gd. IIACR-Gd. IB, IFTA-Gd. IIIACR-Gd. IIAACR-Gd. IIA, IFTA-Gd. IACR-Gd. IIIAMR-Gd. II (Capillary/Glomerular)IFTA-Gd. IIFTA-Gd. II
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept00000102000110000010
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept50010214100101222052
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac31101120011000000141

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Total Daily Prescribed Pill Count

This is a measure of the total number of pills a participant was prescribed on a given day (NCT01856257)
Timeframe: Day 28, Day 84, Week 28, Week 36, and Week 52

,,
Interventionpills per day (Mean)
Day 28Day 84Week 28Week 36Week 52
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept23.521.016.613.913.7
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept18.917.215.515.415.7
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac25.822.219.719.124.4

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Standardized Blood Pressure Measurement at Wk 52 Post-Transplant

"A blood pressure measurement consists of two numbers: the systolic and diastolic pressures. Systolic pressure measures the pressure in blood vessels when the heart beats. Diastolic pressure measures the pressure in blood vessels between beats of the heart.~Systolic measures of <120 and diastolic measures of <80 are considered normal.~Systolic measures of 120-139 and diastolic measures of 80-89 are considered at risk (or pre-hypertension).~Systolic measures of ≥140 and diastolic measures of ≥90 are considered high." (NCT01856257)
Timeframe: Week 52

,,
InterventionmmHg (Mean)
Systolic BP at W52Diastolic BP at W52
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept132.075.7
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept133.779.1
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac135.077.7

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Hemoglobin A1c (HbA1c) Measurements Over Time

"Hemoglobin A1c (HbA1c) measures the average blood glucose levels over 8-12 weeks, thus acting as a useful long-term gauge of blood glucose control:~A value below 6.0% reflects normal levels,~6.0% to 6.4% reflects prediabetes, and~a value of ≥ 6.5% reflects diabetes." (NCT01856257)
Timeframe: Baseline (Pre-Transplant) and Days 28 and -84, and Weeks 28, -36, and -52 Post-Transplant

,,
Interventionpercentage (Mean)
BaselineDay 28Day 84Week 28Week 36Week 52
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept5.95.45.45.65.55.8
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept5.75.65.56.05.96.7
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac5.75.45.66.26.77.8

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Fasting Lipid Profile at Wk 52 Post-Transplant

"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤ 20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease." (NCT01856257)
Timeframe: Week 52

,,
Interventionmg/dL (Mean)
Total cholesterolNon-HDLLDLHDLTriglyceride
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept174.8130.894.644.0182.8
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept163.7121.286.342.4170.0
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac177.1128.6102.948.5125.8

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Fasting Lipid Profile at Wk 28 Post-Transplant

"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease." (NCT01856257)
Timeframe: Week 28

,,
Interventionmg/dL (Mean)
Total cholesterolNon-HDLLDLHDLTriglyceride
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept167.3115.082.752.3166.6
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept179.5133.5109.846.0153.3
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac169.6119.695.651.0126.4

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Fasting Lipid Profile at Baseline (Pre-Transplant)

"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease." (NCT01856257)
Timeframe: Baseline

,,
Interventionmg/dL (Mean)
Total cholesterolNon-HDLLDLHDLTriglyceride
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept167.6123.465.244.1227.1
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept159.4116.183.143.3194.4
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac167.1122.091.145.1156.8

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Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset of Transplant Procedure

Temperature of >39 degrees Celsius (e.g., 102.2 degrees Fahrenheit) would be an indication of fever most often in response to an infection or illness. Systolic blood pressure <90mm Hg would be an indication of low blood pressure. (NCT01856257)
Timeframe: Within 24 Hours of transplant procedure

,,
InterventionParticipants (Count of Participants)
Fever >39 CelsiusSystolic BP < 90 mmHg
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept00
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept00
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac00

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Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Week 52 Post-Transplant -Based on Criteria Specified by the ADA and WHO

"New onset diabetes is the development of diabetes post-kidney transplant. It was identified by the clinical sites caring for each participant and reported directly in the clinical database. Impaired fasting glucose (IFG) is a determination made by referencing glucose measurements obtained from a standard chemistry panel. Any fasting glucose measure that is between 110 and 125 mg/dL is classified as IFG.~Acronyms: American Diabetes Association (ADA); World Health Organization (WHO)." (NCT01856257)
Timeframe: Transplantation through Week 52

,,
InterventionParticipants (Count of Participants)
New onset diabetes during first 52 weeksImpaired fasting glucose at week 52
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept00
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept10
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac12

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Count of Participants With Treated Diabetes Between Day 14 and Wk 52 Post-Transplant

Treated diabetes is defined as receipt of any oral medication or insulin for the treatment of diabetes for >14 days. (NCT01856257)
Timeframe: Day 14 through week 52

InterventionParticipants (Count of Participants)
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac3
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept2
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept0

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Count of Participants With Use of Anti-hypertensive Medication at Wk 52 Post-Transplant

Anti-hypertensive medications are a class of drugs that are used to treat hypertension. The medications seek to prevent the complications of high blood pressure, such as stroke and myocardial infarction. (NCT01856257)
Timeframe: Week 52

InterventionParticipants (Count of Participants)
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac18
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept23
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept8

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Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant

"The estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease equation (MDRD):~A score of ≥ 90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate severe or endstage kidney failure." (NCT01856257)
Timeframe: Week 52

InterventionmL/min/1.73m^2 (Mean)
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac56.1
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept57.0
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept58.2

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Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant

"eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or end stage kidney failure." (NCT01856257)
Timeframe: Week 52

InterventionmL/min/1.73m^2 (Mean)
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac59.2
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept61.5
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept63.0

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Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant

Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade equal to or greater than IA by Banff 2007 criteria as determined by local pathology. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection. Originally it was 2 endpoints but all participants' highest grade was also their first grade so only reporting their first grade. (NCT01856257)
Timeframe: Transplantation through Week 52

,,
InterventionParticipants (Count of Participants)
IAIBIIAIIBIII
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept22000
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept31402
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac01000

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Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 52

Adverse events were collected systematically from enrollment through Wk 52, the last study visit. Provided are numbers of participants with ≥ 1 adverse event (serious or non-serious adverse events) by treatment arm. (NCT01856257)
Timeframe: Enrollment through Week 52

,,
InterventionParticipants (Count of Participants)
Adverse EventsSerious Adverse Events
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept96
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept2821
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac2119

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Type of Treatment for Detected Graft Rejection

"Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of treatment are presented here for rejection. Acronyms and abbreviations are defined below.~ATG=Thymoglobulin" (NCT01856257)
Timeframe: Transplantation through Week 52

,,
InterventionBiopsy (Number)
ATGATG, Pulse SteroidsATG, Pulse Steroids, PrografAntibioticPlasmapheresisPlasmapheresis, Oral SteroidsPulse SteroidsPulse Steroids, LeflunomidePulse Steroids, Plasmapheresis, EculizumabPrednisone
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept0200003000
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept1510009102
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac0001116010

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Count of Participant Deaths or Graft Loss by Wk 52 Post-Transplant

This measure counts deaths and graft loss occurring at any point post transplantation. Graft loss is defined as 90 days of dialysis dependency. (NCT01856257)
Timeframe: Transplantation through Week 52

InterventionParticipants (Count of Participants)
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac2
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept0
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept0

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Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant

Viral infections following renal transplantation is significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during the study, using participant blood samples. Displayed are counts of participants who experienced BKV and CMV viremia as adverse events by treatment arm. (NCT01856257)
Timeframe: Transplantation through Week 52

,,
InterventionParticipants (Count of Participants)
BKVCMV
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept11
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept46
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac01

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The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant

"The estimated Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥ 90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or endstage kidney failure.~An estimate of the slope, or change over time, in eGFR was produced using standard statistical linear modeling procedures. The estimate was then re-scaled so that it could be interpreted as a change in eGFR per month. Positive numbers indicate increasing kidney function.~Larger numbers indicate greater change in kidney function." (NCT01856257)
Timeframe: Day 28 through Week 52 Post-Transplant

InterventioneGFR change over time (by month) (Mean)
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac0.3
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept1.3
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept0.8

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Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant

Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood. (NCT01856257)
Timeframe: Baseline (Pre-Transplant), Week 28, and Week 52

,,
InterventionParticipants (Count of Participants)
BaselineWeek 28Week 52
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept345
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept799
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac1389

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Count of Participants With Acute Cellular Rejection Grade ≥ IA Defined by Banff 2007 Criteria By Wk 52 Post-Transplant

Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade equal to or greater than IA by Banff 2007 criteria as determined by local pathology. (NCT01856257)
Timeframe: Transplantation through Week 52

InterventionParticipants (Count of Participants)
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac1
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept10
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept4

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Count of Participants With Antibody Mediated Rejection by Wk 52 Post-Transplant

Antibody mediated rejection is defined by diffusely positive staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury and was determined by local pathology. (NCT01856257)
Timeframe: Transplantation through Week 52

InterventionParticipants (Count of Participants)
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac1
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept1
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept0

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Count of Participants With Biopsy Proven Acute Rejection By Wk 52 Post-Transplant

Biopsy proven acute rejection definition: histologic evidence of a Banff grade of ≥1A per local pathologist. (NCT01856257)
Timeframe: Transplantation through Week 52

InterventionParticipants (Count of Participants)
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac1
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept10
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept4

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Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant

"The stages of Chronic Kidney Disease (CKD) are defined using the participant's GFR value:~Stage 1 if GFR value is ≥ 90 (kidney function is normal)~Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease)~Stage 3A if 45 <= GFR < 60*~Stage 3B if 30 <= GFR < 45*~Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function)~Stage 5 if GFR < 15 (severe or end stage kidney failure).~Stages 3A abd 3B indicate moderately reduced kidney function.*" (NCT01856257)
Timeframe: Week 52

InterventionParticipants (Count of Participants)
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac4
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept4
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept0

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Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant

Delayed grafted function is defined as dialysis in the first week on one or more occasions for any indication other than the treatment of acute hyperkalemia in the setting of otherwise acceptable renal function. (NCT01856257)
Timeframe: Transplantation through Week 52

InterventionParticipants (Count of Participants)
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac6
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept9
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept0

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Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant

"eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or end stage kidney failure." (NCT01856257)
Timeframe: Week 52

InterventionParticipants (Count of Participants)
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac21
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept15
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept6

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Count of Participants With Epstein-Barr Virus (EBV) Infection as Reported on the Case Report Form as Adverse Events

Viral infections following renal transplantation, including but not limited to EBV infection, is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. (NCT01856257)
Timeframe: Transplantation through Week 52

InterventionParticipants (Count of Participants)
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac0
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept0
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept0

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Count of Participants With Graft Rejection by Wk 52 Post-Transplant

The number of participants who were treated by their local physician for any type of rejection including, but not limited to cellular rejection and antibody- mediated rejection of the transplanted kidney regardless of the presence of a biopsy. (NCT01856257)
Timeframe: Transplantation through Week 52

InterventionParticipants (Count of Participants)
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac7
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept14
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept4

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Count of Participants With Infections Requiring Hospitalization or Systemic Therapy by Wk 52 Post-Transplant

Infections of certain types (i.e., excluding those identified in the protocol as occurring commonly in this study population) were required to be reported as a serious adverse event if they required either inpatient hospitalization or prolongation of a current hospitalization. (NCT01856257)
Timeframe: Transplantation through Week 52

InterventionParticipants (Count of Participants)
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac1
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept8
Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept2

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Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit

(NCT01872611)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac10.7
Vehicle8.9

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Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90

BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis. (NCT01872611)
Timeframe: Baseline to Day 14, and maintained through Day 90

InterventionPercentage of participants (Number)
Nepafenac48.8
Vehicle50.5

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Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)

Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis. (NCT01872611)
Timeframe: Day 0 to Day 90

InterventionPercentage of participants (Number)
Nepafenac5.9
Vehicle14.3

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Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit

(NCT01872611)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac18.7
Vehicle16.7

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Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90

(NCT01872611)
Timeframe: Baseline to Day 90

InterventionPercentage of participants (Number)
Nepafenac65.4
Vehicle65.9

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Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60

(NCT01872611)
Timeframe: Baseline to Day 60

InterventionPercentage of participants (Number)
Nepafenac68.9
Vehicle62.1

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To Assess Post Donor Lymphocyte Infusion (DLI) Chimerism

To assess the number of Participants with 100% donor chimerism at 6 months post donor lymphocyte infusion (DLI) (NCT01875237)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

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To Assess the Proportion of Patients Developing Grade I-IV Acute GvHD

To assess the proportion of patients developing grade I-IV acute GvHD by Day 28, 56, and 180 post DLI. (NCT01875237)
Timeframe: Day 28, 56, and 180 post DLI.

,
InterventionParticipants (Count of Participants)
Day 28Day 56Day 180
Transplant Only000
Transplat Plus DLI110

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To Assess the Proportions of GvHD Response Post-administration of AP1903.

To assess the proportions of GvHD complete response (CR), partial response (PR), mixed response, no response, and progression among surviving patients at Day 3, 7, 14, 28, and 56 post-administration of AP1903. (NCT01875237)
Timeframe: Day 3, 7, 14, 28, and 56 post-administration of AP1903

InterventionParticipants (Count of Participants)
Day 3 post-administration of AP190371985950Day 3 post-administration of AP190371985951Day 7 post-administration of AP190371985951Day 7 post-administration of AP190371985950Day 14 post-administration of AP190371985951Day 14 post-administration of AP190371985950Day 28 post-administration of AP190371985951Day 28 post-administration of AP190371985950Day 56 post-administration of AP190371985951Day 56 post-administration of AP190371985950
no responsecomplete responseprogressionpartial response
Transplat Plus DLI1
Transplat Plus DLI0
Transplant Only0

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To Assess the Incidence of Acute GvHD Flare After CR/PR Requiring Additional Agent for Systemic Therapy Before Day 56 Post-administration of AP1903.

"To assess participants with incidence of acute GvHD flare after CR/PR requiring additional agent (including 2.5 mg/kg/day of prednisone [or methylprednisolone equivalent of 2 mg/kg/day]) for systemic therapy before Day 56 post-administration of AP1903." (NCT01875237)
Timeframe: before Day 56 post AP1903

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

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To Assess the Incidence of GvHD Treatment Failure Post-administration of AP1903.

To assess the incidence of GvHD treatment failure, defined as no response, progression, administration of additional therapy for GvHD, or mortality post-administration of AP1903. (NCT01875237)
Timeframe: Day 3, 7, 14, 28, and 56 post-administration of AP1903.

,
InterventionParticipants (Count of Participants)
Day 3 post-administration of AP1903.Day 7 post-administration of AP1903.Day 14 post-administration of AP1903.Day 28 post-administration of AP1903.Day 56 post-administration of AP1903.
Transplant Only00000
Transplat Plus DLI11111

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Number of Participants Assessed Post Donor Lymphocyte Infusion (DLI): Disease-free Survival & Non-relapse Mortality, Chimerism and GVHD.

Participants to assess at 6 months post donor lymphocyte infusion (DLI): disease-free survival & non-relapse mortality, chimerism and GVHD (NCT01875237)
Timeframe: 6 months

,
InterventionParticipants (Count of Participants)
disease-free survivaIchimerism post DLIGVHD post DLInon-relapse mortality
Transplant Only0000
Transplat Plus DLI1110

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To Assess the Incidence of Epstein-Barr Virus -PTLD or EBV Reactivation Requiring Therapy Post DLI.

To assess the incidence of Epstein-Barr virus (EBV)-associated lymphoproliferative disorder or EBV reactivation requiring therapy post DLI. (NCT01875237)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

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To Evaluate the Safety of Donor Lymphocyte Infusion Followed by Dimerizer Drug, AP1903 by Number of Participants With Adverse Events.

To evaluate the safety of the infusion of inducible caspase 9 (BPZ-1001) modified T-cells followed by dimerizer drug, AP1903. Safety evaluated by number of participants with Adverse events. (NCT01875237)
Timeframe: up to 3.5 years

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

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Mean Rate of Change of Slow Vital Capacity (SVC) During Treatment Compared to Pre-Treatment

Vital capacity (VC), percent of predicted normal, was determined using the slow VC method. SVC measures the amount of air exhaled following a deep breath. For this test, participants hold a mouthpiece in their mouth, breathe in deeply, and breathe out as much air as they can. The test was done seated in a chair and then repeated while lying on an exam table at the Screening Visit. For all other visits, this test was done while seated in a chair. This test takes 15-20 minutes. SVC was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. SVC is a way to measure respiratory insufficiency in persons with ALS and SVC decreases as ALS progresses. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline over time. (NCT01884571)
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)

Interventionpercent predicted change per month (Mean)
Immunosuppression Regimen-0.18

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Mean Rate of Change of Hand-Held Dynamometry (HHD) During Treatment Compared to Pre-Treatment

Hand held dynamometry (HHD) is a measure of muscle strength and scores decrease as ALS progresses. Six proximal muscle groups were examined bilaterally in both upper and lower extremities. Mean and standard deviation for each muscle group are established from the initial values for each participant. Strength determinations were converted to Z scores and averaged to provide an HHD megascore. The Z-score indicates the number of standard deviations away from the mean of 0. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. HHD was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in strength over time. (NCT01884571)
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)

Interventionz-score change per month (Mean)
Immunosuppression Regimen-0.05

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Mean Rate of Change of ALSFRS-R Scores During Treatment Compared to Pre-Treatment

The ALS Functional Rating Scale - Revised (ALSFRS-R) is an ordinal rating scale (0 through 4) used to determine the ALS patient's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). Total scores range from 0 (most impaired) to 48 (normal ability). ALSFRS-R was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in ability over time. (NCT01884571)
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)

Interventionunits on a scale change per month (Mean)
Immunosuppression Regimen-0.24

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Mean Rate of Change in Grip Strength Treatment Compared to Pre-Treatment

Hand grip was measured using a study approved dynamometer to test the maximum isometric strength of the hand and forearm muscles. The grip strength of the left and right hands were analyzed together. Grip strength was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. Grip strength is a measurement of muscle strength and declines as ALS progresses. A positive value means that scores during treatment were higher than pre-treatment scores, indicating an increase in grip strength over time. (NCT01884571)
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)

Interventionpounds change per month (Mean)
Immunosuppression Regimen1.38

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Collection of Cerebrospinal Fluid for Future Analysis of Cytokine Levels

Lumbar punctures (LPs) were performed to collect cerebrospinal fluid (CSF). CSF is banked for future use to characterize immune system markers and to further the understanding of the immune factors that contribute to disease progression in ALS. Cytokines are markers of neuroinflammation and can be categorized as neurotoxic or neuroprotective. The role that cytokines play in in ALS progression is still not yet fully understood. (NCT01884571)
Timeframe: Pre-Treatment Period (two months prior to the start of treatment), Treatment Period (Months 2 and 6), Post-Treatment Period (Month 12)

InterventionParticipants (Count of Participants)
Immunosuppression Regimen29

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Collection of Blood for Future Analysis of Peripheral Blood Mononuclear Cells (PBMCs)

Blood was drawn and banked for future use in order to characterize immune system markers and further the understanding of the immune factors that contribute to disease progression in ALS. (NCT01884571)
Timeframe: Pre-Treatment Period (2 months prior to the start of treatment), Treatment Period (Day 1 and Months 1, 2, 4, 6), Post-Treatment Period (Months 8 and 12)

InterventionParticipants (Count of Participants)
Immunosuppression Regimen31

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Mean Rate of Change of T-cell Subsets in Blood Treatment Compared to Pre-Treatment

Blood was collected for ribonucleic acid (RNA) and the mean rate of decline of T-cells during the 6 month treatment period compared to the pre-treatment period was assessed (blood was collected twice during the 3-month long lead in period). The precise role that T-cells have in ALS is unknown and this study aims to further the understanding of how T-cells operate in persons with ALS. T-cell measurement is a ratio where the relative expression levels of FOXP3 messenger ribonucleic acid (mRNA) was calculated using the Comparative CT Method (ΔΔCT Method), normalizing to β-actin. Samples were obtained during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in T-cells over time. (NCT01884571)
Timeframe: Pre-Treatment Period (2 months prior to the start of treatment), Treatment Period (Day 1 and Months 1, 2, 4, 6)

Interventionfold change per month (Mean)
Immunosuppression Regimen-0.04

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Number of Participants With an Average Increase in ALSFRS-R Score of One Point Per Month

The ALS Functional Rating Scale - Revised (ALSFRS-R) is an ordinal rating scale (0 through 4) used to determine the ALS patient's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score (best of 48) from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). A clinical response is defined as a rate of change of ALSFRS-R of +6 points over 6 months (mean of +1 point per month), where typically patients with ALS have a decline in ALSFRS-R by an average of -1/month. (NCT01884571)
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)

InterventionParticipants (Count of Participants)
Immunosuppression Regimen0

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Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death

Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI146169
MPA+sCNI131147

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Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up

Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death or loss to follow-up (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI181218
MPA+sCNI170201

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Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects.

Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2 among compliant subjects. (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI6062
MPA+sCNI106102

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Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2.

Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2. (NCT01950819)
Timeframe: Month 12 is Primary, Month 24 secondary

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI489489
MPA+sCNI456443

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Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2

Incidence of tBPAR (excluding grade IA rejections) or GFR<50 mL/min/1.73m2 (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI475475
MPA+sCNI441426

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Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections

"Incidence of tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), excluding grade IA rejections. Grades for T-cell mediated rejection, with increasing severity:~Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IIA - Mild to moderate intimal arteritis~Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area~Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)" (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI6674
MPA+sCNI5355

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Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events)

"Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing severity:~Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IIA - Mild to moderate intimal arteritis~Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area~Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)" (NCT01950819)
Timeframe: Month 12 and 24

,
Interventionevents (Number)
overall number of tBPAR regardless of gradenumber of tBPAR regardless of grade days 1-90number of tBPAR regardless of grade days 91-180number of tBPAR regardless of grade days 181-360number of tBPAR regardless of grade days 361-540number of tBPAR regardless of grade days 541-720number of tBPAR regardless of grade days 721-810
EVR+rCNI14672242512112
MPA+sCNI1166314201522

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Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants)

"Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing severity:~Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IIA - Mild to moderate intimal arteritis~Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area~Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)" (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
Patient's maximum tBPAR grade : no grade (missing)Patient's maximum tBPAR grade : grade IAPatient's maximum tBPAR grade : grade IBPatient's maximum tBPAR grade : grade IIAPatient's maximum tBPAR grade : grade IIBPatient's maximum tBPAR grade : grade III
EVR+rCNI2534232196
MPA+sCNI1836172430

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Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR

Renal allograft function : mean estimated glomerular filtration rate, eGFR (NCT01950819)
Timeframe: Baseline (week 4), Month 12 and 24

,
InterventionmL/min/1.73m2 (Mean)
baseline (week 4)month 12month 24
EVR+rCNI53.1353.2952.63
MPA+sCNI52.2554.4954.91

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Renal Function Assessed by Creatinine Lab Values

Mean Renal function as assessed in clinical practice, by ceatinine values. Analysis is done without considering missing values for analysis. (NCT01950819)
Timeframe: Month 12 and 24

,
Interventionmicromol/L (Mean)
screening baseline (creatinine, micromol/L)month 12 (creatinine, micromol/L)month 24 (creatinine, micromol/L)
EVR+rCNI590.1129.8130.1
MPA+sCNI601.8128.6127.6

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Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported

Mean Renal function as used in clinical practice, using different formula for calculation of renal function than MDRD4 (our primary efficacy parameter), and other alternate formulae (e.g. CKD-EPI). Analysis is done without considering missing values for analysis. (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionmL/min/1.73m2 (Mean)
eGFR (Hoek) baseline (mL/min/1.73m2)eGFR (Hoek) month 12 (mL/min/1.73m2)eGFR (Hoek) month 24 (mL/min/1.73m2)eGFR (MDRD4) baseline (mL/min/1.73m2)eGFR (MDRD4) month 12 (mL/min/1.73m2)eGFR (MDRD4) month 24 (mL/min/1.73m2)eGFR-CKDEPI baseline (mL/min/1.73m2)eGFR-CKDEPI month 12(mL/min/1.73m2)eGFR-CKDEPI month 24 (mL/min/1.73m2)
EVR+rCNI21.3850.0849.8611.7957.5958.0711.2958.8359.39
MPA+sCNI20.1052.0052.7511.5657.5858.6811.0558.7559.95

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Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios.

Mean urinary protein and albumin excretion by treatment estimated by mean urinary protein/creatinine and urinary albumin/creatinine ratios. (NCT01950819)
Timeframe: Baseline, Month 12 and 24

,
Interventionmg/g (Mean)
albumine /creatinine ratio baselinealbumine /creatinine ratio month 12albumine /creatinine ratio month 24protein /creatinine ratio baselineprotein /creatinine ratio month 12protein /creatinine ratio month 24
EVR+rCNI1019.75150.061149.0491648.10298.557290.242
MPA+sCNI646.111111.322116.6181142.59234.698233.009

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Evolution of Renal Function, as eGFR, Over Time by Slope Analysis.

Rate of change of renal function, as eGFR, calculated using MDRD4 formula (Coresh, 2003) and adjusted by covariates. (NCT01950819)
Timeframe: Month 12 and 24

InterventionmL / min / 1.73m2 / day (Mean)
EVR+rCNI0.0001
MPA+sCNI0.0047

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Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation.

Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation. (NCT01950819)
Timeframe: Month 24

InterventionParticipants (Count of Participants)
EVR+rCNI276
MPA+sCNI152

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Incidence of Major Cardiovascular Events.

Incidence of major cardiovascular events by Preferred Term (NCT01950819)
Timeframe: Month 24

InterventionParticipants (Count of Participants)
EVR+rCNI66
MPA+sCNI86

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Incidence of Malignancies.

Incidence of malignancies. (NCT01950819)
Timeframe: Month 24

InterventionParticipants (Count of Participants)
EVR+rCNI41
MPA+sCNI39

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Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup

Incidence of composite of tBPAR or eGRF<50 mL/min/1.73m2 by subgroup (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI489489
MPA+sCNI456443

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Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events.

Incidence of cytomegalovirus and BK virus, new onset diabetes mellitus, chronic kidney disease with associated proteinuria and calcineurin inhibitor associated adverse events. (NCT01950819)
Timeframe: Month 24

,
InterventionParticipants (Count of Participants)
clinical signs of CMV infectionany BKV infectionnew onset of diabetes mellitusat least one event of interest
EVR+rCNI53103144871
MPA+sCNI132154138764

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Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection

Incidence of death, graft loss, tBPAR (treated biopsy proven acute rejection), BPAR (biopsy proven acute rejection), tAR (treated acute rejection), AR (acute rejection) and humoral rejection (aAMR : active antibody mediated rejection and cAMR: chronic antibody mediated rejection) (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
deaths month 12deaths month 24graft loss month 12graft loss month 24tBPAR month 12tBPAR month 24BPAR month 12BPAR month 24tAR month 12tAR month 24AR month 12AR month 24aAMR month 12aAMR month 24cAMR month 12cAMR month 24
EVR+rCNI203233371071181141271291451471677384913
MPA+sCNI2836283291989510411712613314461691418

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Incidence of eGFR < 50 mL/Min/1.73m2

Incidence of eGFR < 50 mL/min/1.73m2 (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI456474
MPA+sCNI424423

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Incidence of Failure on the Composite Endpoint of Graft Loss or Death.

Incidence of failure on the composite endpoint of graft loss or death. (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI5167
MPA+sCNI5465

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Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2

Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR < 50 mL/min/1.73m2 (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI497497
MPA+sCNI466457

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Tear Film Break-Up Time

Tear Film Break-Up Time measures the amount of time, in seconds, that the tear film completely coats the ocular surface after each blink. The longer the amount of time the tear film completely coats the ocular surface is considered to be better than a shorter amount of time. (NCT01977781)
Timeframe: 10 weeks

InterventionSeconds (Mean)
Tacrolimus2.6
Methylprednisolone Sodium Succinate1.0

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Schirmer Tear Test (mm)

Schirmer tear test measures the amount of tear secretion produced by a patient in millimeters (mm). Generally, the greater amounts of tear secretion is better than smaller amounts of tear secretion. The minimum value of this scale is 0 mm of tear secretion and there is no maximum value to this scale. (NCT01977781)
Timeframe: 10 weeks

Interventionmillimeter (mm) (Mean)
Tacrolimus3.5
Methylprednisolone Sodium Succinate3.5

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Ocular Surface Disease Index (OSDI) Questionnaire

The OSDI questionnaire is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate each of the dry eye symptoms on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. (NCT01977781)
Timeframe: 10 weeks

Interventionunits on a scale (Mean)
Tacrolimus42
Methylprednisolone Sodium Succinate28

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Intraocular Pressure

Intraocular pressure is the measure of the fluid pressure within the eye as measured by tonometry. Intraocular pressure is normally measured in millimeters of mercury (mmHg). The normal range for intraocular pressure is 12-20 mmHg, there is no better or worse measurement. (NCT01977781)
Timeframe: 10 weeks

Interventionmillimeters of mercury (mmHg) (Mean)
Tacrolimus16.5
Methylprednisolone Sodium Succinate17.1

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Corneal Epitheliopathy (Corneal Fluorescein Staining Using the NEI Grading Scheme)

Corneal fluorescein staining is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The corneal fluorescein staining scale ranges from 0 to 15, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy. (NCT01977781)
Timeframe: 10 weeks

Interventionunits on a scale (Mean)
Tacrolimus3.7
Methylprednisolone Sodium Succinate6.6

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Visual Acuity

Visual acuity is measured by asking subjects to read letters on a chart that consists of different rows of letters. Each row of letters corresponds to different levels of visual acuity. The Logarithm of the Minimum Angle of Resolution (LogMAR) scale generally ranges from 0 to 1, with 0 corresponding to 20/20 vision and 1 corresponding to 20/200 vision. The range from 0-1 is not absolute, however, as patients who have vision better than 20/20 or vision worse than 20/200 will score out side of the 0 to 1 range. (NCT01977781)
Timeframe: 10 weeks

InterventionLogMAR Scale (Mean)
Tacrolimus0.13
Methylprednisolone Sodium Succinate0.13

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Ocular Burning Sensation, Ocular Discharge, Ocular Redness, Ocular Itching, Foreign Body Sensation

Ocular burning sensation, ocular discharge, ocular redness, ocular Itching, and foreign body sensation were measured to evaluate the safety and tolerability of topical tacrolimus 0.05% twice a day in the treatment of patients with ocular GVHD. Safety and tolerability of topical tacrolimus 0.05% twice a day will be monitored by the occurrence of systemic and ocular adverse events in addition to symptoms directly related to the instillation or use of the investigational medication. Subjects will be monitored at each study visit for the occurrence of any adverse events found through examination or patient reports. Tolerability will be evaluated at every visit with a self-response questionnaire that assessed burning sensation, discharge, redness, itchiness, and foreign body sensation on a scale from 0 to 4 (none = 0, trace = 1, mild = 2, moderate = 3, and severe = 4). Where a higher value represents more symptoms (less tolerability). (NCT01977781)
Timeframe: 10 weeks

,
Interventionunits on a scale (Mean)
Ocular Burning SensationOcular DischargeOcular RednessOcular ItchingForeign Body Sensation
Methylprednisolone Sodium Succinate2.230.260.430.600.57
Tacrolimus3.500.161.250.500.70

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Progression Free Survival

Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first. (NCT01985126)
Timeframe: Up to 14.4 Months

Interventionmonths (Median)
Daratumumab 8 mg/kg4.86
Daratumumab 16 mg/kg3.65

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Percentage of Participants With Overall Response

Overall response defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). Per IMWG criteria, sCR: is defined as normal free light chain (FLC) ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5 % plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein plus urine M-protein level < 100mg/24 hours; PR: >= 50 % reduction of serum M-protein and reduction in 24 hour urinary M-protein by >= 90% or to <200 mg/24 hours; if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. (NCT01985126)
Timeframe: Up to 14.4 Months

Interventionpercentage of participants (Number)
Daratumumab 8 mg/kg11.1
Daratumumab 16 mg/kg29.2

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Percentage of Participants With Clinical Benefit

Clinical benefit rate defined as percentage of participants who achieved minimal response (MR) or better. MR: >=25% but <= 49% reduction of serum M-protein and reduction in urine M-protein by 50%-89%. If present at baseline 25% to 49% reduction in size of soft tissue plasmacytomas. (NCT01985126)
Timeframe: Up to 14.4 Months

Interventionpercentage of participants (Number)
Daratumumab 8 mg/kg22.2
Daratumumab 16 mg/kg34.0

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Overall Survival

Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method. (NCT01985126)
Timeframe: Approximately up to 3 years

Interventionmonths (Median)
Daratumumab 8 mg/kg19.45
Daratumumab 16 mg/kg18.60

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Duration of Response

Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in IMWG criteria. Disease progression (IMWG criteria): increase of 25 percent (%) from lowest response level in Serum M-component (the absolute increase must be >=0.5 g/dL) and/or; urine M-component (the absolute increase must be >=200 mg/24 hours) and/or; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase must be >10 milligram per deciliter (mg/dL); Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 millimole per liter [mmol/L]) that can be attributed solely to the plasma cell proliferative disorder. (NCT01985126)
Timeframe: Up to 14.4 Months

Interventionmonths (Median)
Daratumumab 8 mg/kgNA
Daratumumab 16 mg/kg7.4

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Time to Response

Time to response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). (NCT01985126)
Timeframe: Up to 14.4 Months

Interventionmonths (Median)
Daratumumab 8 mg/kg0.99
Daratumumab 16 mg/kg0.99

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Time to Disease Progression

Time to progression was defined as the number of days from the date of first dose of daratumumab to the date of first record of disease progression. (NCT01985126)
Timeframe: Up to 14.4 Months

Interventionmonths (Median)
Daratumumab 8 mg/kg4.86
Daratumumab 16 mg/kg3.71

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Graft Histology - Percentage of Participants With at Least One Borderline Lesion at Week 12 and Week 52

Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death. (NCT02005562)
Timeframe: Weeks 12 and 52

,
Interventionpercentage of participants (Number)
Week 12Week 52
Mycophenolate Mofetil, Adapted Dose7.96.4
Mycophenolate Mofetil, Fixed Dose12.45.0

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Creatinine Clearance Values Estimated With the Modification of Diet in Renal Disease (MDRD) Simplified Equation

The mean creatinine clearance values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52 estimated using the MDRD simplified equation. For males, the MDRD simplified equation was defined as MDRD (mL/min/1.73 square meters [m^2]) =186 multiplied by (*) serum creatinine in mg/L raised to the power of (^) -1.154 * age ^ -0.203. For females, the MDRD simplified equation was defined as MDRD (mL/min/1.73 m^2) = males formula * 0.742. (NCT02005562)
Timeframe: Weeks 2, 4, 6, 12, 16, 26, 39, and 52

,
InterventionmL/min/1.73 m^2 (Mean)
Week 2 (n=120,114)Week 4 (n=119,113)Week 6 (n=119,113)Week 12 (n=117,112)Week 16 (n=116,112)Week 26 (n=115,112)Week 40 (n=114,108)Week 52 (n=115,110)
Mycophenolate Mofetil, Adapted Dose40.6145.0248.1250.9350.9354.2252.2350.82
Mycophenolate Mofetil, Fixed Dose39.6041.3144.6947.6848.5249.4650.0148.88

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Creatinine Clearance Values Estimated With the Cockcroft-Gault Equation (Milliliters Per Minute [mL/Min])

The mean creatinine clearance values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52 estimated using the Cockcroft-Gault equation. (NCT02005562)
Timeframe: Weeks 2, 4, 6, 12, 16, 26, 39, and 52

,
InterventionmL/min (Mean)
Week 2 (n=120,114)Week 4 (n=119,113)Week 6 (n=119,113)Week 12 (n=117,112)Week 16 (n=116,112)Week 26 (n=115,112)Week 40 (n=114,108)Week 52 (n=115,110)
Mycophenolate Mofetil, Adapted Dose46.6851.0353.6656.5556.5560.2159.1758.29
Mycophenolate Mofetil, Fixed Dose45.2646.7349.7753.0153.4955.1856.8156.45

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Time to Occurrence of First BPAR Between Day 0 and Week 52 - Percentage of Participants With an Event

BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection at Week 12 was included in the analysis. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10% compared to BL values and BPAR of Grade ≥1 according to Banff 1997 classification at Week 12. The occurrence of the first BPAR was defined as the time from randomization to the first recorded BPAR between Day 0 and Week 52. The results of protocol biopsies at Week 12 were taken into account. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death. (NCT02005562)
Timeframe: Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52

Interventionpercentage of participants (Number)
Mycophenolate Mofetil, Adapted Dose24.6
Mycophenolate Mofetil, Fixed Dose14.9

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Time to Occurrence of First BPAR Between Day 0 and Week 52

BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection at Week 12 was included in the analysis. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10% compared to BL values and BPAR of Grade ≥1 according to Banff 1997 classification at Week 12. The occurrence of the first BPAR was defined as the time from randomization to the first recorded BPAR between Day 0 and Week 52. The results of protocol biopsies at Week 12 were taken into account. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death. (NCT02005562)
Timeframe: Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52

Interventiondays (Median)
Mycophenolate Mofetil, Adapted DoseNA
Mycophenolate Mofetil, Fixed DoseNA

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Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Before Week 12 or Acute Subclinical Rejection on Protocol Biopsy at Week 12

BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10 percent (%) compared to baseline (BL) values and BPAR of Grade greater than or equal to (≥) 1 according to Banff 1997 classification at Week 12. (NCT02005562)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Mycophenolate Mofetil, Adapted Dose24.2
Mycophenolate Mofetil, Fixed Dose19.8

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Time to Graft Loss

The median time, in days, from randomization to graft loss event. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death. (NCT02005562)
Timeframe: Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52

Interventiondays (Median)
Mycophenolate Mofetil, Adapted DoseNA
Mycophenolate Mofetil, Fixed DoseNA

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Participant Survival

Participants survival was defined as the percentage of participants living with or without a functioning graft between Weeks 0 and 52. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death. (NCT02005562)
Timeframe: Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52

Interventionpercentage of participants (Number)
Mycophenolate Mofetil, Adapted Dose98.4
Mycophenolate Mofetil, Fixed Dose98.3

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Graft Loss - Percentage of Participants With an Event

Graft loss was defined as physical loss (nephrectomy), functional loss [necessitating maintenance dialysis for greater than (>)8 weeks], retransplant or death. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death. (NCT02005562)
Timeframe: Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52

Interventionpercentage of participants (Number)
Mycophenolate Mofetil, Adapted Dose5.6
Mycophenolate Mofetil, Fixed Dose5.0

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Serum Creatinine Values [Micromoles Per Liter (µmol/L)]

The mean serum creatinine values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52. (NCT02005562)
Timeframe: Weeks 2, 4, 6, 12, 16, 26, 39, and 52

,
Interventionµmol/L (Mean)
Week 2 (n=120,114)Week 4 (n=119,113)Week 6 (n=119,113)Week 12 (n=117,112)Week 16 (n=116,112)Week 26 (n=115,112)Week 40 (n=114,108)Week 52 (n=115,110)
Mycophenolate Mofetil, Adapted Dose202.41168.92155.74140.80145.48131.73136.24148.62
Mycophenolate Mofetil, Fixed Dose201.31174.86158.96147.70148.48143.73141.89144.72

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Percentage of Participants With at Least One BPAR at Week 12 and Week 52

BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death. (NCT02005562)
Timeframe: Weeks 12 and 52

,
Interventionpercentage of participants (Number)
Week 12Week 52
Mycophenolate Mofetil, Adapted Dose14.19.1
Mycophenolate Mofetil, Fixed Dose10.010.0

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Graft Histology - Percentage of Participants With at Least One Chronic Graft Nephropathy at Week 12 and Week 52

Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death. (NCT02005562)
Timeframe: Weeks 12 and 52

,
Interventionpercentage of participants (Number)
Week 12Week 52
Mycophenolate Mofetil, Adapted Dose20.632.5
Mycophenolate Mofetil, Fixed Dose17.434.7

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Health Assessment Questionnaire-Disability Index (HAQ-DI)

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. (NCT02006706)
Timeframe: Baseline, Week 24

Interventionscore on a scale (Mean)
BaselineWeek 24
Rituximab/Methylprednisolone/MTX1.911.05

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Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24

DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale [VAS]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity. (NCT02006706)
Timeframe: Baseline, Week 24

Interventionscore on a scale (Mean)
Rituximab/Methylprednisolone/MTX2.98

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Number of Transplanted Participants Who Developed Donor- Specific Antibody After Initiation of Immunosuppression Withdrawal

Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection. (NCT02029638)
Timeframe: Initiation of Immunosuppression Withdrawal to End of Study (to 25 months)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted0

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Number of Transplanted Participants Who Developed Donor-Specific Antibody During Study Participation

Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted0

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Number of Transplanted Participants Who Died

Number of participant deaths after receiving a transplant per protocol. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted1

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Number of Transplanted Participants Who Remained Off Immunosuppression for at Least 52 Weeks, Including Those in Whom the 52 Week Biopsy Was Not Performed

Number of transplanted participants who remained off immunosuppression for ≥52 weeks, including those in whom the 52 week biopsy was not performed. This outcome included participants who were able to withdrawal successfully from all immunosuppression medication and remain off all immunosuppression for 52 weeks after the completion of withdrawal. (NCT02029638)
Timeframe: Transplant to 52 Weeks after Discontinuation of All Immunosuppression

InterventionParticipants (Count of Participants)
Enrolled, Transplanted0

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Number of Transplanted Participants With Acute Renal Allograft Rejection

Acute renal allograft rejection demonstrated either by biopsy or clinically (when a biopsy could not be performed). This measure includes participants with biopsy proven acute renal allograft rejection and those that have creatinine values 25% or greater relative to baseline for over 72 hours. Baseline serum creatinine is defined as the average of the lowest three serum creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted1

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Number of Transplanted Participants With Chronic T Cell-Mediated or Antibody-Mediated Rejection

Outcome includes participants who experienced chronic T cell-mediated rejection, antibody-mediated rejection and progressive interstitial fibrosis/tubular atrophy (IF/TA), transplant glomerulopathy or chronic obliterative arteriopathy, without an alternative, non-rejection related cause. Reference: Banff 2007 Classification Renal Allograft Pathology definition of terms. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted1

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Number of Transplanted Participants With Engraftment Syndrome

Engraftment syndrome is a complication that can occur following bone marrow transplant. The presence of engraftment syndrome is diagnosed by monitoring the common symptoms, which include: fever, rash, fluid in the lungs, and serum creatinine values above 4 mg/dL occurring within a week of absolute neutrophil recovery (e.g., first day after three consecutive daily absolute neutrophil counts ≥ 500 per µL), without apparent other cause. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted0

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Percent of Participants Who Achieved Operational Tolerance

Operational tolerance is defined as remaining off all immunosuppression 52 weeks after completion of immunosuppression withdrawal, with no evidence of biopsy-proven allograft rejection and, with acceptable renal function defined as a serum creatinine that has increased no more than 25% above baseline at the primary endpoint visit. Baseline creatinine is defined as the average of the lowest three creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval. (NCT02029638)
Timeframe: Transplantation through 52 Weeks after Discontinuation of All Immunosuppression

InterventionPercent of participants (Number)
Enrolled, Transplanted0

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Number of Days From Transplant to Platelet Count Recovery

Time (in days) from transplant to the first day of a platelet count of ≥20,000 per μL without a prior platelet transfusion in the preceding seven days. Low platelet numbers is associated with increased risk of bleeding and bruising. A healthy person has a platelet count ranging from 150,000 to 450,000 platelets per microliter of blood. (NCT02029638)
Timeframe: Transplant to Platelet Count Recovery

InterventionDays (Mean)
Enrolled, Transplanted36

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Duration in Days of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy

AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Time (in days) from the start date of the AE until the end date of the AE. Two events contributed to this calculation. (NCT02029638)
Timeframe: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)

InterventionDays (Mean)
Enrolled, Transplanted9.5

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Duration in Days of Graft-versus-Host Disease in Transplanted Participants

Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. Duration (in days) is measured as the time from the start of the GVHD event to the end of the GVHD event. (NCT02029638)
Timeframe: Transplant to Two Years Post-Transplant

InterventionDays (Mean)
Enrolled, Transplanted7

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Number of Days From Neutrophil Nadir to Absolute Neutrophil Recovery

Time (in days) from neutrophil nadir, the first day post-transplant on which the absolute neutrophil count (ANC) is below 500 per µL, to the first day after three consecutive daily ANCs ≥ 500 per µL. ANC is a measure of the number of neutrophils present in the blood. Neutrophils are a type of white blood cell that fight against infection. A healthy person has an ANC between 2,500 and 6,000 per µL. A value below 500 per µL means the risk of infection is higher. (NCT02029638)
Timeframe: Post-Transplant Neutrophil Nadir to Neutrophil Recover

InterventionDays (Mean)
Enrolled, Transplanted15

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Number of Days Post-Transplant to the First Episode of Acute Rejection Requiring Treatment

Number of days post-transplant to the first episode of acute rejection that required treatment. This includes acute rejection episodes requiring treatment that were not biopsy proven. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

InterventionDays (Mean)
Enrolled, Transplanted23

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Number of Participants Experiencing an Incidence of Graft-versus-Host Disease Post-Transplant

Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. (NCT02029638)
Timeframe: Transplant to Two Years Post-Transplant

InterventionParticipants (Count of Participants)
Enrolled, Transplanted1

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Number of Participants Free From Return to Immunosuppression for the Duration of the Study

Participants who were able to withdrawal successfully from all immunosuppression medication and remained off all immunosuppression medication for the remainder of the study. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 Months)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted0

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Number of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy

AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. (NCT02029638)
Timeframe: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)

,
InterventionEvents (Number)
InfectionWound complicationsPost-transplant diabetesHemorrhagic cystitisMalignancy
Enrolled, Not Transplanted00000
Enrolled, Transplanted20000

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Number of Adverse Events (AEs) by Severity- Including Infection, Wound Complications, Post-Transplant Diabetes, Hemorrhagic Cystitis and Malignancy

AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0. (NCT02029638)
Timeframe: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)

,
InterventionEvents (Number)
Grade 1Grade 2Grade 3Grade 4Grade 5
Enrolled, Not Transplanted00000
Enrolled, Transplanted00200

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Histological Severity of Biopsies Demonstrating Acute Rejection as Defined by Banff 2007 Classification Renal Allograft Pathology

This outcome includes results from biopsies with proven acute renal allograft rejection according to the 2007 Banff Classification Renal Allograft Pathology. A Banff result of indeterminate is not classified as rejection. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

Interventionparticipants (Number)
Acute Cellular Rejection Banff Grade IAAcute Cellular Rejection Banff Grade IBAcute Cellular Rejection Banff Grade IIAAcute Cellular Rejection Banff Grade IIBAcute Cellular Rejection Banff Grade IIIAcute Antibody Mediated Rejection
Enrolled, Transplanted000000

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BCTQ Functional Limitations Subscale 6 Months

Comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection1.91
Wrist Splint1.89

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BCTQ Functional Limitations Subscale 6 Months (CC)

Sensitivity analysis for comparison of BCTQ function limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection1.85
Wrist Splint1.88

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention)

Subgroup analysis was performed in patients who did not state a preference of intervention. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.03
Wrist Splint2.26

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Hand-wrist Pain Intensity 6 Weeks (CC)

Sensitivity analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (scale 0-10, higher score indicates more pain) on participants with complete data. (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection3.33
Wrist Splint4.28

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Hand-wrist Pain Intensity 6 Weeks (PP)

Per protocol analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (higher score indicates more pain) on participants with complete data. (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection3.33
Wrist Splint4.44

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NHS Cost Differences at 6 Months

Cost of interventions at 6 months (NCT02038452)
Timeframe: 6 months

InterventionUK Pounds (Mean)
Steroid Injection346.78
Wrist Splint313.24

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Hand-wrist Pain Intensity 6 Months (PP)

Per protocol analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data. (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection4.11
Wrist Splint3.38

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Hand-wrist Pain Intensity 6 Months (CC)

Sensitivity analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data. (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection4.11
Wrist Splint3.29

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Hand-wrist Pain Intensity 6 Months

Comparison of pain scores between treatment groups at 6 months follow-up. 0-10 scale, higher score indicates more pain. (NCT02038452)
Timeframe: 6 months

Interventionunits on a scale (Mean)
Steroid Injection4.32
Wrist Splint3.46

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Hand-wrist Pain Intensity Over 24 Months: 24 Months

Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 24 months. (NCT02038452)
Timeframe: 24 months

Interventionscore on a scale (Mean)
Steroid Injection2.81
Wrist Splint2.40

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BCTQ Symptom Severity Subscale 6 Weeks (PP)

"Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ:~Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.07
Wrist Splint2.44

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference)

Subgroup analysis was performed in patients who did not receive the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.15
Wrist Splint2.40

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP))

Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.96
Wrist Splint2.28

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC))

Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.95
Wrist Splint2.29

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Hand-wrist Pain Intensity Over 24 Months: 6 Months

Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 months. (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection4.11
Wrist Splint3.29

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Hand-wrist Pain Intensity Over 24 Months: 6 Weeks

Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 weeks. (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection3.33
Wrist Splint4.28

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BCTQ Symptom Severity and Functional Limitations 6 Months (PP)

Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.09
Wrist Splint2.02

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BCTQ Symptom Severity and Functional Limitations 6 Months (CC)

Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.08
Wrist Splint2.04

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BCTQ Symptom Severity and Functional Limitations 6 Months

Comparison of overall BCTQ between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.15
Wrist Splint2.06

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection)

Subgroup analysis was performed in patients who preferred injection. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.88
Wrist Splint2.40

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NHS Cost Differences at 12 Months

Cost of interventions at 12 months (NCT02038452)
Timeframe: 12 months

InterventionUK Pounds (Mean)
Steroid Injection508.69
Wrist Splint395.54

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BCTQ Functional Limitations Subscale 6 Weeks (PP)

"Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data.~BCTQ: Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.88
Wrist Splint2.06

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BCTQ Functional Limitations Subscale 6 Weeks (CC)

Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.86
Wrist Splint2.10

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BCTQ Functional Limitations Subscale 6 Weeks

Comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (1-5 scale, higher score indicates more severe functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.88
Wrist Splint2.09

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BCTQ Functional Limitations Subscale 6 Months (PP)

Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection1.89
Wrist Splint1.84

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint)

Subgroup analysis was performed in patients who preferred splint. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.15
Wrist Splint2.40

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference)

Subgroup analysis was performed in patients who were allocated the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.88
Wrist Splint2.19

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BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months

Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment). Results are presented at 12 months. BCTQ: Boston Carpal Tunnel Questionnaire. (NCT02038452)
Timeframe: 12 months

Interventionscore on a scale (Mean)
Steroid Injection1.98
Wrist Splint2.05

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BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months

Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up. Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 months. BCTQ: Boston Carpal Tunnel Questionnaire. (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.08
Wrist Splint2.04

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BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks

Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 weeks. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.95
Wrist Splint2.30

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BCTQ Symptom Severity Subscale 6 Months (PP)

"Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ:~Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.28
Wrist Splint2.15

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BCTQ Symptom Severity Subscale 6 Months

Comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.33
Wrist Splint2.18

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NHS Cost Differences at 24 Months

Cost of interventions at 24 months (NCT02038452)
Timeframe: 24 months

InterventionUK Pounds (Mean)
Steroid Injection657.87
Wrist Splint586.77

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BCTQ Symptom Severity Subscale 6 Months (CC)

"Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ:~Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.29
Wrist Splint2.16

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Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks

Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.02
Wrist Splint2.29

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Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months

Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 24 months. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 24 months

Interventionscore on a scale (Mean)
Steroid Injection1.79
Wrist Splint1.73

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QALYS at 6 Months (Cross-walk Tariff)

"The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score.~Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values." (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection0.354
Wrist Splint0.356

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QALYS at 24 Months (Cross-walk Tariff)

"The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score.~Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values." (NCT02038452)
Timeframe: 24 months

Interventionscore on a scale (Mean)
Steroid Injection1.461
Wrist Splint1.497

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QALYS at 12 Months (Cross-walk Tariff)

"The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score.~Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values." (NCT02038452)
Timeframe: 12 months

Interventionscore on a scale (Mean)
Steroid Injection0.723
Wrist Splint0.736

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NHS Cost Differences at 6 Months (CC)

Complete case analysis on the cost of interventions at 6 months (NCT02038452)
Timeframe: 6 months

InterventionUK Pounds (Mean)
Steroid Injection353.48
Wrist Splint306.42

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BCTQ Symptom Severity Subscale 6 Weeks

Comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.12
Wrist Splint2.43

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BCTQ Symptom Severity Subscale 6 Weeks (CC)

"Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ:~Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.07
Wrist Splint2.44

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Hand-wrist Pain Intensity Over 24 Months: 12 Months

Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 12 months. (NCT02038452)
Timeframe: 12 months

Interventionscore on a scale (Mean)
Steroid Injection3.17
Wrist Splint3.14

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Hand-wrist Pain Intensity 6 Weeks

Comparison of pain scores between treatment groups at 6 weeks follow-up (0-10 scale, higher score indicates more pain). (NCT02038452)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Steroid Injection3.42
Wrist Splint4.28

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Percentage of Participants With ACR20 Response After Third Course

A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after third course of rituximab (median duration of 162.9 weeks)

Interventionpercentage of participants (Number)
Rituximab73.2

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Percentage of Participants Who Discontinued Treatment Due to Insufficient Response

(NCT02093026)
Timeframe: First, second, third, fourth, fifth, sixth, and seventh course of rituximab (up to a median of approximately 2, 62, 124, 186, 248, 310, and 372 weeks, respectively)

Interventionpercentage of participants (Number)
First courseSecond courseThird courseFourth courseFifth courseSixth courseSeventh course
Rituximab1.12.32.02.00.80.00.6

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Percentage of Participants With ACR50 and ACR70 Response

A participant had an ACR50 and ACR70 response if there was at least a 50% or 70% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of disease activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (CRP or ESR). The ACR50 and ACR70 responses were compared to Baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)

Interventionpercentage of participants (Number)
ACR50: 24 weeks after first courseACR50: 24 weeks after second courseACR50: 24 weeks after third courseACR50: 24 weeks after fourth courseACR50: 24 weeks after fifth courseACR50: 24 weeks after sixth courseACR50: 24 weeks after seventh courseACR70: 24 weeks after first courseACR70: 24 weeks after second courseACR70: 24 weeks after third courseACR70: 24 weeks after fourth courseACR70: 24 weeks after fifth courseACR70: 24 weeks after sixth courseACR70: 24 weeks after seventh course
Rituximab39.441.944.846.940.040.036.516.321.620.020.018.920.918.9

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Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR

DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (millimeters per hour [mm/hour]), and Patient's Global Assessment of Disease Activity (VAS: 0=no disease activity to 100=maximum disease activity). DAS28-ESR = 0.56*square root (sqrt)(TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*Patient's Global Assessment of Disease Activity. Total score range: 0-10, higher score=more disease activity. DAS28-ESR <= 3.2 implied low disease activity (LDA) and DAS28-ESR <2.6 = clinical remission. (NCT02093026)
Timeframe: 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)

Interventionpercentage of participants (Number)
LDA: 24 weeks after first courseLDA: 24 weeks after second courseLDA: 24 weeks after third courseLDA: 24 weeks after fourth courseLDA: 24 weeks after fifth courseLDA: 24 weeks after sixth courseLDA: 24 weeks after seventh courseRemission: 24 weeks after first courseRemission: 24 weeks after second courseRemission: 24 weeks after third courseRemission: 24 weeks after fourth courseRemission: 24 weeks after fifth courseRemission: 24 weeks after sixth courseRemission: 24 weeks after seventh course
Rituximab24.330.129.328.023.827.324.711.316.817.115.715.717.313.7

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Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 24 Weeks Following Each Course

The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement. (NCT02093026)
Timeframe: 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)

Interventionunits on a scale (Mean)
24 weeks after first course24 weeks after second course24 weeks after third course24 weeks after fourth course24 weeks after fifth course24 weeks after sixth course24 weeks after seventh course
Rituximab-0.51-0.48-0.43-0.47-0.44-0.38-0.37

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Percentage of Participants With ACR20 Response After Seventh Course

A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after seventh course of rituximab (median duration of 406.7 weeks)

Interventionpercentage of participants (Number)
Rituximab59.5

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Percentage of Participants With ACR20 Response After Second Course

A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after second course of rituximab (median duration of 90.9 weeks)

Interventionpercentage of participants (Number)
Rituximab70.8

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Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response After First Course

A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in tender joint count (TJC) and swollen joint count (SJC) (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either C-reactive protein [CRP] or erythrocyte sedimentation rate [ESR]). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after first course of rituximab (up to approximately 26 weeks)

Interventionpercentage of participants (Number)
Rituximab67.1

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Percentage of Participants With ACR20 Response After Fourth Course

A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after fourth course of rituximab (median duration of 232 weeks)

Interventionpercentage of participants (Number)
Rituximab75.1

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Percentage of Participants With ACR20 Response After Fifth Course

A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after fifth course of rituximab (median duration of 297.3 weeks)

Interventionpercentage of participants (Number)
Rituximab69.7

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American College of Rheumatology Index of Improvement (ACRn) Response

The ACRn is calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (patient's assessment of disease activity; patient's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value [either CRP or ESR]). The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA. ACRn scores were calculated considering the original baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)

Interventionunits on a scale (Mean)
24 weeks after first course24 weeks after second course24 weeks after third course24 weeks after fourth course24 weeks after fifth course24 weeks after sixth course24 weeks after seventh course
Rituximab31.0734.1536.9339.5933.7629.7424.87

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Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'

DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and Physician's Global Assessment of Disease Activity (VAS: 0=no disease activity to 100=maximum disease activity). DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*Patient's Global Assessment of Disease Activity. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with a DAS28 score less than or equal to (≤) 3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to less than or equal to (≤) 5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1. (NCT02093026)
Timeframe: 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)

Interventionpercentage of participants (Number)
Moderate: 24 weeks after first courseModerate: 24 weeks after second courseModerate: 24 weeks after third courseModerate: 24 weeks after fourth courseModerate: 24 weeks after fifth courseModerate: 24 weeks after sixth courseModerate: 24 weeks after seventh courseGood: 24 weeks after first courseGood: 24 weeks after second courseGood: 24 weeks after third courseGood: 24 weeks after fourth courseGood: 24 weeks after fifth courseGood: 24 weeks after sixth courseGood: 24 weeks after seventh course
Rituximab57.858.559.560.962.157.060.024.330.429.127.924.327.125.7

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Percentage of Participants With ACR20 Response After Sixth Course

A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after sixth course of rituximab (median duration of 354.4 weeks)

Interventionpercentage of participants (Number)
Rituximab68.2

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Time Since Last Treatment Course

Time since last treatment course = The last day of the last dose of rituximab to date of last contact. Date of last contact is the last available date of efficacy, complete medication start date, laboratory, adverse event assessments, early withdrawal visit, date of last contact, or date of death. (NCT02093026)
Timeframe: Baseline up to 10 years

Interventionyears (Mean)
Rituximab4.21

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Number of Participants With Overall Response Rate (CR + PR)

Overall response rate (CR + PR) at day 28. Partial Response (PR) is defined as improvement in one or more organs involved with GVHD symptoms without progression in others. For a response to be scored as PR on day 28, the patient must be in PR on day 28 and have had no intervening non-study therapy for acute GVHD. (NCT02133924)
Timeframe: Day 28

InterventionParticipants (Count of Participants)
Participants With High Risk Acute Graft-Versus-Host Disease45

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Number of Participants With Complete Response (CR)

The primary endpoint for this clinical study is the proportion of complete response, CR (that is, the percent of patients with skin, liver, and GI GVHD - all stage 0) at day 28 of study treatment. Stage 0 = no rash, total bilirubin <2 mg/dl, diarrhea <500 ml/d (NCT02133924)
Timeframe: Day 28

InterventionParticipants (Count of Participants)
Participants With High Risk Acute Graft-Versus-Host Disease34

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Number of Participants Who Received Additional GVHD Therapies

Number of participants who received additional GVHD therapies (defined as the initiation of a new acute GVHD therapy, regardless of duration) (NCT02133924)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Participants With High Risk Acute Graft-Versus-Host Disease33

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Number of Participants With Non-Relapse Mortality (NRM)

Number of participants with Non-Relapse Mortality (NRM) at 6 months and 1 year (NCT02133924)
Timeframe: 6 months and 1 year

InterventionParticipants (Count of Participants)
6 months1 year
Participants With High Risk Acute Graft-Versus-Host Disease2528

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Time to Discontinuation of Steroid Therapy

Time in days to discontinuation of steroid therapy. (NCT02133924)
Timeframe: up to 365 days

Interventiondays (Median)
Participants With High Risk Acute Graft-Versus-Host Disease108

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Number of Serious Infections

Number of serious infections (defined as score 3 by the Blood and Marrow Transplant Clinical Trials Network) (NCT02133924)
Timeframe: 6 months

Interventionevents (Number)
Participants With High Risk Acute Graft-Versus-Host Disease52

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Number of Participants With SR GVHD

Number of participants with steroid-refractory (SR) GVHD to express cumulative incidence of treatment-refractory GVHD (defined as absence of CR or PR on day 28 of treatment or who receive additional immunosuppression prior to day 28) (NCT02133924)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Participants With High Risk Acute Graft-Versus-Host Disease30

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Number of Participants With Overall Survival (OS)

Number of participants with overall survival at 1 year (NCT02133924)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Participants With High Risk Acute Graft-Versus-Host Disease37

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Absolute Values of Fasting Lipid Values: Mean

"Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following:~Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)" (NCT02137239)
Timeframe: Up to 24 Months

,
Interventionmg/dL (Mean)
TC Month 3TC Month 6TC Month 12TC Month 24HDL Month 3HDL Month 6HDL Month 12HDL Month 24LDL Month 3LDL Month 6LDL Month 12LDL Month 24TG Month 3TG Month 6TG Month 12TG Month 24
Treatment A181.2197.7189.0193.250.646.449.450.196.9115.2107.597.9171.6180.0162.4263.4
Treatment B174.4175169.9168.250.453.949.651.396.593.788.091.5137.8138.3161.3145.0

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Percentage of Participants With Serious Adverse Events (SAEs)

Percentage of participants with SAEs up to 24 months post-transplant (NCT02137239)
Timeframe: Up to 24 months Post-Transplant

InterventionPercentage of participants with SAEs (Number)
Treatment A52.0
Treatment B60.6

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Percentage of Participants With Adverse Events (AEs)

Percentage of participants with AEs up to 24 months post-transplant (NCT02137239)
Timeframe: Up to 24 months Post-Transplant

InterventionPercentage of participants with AEs (Number)
Treatment A100.0
Treatment B97.0

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Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months

Number of Participants with Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6 Months (NCT02137239)
Timeframe: 6 Months

InterventionPercentage of participants (Number)
Treatment A7.7
Treatment B9.4

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Absolute Values of Fasting Lipid Values: Median

"Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following:~Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)" (NCT02137239)
Timeframe: Up to 24 Months

,
Interventionmg/dL (Median)
TC Month 3TC Month 6TC Month 12TC Month 24HDL Month 3HDL Month 6HDL Month 12HDL Month 24LDL Month 3LDL Month 6LDL Month 12LDL Month 24TG Month 3TG Month 6TG Month 12TG Month 24
Treatment A167.0187.0184.0193.045.045.550.049.089.099.5104.0103.5147.0157.5154.0159.0
Treatment B173.0178.0171.5166.049.049.047.049.095.0100.091.586.0128.0126.0130.0114.0

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Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months

"Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6, 12 and 24 Months~Change in the incidence of CSBPAR at 6, 12 and 24 months post transplant, in the belatacept + EVL(Treatment A) as compared to TAC + MMF (Treatment B)." (NCT02137239)
Timeframe: Up to 24 Months

,
InterventionPercentage of CSBPAR (Number)
CSBPAR at 6 MonthsCSBPAR at 12 monthsCSBPAR at 24 Months
Treatment A7.711.515.4
Treatment B9.412.512.5

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Mean and Mean Change From Baseline in Blood Glucose

Mean fasting blood glucose levels, and mean changes from baseline values at Months 6, 12 and 24 months post- transplant (NCT02137239)
Timeframe: Up to 24 months

,
Interventionmg/dL (Mean)
Mean Value at 6 monthsChange from baseline at 6 monthsMean Value at 12 monthsChange from baseline at 12 monthsMean Value at 24 monthsChange from baseline at 24 months
Treatment A107.24.9101.1-1.3127.522.3
Treatment B107.24.8127.520.6111.815.0

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Urine Protein Creatinine Ratio (UPr/Cr)

Urine protein to creatinine ratio (UPr/Cr) at 3, 6, 12 and 24 months post-transplant. (NCT02137239)
Timeframe: Up 24 Months post-transplant

,
Interventionmg Protein/mg Creatinine (Mean)
At 3 MonthsAt 6 MonthsAt 12 MonthsAt 24 Months
Treatment A0.31460.38960.28350.3940
Treatment B0.14120.14610.18490.1685

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Treatment Differences in Therapeutic Modalities

Treatment Received for Biopsy Proven Acute Rejection (Banff Grade IA or Higher), or Humoral (Antibody Mediated) Rejection Treatment regimen: Categorical analysis of CSBPAR episodes by treatment received. (NCT02137239)
Timeframe: at 6, 12 and 24 Months

,
InterventionPercentage of participants with CSBPARs (Number)
Corticosteroids (6 months)Lymphocyte depleting agent (6 months)Plasmapheresis (6 months)IVIG (6 months)Rituximab (6 months)Corticosteroids (12 months)Lymphocyte depleting agent (12 months)Plasmapheresis (12 months)IVIG (12 months)Rituximab (12 months)Corticosteroids (24 months)Lymphocyte depleting agent (24 months)Plasmapheresis (24 months)IVIG (24 months)Rituximab (24 months)
Treatment A7.7000015.43.800019.23.8000
Treatment B9.46.303.1012.56.303.1012.56.303.10

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Time to Event: Graft Loss and Death

The Number of days to participant Graft Loss and death for any reason (NCT02137239)
Timeframe: Up to 728 Days

,
InterventionDays (Number)
Graft Loss
Treatment A107
Treatment B2

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Percentage of Particpants With Laboratory Test Abnormalities (LTAs)

Percentage of participants with laboratory tests with marked laboratory abnormalities (NCT02137239)
Timeframe: At 24 Months

,
InterventionPercentage of participants (Number)
Hemoglobin (Low)Leukocytes (low)Lymphocyte (Absolute) (low)Neutrophils (Absolute) (low)Aspartate Aminotransferase (High)Creatinine (High)Inorganic Phosphorus (low)Potassium (high)Sodium (low)Albumin (low)Glucose (high)Triglycerides (high)Uric Acid (high)
Treatment A12.0084.004.016.024.04.04.008.012.08.0
Treatment B6.13.069.73.003.012.1003.012.100

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Percentage of Participants With New Onset Diabetes After Transplant

Percentage of participants with New Onset Diabetes After Transplantation (NODAT) at 6, 12, and 24 months post-transplant. (NCT02137239)
Timeframe: up to 24 months

,
InterventionPercentage of participants (Number)
Up to 6 MonthsUp to 12 MonthsUp to 24 Months
Treatment A11.511.515.4
Treatment B6.36.312.5

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Mean and Mean Change From Baseline in Whole Blood HbA1c

Mean whole blood HbA1C concentrations, and mean changes from baseline values at Months 6, 12 and 24 months post-transplant. (NCT02137239)
Timeframe: Up to 24 months

,
Interventionmg/dL (Mean)
Mean Value at 6 monthsChange from baseline at 6 monthsMean Value at 12 monthsChange from baseline at 12 monthsMean Value at 24 monthsChange from baseline at 24 months
Treatment A6.110.346.180.476.240.66
Treatment B6.130.486.210.326.290.41

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Mean Change From Month 3 in cGFR

The mean change from Month 3 cGFR at 3, 6, 12 and 24 months post-transplant (NCT02137239)
Timeframe: Up 24 Months post-transplant

,
InterventionmL/min/1.73 m^2 (Mean)
At 3 MonthsAt 6 MonthsAt 12 MonthsAt 24 Months
Treatment A0-3.2-3.13.1
Treatment B02.81.46.3

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Mean Changes From Baseline Values for Blood Pressure

Mean changes from baseline values for SBP and DBP at 6, 12 and 24 months post-transplant (NCT02137239)
Timeframe: Up to 24 Months

,
InterventionmmHg (Mean)
Diastolic Month 6Systolic Month 6Diastolic Month 12Systolic Month 12Diastolic Month 24Systolic Month 24
Treatment A1.0-4.02.3-1.10.9-2.3
Treatment B4.8-0.75.4-3.22.1-4.2

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Mean Changes From Baseline Values of Lipid Values

"Mean changes from baseline values in the following:~Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)" (NCT02137239)
Timeframe: at months 12 and 24

,
Interventionmg/dL (Mean)
TC Month 12TC Month 24HDL Month 12HDL Month 24LDL Month 12LDL Month 24TG Month 12TG Month 24
Treatment A25.726.65.46.225.717.43.3106.8
Treatment B-2.810.01.94.810.815.7-86.1-13.6

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Median Calculated Glomerular Filtration Rate (cGFR)

Median cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula (NCT02137239)
Timeframe: Up 24 Months post-transplant

,
InterventionmL/min/1.73 m^2 (Median)
At 3 MonthsAt 6 MonthsAt 12 MonthsAt 24 Months
Treatment A64.064.066.073.5
Treatment B62.067.062.568.0

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Number of Participants Deaths Post Transplant

Number of participant deaths at 6, 12 and 24 months post transplant (NCT02137239)
Timeframe: up to 24 months

,
InterventionParticipants (Count of Participants)
At 6 MonthsAt 12 MonthsAt 24 Months
Treatment A000
Treatment B000

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Number of Participants Who Experience Graft Loss Post Transplant

Number of all participants who experience graft loss at 6, 12 and 24 months post transplant (NCT02137239)
Timeframe: At 6, 12 and 24 months

,
InterventionParticipants (Count of Participants)
At 6 MonthsAt 12 MonthsAt 24 Months
Treatment A111
Treatment B111

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Number of Participants Who Survive With a Functioning Graft

Number of all participants who survive with a functioning graft at 6, 12 and 24 months post transplant (NCT02137239)
Timeframe: At 6, 12 and 24 months

,
InterventionParticipants (Count of Participants)
At 6 MonthsAt 12 MonthsAt 24 Months
Treatment A252525
Treatment B313131

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Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection

"Treatment differences in the severity grades to treat all episodes of CSBPAR at 6, 12, and 24 months post-transplant.~Type 1A - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/Tubular cross section or group of 10 Tubular cell). Type 1B - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/Tubular cross section or group of 10 Tubular cell).Type 2A - Cases with mild to moderate intimal arteritis.Type 2B - Cases with severe intimal arteritis comprising >25% of the luminal area. Type 3 - Cases with transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (v3 with accompanying lymphocytic inflammation)" (NCT02137239)
Timeframe: At 6, 12 and 24 Months

,
InterventionPercentage of Participants (Number)
6 Months: Mild Acute (1A)6 Months: Mild Acute (1B)6 Months: Moderate Acute (2A)6 Months: Moderate Acute (2B)6 Months: Severe Acute12 Months: Mild Acute (1A)12 Months: Mild Acute (1B)12 Months: Moderate Acute (2A)12 Months: Moderate Acute (2B)12 Months: Severe Acute24 Months: Mild Acute (1A)24 Months: Mild Acute (1B)24 Months: Moderate Acute (2A)24 Months: Moderate Acute (2B)24 Months: Severe Acute
Treatment A3.807.7007.707.70011.507.700
Treatment B03.16.3003.13.16.3003.13.16.300

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Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)

Characterization of any de novo DSA detected by IgM and IgG subclasses, and by the presence or absence of complement fixing properties. (NCT02137239)
Timeframe: Up to 24 Months

,
InterventionPercentage (Number)
Baseline Class 1 DSABaseline Class 2 DSABaseline Both Class 1 and 2 DSADe Novo 12 Month Class 1 DSADe Novo 12 Month Class 2 DSADe Novo 12 Month Both Class 1 and 2 DSADe Novo 24 Month Class 1 DSADe Novo 24 Month Class 2 DSADe Novo 24 Month Both Class 1 and 2 DSA
Treatment A1000000000
Treatment B0000003.4500

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Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)

Percentage of participants with, and titers of pre-existing (pre-transplant) DSA on Day 1 (pre-transplant, pre-dose), and at Months 12 and 24 posttransplant (NCT02137239)
Timeframe: Up to 24 Months

,
InterventionPercentage of Participants (Number)
Baseline Class 1 DSABaseline Class 2 DSABaseline Both Class 1 and 2 DSA12 Month Class 1 DSA12 Month Class 2 DSA12 Month Both Class 1 and 2 DSA24 Month Class 1 DSA24 Month Class 2 DSA24 Month Both Class 1 and 2 DSA
Treatment A10008.00008.0000
Treatment B00003.0303.033.030

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Percentage of Participants With Events of Special Interest (ESIs)

"Percentage of participants which have one of the following events of special interest:~Serious Infections Post-Transplant Lymphoproliferative Disorder (PTLD) Progressive multifocal leukoencephalopathy (PML) Malignancies (Other than PTLD) including non-melanoma skin carcinomas (Malignancies) Tuberculosis Infections Central Nervous System (CNS) Infections Viral Infections Infusion Related reactions within 24 hours since belatacept infusion" (NCT02137239)
Timeframe: Up to 24 Months

,
InterventionPercentage of participants with ESIs (Number)
Serious InfectionsPTLDPMLMalignanciesTBCNS InfectionsViral InfectionsInfusion Related Reactions
Treatment A164.004.00001
Treatment B15.23.003.00000

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Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR).

Time to Clinically suspected biopsy proven acute rejection (NCT02137239)
Timeframe: Up to 24 Months

InterventionMonths (Mean)
Treatment ANA
Treatment BNA

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Absolute Calculated Glomerular Filtration Rate (cGFR): Mean

Absolute (mean and median) cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula (NCT02137239)
Timeframe: Up 24 Months post-transplant

,
InterventionmL/min/1.73 m^2 (Mean)
At 3 MonthsAt 6 MonthsAt 12 MonthsAt 24 Months
Treatment A69.266.066.271.8
Treatment B62.263.962.068.7

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Absolute Values of Blood Pressure: Mean

Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant; (NCT02137239)
Timeframe: Up to 24 Months

,
InterventionmmHg (Mean)
Diastolic Month 3Systolic Month 3Diastolic Month 6Systolic Month 6Diastolic Month 12Systolic Month 12Diastolic Month 24Systolic Month 24
Treatment A78.7134.277.4128.178.7131.078.1130.9
Treatment B77.7131.079.4133.080.1131.078.5131.7

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Absolute Values of Blood Pressure: Median

Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant; (NCT02137239)
Timeframe: Up to 24 Months

,
InterventionmmHg (Median)
Diastolic Month 3Systolic Month 3Diastolic Month 6Systolic Month 6Diastolic Month 12Systolic Month 12Diastolic Month 24Systolic Month 24
Treatment A78.5135.575.5127.077.0130.078.0130.0
Treatment B80.0131.080.0131.081.0126.079.0130.0

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Percentage of Participants With Allograft Survival

Allograft survival is defined as functioning renal transplant. (NCT02152345)
Timeframe: Up to 1 year post-transplantation

InterventionParticipants (Count of Participants)
Belatacept Immunosuppression24
Standard Immunosuppression (Tacrolimus)21

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Number of Participants With Delayed Graft Function (DGF)

"To assess whether treatment with Thymoglobulin induction and belatacept based maintenance immunosuppression would reduce delayed graft function (DGF) rates among recipients of deceased donor renal transplants as measured by clinical findings and NGAL marker, as specified below and defined by others. This will be compared to the incidence of DGF in patients treated with a Tacrolimus based regimen.~Patients who require hemodialysis in the first 7 days after transplantation and/or patients whose serum creatinine decreases <10% during 3 consecutive days after the transplant will be considered to have DGF in the absence of other confounding factors such as obstruction or infection. NGAL will be used as a verification marker of DGF." (NCT02152345)
Timeframe: Up to 3 months post-transplantation

InterventionParticipants (Count of Participants)
Belatacept Immunosuppression12
Standard Immunosuppression (Tacrolimus)15

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Number of Participants With an Allograft Rejection Episode

All rejection episodes will be confirmed by renal transplant biopsy provoked by change in renal function not explained by other clinical causes. (NCT02152345)
Timeframe: Up to 1 year post-transplantation

InterventionParticipants (Count of Participants)
Belatacept Immunosuppression7
Standard Immunosuppression (Tacrolimus)11

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Estimated Glomerular Filtration Rate (eGFR)

Estimated glomerular filtration rate (eGFR) is based on a blood sample (serum creatinine value), age, race, and gender. eGFR estimates best the function of the kidney at any one time. (NCT02152345)
Timeframe: Up to 1 year post-transplantation

InterventionmL/min/1.73m^2 (Mean)
Belatacept Immunosuppression46
Standard Immunosuppression (Tacrolimus)41

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Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale

"The percentages of patients experiencing grade 3+ peripheral neuropathy assessed by the treating clinician using the modified Balis scale. The Modified Balis scale of Pediatric Neuropathy allows clinicians to assign a score for sensory or motor neuropathy symptoms separately. Scores range from 1 to 4 with 1 being the least symptomatic state and 4 indicating a severe debility. The percentages of patients (with a score >/=3) will be compared between the 2 arms by two-sample Z test at 1-sided alpha level of 0.05." (NCT02166463)
Timeframe: From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.

InterventionPercentage of patients (Number)
Arm I (ABVE-PC)5.5
ARM II (Bv-AVEPC)6.7

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Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review

The percentages of patients (with available PET scan) with no SRL and no PD will be compared between the two randomized arms to see if brentuximab vedotin in the chemotherapy backbone of doxorubicin hydrochloride, vincristine sulfate, etoposide, prednisone and cyclophosphamide (Bv-AVEPC) arm has a higher rate of early response compared to doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide (ABVE-PC) arm. Two-sample Z test of proportions at 1-sided alpha level of 0.05 will be used for these comparisons. (NCT02166463)
Timeframe: After 42 days of chemotherapy

InterventionPercentage of patients (Number)
Arm I (ABVE-PC)80.7
ARM II (Bv-AVEPC)81.2

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Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death

Primary analysis will be based 1-sided log rank test comparison of EFS curves between the 2 randomized arms per intention-to-treat principle. Progression is defined as an ≥50% increase of in the product of the perpendicular diameters of any of the involved nodes or nodal masses or focal organ lesions in sites that were persistently PET positive; or recurrent PET positive lesions (Deauville 4, 5) in sites that had previously been PET negative regardless of change of size, as was the development of new PET avid measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Relapse is defined in patients who achieved a prior CR but subsequently has an increase of ≥50% of the PPD in prior nodal or extranodal sites in a recurrently PET positive lesion(s), or the development of new measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Second malignancy is defined based on report of a cancer that is not considered to be classic Hodgkin Lymphoma. (NCT02166463)
Timeframe: Up to 48 months after the last enrollment

Interventionpercentage of participants (Number)
Arm I (ABVE-PC)82.5
ARM II (Bv-AVEPC)92.1

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Bayley III Gross Motor Scaled Score (Change From Baseline to 12 Month)

Bayley III Gross Motor Scaled Score measures motor development. This is normed for typically developing children and follow a bell shaped curve. The scale has mean of 10 +/-3 for children at all ages and is bell shaped. Therefore the two standard deviation range is 16 to 4 with higher values indicated better performance. Lower values have been shown to be common in boys with DMD and it this study the baseline average score was 4.2. (NCT02167217)
Timeframe: One year

Interventionunits on a scale (Mean)
Oral Prednisolone4.8

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GVHD-free Survival Rate

Graft-versus-host disease (GVHD) free survival is defined as achieving complete response without death or relapse or requiring secondary immunosuppressive therapy . Proportions are reported descriptively. GVHD-free survival was assessed using the Kaplan-Meier method. (NCT02176031)
Timeframe: Day 56

Interventionpercentage of patients (Number)
Natalizumab33.3

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Overall Survival (OS) Rate

Overall survival (OS) is defined from the date of natalizumab infusion to death or censored at last clinical evaluation. OS was estimated using the Kaplan-Meier method. (NCT02176031)
Timeframe: 2 years

Interventionpercentage of patients (Number)
Natalizumab43

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Rate of GVHD Flares

Number of subjects who experienced graft-versus-host disease (GVHD) flares requiring therapy after initial complete response (CR) or partial response (PR) by day 28 after the first dose of Natalizumab. (NCT02176031)
Timeframe: by Day 28

InterventionParticipants (Count of Participants)
Natalizumab0

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GI aGVHD Response Rate

Gastrointestinal (GI) acute graft-versus-host disease (GVHD) Response is defined by complete response, very good partial response, or partial response in signs and symptoms of GI aGVHD. (NCT02176031)
Timeframe: Day 28, Day 56

Interventionpercentage of patients (Number)
Overall response rate for GI GVHD at Day 28Overall response rate for GI GVHD at Day 56
Natalizumab5752

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Percentage Steroid Dose Was Reduced at Day 28, 56, and 100 in Comparison to Steroid Dose at First Administration of Natalizumab.

Median percentage steroid dose was reduced at Day 28, Day 56, and Day 100 in comparison to steroid dose at first administration of Natalizumab. (NCT02176031)
Timeframe: Day 28, 56, and 100

Interventionpercentage of steroid dose (Median)
Median reduction in steroid dose at day 28Median reduction in steroid dose at day 56Median reduction in steroid dose at day 100
Natalizumab427185

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Graft-verus-host Disease (GVHD) Response Rate

"Complete Response (CR) is defined as resolution of all signs and symptoms of acute GVHD.~Very Good Partial Response (VGPR) is defined by no rash or residual erythematous rash involving less than 25% of the body surface, and total serum bilirubin concentration less than 2 mg/dL or less than 25% of baseline at enrollment and tolerating food or enteral feeding, predominantly formed stools, no overt gastrointestinal bleeding or abdominal cramping, and no more than occasional nausea and vomiting.~Partial Response (PR) is defined as an improvement of one stage in one or more organs without progression in any other organ.~Non-response (NR) is defined as no reduction in any GVHD organ staging.~Progression is defined as either new organ involvement on day +8 or thereafter, or increased organ specific symptoms sufficient to increase the organ stage by one or more or the initiation of an additional GVHD agent.~Overall Response Rate (ORR) is the sum of CR, VGPR, and PR." (NCT02176031)
Timeframe: 28 Days, 56 Days

InterventionParticipants (Count of Participants)
Overall Response at Day 28Complete Response at Day 28Very Good Partial Response at Day 28Partial Response at Day 28Non-response/Progression of GVHD at Day 28Overall Response at Day 56Complete Response at Day 56Very Good Partial Response at Day 56Partial Response at Day 56Non-response/Progression of GVHD at Day 56
Natalizumab127237117226

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Number of Participants With Secondary Graft Failure

"The cumulative incidence of secondary graft failure will be estimated using the Kalbfleisch-Prentice method. Deaths due to toxicity and relapse before day 100 are the competing events.~Secondary graft failure or graft rejection will be defined as no evidence of donor chimerism by umbilical cord blood (UCB) and/or haploidentical donor (<10%), or too few cells to perform adequate chimerism analysis, in research participants with prior neutrophil engraftment.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced secondary graft failure is provided." (NCT02199041)
Timeframe: 100 days after transplantation

InterventionParticipants (Count of Participants)
Treatment0

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Number of Participants With Event-free Survival (EFS)

"The Kaplan-Meier estimate of EFS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) - date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not experience any events defined above is provided." (NCT02199041)
Timeframe: One year after transplantation

InterventionParticipants (Count of Participants)
Treatment4

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Number of Participants by Severity With Chronic Graft Versus Host Disease (GVHD) in the First 100 Days After HCT

"Cumulative incidence of acute and chronic GVHD was estimated using Kalbfleisch-Prentice method. Death is competing risk event. SAS macro (bmacro252-Excel2007cin) available St. Jude was used for such analysis. Severity of chronic GVHD was evaluated using National Institutes of Health (NIH) Consensus Global Severity Scoring. Mild is considered a better outcome with severe being the worst.~Criteria for grading chronic GVHD:~Mild: 1-2 organs/sites, maximum organ score of 1, and lung score of 1. Moderate: 3 or more organs/sites and maximum organ score of 1 and lung score of 1, OR at least 1 organ/site and maximum organ score of 2 and lung score of 1. Severe: At least 1 organ/site and maximum organ score of 3 and lung score of 2-3.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced chronic GVHD is provided." (NCT02199041)
Timeframe: 100 days after transplantation

InterventionParticipants (Count of Participants)
No Chronic GVHDMildModerateSevere
Treatment11001

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Number of Participants by Severity With Acute Graft Versus Host Disease (GVHD) in the First 100 Days After HCT

"Cumulative incidence of acute GVHD was estimated using Kalbfleisch-Prentice method. Death is the competing risk event. SAS macro (bmacro252-Excel2007cin) available at St. Jude was used for analysis. Severity of GVHD and stage were determined using the Clinical Oncology Group (COG) Stem Cell Committee Consensus Guidelines for establishing organ stage and overall grade of acute GVHD. Participants are graded on a scale from I to IV, with I being mild and IV being severe.~Overall Clinical Grade (based on the highest stage obtained):~Grade 0: No stage 1-4 of any organ. Grade I: Stage 1-2 skin and no liver or gut involvement. Grade II: Stage 3 skin, or Stage I liver involvement, or Stage 1 gastrointestinal (GI).~Grade III: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI. Grade IV: Stage 4 skin, liver or GI involvement.~Due to early close of study, a small number of patients were enrolled. The number of patients who experienced acute GVHD is provided." (NCT02199041)
Timeframe: 100 days after transplantation

InterventionParticipants (Count of Participants)
No Acute GVHDGrade IGrade IIGrade IIIGrade IV
Treatment80121

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Number of Participants With Malignant Relapse

"Relapse was evaluated using standard World Health Organization (WHO) criteria for each disease. The estimate of cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Relapse defined as the recurrence of original disease. Death is the competing risk event. The analysis will be implemented using Statistical Analysis System (SAS) macro (bmacro252-Excel2007cin).~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced malignant relapse is provided" (NCT02199041)
Timeframe: One year after transplantation

InterventionParticipants (Count of Participants)
Treatment7

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Number of Participants With Overall Survival (OS)

"The Kaplan-Meier estimate of OS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007kme) available in the Department of Biostatistics at St. Jude, where OS = min (date of last follow-up, date of death) - date of hematopoietic cell transplantation (HCT) and all participants surviving after 1 year post-transplant will be considered as censored.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not die at 1 year post-transplant is provided." (NCT02199041)
Timeframe: One year after transplantation

InterventionParticipants (Count of Participants)
Treatment6

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Number of Participants With Neutrophil Engraftment

Neutrophil engraftment is defined as absolute neutrophil count (ANC) recovery of ≥ 0.5 x 10^9/L (500/mm^3) for three consecutive laboratory values obtained on different days (derived from either donor). Date of engraftment is the date of the first of the three consecutive laboratory values. The number of patients engrafted by day +42 post-transplant is provided. (NCT02199041)
Timeframe: Until day 42 post-transplant

InterventionParticipants (Count of Participants)
Treatment11

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Change in Shoulder Function, as Measured by the QuickDASH ®

The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference) (NCT02242630)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Methylprednisolone, 20 mg19.2
Methylprednisolone, 40 mg21.3
Triamcinolone, 20 mg19.1
Triamcinolone, 40 mg24.7

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Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale

Change in shoulder pain reported by the subject after injection at 6 weeks. The subject will report shoulder pain on a scale from 0 (no pain) to 10 (maximal pain) after injection. A 2 point change is expected. (NCT02242630)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Methylprednisolone, 20 mg1.0
Methylprednisolone, 40 mg1.8
Triamcinolone, 20 mg1.9
Triamcinolone, 40 mg1.8

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Corneal Fluorescein Staining (CFS)

Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy. (NCT02256969)
Timeframe: 4 week Time Point

Interventionunits on a scale (Mean)
Meibomian Gland Probing Plus Lubricant2.4
Sham Meibomian Gland Probing Plus Lubricant2.0
Meibomian Gland Probing Plus Blephamide1.4

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Ocular Surface Disease Index (OSDI)

A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. (NCT02256969)
Timeframe: 4 week Time Point

Interventionunits on a scale (Mean)
Meibomian Gland Probing Plus Lubricant38.7
Sham Meibomian Gland Probing Plus Lubricant36.9
Meibomian Gland Probing Plus Blephamide37.3

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Tear Break Up Time (TBUT)

TBUT measures the amount of time, in seconds, a dry spot appears in the tear film after each blink. Values less than 10 seconds are considered abnormal. (NCT02256969)
Timeframe: 4 week Time Point

InterventionSeconds (Mean)
Meibomian Gland Probing Plus Lubricant3.5
Sham Meibomian Gland Probing Plus Lubricant4.2
Meibomian Gland Probing Plus Blephamide3.2

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Symptom Assessment in Dry Eye (SANDE)

A two-item survey used to assess the frequency and severity of dry eye disease. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. (NCT02256969)
Timeframe: 4 week Time Point

Interventionunits on a scale (Mean)
Meibomian Gland Probing Plus Lubricant49.1
Sham Meibomian Gland Probing Plus Lubricant50.2
Meibomian Gland Probing Plus Blephamide47.6

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Percentage of Participants With a Sustained Complete Response

"The percentage of participants who achieved a sustained complete response, defined as a complete response achieved at Week 48 and Week 96.~Complete response was defined as meeting all of the following criteria:~Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 48, Week 96

Interventionpercentage of participants (Number)
Rituximab/Cyclophosphamide (RC)26.7
Rituximab/Cyclophosphamide/Belimumab (RCB)28.6

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Count of Participants: Frequency of Non-renal Flares by Week 24

"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 24

,
InterventionParticipants (Count of Participants)
0 Non-renal flares1 Non-renal flare2 Non-renal flares
Rituximab/Cyclophosphamide (RC)2110
Rituximab/Cyclophosphamide/Belimumab (RCB)2001

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Count of Participants: Frequency of Non-renal Flares by Week 48

"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 48

,
InterventionParticipants (Count of Participants)
0 Non-renal flares1 Non-renal flares2 Non-renal flare
Rituximab/Cyclophosphamide (RC)2020
Rituximab/Cyclophosphamide/Belimumab (RCB)2001

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Frequency of Specific Adverse Events of Interest By Event by Week 96

"Number of ≥ Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.~Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0." (NCT02260934)
Timeframe: Week 96

,
InterventionEvents (Number)
Any event leading to death≥Grade 2 leukopenia or thrombocytopeniaPremature ovarian failureMalignancyVenous thromboembolic event
Rituximab/Cyclophosphamide (RC)013003
Rituximab/Cyclophosphamide/Belimumab (RCB)016000

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Frequency of Specific Adverse Events of Interest By Participant, By Week 96

"Number of participants who experienced ≥Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.~Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0." (NCT02260934)
Timeframe: Week 96

,
InterventionParticipants (Count of Participants)
Any event leading to death≥Grade 2 leukopenia or thrombocytopeniaPremature ovarian failureMalignancyVenous thromboembolic event
Rituximab/Cyclophosphamide (RC)06002
Rituximab/Cyclophosphamide/Belimumab (RCB)06000

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Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96

"The percentage of participants who were hypocomplementemic for complement component, C3, defined as a C3 level <90 mg/dL.~Serum C3 complement is a protein which can be measured in the blood. Low blood levels of C3 are common in those with active lupus." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)57.155.061.1
Rituximab/Cyclophosphamide/Belimumab (RCB)30.030.027.8

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Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96

"The percentage of participants who were hypocomplementemic for complemen component C4, defined as a C4 level <10 mg/dL.~Serum C4 complement is a protein which can be measured in the blood. Low blood levels of C4 are common in those with active lupus." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)19.015.016.7
Rituximab/Cyclophosphamide/Belimumab (RCB)5.015.011.1

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Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96

"The percentage of participants who achieved a complete response, defined as meeting all of the following criteria:~Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥ 120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)23.835.033.3
Rituximab/Cyclophosphamide/Belimumab (RCB)30.042.142.9

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Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96

"The percentage of participants who were anti-double stranded DNA (anti-dsDNA) negative, defined as having anti-dsDNA levels <30 IU/mL.~Anti-dsDNA levels are associated with systemic lupus erythematosus disease activity." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)14.320.00.0
Rituximab/Cyclophosphamide/Belimumab (RCB)15.830.027.8

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Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96

"The percentage of participants who achieved an overall response, defined as meeting all of the following criteria:~>50% improvement in the urine protein-to-creatinine ratio (UPCR) from study entry, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)46.760.053.3
Rituximab/Cyclophosphamide/Belimumab (RCB)55.073.771.4

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Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96

"The percentage of participants who experienced at least one Grade 3 or higher treatment-emergent infectious adverse event. The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0. Grade 3 or higher AEs were classified infectious based on the study team's review of the MedDRA body systems and preferred terms of the AEs." (NCT02260934)
Timeframe: Week 0 to Week 96

,
Interventionpercentage of participants (Number)
Week 0 to Week 24Week 0 to Week 48Week 0 to Week 96
Rituximab/Cyclophosphamide (RC)9.122.727.3
Rituximab/Cyclophosphamide/Belimumab (RCB)4.89.59.5

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Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96

"The percentage of participants who achieved B cell reconstitution, defined as a peripheral blood total B cell count ≥ to the baseline count or the lower limit of normal, whichever was lower. Note: B cell depletion was expected to occur in this study between Weeks 0 and 4, after initiation of rituximab and cyclophosphamide.~Normal peripheral blood B Cell count: 107 to 698 cells/µL." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
InterventionPercentage of Participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)31.335.740.0
Rituximab/Cyclophosphamide/Belimumab (RCB)6.311.830.8

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Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96

The percentage of participants who experienced Grade 4 hypogammaglobulinemia, defined as having a serum Immunoglobulin G (IgG) level < 300 mg/dL. Severity of adverse events (AEs) was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 0 to Week 24Week 0 to Week 48Week 0 to Week 96
Rituximab/Cyclophosphamide (RC)000
Rituximab/Cyclophosphamide/Belimumab (RCB)000

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Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96

The percentage of participants who met the criteria for treatment failure, defined by withdrawal from the protocol treatment regimen due to worsening nephritis, infection, or study medication toxicity. (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 0 to Week 24Week 0 to Week 48Week 0 to Week 96
Rituximab/Cyclophosphamide (RC)18.245.563.6
Rituximab/Cyclophosphamide/Belimumab (RCB)14.328.647.6

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Count of Participants: Frequency of Non-renal Flares by Week 96

"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 96

,
InterventionParticipants (Count of Participants)
0 Non-renal flares1 Non-renal flare2 Non-renal flares
Rituximab/Cyclophosphamide (RC)1840
Rituximab/Cyclophosphamide/Belimumab (RCB)1911

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Reduction of Muscle Relaxation Anti-spasmatic Medications

Decrease (50%) and complete discontinuation of muscle relaxation anti-spasmatic medications (NCT02282514)
Timeframe: Mean 3.6 years

InterventionParticipants (Count of Participants)
Hematopoietic Stem Cell Transplantation14

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Short-form 36 Quality of Life Questionnaire (SF-36 QOL)

Improvement is defined as a statistically significant change in SF-36 QOL score. The scale is 0-100. The lower the score the worse quality of life. (NCT02282514)
Timeframe: mean 3.6 years

Interventionunits on a scale (Geometric Mean)
Pre TreatmentPost Treatment
Hematopoietic Stem Cell Transplantation37.7558.35

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Overall Survival

Number of Participants who Did Not Experience Treatment-Related Mortality (NCT02282514)
Timeframe: Mean 3.6 years

Interventionparticipants (Number)
Hematopoietic Stem Cell Transplantation23

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Time to Meet Physical Therapy Discharge Criteria

Time to reach physical therapy (PT) goals (NCT02292082)
Timeframe: First 3 days post-operatively

InterventionMinutes (Mean)
Peri-Articular Injections Only2109.3
Peri-Articular Injections and Adductor Canal Block1883.1

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NRS Pain Score With Movement POD2

NRS pain with movement as reported by the patient. Rated from 0-10. 0 being no pain, 10 being the worst pain imaginable. (NCT02292082)
Timeframe: 48 hours after surgery

Interventionscore on a scale (Mean)
Peri-Articular Injections Only4.7
Peri-Articular Injections and Adductor Canal Block5.2

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Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1

Patient reported pain scores on postoperative day 1 from 0-10. 0 being no pain, 10 being the worst pain imaginable. (NCT02292082)
Timeframe: 24 hours after operating room discharge

Interventionscore on a scale (Mean)
Peri-Articular Injections Only4.3
Peri-Articular Injections and Adductor Canal Block3.9

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Opioid Consumption POD2

Opioid consumption over hours 24-48 postoperatively. Measured in mg OME (oral morphine equivalents). Higher equates to more opioids consumed. (NCT02292082)
Timeframe: 24-48 hours postoperative

Interventionmg OME (Mean)
Peri-Articular Injections Only67.9
Peri-Articular Injections and Adductor Canal Block60.1

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Opioid Consumption Postoperative Day (POD) 1

Opioid consumption for patients from 0-24 hours postoperative, measured in mg OME (oral morphine equivalents) (NCT02292082)
Timeframe: 0-24 hours postoperatively

Interventionmg OME (Mean)
Peri-Articular Injections Only58.4
Peri-Articular Injections and Adductor Canal Block47.5

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Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively

Measures: least pain in the last 24 hours. Scores are measured from 0-10. 0 being no pain to 10 being the worst pain imaginable. (NCT02292082)
Timeframe: Participants will be followed for the duration of 2 days post operatively in the hospital

Interventionscore on a scale (Mean)
Peri-Articular Injections Only1.5
Peri-Articular Injections and Adductor Canal Block0.8

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Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively

Least pain experienced from 24-48 hours postoperative on a scale from 0-10. 0 being no pain at all to 10 being the worst pain imaginable (NCT02292082)
Timeframe: 24-48 hours postoperative

Interventionscore on a scale (Mean)
Peri-Articular Injections Only1.7
Peri-Articular Injections and Adductor Canal Block1.8

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Hospital Length of Stay

Measured in minutes. (NCT02292082)
Timeframe: Average of 3 days

InterventionMinutes (Mean)
Peri-Articular Injections Only3491
Peri-Articular Injections and Adductor Canal Block3394.4

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Knee Society Score (KSS) at 6 Weeks Postoperatively

KSS (Knee Society Score) score measured at 6 weeks postoperatively. The scale is from 0-100. Scores below 60 indicate poor function, 60-69 indicate fair, 70-79 indicate good, and 80-100 indicate excellent functional scores. KSS measures knee pain, flexion contracture,extension lag, alignment, stability, and total range of flexion and generates an associated score correlating to knee function. Higher is better. There is no sub score - only the cumulative Knee Society Score. (NCT02292082)
Timeframe: Post operatively at approximately 6 weeks after surgery

Interventionscore on a scale (Mean)
Peri-Articular Injections Only85.2
Peri-Articular Injections and Adductor Canal Block75.2

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Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively

Painout most pain experienced 24-48 hours postoperatively measured on a scale from 0-10. Higher scores indicate higher pain levels. (NCT02292082)
Timeframe: 24-48 hours postoperative

Interventionscore on a scale (Mean)
Peri-Articular Injections Only6.9
Peri-Articular Injections and Adductor Canal Block6.6

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Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively

Painout most pain experienced 0-24 hours postoperatively, measured from 0-10. 0 being no pain to 10 being the worst pain imaginable (NCT02292082)
Timeframe: 0-24 hours postoperatively

Interventionscore on a scale (Mean)
Peri-Articular Injections Only6.7
Peri-Articular Injections and Adductor Canal Block5.3

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Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)

"MSFC score is a composite score calculated from 3 tests: 1) Timed 25-Foot walk (leg function); 2) 9-Hole Peg Test (arm function); and 3) Paced Auditory Serial Addition Test (cognitive function). The results are combined to create a single score (the MSFC Z-Score) to measure performance and change over time in subjects with MS. MSFC Z-score = {Z arm + Z leg + Z cognitive} / 3.0. A positive score indicates that, on average, an individual performed better than the reference population and a negative score indicates that, on average, an individual performed worse than the reference population.~The Expanded Disability Status Scale (EDSS) is used to quantify disability due to symptoms of MS and to track changes in disability status over time. Scores range from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Scores are determined by performing a neurological exam and given in increments of 0.5." (NCT02296346)
Timeframe: 1 year

,
Interventionscore on a scale (Mean)
EDSS ScoreMSFC Z-Score
Corticosteroid Arm6.250.6751
ECP Arm61.1031

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Number of Participants With Response or Remission at End of 4 Weeks

Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 4 weeks (NCT02392286)
Timeframe: 4 weeks

InterventionParticipants (Count of Participants)
Weight-based5
Fixed Dose5

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Number of Participants With Response or Remission at End of 12 Weeks

Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 12 weeks (NCT02392286)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Weight-based5
Fixed Dose7

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Number of Participants With Response or Remission at End of 1 Week

Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 1 week (NCT02392286)
Timeframe: 1 week

InterventionParticipants (Count of Participants)
Weight-based5
Fixed Dose5

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Number of Participants With Response at End of 2 Weeks

Number of participants with at least a 3-point drop in Harvey-Bradshaw Index at end of 2 weeks (NCT02392286)
Timeframe: 2 weeks

InterventionParticipants (Count of Participants)
Weight-based4
Fixed Dose6

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Number of Participants With Corticosteroid-associated Side Effects

Number of participants with side effects that may be associated with use of corticosteroids such as mood swings, sleep disturbance, edema, acne, bruising, myalgias. (NCT02392286)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Weight-based5
Fixed Dose7

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Number of Participants in Remission at End of 2 Weeks

Number of participants with Harvey Bradshaw Index < 5 at end of 2 weeks. The minimum score obtainable is 0, suggesting absence of disease or remission, while the maximum score obtainable goes beyond 18 points, depending on the number of stools the patient identifies per day (because 1 point is given for each stool in a day, there is no specific maximum score. A higher score represents more severe disease. <5 is determined to be remission. (NCT02392286)
Timeframe: 2 weeks

InterventionParticipants (Count of Participants)
Weight-based2
Fixed Dose3

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Anterior Chamber Cell Grade at Week 8

Change from baseline comparison of NS2 ophthalmic drops (0.5%), NS2 (0.5%) and Pred Forte® (0.1%) ophthalmic drops, and Pred Forte® (1%) ophthalmic drops on an anterior chamber cell grade scale of 0 to 4 (0 = absent, 4 = severe). The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor. (NCT02406209)
Timeframe: The efficacy assessment period was assessed at Week 8; baseline was Day 1.

Interventionunits on a scale (Least Squares Mean)
NS2 Ophthalmic Drops (0.5%)-0.7
NS2 (0.5%) and Pred Forte® (0.1%) Ophthalmic Drops-0.9
Pred Forte® (1%) Ophthalmic Drops-0.5

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Relapse Free Survival

Relapse-free survival was defined as the time from treatment response to date of relapse or death, whichever occurred first. (NCT02464657)
Timeframe: Up to 2 years and10 Months

InterventionMonths (Median)
Ph 2 - Nivolumab (3mg) + Idarubicin + Cytarabine18.54

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Overall Survival

Overall survival was defined as the time from the start of treatment to death or date of last follow-up. (NCT02464657)
Timeframe: Up to 2 years and 10 Months

InterventionMonths (Median)
Ph 2 Nivolumab (3mg) + Idarubicin + Cytarabine18.54

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Maximum Tolerated Dose (MTD) of Nivolumab

MTD is highest dose level in which <2 patients of 6 develop first cycle dose-limiting toxicity (DLT). (NCT02464657)
Timeframe: 28 days

Interventionmg/kg (Number)
Ph 1 - Nivolumab (1mg) + Idarubicin + CytarabineNA
Ph 1 - Nivolumab (3mg) + Idarubicin + Cytarabine3

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Event-Free Survival (EFS)

EFS defined as time from the treatment start till treatment failure, relapse, or death whichever comes first. Event Free Survival will be presented by median EFS, which is the time point at which the cumulative survival drops below 50%. If there is no median survival (not reached), it means the cumulative survival was more than 50%. (NCT02464657)
Timeframe: 56 days

InterventionMonths (Median)
Ph 2 Nivolumab (3mg) + Idarubicin + CytarabineNA

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Change in eGFR Between 6 Months and 24 Months as Measured by CKD-EPI

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 6 and 24 was calculated as the month 24 eGFR minus the month 6 eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 6 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental0.8
Control4.8

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Change in eGFR Between 6 Months and 24 Months as Measured by MDRD

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 6 and 24 was calculated as the month 24 eGFR minus the month 6 eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 6 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental1.0
Control5.2

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Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by CKD-EPI

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. Post-transplant nadir was defined as the lowest value of eGFR from the first 6 months post-transplant. The change in eGFR between nadir and month 24 was calculated as the month 24 eGFR minus the nadir eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 6 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental8.5
Control12.0

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Percent of Participants With de Novo DSA.

Donor specific antibody (DSA) can be formed post-transplant as part of the recipient's alloimmune response to the transplanted organ. DSA was determined by a central laboratory. Participants with newly developed DSA (i.e., de novo) following transplant were considered to have met this endpoint. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental8.0
Control3.6

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Percent of Participants With Death or Graft Failure.

Participants who died or experienced graft failure were considered to have met this endpoint. Graft failure was defined as the need for post-transplant dialysis for more than 56 days. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental5.3
Control7.1

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Percent of Participants With Impaired Wound Healing Manifested by Wound Dehiscence, Wound Infection, or Hernia at the Site of the Transplant Incision

Participants were considered to have met this endpoint if they had a reported case of impaired wound healing at the site of the transplant incision manifested by one wound dehiscence, wound infection, or hernia. (NCT02495077)
Timeframe: 24 months post-transplantation

InterventionPercent of participants (Number)
Experimental7.9
Control11.6

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Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.

Biopsies were read by the local pathologist at the hospital where the participant was a patient. These local reads informed clinical care for the participant, which may or may not include prescribing/administering medication to the participant to help with clinical concerns or findings noted on a biopsy. Participants were considered to have met this endpoint if they have a report of receiving treatment for clinical or biopsy-proven rejection during the 24 month post-transplant follow-up. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental16.2
Control27

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Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.

Biopsies were read by the local pathologist at the hospital where the participant was a patient. These local reads informed clinical care for the participant, which may or may not include prescribing/administering medication to the participant to help with clinical concerns or findings noted on a biopsy. Participants were considered to have met this endpoint if they have a report of receiving treatment for clinical or biopsy-proven rejection during the first 6 months post-transplant. (NCT02495077)
Timeframe: 6 months post-transplantation

Interventionpercentage of participants (Number)
Experimental12.6
Control20.5

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Percent of Participants With Malignancy.

Participants were considered to have met this endpoint if they had a reported case of malignancy. (NCT02495077)
Timeframe: 24 months post-transplantation

InterventionPercent of Participants (Number)
Experimental1.8
Control0.9

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Percent of Participants With Mycobacterial or Fungal Infections

Participants were considered to have met this endpoint if they had at least one mycobacterial of fungal infection. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental6.1
Control6.3

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Percent of Participants With Only Graft Failure.

Participants who experienced graft failure were considered to have met this endpoint. Graft failure was defined as the need for post-transplant dialysis for more than 56 days. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental2.7
Control2.7

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Percent of Participants With Primary Non-Function (PNF), Defined as Dialysis-dependency for More Than 3 Months.

Post-transplant dialysis is sometimes required in the setting of kidney transplant. If such dialysis continues for more than 3 months, the participant is considered to have PNF and, as such, meets this endpoint definition. (NCT02495077)
Timeframe: Transplantation through at least month 3 up to month 24

InterventionPercent of Participants (Number)
Experimental2.8
Control0.9

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The Difference Between the Mean eGFR (Modified MDRD) in the Experimental vs. Control Groups.

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the month 24 eGFR for each treatment group. (NCT02495077)
Timeframe: 24-Month post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental52.45
Control57.35

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The Percent of Participants Who Need Dialysis After Week 1.

Participants who needed dialysis after the first week post-transplant were considered to have met this endpoint. (NCT02495077)
Timeframe: 1 week to 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental9.0
Control2.8

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The Percent of Participants Whose Day 2 Serum CRR Was Less Than 30%.

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 2 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. A participant was considered to have met this endpoint if their day 2 serum CRR was less than 30%. (NCT02495077)
Timeframe: Day 2 post-transplantation

Interventionpercentage of participants (Number)
Experimental57.1
Control68.6

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The Percent of Participants Whose Day 5 Serum CRR Was Less Than 70%.

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 5 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. A participant was considered to have met this endpoint if their day 5 serum CRR was less than 70%. (NCT02495077)
Timeframe: Day 5 post-transplantation

Interventionpercentage of participants (Number)
Experimental74.4
Control88.4

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The Percent of Participants With a Serum Creatinine of More Than 3 mg/dL.

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. This endpoint is ascertaining slow graft function in the immediate days post-transplant. A participant was considered to have met this endpoint if their day 5 serum creatinine was greater than 3 mg/dL. (NCT02495077)
Timeframe: Day 5 post-transplantation

Interventionpercentage of participants (Number)
Experimental47.4
Control42.9

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Change From Baseline (Immediately After Surgery) in Serum Creatinine.

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. eGFR values from 24, 48, and 72 hours post-transplant (i.e., days 1, 2, and 3) were used to generate an estimate of the serum creatinine at each time point of interest for each treatment group. (NCT02495077)
Timeframe: 24, 48 and 72 hours post-transplantation

,
Interventionmg/dL (Mean)
24 Hours48 Hours72 Hours
Control6.855.875.21
Experimental7.356.245.77

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eGFR Values as Measured by CKD-EPI

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group. (NCT02495077)
Timeframe: Day 7 post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental41.01
Control41.85

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eGFR Values as Measured by MDRD

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group. (NCT02495077)
Timeframe: Days 30, 60, and 180 post-transplantation

,
InterventionmL/min/1.73m2 (Mean)
Day 30Day 90Day 180
Control48.2048.9950.16
Experimental46.6447.1447.89

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Duration of Delayed Graft Function (DGF), Defined as Time From Transplantation to the Last Required Dialysis Treatment.

Participants are considered to have had DGF if they had at least one dialysis treatment in the first week post-transplant. For this endpoint, duration was calculated as the date of last post-transplant dialysis treatment minus the date of the first post-transplant dialysis treatment. (NCT02495077)
Timeframe: First post-transplant dialysis treatment to last post-transplant dialysis treatment

InterventionDays (Mean)
Experimental13.27
Control15.74

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Days From Transplantation Until Event (ACR, AMR, or Hospitalization for Infection and/or Malignancy)

Participants are considered to have met this endpoint if they experienced biopsy-proven T-cell mediated rejection (ACR) or antibody mediated rejection (AMR) based on central pathology reading or were hospitalized for infection and/or malignancy. For participants who met one or more of these three components, the earliest event date of the three components was used as the time of meeting the endpoint. Participants who did not meet any of the three components were censored at their last date of follow-up. Event (or censor) day was calculated as event (or censor) date minus transplant date. (NCT02495077)
Timeframe: 24 months post-transplantation

InterventionDays to event (Median)
Experimental642
Control613

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Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 5 Divided by the First Creatinine After Surgery.

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 5 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. (NCT02495077)
Timeframe: Day 5 post-transplantation

InterventionPercentage (Mean)
Experimental47.06
Control43.37

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Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 2 Divided by he First Creatinine After Surgery

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 2 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. (NCT02495077)
Timeframe: Day 2 post-transplantation

InterventionPercentage (Mean)
Experimental24.28
Control20.97

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Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by MDRD

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. Post-transplant nadir was defined as the lowest value of eGFR from the first 6 months post-transplant. The change in eGFR between nadir and month 24 was calculated as the month 24 eGFR minus the nadir eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 6 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental8.1
Control11.6

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BANFF Grades of First AMR.

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes. (NCT02495077)
Timeframe: 6 months post-transplantation

InterventionParticipants (Count of Participants)
Experimental0
Control0

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Number of Dialysis Sessions.

The number of dialysis sessions a person had during their first 8 weeks post-transplant was used for this endpoint. (NCT02495077)
Timeframe: 8 weeks post-transplantation

InterventionDialysis sessions (Mean)
Experimental0.14
Control0.26

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Percent of Participants That Required at Least One Dialysis Treatment.

Dialysis within the first week post-transplant is used in the setting of delayed graft function (DGF). Participants are considered to have had DGF if they had at least one dialysis treatment in the first week post-transplant. (NCT02495077)
Timeframe: 1 week post-transplantation

Interventionpercentage of participants (Number)
Experimental31.0
Control35.7

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Percent of Participants With Any Infection Requiring Hospitalization or Resulting in Death.

Participants were considered to have met this endpoint if they had an infection that required hospitalization or resulted in death. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental43.0
Control39.3

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eGFR Values as Measured by MDRD

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group. (NCT02495077)
Timeframe: Day 7 post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental38.93
Control39.96

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Percent of Participants With BANFF Chronicity Scores > or Equal 2 on the 24 Month Biopsy.

The Banff 2013 classification involves scoring numerous characteristics of renal biopsy specimens. The ci (interstitial fibrosis) and ct (tubular atrophy) scores are two such characteristics. The scores can take values of 0, 1, 2, or 3 for each characteristic (ci and ct), indicating increasing severity of disease as the scores increase. Participants are considered to have met this endpoint if their ci + ct score on the 24 month biopsy summed to be > or equal to 2. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental73.1
Control36.4

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Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR)

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive.Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes. (NCT02495077)
Timeframe: 6 months post-transplantation

InterventionParticipants (Count of Participants)
Experimental0.0
Control0.0

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Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR).

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 24 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participant (Number)
Experimental1.3
Control0.0

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Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR or suspicious for AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, C4d staining positive, or suspicious. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes; suspicious-when 2 of 3 factors for acute/active are present. (NCT02495077)
Timeframe: 6 months post-transplantation

Interventionpercentage of participants (Number)
Experimental2.8
Control0.0

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Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR.

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR or suspicious for AMR within 24 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, C4d staining positive, or suspicious. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes; suspicious-when 2 of 3 factors for acute/active are present (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental3.8
Control1.4

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Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR)

Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to IA with or without clinical symptoms within 6 months of transplant were determined to have met the endpoint. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection.Criteria include: IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. (NCT02495077)
Timeframe: 6 month post-transplantation

Interventionpercentage of participants (Number)
Experimental4.2
Control3.0

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Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection

Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of borderline or greater than or equal to IA with or without clinical symptoms within 24 months of transplant were determined to have met the endpoint. Severity is graded as Borderline, IA, IB, IIA, IIB, or III, with borderline representing possible cellular rejection, IA being the mildest form of cellular rejection, and III being the most severe form of cellular rejection. Criteria include: Borderline-no intimal arteritis is present but foci of mild tubulitis; IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental12.8
Control7

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Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection.

Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of borderline or greater than or equal to IA with or without clinical symptoms within 6 months of transplant were determined to have met the endpoint. Severity is graded as Borderline, IA, IB, IIA, IIB, or III, with borderline representing possible cellular rejection, IA being the mildest form of cellular rejection, and III being the most severe form of cellular rejection.Criteria include: Borderline-no intimal arteritis is present but foci of mild tubulitis; IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. (NCT02495077)
Timeframe: 6 months post-transplantation

Interventionpercentage of participants (Number)
Experimental8.5
Control6.1

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Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR).

Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to IA with or without clinical symptoms within 24 months of transplant were determined to have met the endpoint. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection. Criteria include: IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental5.1
Control4.2

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Percent of Participants With BK Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site.

Participants were considered to have met this endpoint if they had a reported case of BK viremia that required a change in their existing immunosuppression or the use of anti-viral therapy. (NCT02495077)
Timeframe: 24 months post-transplantation

InterventionPercent of participants (Number)
Experimental28.9
Control13.4

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Percent of Participants With CMV Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site

Participants were considered to have met this endpoint if they had a reported case of CMV viremia that required a change in their existing immunosuppression or the use of anti-viral therapy. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental18.4
Control11.6

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Change in eGFR Between 3 Months and 24 Months as Measured by CKD-EPI

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 3 and 24 was calculated as the month 24 eGFR minus the month 3 eGFR for each participant. A window of +/- 14 days was used for month 3 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 3 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental2.7
Control4.4

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Change in eGFR Between 3 Months and 24 Months as Measured by MDRD

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 3 and 24 was calculated as the month 24 eGFR minus the month 3 eGFR for each participant. A window of +/- 14 days was used for month 3 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 3 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental2.8
Control4.8

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eGFR Values as Measured by CKD-EPI

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group. (NCT02495077)
Timeframe: Days 30, 90, and 180 post-transplantation

,
InterventionmL/min/1.73m2 (Mean)
Day 30Day 90Day 180
Control50.6351.4452.65
Experimental49.2949.8050.56

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Change From Baseline (Preoperative Exam) in Macular Thickness

Macula is the area in the retina that is responsible for the best central vision. Changes in its thickness may occur after cataract surgery due to the normal inflammatory process that occurs postoperatively but it returns to preoperative values unless there is an underlying disease. (NCT02515045)
Timeframe: Month 1.

InterventionMicrons (Mean)
TriMoxiVanc12.34
TriMoxiVanc + Ilevro10.96
Control9.84

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Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)

Intraocular pressure refers to the pressure inside the eye. It is measured in mmHg using a device called a tonometer. The mean IOP is 15.5 mmHg. Raised IOP after cataract surgery is common and in most cases it is transient and benign. (NCT02515045)
Timeframe: Month 1.

InterventionmmHg (Mean)
TriMoxiVanc-0.5
TriMoxiVanc + Ilevro-1.03
Control-1.1

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Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)

"Cornea is the clear part of the front of the eye. Normal corneal thickness is in average 0.540 mm. The corneal thickness is measured with a handheld device called pachymeter.~An increase in corneal thickness may indicate corneal edema (swelling of the cornea) that could be seen after ocular surgery." (NCT02515045)
Timeframe: Month 1

InterventionMicrons (Mean)
TriMoxiVanc14.44
TriMoxiVanc + Ilevro5.94
Control4.47

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Patients' Bazaz Dysphagia Score - Liquid

Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods. (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

InterventionParticipants (Count of Participants)
Pre-operative72323489Pre-operative72323488POD172323488POD172323489POD272323488POD2723234896-4 weeks723234886-4 weeks723234893 months723234883 months723234896 months723234896 months723234881 year723234881 year72323489
NoneRare
Control47
Treatment54
Control6
Treatment2
Control20
Treatment36
Control33
Treatment20
Control17
Treatment23
Control34
Treatment31
Treatment39
Control18
Treatment17
Control39
Control11
Treatment13
Control42
Treatment41
Control9
Treatment10
Control35
Treatment40
Control10
Treatment7

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Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain

Visual Analog Scale (VAS) - Right arm pain Range from 0 to 100 (best-worst) (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionunits on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control20237463.5
Treatment15.52.2542222.4

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Patients' Pain Scores on the Visual Analog Scale - Neck Pain

Visual Analog Scale (VAS) - Neck pain Range from 0 to 100 (best-worst) (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionunits on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control54.551.55120221412.25
Treatment2648.2526.514.59.566.5

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Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain

Visual Analog Scale (VAS) - Left arm pain Range from 0 to 100 (best-worst) (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionunits on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control17.51056.455.824
Treatment195.356.452.752.51.1751

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Patients' Neck Disability

Neck Disability Index (NDI) Range from 0 to 100 (best-worst) (NCT02539394)
Timeframe: Pre-Op, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionindex (Mean)
Pre-operative4-6 weeks3 months6 months1 year
Control35.535.327.323.920.6
Treatment29.930.817.715.413.2

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Patient Reported Swallowing Difficulty Over 1 Year

"The Eating Assessment Tool (EAT-10) is used to screen for self-perceived oropharyngeal dysphagia (OD) in community-dwelling elders. A summated EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of OD.~Modified Eat-10 : Eat-10 questionnaire without questions 1 (My swallowing problem has caused me to lose weight) and 2 (My swallowing problem interferes with my ability to go out for meals) to be applicable during hospitalization.~Eat-10 interpretation: Score ranging from 0 to 40 (best-worst)~each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question's response Modified EAT-10 interpretation: Score ranging from 0 to 32 (best-worst)~each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question's response" (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operative Eat-10Pre-operative Eat-10 modifiedPOD1 Eat-10POD1 Eat-10 modifiedPOD2 Eat-10POD2 Eat-10 modified4-6 weeks Eat-104-6 weeks Eat-10 modified3 months Eat-103 months Eat-10 modified6 months Eat-106 months Eat-10 modified1 year Eat-101 year Eat-10 modified
Control001614161454221100
Treatment0098.58722000000

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Degree of Dysphagia Patients Experience (Social)

SWAL-QOL survey - Social domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control1009585100100100100
Treatment100100100100100100100

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Degree of Dysphagia Patients Experience (Sleep)

SWAL-QOL survey - Sleep domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control7562.5505062.562.575
Treatment81.2556.2562.575757587.5

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Degree of Dysphagia Patients Experience (Mental)

SWAL-QOL survey - Mental domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control100808595100100100
Treatment10010097.5100100100100

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Degree of Dysphagia Patients Experience (Food Selection)

SWAL-QOL survey - Food Selection domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control1007562.5100100100100
Treatment10093.7575100100100100

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Degree of Dysphagia Patients Experience (Fear Swallow)

SWAL-QOL survey - Fear swallow domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control10093.7587.593.75100100100
Treatment100100100100100100100

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Degree of Dysphagia Patients Experience (Fatigue)

SWAL-QOL survey - Fatigue domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control83.3358.3358.3358.33757575
Treatment83.3358.3366.677583.3383.3391.67

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Degree of Dysphagia Patients Experience (Eating Duration)

SWAL-QOL survey - Eating duration domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control100755087.5100100100
Treatment1007575100100100100

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Degree of Dysphagia Patients Experience (Communication)

SWAL-QOL survey - Communication domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control100100100100100100100
Treatment100100100100100100100

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Degree of Dysphagia Patients Experience (Burden)

SWAL-QOL survey - Burden domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control1005062.5100100100100
Treatment1007575100100100100

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Adverse Event

"Adverse Event (AE) following surgical treatment.~Adverse event were classified by severity based on the AO-ISSG criteria and treatment required:~Mild: Observed, medication, consult, X-ray. Essentially any management that was quick and easy and could be done at bedside Moderate: ICU admission, re-intubation, complication that had a documented prolonged hospital stay, medical procedure (such as flexible endoscopy), re-presentation to ED Severe: Inpatient re-admission, return to OR for any reason, mortality, failed OR.~AE were also categorize as Surgery-site related or unrelated adverse event. Finally, AE were also categorize as potentially related to steroid use (example: leukocytosis, pseudoarthrosis, or wound complications)" (NCT02539394)
Timeframe: 12 month

,
InterventionParticipants (Count of Participants)
Any Adverse Event?Mild/Moderate Adverse Event?Severe Adverse Event?Adverse Event Related to Operated Site?Adverse Event Unrelated to Operated Site?Mild/Moderate Adverse Event Related to Operated Site?Mild/Moderate Adverse Event Unrelated to Operated Site?Severe Adverse Event Related to Operated Site?Severe Adverse Event Unrelated to Operated Site?Adverse Event Potentially Related to Steroid Use?Adverse Event Unrelated to Steroid use?Mild/Moderate Adverse Event Potentially Related to Steroid Use?Mild/Moderate Adverse Event Unrelated to Steroid use?Severe Adverse Event Potentially Related to Steroid Use?Severe Adverse Event Unrelated to Steroid use?
Control444233826362630114394221
Treatment4746338303730301642154112

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Fusion Rate

"Flex-Ex X-rays~Bony bridging on a CT scan~Obvious bony remodeling on lateral X-ray" (NCT02539394)
Timeframe: 12 Months

InterventionParticipants (Count of Participants)
Treatment25
Control23

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Degree of Dysphagia Patients Experience (Eating Desire)

SWAL-QOL survey - Eating desire domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control10083.383.3100100100100
Treatment10087.591.7100100100100

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Patients' Bazaz Dysphagia Score - Solid

Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods. (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

InterventionParticipants (Count of Participants)
Pre-operative72323488Pre-operative72323489POD172323488POD172323489POD272323488POD2723234896-4 weeks723234896-4 weeks723234883 months723234883 months723234896 months723234886 months723234891 year723234891 year72323488
RareOccasionally (only with specific food)NoneFrequent (majority of solids)
Control44
Treatment52
Treatment17
Control8
Control21
Treatment18
Control6
Treatment15
Treatment13
Control19
Control17
Treatment27
Control18
Treatment16
Control11
Treatment11
Treatment2
Control25
Treatment34
Treatment8
Control12
Control2
Treatment0
Control30
Treatment37
Control15
Treatment10
Control5
Treatment3
Control1
Treatment1
Control29
Treatment35
Control7
Treatment6
Control9
Treatment4
Control0

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Terminal Plasma Half-Life (t1/2) of Obinutuzumab

(NCT02550652)
Timeframe: Day 0, Week 24, Week 52

Interventionday (Mean)
Day 0Week 24Week 52
OBINUTUZUMAB 1000MG and MMF13.120.522.1

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Systemic Clearance of Obinutuzumab

(NCT02550652)
Timeframe: Day 0, Week 24, Week 52

InterventionL/day (Mean)
Day 0Week 24Week 52
OBINUTUZUMAB 1000MG and MMF0.2550.1470.137

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Percentage of Participants With First Protocol Defined Overall Response Over the Course of 52 Weeks

OR includes both CRR and partial renal response(PRR). CRR as defined in the primary outcome measure above. PRR defined as 50% improvement in upcr, with one of these conditions met: 1. If baseline upcr is ≤3.0, then upcr of <1.0. 2. If baseline pcr is > 3.0, then upcr of <3.0, serum creatinine ≤15% above baseline value, and no urinary red cell casts and either RBCs/HPF ≤50% above baseline or <10 RBCs/HPF. Percentage of participants with response at various time points were measured using Kaplan Meier method. (NCT02550652)
Timeframe: From baseline to Week 52

,
Interventionpercentage of participants (Number)
Week 12Week 24Week 36Week 52
OBINUTUZUMAB 1000MG and MMF26576375
PLACEBO and MMF19415158

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Percentage of Participants With First Protocol Defined CRR Over the Course of 52 Weeks

CRR included normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 RBCs/HPF and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the ULN range of central laboratory values if baseline serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values. Percentage of participants with response at various time points were measured using Kaplan Meier method. (NCT02550652)
Timeframe: From Baseline to Week 52

,
Interventionpercentage of participants (Number)
Week 12Week 24Week 36Week 52
OBINUTUZUMAB 1000MG and MMF10263650
PLACEBO and MMF10283540

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Percentage of Participants With Anti-Drug Antibody (ADA) to Obinutuzumab

Antibodies are a blood protein produced in response to and counteracting a specific antigen. (NCT02550652)
Timeframe: From baseline up to Week 104

Interventionpercentage of participants (Number)
OBINUTUZUMAB 1000MG and MMF9.38

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Percentage of Participants Who Achieve Protocol Defined Third mCRR (mCRR3) at Week 52

mCRR3 is defined by normalization of serum creatine as evidenced by serum creatinine ≤ the ULN range of central laboratory values and urinary protein to creatinine ratio < 0.5. (NCT02550652)
Timeframe: Week 52

Interventionpercentage of participants (Number)
OBINUTUZUMAB 1000MG and MMF46.0
PLACEBO and MMF38.7

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Percentage of Participants Who Achieve Protocol Defined Second mCRR (mCRR2) at Week 52

mCRR2 is defined by normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 RBCs/HPF and the absence of red cell casts), and urinary protein to creatinine ratio <0.5. Normalization of serum creatinine as evidenced by the following: Serum creatinine ≤15% above baseline if baseline (Day 1) serum creatinine is above the normal range of the central laboratory values or ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values. (NCT02550652)
Timeframe: Week 52

Interventionpercentage of participants (Number)
OBINUTUZUMAB 1000MG and MMF44.4
PLACEBO and MMF33.9

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Maximum Observed Plasma Concentration (Cmax) of Obinutuzumab

(NCT02550652)
Timeframe: Week 0, Week 24, Week 52

Interventionug/mL (Mean)
Week 0-24Week 24-52Week 0-52
OBINUTUZUMAB 1000MG and MMF559605605

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Percentage of Participants Who Achieve Protocol Defined Partial Renal Response (PRR) at Week 52

PRR defined as serum creatinine ≤15% above baseline value, no urinary red cell casts and either RBCs/HPF ≤ 50% above baseline or < 10 RBCs/HPF, 50% improvement in urine protein:creatinine ratio, with one of following conditions met: 1. If baseline urine protein:creatinine ratio is ≤ 3.0, then a urine protein:creatinine ratio of < 1.0. 2. If baseline protein:creatinine ratio is > 3.0, then a urine protein:creatinine ratio of < 3.0. (NCT02550652)
Timeframe: From baseline to Week 52

Interventionpercentage of participants (Number)
OBINUTUZUMAB 1000MG and MMF55.6
PLACEBO and MMF33.9

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Percentage of Participants Who Achieve Protocol Defined Overall Response (OR) at Week 52

OR includes both CRR and partial renal response (PRR). CRR as defined in the primary outcome measure above. PRR defined as 50% improvement in urine protein:creatinine ratio, with one of following conditions met: 1. If baseline urine protein:creatinine ratio is ≤ 3.0, then urine protein:creatinine ratio of <1.0. 2. If baseline protein:creatinine ratio is > 3.0, then urine protein:creatinine ratio of <3.0, serum creatinine ≤15% above baseline value, and no urinary red cell casts and either RBCs/HPF ≤50% above baseline or <10 RBCs/HPF. (NCT02550652)
Timeframe: From baseline to Week 52

Interventionpercentage of participants (Number)
OBINUTUZUMAB 1000MG and MMF55.6
PLACEBO and MMF35.5

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Change From Baseline of Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Score

Each VAS had a range from 0-100 with higher scores indicating greater symptom impact on global health status. (NCT02550652)
Timeframe: Baseline (Day 1), Weeks 4, 12, 24, 36, 52

,
Interventionscore on scale (Mean)
BaselineWeek 4Week 12Week 24Week 36Week 52
OBINUTUZUMAB 1000MG and MMF41.3-14.4-19.9-25.0-24.8-25.4
PLACEBO and MMF39.4-8.7-11.6-20.8-19.6-23.3

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Area Under the Plasma Concentration Versus Time Curve (AUC) of Obinutuzumab

(NCT02550652)
Timeframe: Week 0, Week 24, Week 52

Interventionug/mL*day (Mean)
Week 0-24Week 24-52Week 0-52
OBINUTUZUMAB 1000MG and MMF105951581126406

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Volume of Distribution Under Steady State (Vss) of Obinutuzumab

(NCT02550652)
Timeframe: Day 0, Week 24, Week 52

InterventionL (Mean)
Day 0Week 24Week 52
OBINUTUZUMAB 1000MG and MMF3.673.673.67

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Percentage of Participants Who Achieve Protocol Defined Modified CRR (mCRR1) at Week 52

mCRR1 has got two components only, i.e. serum Creatinine and urinary protein to creatinine ratio. mCRR1 is defined by attainment of normalization of serum creatinine as evidenced by 1.) serum creatinine ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine ≤ the ULN range of central laboratory values and 2.) Urinary protein to creatinine ratio <0.5. (NCT02550652)
Timeframe: Week 52

Interventionpercentage of participants (Number)
OBINUTUZUMAB 1000MG and MMF39.7
PLACEBO and MMF25.8

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Percentage of Participants Who Achieve Protocol Defined Complete Renal Response (CRR) at Week 52

Percentage of participants with normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 red blood cells (RBCs)/high-power field (HPF) and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the upper limit of normal (ULN) range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values. (NCT02550652)
Timeframe: From baseline to Week 52

Interventionpercentage of participants (Number)
OBINUTUZUMAB 1000MG and MMF34.9
PLACEBO and MMF22.6

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Change From Baseline in Complement Component 3 (C3) Levels at Week 52

Complement C3 is a blood test that reflects activation of complement pathway associated with immune deposition in certain autoimmune diseases. (NCT02550652)
Timeframe: Baseline and Week 52

Interventiong/L (Mean)
OBINUTUZUMAB 1000MG and MMF0.311
PLACEBO and MMF0.108

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Change From Baseline in C4 Levels at Week 52

Complement C4 is a blood test that reflects activation of complement pathway associated with immune deposition in certain autoimmune diseases. (NCT02550652)
Timeframe: Baseline, Week 52

Interventiong/L (Mean)
OBINUTUZUMAB 1000MG and MMF0.101
PLACEBO and MMF0.003

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Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody Levels at Week 52

Anti-dsDNA antibodies are a group of anti-nuclear antibodies targeting double stranded DNA. (NCT02550652)
Timeframe: Baseline and Week 52

Interventionlog IU/mL (Mean)
OBINUTUZUMAB 1000MG and MMF-0.810
PLACEBO and MMF-0.080

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Percentage of Participants Who Achieve Protocol Defined CRR at Week 24

CRR defined as normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 red blood cells (RBCs)/high-power field (HPF) and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the upper limit of normal (ULN) range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values. (NCT02550652)
Timeframe: Week 24

Interventionpercentage of participants (Number)
OBINUTUZUMAB 1000MG and MMF23.8
PLACEBO and MMF24.2

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Percentage of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs), Infections and Serious infections. (NCT02550652)
Timeframe: From Baseline up to Week 104

,
Interventionpercentage of participants (Number)
Adverse EventsGrade 3 AEsGrade 4 AEsGrade 5 AEsSerious Adverse EventsInfectionsSerious infections
OBINUTUZUMAB 1000MG and MMF90.629.710.91.625.075.07.8
PLACEBO and MMF88.524.613.16.629.562.318.0

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Percent Change From Baseline in Circulating CD19-Positive B-Cell Levels

CD19+ B cell is a B-lymphocyte with a transmembrane protein that is encoded by the gene CD19. (NCT02550652)
Timeframe: Baseline, Week 2, Week 4, Week 12, Week 24, Week 52

,
InterventionPercent change of cells/uL (Mean)
Week 2Week 4Week 12Week 24Week 52
OBINUTUZUMAB 1000MG and MMF-97.469-98.777-97.045-96.628-98.620
PLACEBO and MMF39.293-5.1860.661-11.44637.695

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Visual Analog Scale

The visual analog scale for overall symptoms will be used to define disease severity. Range of 0 to 10. As per the European Position Paper 2012, mild, moderate, and severe disease will be defined as 0 to and including 3, > 3 to and including 7, and > 7 to and including 10, respectively. (NCT02569437)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
Baseline12 weeks
Doxycycline8.45.2
Sugar Pill8.14.5

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Subjective Symptom Composite Scoring

"A subjective symptom score will be extracted from the patient's score (on a scale of 0-5, where 0 defines no problems with the given symptom and 5 defines maximal problems ) on the SNOT-22 for each fo the following symptoms: blockage/congestion, runny nose, post-nasal discharge, facial pain/pressure, and sense of taste/smell. Range of 0 to 25, with higher score reflecting worse symptoms." (NCT02569437)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
Baseline12 weeks
Doxycycline16.311.9
Sugar Pill17.113.6

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Sino-nasal Outcome Test (SNOT 22)

a validated 22 item quality of life questionnaire for patients with chronic rhinosinusitis. Range of 0 to 110, higher scores indicate worse outcome (NCT02569437)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
Baseline12 weeks
Doxycycline55.243.7
Sugar Pill54.449.8

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Middle Meatus Culture

Culture swab for the presence or absence of microbial growth (NCT02569437)
Timeframe: Baseline and 12 weeks

,
InterventionParticipants (Count of Participants)
Culture growth at initial visit and 12 week visitCulture growth initial visit, none at 12 weeksNo growth initial visit, but growth at 12 weeks
Doxycycline512
Sugar Pill221

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Endoscopic Nasal Polyp Score

"0- Absence of nasal polyps~Polyps confined to the middle meatus and not beyond the inferior border of the middle turbinate~Polyps reaching below the lower border of the middle turbinate~Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate~Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate Nasal polyp scores. The score is determined for each nostril, and the two scores added for a total nasal polyp score. Range of 0 to 8, graded on a size system from 0 to 4 and summed from the right and left nostrils." (NCT02569437)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
Baseline12 weeks
Doxycycline6.04.3
Sugar Pill6.54.9

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The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale

The KOOS holds 42 items in five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. (NCT02576249)
Timeframe: 3 months after the injection

Interventionunits on a scale (Mean)
Ropivacaine and Methylprednisolone63.1
Saline and Methylprednisolone67.2

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Pain Scale Score

Pain was measured by a Visual Analog Scale (VAS) marked from 0 (no pain) to 10 (unbearable pain) at rest and with activity. It was collected at baseline (pre-injection), immediately post-injection on the day of surgery, and at 2 weeks and 3 months. (NCT02576249)
Timeframe: Pre-injection, immediately post-injection, 2 weeks, 3 months

,
Interventionunits on a scale (Mean)
Pre-injection ActivityPre-injection RestImmediately Post-injection ActivityImmediately Post-injection Rest2 Weeks Activity2 Weeks Rest3 Months Activity3 Months Rest
Ropivacaine and Methylprednisolone6.42.41.91.23.61.73.92.6
Saline and Methylprednisolone5.842.41.43.62.74.62.8

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Tegner Activity Level Scale

"The Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury.~A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score >6 can only be achieved if the person participates in recreational or competitive sport." (NCT02576249)
Timeframe: baseline (pre-injection), 2 weeks, 3 months

,
Interventionunits on a scale (Mean)
baseline (pre-injection)2 weeks3 months
Ropivacaine and Methylprednisolone3.54.33.5
Saline and Methylprednisolone3.03.23

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11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score

Score for the 11-item DASH scale, a measure of activity limitations related to the upper extremity. Score range 0 (best) to 100 (worst) (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
Methylprednisolone 80 mg13.1
Methylprednisolone 40 mg16.9
Placebo19.3

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Bodily Pain Score

Score for the 2-item bodily pain scale, range 0 (worst) to 100 (best). (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
Methylprednisolone 80 mg81.4
Methylprednisolone 40 mg79.9
Placebo78.2

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Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand

Number of patients who have had carpal tunnel release surgery on the study hand. (NCT02652390)
Timeframe: 5 to 7 years

InterventionParticipants (Count of Participants)
Methylprednisolone 80 mg31
Methylprednisolone 40 mg34
Placebo36

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Satisfaction Score

Visual analog scale about treatment satisfaction, score 0 (worst) to 100 (best). (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
Methylprednisolone 80 mg77.5
Methylprednisolone 40 mg71.4
Placebo68.4

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Palmar Pain Score

Score for pain in the proximal palm and related activity limitations, range 0 (worst) to 100 (best). (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
Methylprednisolone 80 mg86.4
Methylprednisolone 40 mg84.6
Placebo83.0

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Symptom Severity Score

Change in symptom severity score from baseline to 5 to 7 years. Score range 1 (no symptoms) to 5 (most severe symptoms). (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
80-mg Mrthylprednisolone and no Surgery1.34
Surgery After Methylprednisolone or Placebo1.53

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Left and Right Ventricular Diastolic Area (cm^2) by Echocardiography.

Results are provided on left ventricular end-diastolic area (LVEDA) and right ventricular diastolic area (RVEDA) by echocardiography within 12 hours and 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.

,
Interventioncm^2 (Mean)
LVEDA within 12 hours after ROSCRVEDA within 12 hours after ROSCLVEDA at 72 hours after ROSCRVEDA at 72 hours after ROSC
Control Group22.813.018.512.6
Steroids Group23.112.123.114.5

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Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.

Results are provided for CO at 48 hours after ROSC (NCT02790788)
Timeframe: Time points of measurement: 48 hours after ROSC.

InterventionL/min (Mean)
Steroids Group5.8
Control Group5.7

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Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.

Results are provided for CO at 24 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 24 hours after ROSC.

InterventionL/min (Mean)
Steroids Group5.6
Control Group5.4

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Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.

RESULTS ARE PROVIDED FOR CARDIAC OUTPUT (CO) AT 4 HOURS AFTER ROSC. (NCT02790788)
Timeframe: Time points of measurement: 4 hours after ROSC.

InterventionL/min (Mean)
Steroids Group4.9
Control Group5.0

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Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.

Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the third, pre-specified time point of measurement, i.e. at 24 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 24 hours after ROSC.

InterventionmmHg (Mean)
Steroids Group79.9
Control Group81.9

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Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.

Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the fourth, pre-specified time point of measurement, i.e. at 48 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 48 hours after ROSC.

InterventionmmHg (Mean)
Steroids Group80.2
Control Group84.2

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Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.

Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the fifth, pre-specified time point of measurement, i.e. at 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 72 hours after ROSC.

InterventionmmHg (Mean)
Steroids Group85.2
Control Group84.7

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Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).

Results on early postresuscitation, mean arterial blood pressure (mmHg) are provided for the second, pre-specified time point of measurement, i.e. at 4 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 4 hours after ROSC.

InterventionmmHg (Mean)
Steroids Group83.9
Control Group78.9

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Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).

Results on early postresuscitation, mean arterial blood pressure (mmHg) are provided for the first, pre-specified time point of measurement, i.e. at 20 min after the return of spontaneous circulation (ROSC). (NCT02790788)
Timeframe: Time point of measurement: 20 min after the return of spontaneous circulation (ROSC).

InterventionmmHg (Mean)
Steroids Group78.4
Control Group75.1

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Steroid-associated Complications.

Episodes of 1) Hyperglycemia (defined as Blood Glucose >200 mg/dL), 2) Hypernatremia (defined as blood gas analysis-derived sodium ion concentration >150 mEq/L), and 3) Infections (defined as any microbiologically documented, intensive care unit-acquired, or hospital-acquired infection). (NCT02790788)
Timeframe: Up to 180 days postrandomization.

,
InterventionNumber of Episodes per Patient (Median)
No. of Episodes of HyperglycemiaNo. of Episodes of HypernatremiaNo. of Episodes of Infections
Control Group000
Steroids Group000

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Left and Right Ventricular Ejection Fraction (%) by Echocardiography.

Results are provided on left ventricular ejection fraction (LVEF) and right ventricular ejection fraction (RVEF) within 12 hours and 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.

,
InterventionPercentage (Mean)
LVEF within 12 hours after ROSCRVEF within 12 hours after ROSCLVEF at 72 hours after ROSCRVEF at 72 hours after ROSC
Control Group45.942.75044.7
Steroids Group42.341.74542.8

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Eccentricity Index by Echocardiography.

"Eccentricity index (ECCI) is defined as the ratio of the left ventricular (LV) longitudinal (or anteroposterior) diameter to the LV transverse (or septo-lateral) diameter, measured at end diastole and end systole in a short-axis view. Pertinent results are provided for a first determination within 12 hours after ROSC and a second determination at 72 hours after ROSC." (NCT02790788)
Timeframe: Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.

,
InterventionECCENTRICITY INDEX (Mean)
End-diastolic ECCI within 12 hours after ROSCEnd-systolic ECCI within 12 hours after ROSCEnd-diastolic ECCI at 72 hours after ROSCEnd-systolic ECCI at 72 hours after ROSC
Control Group1.31.31.31.3
Steroids Group1.21.31.21.2

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Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL).

Logarithm (base 10)-transformed serum levels of tumor necrosis factor alpha (TNFa), interleukin (IL)-1 beta, IL-6, IL-8, and IL-10; blood samples were obtained by venipuncture. (NCT02790788)
Timeframe: Time points of measurement: 4, 24, 48, and 72 hours postresuscitation.

,
InterventionLog(10) transformed values of pg/mL (Mean)
IL-6 at 4 hours after ROSCTNFα at 4 hours after ROSCIL-1β at 4 hours after ROSCIL-8 at 4 hours after ROSCIL-10 at 4 hours after ROSCIL-6 at 24 hours after ROSCTNFα at 24 hours after ROSCIL-1β at 24 hours after ROSCIL-8 at 24 hours after ROSCIL-10 at 24 hours after ROSCIL-6 at 48 hours after ROSCTNFα at 48 hours after ROSCIL-1β at 48 hours after ROSCIL-8 at 48 hours after ROSCIL-10 at 48 hours after ROSCIL-6 at 72 hours after ROSCTNFα at 72 hours after ROSCIL-1β at 72 hours after ROSCIL-8 at 72 hours after ROSCIL-10 at 72 hours after ROSC
Control Group2.222.032.032.431.761.992.002.092.291.541.911.962.032.171.531.901.962.042.191.45
Steroids Group2.191.972.072.391.762.062.022.062.271.691.871.992.092.151.561.932.002.052.151.66

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Core Body Temperature in Degrees Celcius.

Results are provided for core body temperature averaged over the following time intervals after ROSC: 1) 0-6 hours; 2) 6-12 hours; 3) 12-18 hours; 4) 18-24 hours; 5) 24-30 hours; 6) 30-36 hours; 7) 36-42 hours; and 42-48 hours. (NCT02790788)
Timeframe: Time points of measurement: Hourly from intensive care admission to 48 hours postresuscitation.

,
InterventionDegrees Celcius (Mean)
Temperature averaged over 0-6 hours after ROSCTemperature averaged over 6-12 hours after ROSCTemperature averaged over 12-18 hours after ROSCTemperature averaged over 18-24 hours after ROSCTemperature averaged over 24-30 hours after ROSCTemperature averaged over 30-36 hours after ROSCTemperature averaged over 36-42 hours after ROSCTemperature averaged over 42-48 hours after ROSC
Control Group35.636.636.536.336.236.236.236.3
Steroids Group36.536.336.036.136.136.036.136.2

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Cerebral Blood Flow Index by Near Infrared Spectroscopy With Indocyanine Green.

Results are reported for 2 pairs of cerebral blood flow index (CBFI) measurements performed each time at a lower and a higher level of mean arterial pressure (MAP) at the following time points: 1) at 4 hours after ROSC and 2) at 72 hours after ROSC (NCT02790788)
Timeframe: Time points of measurement: 4 and 72 hours postresuscitation.

,
InterventionnM/s (Mean)
CBFI 4 HOURS POST-ROSC MEAN MAP=75.5 MMHGCBFI 4 HOURS POST-ROSC MEAN MAP=96.0 MMHGCBFI 72 HOURS POST-ROSC MEAN MAP=75.5 MMHGCBFI 72 HOURS POST-ROSC MEAN MAP= 97.0 MMHG
Control Group3.33.53.43.8
Steroids Group4.04.24.34.9

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Survival to Hospital Discharge With Favorable Functional Outcome.

Survival to hospital discharge with a Cerebral Performance Category (CPC) Score of 1 or 2. The CPC Score ranges can have the following values: 1, 2, 3, 4, and 5; lower Scores correspond to better outcomes, whereas higher Scores reflect worsening outcomes, e.g. a Score of 4 means Coma or Vegetative state, and a Score of 5 means Brain Death. (NCT02790788)
Timeframe: Up to 180 days postrandomization.

InterventionParticipants (Count of Participants)
Steroids Group2
Control Group5

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Organ Failure-free Days.

Number of organ failure-free days during days 1 through 60 postrandomization. Organ failure free=corresponding Sequential Organ Failure Assessment Subscore <3; each subscore can have the following values: 0, 1, 2, 3, and 4; increasing values indicate worsening organ failure. (NCT02790788)
Timeframe: Days 1 to 60 postrandomization.

InterventionNumber of Days without Organ Failure (Median)
Steroids Group0
Control Group0

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Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.

Results on postresuscitation central venous oxygen saturation (%) are provided for the third, pre-specified time point of measurement, i.e., at 24 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 24 hours after ROSC.

InterventionPercent Hemoglobin Concentration (Mean)
Steroids Group71.1
Control Group70.1

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Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.

Results on postresuscitation central venous oxygen saturation (%) are provided for the fourth, pre-specified time point of measurement, i.e., at 48 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 48 hours after ROSC.

InterventionPercent Hemoglobin Concentration (Mean)
Steroids Group73.3
Control Group70.5

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Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.

Results on postresuscitation central venous oxygen saturation (%) are provided for the fifth, pre-specified time point of measurement, i.e., at 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 72 hours after ROSC.

InterventionPercent Hemoglobin Saturation (Mean)
Steroids Group72.5
Control Group70.4

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Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port (as Feasible).

Results on postresuscitation central venous oxygen saturation (%) are provided for the second, pre-specified time point of measurement, i.e., at 4 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 4 hours after ROSC.

InterventionPercent Hemoglobin Concentration (Mean)
Steroids Group67.4
Control Group56.8

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Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.

Results are provided for CO at 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 72 hours after ROSC.

InterventionL/min (Mean)
Steroids Group5.8
Control Group5.6

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Number of Participants Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)

Number of participants (biological replicates) that were successfully sampled for RNA-seq differential gene expression analysis in glucocorticoid-treated immune cells. The analysis employed a cutoff value of < 5% false-discovery rate (FDR) to select the transcripts that were considered differentially expressed at each time point. The resulting gene lists were contrasted to determine which genes were uniquely differentially expressed in different cell types. (NCT02798523)
Timeframe: Up to 2 or 4 hours post infusion depending on group

InterventionParticipants (Count of Participants)
Up to 2 Hours Post Infusion5
Up to 4 Hours Post Infusion20

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Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to First Course of Azacitidine

Will calculate the percentage of CpG site methylation for all patients before the first course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 6, Day 1 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)

InterventionPercentage of CpG methylation (Mean)
KMT2A-Rearranged78.17

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Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of Second Course of Azacitidine

Will calculate the percentage of CpG site methylation for all patients after the second course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 13, Day 5 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)

InterventionPercentage of CpG methylation (Mean)
KMT2A-Rearranged74.52

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Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of First Course of Azacitidine

Will calculate the percentage of CpG site methylation for all patients after the first course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 6, Day 5 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)

InterventionPercentage of CpG methylation (Mean)
KMT2A-Rearranged75.54

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Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to Second Course of Azacitidine

Will calculate the percentage of CpG site methylation for all patients before the second course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 13, Day 1 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)

InterventionPercentage of CpG methylation (Mean)
KMT2A-Rearranged76.5

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Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R)

Proportion of KMT2A-Rearranged patients treated with azacitidine with Dose Limiting Toxicities (DLTs) from the first course of azacitidine administration up to fourth course of azacitidine administration. (NCT02828358)
Timeframe: 6 months

Interventionpercentage of participants (Number)
KMT2A-Rearranged6.45

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Medication Preference as Assessed by Self-report

"Participants will be asked, by phone, if they would want the same medication during a subsequent visit to the emergency department. Reported values indicate participants who responded yes." (NCT02847494)
Timeframe: 7 days after discharge from emergency department

InterventionParticipants (Count of Participants)
Control76
Experimental75

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Number of Participants With Sustained Headache Freedom

Sustained headache freedom is defined as achieving a headache intensity = none within two hours of treatment and maintaining this level, without requiring additional headache medication, for 7 days following discharge from the Emergency Department. Participants will be asked by phone how number of days they experienced headaches during the week after discharge from the emergency department. Reported values are participants who experienced no headaches at all during the 7 days immediately following discharge. (NCT02847494)
Timeframe: 7 days after discharge from emergency department

InterventionParticipants (Count of Participants)
Control10
Experimental6

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Headache Days as Self-reported by Participants

At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged. (NCT02847494)
Timeframe: 7 days after discharge from emergency department

Interventiondays (Mean)
Control3.0
Experimental3.3

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Failure-free Survival (FFS)

Defined as the time from first dose of ruxolitinib to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD). (NCT02953678)
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)

Interventiondays (Median)
Ruxolitinib in Combination With Corticosteroids85.0

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Percentage of Participants With Six-month Duration of Response (DOR)

Defined as the time from first response until graft-versus-host disease (GVHD) progression or death. DOR was assessed when all participants who were on the study completed the Day 180 visit. (NCT02953678)
Timeframe: From Baseline up to 6 months

Interventionpercentage of participants (Number)
Ruxolitinib in Combination With Corticosteroids68.2

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Overall Survival (OS)

Defined as the time from study enrollment (first day of ruxolitinib treatment) to death due to any cause. (NCT02953678)
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)

Interventiondays (Median)
Ruxolitinib in Combination With Corticosteroids232.0

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Percentage of Participants With Three-month DOR

Defined as the time from first response until GVHD progression or death. DOR was assessed when all participants who were on the study completed the Day 84 visit. (NCT02953678)
Timeframe: From Baseline up to 3 months

Interventionpercentage of participants (Number)
Ruxolitinib in Combination With Corticosteroids84.5

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Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs

AE was any unfavorable and unintended sign, symptom, or disease temporally associated with use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Serious AE was any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. TEAE was an AE that was reported for the first time, or worsening of a pre-existing event after the first dose of study drug (until 30 days after the last dose of study drug). Severity of AEs was described and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03). Grade 3 and above would constitute a severe, life-threatening, or death event. (NCT02953678)
Timeframe: From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)

InterventionParticipants (Count of Participants)
TEAEsSerious TEAEsGrade 3 or Higher TEAEs
Ruxolitinib in Combination With Corticosteroids715969

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Relapse Rate

Defined as the percentage of participants whose underlying malignancy relapsed. (NCT02953678)
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)

Interventionpercentage of participants (Number)
Ruxolitinib in Combination With Corticosteroids7.0

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Overall Response Rate (ORR) at Day 28

Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR). (NCT02953678)
Timeframe: From baseline to Day 28

InterventionParticipants (Count of Participants)
Responders - CRResponders - VGPRResponders - PR
Ruxolitinib in Combination With Corticosteroids19713

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Overall Response Rate (ORR)

Defined as the percentage of participants demonstrating a CR, VGPR, or PR. (NCT02953678)
Timeframe: From baseline to days 14, 56, and 100

Interventionpercentage of participants (Number)
Day 14Day 56Day 100
Ruxolitinib in Combination With Corticosteroids62.036.632.4

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Nonrelapse Mortality (NRM)

Defined as the proportion of subjects who died due to causes other than malignancy relapse. (NCT02953678)
Timeframe: From baseline to Months 6, 9, 12, and 24

Interventionpercentage of participants (Number)
6 months9 months12 months24 months
Ruxolitinib in Combination With Corticosteroids44.448.252.964.8

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Dose Modifications

Number of dose modifications from baseline to 3 months post-conversion. (NCT02953873)
Timeframe: Baseline to 3 months post conversion

Interventionnumber of dose modifications (Median)
Homozygous CYP3A5 1 expressorsHeterozygous CYP3A5 1 expressorsCYP3A5 1 non expressers
Conversion Arm124

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Number of Days to Reach Therapeutic Trough Goal

Days to reach therapeutic goal after conversion (NCT02953873)
Timeframe: Baseline to 3 months post conversion

Interventionnumber of days (Median)
Homozygous CYP3A5 1 expressorsHeterozygous CYP3A5 1 expressorsCYP3A5 1 non-expressors
Conversion Arm151015

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Dose-normalized Trough

Difference in dose-normalized trough at steady state before and after conversion from tacrolimus IR to Astagraf XL® (NCT02953873)
Timeframe: Baseline to 3 months post-conversion

Interventionng/dL (Median)
Pre-Conversion Dose TroughPost-Conversion Dose Trough
Conversion Arm0.590.44

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Total Daily Dose

Difference in Total Daily Dose necessary for steady state therapeutic goal (NCT02953873)
Timeframe: Baseline to 3 months post conversion

Interventionmg (Median)
Pre-Conversion Tacrolimus DosePost-Conversion Tacrolimus Dose
Conversion Arm1015

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Weight-Based Dose Requirement

Weight-based dose requirements to reach therapeutic goal pre- and post-conversion (NCT02953873)
Timeframe: Baseline to 3 months post conversion

Interventionmg/kg (Median)
Pre-ConversionPost-Conversion
Conversion Arm0.110.16

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Self-reported Medication Adherence From Baseline to 6 Months.

Percent of subjects reporting high medication adherence at baseline compared to 6 months post-conversion, using the Morisky Medication Adherence scale (MMAS). The MMAS rates medication adherence on a scale of 0 to 8. 0 is high adherence, 1-2 is medium adherence, and greater than or equal to 3 is low adherence. (NCT02954198)
Timeframe: 6 months post conversion

,
Intervention% of participants (Number)
Baseline6 months post-conversion
Control: Envarsus + MMF8059
Intervention: Envarsus + Everoliumus4547

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Percent of Participants Who Experienced Kidney Transplant Graft Loss

Measure and compare time-to-event analysis between the two arms graft loss (time to event analysis) (NCT02954198)
Timeframe: Baseline to 6 months post conversion

InterventionParticipants (Count of Participants)
Control: Envarsus + MMF0
Intervention: Envarsus + Everoliumus0

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Percent of Participants Experiencing Acute Allograft Rejection

Estimate the composite of treatment failure rate, defined as acute allograft rejection with a Banff grade 1A or higher, graft loss, or death at six months post-conversion, in patients converted to a once-daily immunosuppressant regimen of Envarsus®, everolimus, and prednisone versus patients converted to a twice-daily regimen of Envarsus®, MMF, and prednisone. (NCT02954198)
Timeframe: Baseline to 6 months post conversion

InterventionParticipants (Count of Participants)
Control: Envarsus + MMF0
Intervention: Envarsus + Everoliumus0

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Subject Specific Change on Medication Side Effect Scale

Examine subject specific change on a validated Medication Side Effect Scale at the time of the conversion versus six months post-conversion, compared between the two arms. Side effect burden scale is from 0 to 180. A lower score is less side effect burden, a higher score is more side effect burden. (NCT02954198)
Timeframe: Baseline to 6 months post conversion

,
Interventionunits on a scale (Mean)
Baseline6 month post-conversion
Control: Envarsus + MMF7193
Intervention: Envarsus + Everoliumus3738

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Failure-free Survival - Percentage of Participants With an Event

Failure-free survival was defined as the absence of all of the following criteria: Need for second-line treatment for acute GvHD, Non-relapse mortality (death during continuous complete remission) and recurrent malignancy. (NCT02956122)
Timeframe: Days 100 and 180

InterventionPercentage of participants (Number)
Day 100Day 180
GLASSIA100100

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Graft-versus-host Disease (GvHD)-Free Survival - Percentage of Participants With an Event

GVHD-free survival was defined as being alive without previous onset of acute GVHD or chronic GVHD requiring immunosuppressive therapy. (NCT02956122)
Timeframe: Days 28, 56, 100, 180 and 365

InterventionPercentage of participants (Number)
Day 28Day 56Day 100Day 180Day 365
GLASSIA100100100100100

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Percentage of Participants Achieving Overall Response (OR) At Day 28

OR was defined as graft-versus-host disease (GvHD) complete response (CR) + partial response (PR), defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage and GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs. (NCT02956122)
Timeframe: Day 28

InterventionPercentage of participants (Number)
GLASSIA100

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Incidence of Chronic Graft-versus-host Disease (GvHD)

Incidence of chronic GvHD at Days 180 and 365 was reported. (NCT02956122)
Timeframe: Days 180 and 365

InterventionParticipants (Number)
Day 180Day 365
GLASSIA00

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Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

Clinical laboratory assessments such as hematology, clinical chemistry, lipid and coagulation panels and urinalysis were performed. (NCT02956122)
Timeframe: Baseline up to Day 56

InterventionParticipants (Count of Participants)
GLASSIA0

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"Area Under the Plasma Concentration Curve From Time Zero to Time t AUC(0-t) of GLASSIA"

AUC(0-t) of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

Interventionh*mg/dL (Number)
GLASSIA: Day 1: 90 mg/kg16300
GLASSIA: Day 13: 30 mg/kg11000
GLASSIA: Day 22: 120 mg/kg40400
GLASSIA: Day 50: 120 mg/kg33400

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Apparent Terminal Half-life (t1/2) of GLASSIA

Apparent terminal half-life (hour), determined as ln2/lambda-z. lambda-z is the apparent terminal rate constant (one per hour), determined by linear regression of the terminal points of the log-linear concentration-time curve. Visual assessment will be used to identify the terminal linear phase of the concentration-time profile. A minimum of 3 data points will be used for determination. t1/2 of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

InterventionHour (h) (Number)
GLASSIA: Day 1: 90 mg/kg152
GLASSIA: Day 13: 30 mg/kg117
GLASSIA: Day 22: 120 mg/kg317
GLASSIA: Day 50: 120 mg/kg247

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Apparent Volume of Distribution at Steady State (Vss) of GLASSIA

Vss of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

InterventionDeciliter (dL) (Number)
GLASSIA: Day 13: 30 mg/kg50.9
GLASSIA: Day 22: 120 mg/kg123
GLASSIA: Day 50: 120 mg/kg91.1

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Number of Participants With Clinically Significant Changes in Vital Signs

Vital signs included body temperature, respiratory rate, pulse rate and systolic and diastolic blood pressure. (NCT02956122)
Timeframe: Baseline up to Day 56

InterventionParticipants (Count of Participants)
GLASSIA0

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Maximum Observed Plasma Concentration (Cmax) of GLASSIA

Cmax of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

InterventionMilligrams per deciliter (mg/dl) (Number)
GLASSIA: Day 1: 90 mg/kg339
GLASSIA: Day 13: 30 mg/kg262
GLASSIA: Day 22: 120 mg/kg390
GLASSIA: Day 50: 120 mg/kg409

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Number of Participants With Recurrence of Primary Malignancies

Incidence of recurrence of primary malignancies was reported. (NCT02956122)
Timeframe: Baseline up to Day 365

InterventionParticipants (Count of Participants)
GLASSIA0

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Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180

Grading of GvHD was performed by the investigator according to the modified International Bone Marrow Transplant Registry (IBMTR) grading system which classifies the degree of involvement of each organ system by stage on a scale of 0 to 4. The degree of skin involvement was staged depending upon degree and severity of the lesions: Stage 1: Maculopapular rash over less than (<) 25% of body area, Stage 2: Maculopapular rash over 25 to 50% of body area, Stage 3: Generalized erythroderma, Stage 4: Generalized erythroderma with bullous formation. Degree of GI involvement was staged based on severity of diarrhoea: Stage 1: 500 to 1000 mL/day,Stage 2: 1000 to 1500 mL/day, Stage 3: 1500 to 2000 mL/day, Stage 4: greater than (>) 2000 mL/day OR pain OR ileus. Degree of liver involvement was staged based upon serum total bilirubin level as follows: Stage 1: 2 to 3 mg/dL, Stage 2: 3 to 6 mg/dL, Stage 3: 6 to 15 mg/dL, Stage 4: >15 mg/dL. (NCT02956122)
Timeframe: Days 28, 56 and 180

InterventionParticipants (Count of Participants)
Day 28: Degree of skin Involvement72260019Day 28: Degree of GI Involvement72260019Day 28: Degree of liver Involvement72260019Day 56: Degree of skin Involvement72260019Day 56: Degree of GI Involvement72260019Day 56: Degree of liver Involvement72260019Day 180: Degree of skin Involvement72260019Day 180: Degree of GI Involvement72260019Day 180: Degree of liver Involvement72260019
Stage 1Stage 3Stage 4Stage 0Stage 2
GLASSIA1
GLASSIA0

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Overall Survival (OS) - Percentage of Participants With an Event

OS was defined as the time from the date of randomization to the date of death due to any cause. (NCT02956122)
Timeframe: Days 100, 180 and 365

InterventionPercentage of participants (Number)
Day 100Day 180Day 365
GLASSIANANANA

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Area Under the Plasma Concentration Curve (AUC0-inf) From Time Zero to Infinity

AUC of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours; Day 13: through 48 hours; Day 22 and Day 50: through approximately 168 hours

InterventionHour*milligrams per deciliter (h*mg/dL) (Number)
GLASSIA: Day 1: 90 mg/kg61500
GLASSIA: Day 13: 30 mg/kg43500
GLASSIA: Day 22: 120 mg/kg126000
GLASSIA: Day 50: 120 mg/kg117000

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Percentage of Participants Achieving Overall Response at Day 56

Overall response was defined as graft-versus-host disease (GvHD) complete response (CR) + partial response (PR), defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage - GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs. (NCT02956122)
Timeframe: Day 56

InterventionPercentage of participants (Number)
GLASSIA100

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Systemic Clearance at Steady State (CLss) of GLASSIA

CLss of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

InterventionDeciliters per hour (dL/h) (Number)
GLASSIA: Day 13: 30 mg/kg0.297
GLASSIA: Day 22: 120 mg/kg0.286
GLASSIA: Day 50: 120 mg/kg0.260

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All-cause Mortality - Percentage of Participants With an Event

All-cause mortality was defined as the time from HSCT to death due to any cause. (NCT02956122)
Timeframe: Days 28, 56, 100 and 180

InterventionPercentage of participants (Number)
Day 28Day 56Day 100Day180
GLASSIA0000

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Percentage of Participants Achieving Gastrointestinal (GI) Response at Day 28

GI response was defined as complete response (CR) + partial response (PR), defined as: - GI CR was able to eat; not requiring parenteral nutrition, and passing primarily formed stools - GI PR was decrease in need for parenteral nutrition to less than or equal to (<=) 50% of required calories; and reduction of stool volume by greater than or equal to (>=) 50%, without ileus. (NCT02956122)
Timeframe: Day 28

InterventionPercentage of participants (Number)
GLASSIA100

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Prostate Specific Antigen Levels

Change in serum testosterone levels after one year of treatment against baseline (NCT02962284)
Timeframe: One year

Interventionng/dL (Mean)
Preceding Treatment - Yonsa-60.12
Preceding Treatment - Zytiga-112.76

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Testosterone Complete Suppression

Proportion of subjects with complete suppression of testosterone levels (NCT02962284)
Timeframe: 360 days

Interventionpercentage of subjects (Number)
Preceding Treatment - Yonsa100
Preceding Treatment - Zytiga87.5

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Percentage of Subjects With Prostate Specific Antigen - 50 Response

A decrease of ≥50% reduction from baseline of the study CHL-AA-201 (NCT02962284)
Timeframe: 360 days

Interventionpercentage of number of subjects (Number)
Preceding Treatment - Yonsa60.0
Preceding Treatment - Zytiga55.6

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Number of Subjects With Adverse Events

Adverse events (NCT02962284)
Timeframe: one year

InterventionParticipants (Number)
Preceding Treatment - Yonsa8
Preceding Treatment - Zytiga9

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Testosterone Levels

Change in serum testosterone levels from baseline (NCT02962284)
Timeframe: Baseline and 360 days

Interventionng/dL (Mean)
Preceding Treatment - Yonsa-6.24
Preceding Treatment - Zytiga-5.87

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Proportion of Subjects With Disease Progression

Number of participants who had disease progression (NCT02962284)
Timeframe: one year

InterventionParticipants (Count of Participants)
Preceding Treatment - Yonsa1
Preceding Treatment - Zytiga3

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Best Corrected Visual Acuity at 3 Months

Best uncorrected visual acuity will be measured at 3 months (NCT03123614)
Timeframe: 3 months

InterventionlogMAR (Mean)
Loteprednol Etabonate 0.5% Oph Gel-0.120
Prednisolone Acetate 1% Oph Susp-0.114

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Number of Eyes With Corneal Haze

As determined by slit lamp examination (NCT03123614)
Timeframe: 12 months

InterventionEyes (Count of Units)
Loteprednol Etabonate 0.5% Oph Gel3
Prednisolone Acetate 1% Oph Susp7

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Uncorrected Visual Acuity

Best uncorrected visual acuity will be measured at 3 months (NCT03123614)
Timeframe: 3 months

InterventionlogMAR (Mean)
Loteprednol Etabonate 0.5% Oph Gel-0.078
Prednisolone Acetate 1% Oph Susp-0.075

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Change in Intraocular Pressure (IOP) From Baseline Through Month 3

Intraocular pressure will be measured by applanation tonometry (NCT03123614)
Timeframe: Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op

,
InterventionmmHg (Mean)
Baseline intraocular pressure (IOP)IOP 1 week postopIOP 1 month postopIOP 2 months postopIOP 3 months postop
Loteprednol Etabonate 0.5% Oph Gel14.3813.6714.1513.3613.15
Prednisolone Acetate 1% Oph Susp14.3013.2814.6013.1612.22

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Cmin of Itacitinib When Administered in Combination With Corticosteroids

Defined as minimum observed plasma concentration. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

InterventionnM (Mean)
Itacitinib Plus Corticosteroids72.5

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Duration of Response

Defined as the interval from first response until GVHD progression or death. (NCT03139604)
Timeframe: Baseline through 30-35 days after end of treatment, total particpation expected to average 24 months

Interventiondays (Median)
Itacitinib Plus Corticosteroids587
Placebo Plus CorticosteroidsNA

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Failure-free Survival

Defined as the proportion of subjects who are still alive, have not relapsed, have not required additional therapy for aGVHD, and have not demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD) (NCT03139604)
Timeframe: 6 months from randomization

Interventionproportion of participants (Number)
Itacitinib Plus Corticosteroids44.29
Placebo Plus Corticosteroids40.00

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Incidence Rate of aGVHD Flares

(NCT03139604)
Timeframe: up to day 100

Interventionparticipants (Number)
Itacitinib Plus Corticosteroids42
Placebo Plus Corticosteroids48

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Incidence Rate of Secondary Graft Failure

Defined as > 95% recipient cells any time after engraftment with no signs of relapse, OR retransplantation because of secondary neutropenia (< 0.5 × 109/L) and/or thrombocytopenia (< 20 × 109/L) within 2 months of transplantion (NCT03139604)
Timeframe: Randomization through end of Study, study duration expected to average 24 months

Interventionparticipants (Number)
Itacitinib Plus Corticosteroids2
Placebo Plus Corticosteroids0

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Number of Treatment-emergent Adverse Events With INCB39110

Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment (NCT03139604)
Timeframe: 30-35 days after end of treatment, approximately 24 months

Interventionparticipants (Number)
Itacitinib Plus Corticosteroids208
Placebo Plus Corticosteroids214

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Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index

Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR). (NCT03139604)
Timeframe: Day 28

InterventionPercentage of Participants (Number)
Itacitinib Plus Corticosteroids74.0
Placebo Plus Corticosteroids66.4

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AUC of Itacitinib When Administered in Combination With Corticosteroids

Defined as area under the concentration-time curve. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

InterventionnM*h (Mean)
Itacitinib Plus Corticosteroids6720

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CL/F of Itacitinib When Administered in Combination With Corticosteroids

Defined as oral dose clearance. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

InterventionL/h (Mean)
Itacitinib Plus Corticosteroids104

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Nonrelapse Mortality

Defined as the percentage of participants who died due to causes other than malignancy relapse. (NCT03139604)
Timeframe: Month 6,9,12 and 24

,
Interventionparticipants (Number)
6 Months9 Months12 Months24 Months
Itacitinib Plus Corticosteroids36465156
Placebo Plus Corticosteroids37455252

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Proportion of Subjects Who Discontinue Immunosuppressive Medications

Summary statistics of subjects discontinuing immunosuppressive medications will be calculated (NCT03139604)
Timeframe: Days 56 and 100

,
Interventionparticipants (Number)
Day 56Day 100
Itacitinib Plus Corticosteroids1211
Placebo Plus Corticosteroids108

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Proportion of Subjects Who Discontinue Corticosteroids

Average and cumulative corticosteroid dose usage will be calculated and proportion of subjects discontinuing corticosteroids will be tabulated (NCT03139604)
Timeframe: Days 28, 56, 100, and 180

,
Interventionparticipants (Number)
Day 28Day 56Day 100Day 180
Itacitinib Plus Corticosteroids3163939
Placebo Plus Corticosteroids3114545

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Objective Response Rate

(NCT03139604)
Timeframe: Days 14, 56 and 100

,
Interventionparticipants (Number)
Day 14Day 56Day 100
Itacitinib Plus Corticosteroids17013892
Placebo Plus Corticosteroids16012496

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Cmax of Itacitinib When Administered in Combination With Corticosteroids

Defined as maximum observed plasma concentration. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

InterventionnM (Mean)
Itacitinib Plus Corticosteroids796

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Incidence Rate of cGVHD

(NCT03139604)
Timeframe: Days 180 and 365

,
Interventionparticipants (Number)
Day 180Day 365
Itacitinib Plus Corticosteroids2543
Placebo Plus Corticosteroids3658

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Tmax of Itacitinib When Administered in Combination With Corticosteroids

Defined as time to maximum plasma concentration. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

Interventionhrs (Median)
Itacitinib Plus Corticosteroids2.1

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Time to Response

Defined as the interval from treatment initiation to first response (NCT03139604)
Timeframe: End of Study, total particpation expected to average 24 months

Interventiondays (Mean)
Itacitinib Plus Corticosteroids9.9
Placebo Plus Corticosteroids10.1

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Relapse Rate of Malignant and Nonmalignant Hematologic Disease

Defined as the proportion of subjects whose underlying hematologic disease relapses (NCT03139604)
Timeframe: Randomization through end of Study, study duration expected to average 24 months

Interventionpercentage (Number)
Itacitinib Plus Corticosteroids12.4
Placebo Plus Corticosteroids11.4

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Overall Survival (OS)

Defined as the interval from study enrollment to death due to any cause. (NCT03139604)
Timeframe: End of Study up to approximately 24 months

Interventiondays (Median)
Itacitinib Plus Corticosteroids365
Placebo Plus Corticosteroids348.5

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Number of Participants With a Post-operative Length of Stay Greater Than 90 Days

Calculated as discharge date minus surgery date. (NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm18
Placebo Arm29

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Number of Participants With Any Other Post-operative Complications From the Start of Study Drug Administration Until Hospital Discharge.

(NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm237
Placebo Arm264

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Number of Participants With Death or Major Complication as Defined by an Outcome in One of the 7 Highest Global Ranking Categories

The 7 highest global ranking categories range from 91 (postoperative length of hospital stay > 90 days) to 97 (operative mortality). (NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm103
Placebo Arm122

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Number of Participants With Mortality, Including In-hospital Mortality or Mortality After Hospital Discharge But Within 30 Days of the Last Dose of Study Drug

(NCT03229538)
Timeframe: up to 30 days

InterventionParticipants (Count of Participants)
Methylprednisolone Arm12
Placebo Arm17

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Number of Participants With Occurrence of Any One or More of the Following STS-CHSD-defined Major Post-operative Infectious Complications: Postprocedural Infective Endocarditis, Pneumonia, Sepsis, Deep Wound Infection, Mediastinitis.

(NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm31
Placebo Arm24

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Number of Participants With Post-operative Low Cardiac Output Syndrome

"Based upon the STS-CHSD registry defined cardiac dysfunction resulting in low cardiac output complication variable." (NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm31
Placebo Arm37

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Number of Participants With Prolonged Mechanical Ventilation (Greater Than 7 Days)

(NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm41
Placebo Arm51

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ASES Scores at Each Time Point

ASES (American Shoulder & Elbow Surgeon) score. Data points a change for all pre-specified time points and is reported. ASES has 11 items scored by Pain VAS (1 question) Function (10 questions); Score: 0-100 (Higher score is better). (NCT03232749)
Timeframe: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months

Interventionscore on a scale (Mean)
Baseline ASES score2 Week ASES score1 Month ASES scrore2 Month ASES score3 Month ASES score6 Month ASES score
Symptomatic Primary Osteoarthritis of the Shoulder48.5279.7273.8628.6071.7861.48

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SST (Simple Shoulder Test) Scores at Each Time Point

SST (Simple Shoulder Test) score improvement > 2.4 points. 12 items that are answered yes/no (measures functional limitations of the affected shoulder): Scored: 0-12 (Higher score is better) (NCT03232749)
Timeframe: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months

Interventionscore on a scale (Mean)
Baseline SST Score2 Week SST Score1 Month SST Score2 Month SST Score3 Month SST Score6 Month SST Score
Symptomatic Primary Osteoarthritis of the Shoulder5.298.407.325.926.737.00

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Visual Analog Scale Scores at Each Time Point.

VAS (Visual Analog Scale) pain score improvement > 1.4 points (The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0=no pain and 10=worst pain). The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0=no pain and 10=worst pain. (NCT03232749)
Timeframe: Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months

Interventionscore on a scale (Mean)
Baseline VAS scorePost-injection VAS score2 Weeks VAS score1 Month VAS score2 Month VAS score3 Month VAS score6 Month VAS score
Symptomatic Primary Osteoarthritis of the Shoulder4.541.861.182.052.562.502.44

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Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15

"Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)).~The conjunctival redness was averaged across all subjects at each time point." (NCT03320434)
Timeframe: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Patanol1.2421.6171.592
PRT-2761 0.5%1.7231.9201.857
PRT-2761 0%1.9731.9912.036
PRT-2761 1%2.0562.1762.222

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Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1

"Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)).~The conjunctival redness was averaged across all subjects at each time point." (NCT03320434)
Timeframe: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1.

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Patanol1.5921.8331.917
PRT-2761 0.5%1.2821.4111.371
PRT-2761 0%1.9572.1812.164
PRT-2761 1%1.4911.5261.603

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Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15

Ocular Itching was assessed by the subjects using a 0 to 4 point scale(0=none (best/no itching) to 4=severe (worst/most itching)). The ocular itching was averaged across all subjects at each time point. (NCT03320434)
Timeframe: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15

,,,
Interventionunits on a scale (Mean)
5 minutes post-CAC7 minutes post-CAC10 minutes post-CAC
Patanol0.7750.8080.833
PRT-2761 0.5%2.4312.3621.922
PRT-2761 0%2.5272.3661.929
PRT-2761 1%2.6112.6022.204

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Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1

Ocular Itching was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no itching) to 4=severe (worst/most itching). The ocular itching was averaged across all subjects at each time point. (NCT03320434)
Timeframe: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1

,,,
Interventionunits on a scale (Mean)
5 minutes post-CAC7 minutes post-CAC10 minutes post-CAC
Patanol1.2171.3581.258
PRT-2761 0.5%2.5732.6772.250
PRT-2761 0%2.6472.6292.190
PRT-2761 1%2.5002.5092.293

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Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Months 4 and 8

EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other). EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicated worst outcomes. (NCT03368664)
Timeframe: Baseline, Months 4 and 8

Interventionscores on scale (Mean)
Month 4Month 8
Alemtuzumab0.050.00

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Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Participants With New or Enlarged T2 Lesions Per MRI Scan

Number of participants with at least one new or enlarged T2 lesions per MRI scan was reported in this outcome measure. Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during treatment period divided by the total number of scans performed during treatment period. (NCT03368664)
Timeframe: Period 1: Month -4 up to Month 0, Period 2: Month 4 to Month 8

InterventionParticipants (Count of Participants)
Period 110
Period 23

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Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan

Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during a specified period divided by the total number of scans performed during that specified period. (NCT03368664)
Timeframe: Period 1: Month -4 up to Month 0, Period 2: Month 4 to Month 8

Interventionlesions per scan (Number)
Period 13.53
Period 20.13

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Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24

MFIS is a structured, self-report questionnaire consisting of 21 items assessing the effects of fatigue. All 21 items are scaled 0 to 4, with higher scores indicating a greater impact of fatigue on participant's activities. The Total MFIS score ranges from 0 to 84. A score of 0 indicates fatigue has no impact on activities and the high-end score indicates fatigue has extreme impact on activities. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Week 8, 12 and 24

Interventionunits on a scale (Number)
Participant 6: Week 8Participant 7: Week 8Participant 6: Week 12Participant 7: Week 12Participant 7: Week 24
Placebo + IFN Beta-1a + Methylprednisolone2729273043

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Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24

MFIS is a structured, self-report questionnaire consisting of 21 items assessing the effects of fatigue. All 21 items are scaled 0 to 4, with higher scores indicating a greater impact of fatigue on participant's activities. The Total MFIS score ranges from 0 to 84. A score of 0 indicates fatigue has no impact on activities and the high-end score indicates fatigue has extreme impact on activities. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Week 8, 12 and 24

Interventionunits on a scale (Number)
Participant 1: Week 8Participant 2: Week 8Participant 3: Week 8Participant 4: Week 8Participant 5: Week 8Participant 1: Week 12Participant 3: Week 12Participant 4: Week 12Participant 5: Week 12Participant 1: Week 24Participant 3: Week 24Participant 4: Week 24Participant 5: Week 24
D-aspartate + IFN Beta-1a + Methylprednisolone82715218612121510481215

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Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)

TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motor neurons. Long term potentiation can be measured non invasively and painlessly, in awake humans through transcranial magnetic stimulation (TMS). TMS uses high intensity, brief duration, magnetic fields that, when applied on the scalp, can activate neurons within a small focal region of the cerebral cortex, through electromagnetic induction. Motor Evoked Potentials (MEP) amplitudes elicited by single TMS pulses of increasing intensity (110, 120 and 130% of the Resting Motor Threshold [RMT]) will be measured to calculate recruitment curves of the motor cortex. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Baseline (0 minute) and Post-Baseline (15 minutes) at Week 8

Interventionmillivolts (Number)
Participants 6: Week 8 (Baseline): 110% RMTParticipants 6: Week 8 (Baseline): 120% RMTParticipants 6: Week 8 (Baseline): 130% RMTParticipants 6: Week 8 (Post-baseline): 110% RMTParticipants 6: Week 8 (Post-baseline): 120% RMTParticipants 6: Week 8 (Post-baseline): 130% RMTParticipants 7: Week 8 (Baseline): 110% RMTParticipants 7: Week 8 (Baseline): 120% RMTParticipants 7: Week 8 (Baseline): 130% RMTParticipants 7: Week 8 (Post-baseline): 110% RMTParticipants 7: Week 8 (Post-baseline): 120% RMTParticipants 7: Week 8 (Post-baseline): 130% RMT
Placebo + IFN Beta-1a + Methylprednisolone288311826911253314014930135138

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Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)

TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motor neurons. Long term potentiation can be measured non invasively and painlessly, in awake humans through transcranial magnetic stimulation (TMS). TMS uses high intensity, brief duration, magnetic fields that, when applied on the scalp, can activate neurons within a small focal region of the cerebral cortex, through electromagnetic induction. Motor Evoked Potentials (MEP) amplitudes elicited by single TMS pulses of increasing intensity (110, 120 and 130% of the Resting Motor Threshold [RMT]) will be measured to calculate recruitment curves of the motor cortex. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Baseline (0 minute) and Post-Baseline (15 minutes) at Week 8

Interventionmillivolts (Number)
Participants 1: Week 8 (Baseline): 110% RMTParticipants 1: Week 8 (Baseline): 120% RMTParticipants 1: Week 8 (Baseline): 130% RMTParticipants 1: Week 8 (Post-baseline): 110% RMTParticipants 1: Week 8 (Post-baseline): 120% RMTParticipants 1: Week 8 (Post-baseline): 130% RMTParticipants 3: Week 8 (Baseline): 110% RMTParticipants 3: Week 8 (Baseline): 120% RMTParticipants 3: Week 8 (Baseline): 130% RMTParticipants 3: Week 8 (Post-baseline): 110% RMTParticipants 3: Week 8 (Post-baseline): 120% RMTParticipants 3: Week 8 (Post-baseline): 130% RMT
D-aspartate + IFN Beta-1a + Methylprednisolone3010514239128154239511531103118

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Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24

Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Week 8, 12 and 24

Interventionunits on a scale (Number)
Participant 6: Week 8Participant 7: Week 8Participant 6: Week 12Participant 7: Week 12Participant 7: Week 24
Placebo + IFN Beta-1a + Methylprednisolone4.32.24.14.13.3

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Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24

Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Week 8, 12 and 24

Interventionunits on a scale (Number)
Participant 1: Week 8Participant 2: Week 8Participant 3: Week 8Participant 4: Week 8Participant 5: Week 8Participant 1: Week 12Participant 3: Week 12Participant 4: Week 12Participant 5: Week 12Participant 1: Week 24Participant 3: Week 24Participant 4: Week 24Participant 5: Week 24
D-aspartate + IFN Beta-1a + Methylprednisolone1.22.61.71.111.32.6211.32.821.1

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Donor-specific HLA Antibodies, Re-transplantation, or Death

The Outcome Measure is a composite primary endpoint of the development of donor-specific HLA antibodies, re-transplantation, or death. Testing for donor-specifc HLA antibodies was performed at study-specified time points using the single antigen bead assay at the study core lab. Donor-specific HLA antibodies were defined as reactivity with a mean fluorescence intensity (MFI) ≥ 2,000. (NCT03388008)
Timeframe: 365 days

,
Interventionparticipants (Number)
DeathDonor-specific HLA antibodiesRe-transplantation
Belatacept-based Immunosuppression530
Standard of Care030

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PACU Stay

from operation to discharge from PACU (NCT03403517)
Timeframe: up to 24 hours

Interventionminutes (Median)
Methylprednisolone203
Dexamethasone186

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Total Complication Rate

any complications, 30 day morbidity (NCT03403517)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Methylprednisolone19
Dexamethasone19

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Mortality

any cause mortality (NCT03403517)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Methylprednisolone0
Dexamethasone0

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Complications, Post-anesthesia Care Unit (PACU)

Number of patients with any complication at any time, during stay in the PACU. Complications according to DASAIMS discharge criteria (modified Aldrete criteria) (NCT03403517)
Timeframe: up to 24 hours

InterventionParticipants (Count of Participants)
Methylprednisolone51
Dexamethasone58

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Hospital Stay

from operation to discharge (NCT03403517)
Timeframe: 3 months

Interventionhours (Median)
Methylprednisolone98
Dexamethasone102

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Change From Baseline (Preoperative Exam) in Macular Thickness

Thickness of the macula measured in microns, recorded as the change from baseline. (NCT03578276)
Timeframe: Month 1

Interventionmicrons (Mean)
LessDrops4.91
Standard of Care1.30

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Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)

Thickness of the cornea measured in microns, measured as the change from baseline (NCT03578276)
Timeframe: Month 1

Interventionmicrons (Mean)
LessDrops3.18
Standard of Care0.63

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Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)

Measurement of the pressure inside the eye in mmHg, recorded as the change from baseline (NCT03578276)
Timeframe: Month 1

InterventionmmHg (Mean)
LessDrops-0.33
Standard of Care-0.21

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Survival of Treatment

Survival of Hematopoietic Stem Cell Transplant during treatment and post treatment up to 1 year. (NCT03593902)
Timeframe: During Treatment and Post Treatment up to 1 year

InterventionParticipants (Count of Participants)
Hematopoietic Stem Cell Transplantation9

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Change in Skin Score by mRSS

Defined by at least a 25% improvement (decline) in skin score by modified Rodnan skin score (mRSS) if skin score is greater than 14 on enrollment. If skin score is less than 14 on enrollment, improvement is defined by at least a 5% improvement on mRSS. The modified Rodnan skin score (MRSS) is a measure for skin disease in scleroderma and is calculated by summation of skin thickness in 17 different body sites. The scale ranges from at total score of normal skin thickness (0) to severe thickness (51). (NCT03593902)
Timeframe: Pre Treatment and Post Treatment

Interventionunits on a scale (Mean)
Pre TreatmentPost Treatment
Hematopoietic Stem Cell Transplantation2516

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Number of Participants With a Favorable Neurological Outcome at 30 Days

A favorable neurological outcome will be defined as a cerebral performance category score of 1 or 2. The cerebral performance category score is a 5-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes. (NCT03640949)
Timeframe: At 30 days

InterventionParticipants (Count of Participants)
Vasopressin and Methylprednisolone18
Placebo20

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Number of Participants That Survived 30 Days

(NCT03640949)
Timeframe: At 30 days

InterventionParticipants (Count of Participants)
Vasopressin and Methylprednisolone23
Placebo31

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Number of Participants With Return of Spontaneous Circulation

Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes (NCT03640949)
Timeframe: During the cardiac arrest, an average of 20 minutes

Interventionparticipants (Number)
Vasopressin and Methylprednisolone100
Placebo86

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Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7

Participants were instructed to log their pain twice daily (morning and night) using a VAS pain scale of 0-10 (0: no pain, 10: highest amount of pain) for the first 7 days after injection. Participants were instructed to bring that pain journal to their 2-week visit. Average daily scores are presented. (NCT03704584)
Timeframe: Post injection day (1-7), 2 weeks and at 6 weeks post intervention

,
Interventionscore on a scale (Mean)
Post injection day 1Post injection day 2Post injection day 3Post injection day 4Post injection day 5Post injection day 6Post injection day 7
Control Group (Corticosteroid Alone)3.73.02.62.22.01.51.6
Treatment Group (Corticosteroid Injection Plus Lidocaine)3.72.21.71.11.00.690.58

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Number of Patients With Subsequent Reinjection and Surgical Operation

The number of patients with subsequent reinjection and surgical operation was collected during follow up. (NCT03704584)
Timeframe: End of follow up (6 weeks post intervention)

InterventionParticipants (Count of Participants)
Treatment Group (Corticosteroid Injection Plus Lidocaine)0
Control Group (Corticosteroid Alone)0

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10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group

Pain will be assessed with a 10-point scale (0: no pain, 10: highest amount of pain) of anticipated pain and anxiety before injection and a 10-point pain scale of the pain of the needle, medication, overall pain and anxiety after the injection was administered to the participants. (NCT03704584)
Timeframe: Pre injection, Post injection day, 2 weeks and at 6 weeks

,
Interventionscore on a scale (Mean)
Pre-Injection: How painful do you think the injection will be?Pre-Injection: How painful do you think it will be 1-minute after the injection?Pre-Injection: How nervous are you about the injection?Post-Injection: Actual pain of the needlePost-Injection: Actual pain of the medicationPost-Injection: Actual pain 1-minute after the injection
Control Group (Corticosteroid Alone)5.43.23.54.24.31.7
Treatment Group (Corticosteroid Injection Plus Lidocaine)5.94.44.04.34.71.7

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Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

A TEAE was defined as an AE that began or worsened from Baseline after the first administration of study drug. (NCT03721965)
Timeframe: up to 45 days

InterventionParticipants (Count of Participants)
Cohort 1 : Itacitinib + Corticosteroids2

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Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study

To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48). (NCT03797872)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
Standard Care0

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Percentage of IRRs Regardless of Grade by Cycle

IRRs were defined as all adverse events (AEs) that occurred during or within 24 hours from the end of study treatment infusion and were judged as related to infusion of study treatment components by the investigator. (NCT03817853)
Timeframe: Within 24 hours from the end of study treatment infusion in all cycles, including maintenance ((1 cycle: 21 or 28 days depending on the chemotherapy selected); up to approximately 2.5 years)

InterventionPercentage of Participants (Number)
Cycle 1 Day 1Cycle 1 Day 2Cycle 1 Day 8Cycle 1 Day 15Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Cycle 7
All Participants49.67.84.54.511.88.34.96.23.64.4

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Duration of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle

The duration, in minutes, of IRRs during all cycles, where obinutuzumab was administered as an SDI. (NCT03817853)
Timeframe: All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)

InterventionMinutes (Mean)
All Participants165.0

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Objective Response Rate (ORR) at the End of Induction (EOI) Therapy

ORR at EOI therapy was defined as the percentage of particpants with either a CR, CR unconfirmed or PR at the EOI visit, as determined by the investigator and according to the guidelines used at the site. (NCT03817853)
Timeframe: Baseline up to end of induction therapy (up to approximately 6 months)

InterventionPercentage of Participants (Number)
Complete ResponsePartial Response
All Participants72.119.1

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Duration (In Minutes) of Obinutuzumab Administration by Cycle

The duration of obinutuzumab administration (in minutes) by cycle was defined as the difference between the end time and the start time of obinutuzumab administration. (NCT03817853)
Timeframe: All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)

InterventionMinutes (Mean)
Cycle(C) 1 Day(D) 1C1D8C1D15C2C3C4C5C6C7C8Maintenance Week 1Maintenance Week 9Maintenance Week 17Maintenance Week 25Maintenance Week 33Maintenance Week 41
All Participants295.96215.97207.52101.48102.9798.3398.2699.4999.5694.54101.4897.2197.6493.8392.5090.00

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Time to IRR From Infusion to Onset of the IRR During Cycle 2

Time to IRR (of any grade) in Cycle 2 was defined as the time from the start of infusion (i.e., start date/time of infusion of the first component of study treatment) in Cycle 2 to the onset of the IRR (of any grade) during Cycle 2. (NCT03817853)
Timeframe: From infusion to onset of IRR during Cycle 2 (1 cycle: 21 or 28 days depending on the chemotherapy selected)

InterventionHours (Mean)
All Participants11.800

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Percentage of Participants With Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product, regardless of causal attribution. An AE was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsened during the study, recurrence of an intermittent medical condition, deterioration in a laboratory value or other clinical test or were related to a protocol-mandated intervention were also considered AEs. Grading was completed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. (NCT03817853)
Timeframe: Baseline up to clinical cut off date (up to approximately 1.5 years)

InterventionPercentage of Participants (Number)
All Participants99.1
Maintenance: Obinutuzumab41.1
Follow-up35.3

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Type of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle

(NCT03817853)
Timeframe: All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)

InterventionPercentage of Participants (Number)
Cycle (C) 5- HypertensionC5 - Renal failureC5 - Weight increased
All Participants33.333.333.3

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Change in EuroQuality of Life (EQ-5D-3L) Index Score

"The EQ-5D-3L survey measures the severity of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participants will be asked to answer questions regarding these measures and to indicate their current experience on a scale from 1 to 3 (1 being no problem and 3 being most extreme problem). A sixth item asks participants to rate their current heath from 0 (worst imaginable) to 100 (best imaginable). The answers to these questions are converted into an index value based on the country respondents live in. Health state index scores typically range from less than 0 to 1, where 0 is a health state equivalent to death and 1 is perfect health. Positive values for the change from baseline score indicate improved health." (NCT03818737)
Timeframe: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

,,,
Interventionscore on a scale (Least Squares Mean)
Absolute Change from Baseline at Month 1Absolute Change from Baseline at Month 3Absolute Change from Baseline at Month 6Absolute Change from Baseline at Month 9Absolute Change from Baseline at Month 12
Adipose-derived MSCs0.10.10.10.10.1
Bone Marrow Derived MSCs0.10.10.10.00.1
Corticosteroid Injection0.10.10.10.10.1
Umbilical Cord Tissue (UCT) MSCs0.10.10.10.10.1

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Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score

The PROMIS-29 assesses seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to participate in social roles and activities. Each of the seven domains has four questions which are scored on a five-point Likert scale. The PROMIS-29 scales are scored using a T-score metric method available at the Assessment Center website (http://assessmentcenter.net). A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Scores higher than 50 indicate more of the specific scale's construct, which may indicate a desirable or an undesirable outcome. (NCT03818737)
Timeframe: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

,,,
Interventiont-score (Mean)
Anxiety Score - BaselineAnxiety Score - Month 1Anxiety Score - Month 3Anxiety Score - Month 6Anxiety Score - Month 9Anxiety Score - Month 12Depression Score - BaselineDepression Score - Month 1Depression Score - Month 3Depression Score - Month 6Depression Score - Month 9Depression Score - Month 12Fatigue Score - BaselineFatigue Score - Month 1Fatigue Score - Month 3Fatigue Score - Month 6Fatigue Score - Month 9Fatigue Score - Month 12Pain Score - BaselinePain Score - Month 1Pain Score - Month 3Pain Score - Month 6Pain Score - Month 9Pain Score - Month 12Physical Function Score - BaselinePhysical Function Score - Month 1Physical Function Score - Month 3Physical Function Score - Month 6Physical Function Score - Month 9Physical Function Score - Month 12Sleep Disturbance Score - BaselineSleep Disturbance Score - Month 1Sleep Disturbance Score - Month 3Sleep Disturbance Score - Month 6Sleep Disturbance Score - Month 9Sleep Disturbance Score - Month 12Social Roles and Activities Score - BaselineSocial Roles and Activities Score - Month 1Social Roles and Activities Score - Month 3Social Roles and Activities Score - Month 6Social Roles and Activities Score - Month 9Social Roles and Activities Score - Month 12
Adipose-derived MSCs47.545.445.445.845.445.345.043.844.044.945.243.947.045.845.346.146.145.258.652.552.151.552.350.840.343.644.345.244.645.249.748.448.348.948.549.047.951.653.352.752.653.5
Bone Marrow Derived MSCs47.145.945.145.946.145.644.744.343.843.945.644.546.845.845.045.946.745.659.153.651.651.552.451.539.343.044.944.543.044.448.947.247.348.648.947.849.552.154.453.153.653.3
Corticosteroid Injection48.245.445.545.345.145.245.645.044644.044.144.548.546.244.845.146.845.360.453.353.553.653.252.738.343.342.943.043.043.650.249.247.948.947.948.846.951.551.652.052.452.2
Umbilical Cord Tissue (UCT) MSCs47.145.945.445.244.944.944.944.944.444.043.444.347.746.946.044.947.145.958.954.852.551.951.851.238.841.943.844.244.444.850.148.347.848.148.948.748.251.052.452.352.853.6

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Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score

The KOOS questionnaire assesses the participant's opinion about their osteoarthritis and associated problems. It consists of 5 subscales: pain, symptoms, activities of daily living (ADL) function, sport and recreation function, and knee related quality of life (QoL). The pain subscale has 9 items and response options are given on a 5-point Likert scale where 0 = no problems and 4 = extreme problems. Scores are transformed to a scale ranging from 0 to 100 with 0 indicating extreme symptoms and 100 indicating no symptoms. The change in KOOS-pain subscale score is the score from each follow-up visit subtracted from the baseline score. A negative value means that pain has worsened from what it was at baseline, while a positive value means that pain has improved from baseline. (NCT03818737)
Timeframe: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

,,,
Interventionscore on a scale (Least Squares Mean)
Absolute Change from Baseline at Month 1Absolute Change from Baseline at Month 3Absolute Change from Baseline at Month 6Absolute Change from Baseline at Month 9Absolute Change from Baseline at Month 12
Adipose-derived MSCs15.416.817.214.717.3
Bone Marrow Derived MSCs15.519.218.116.218.9
Corticosteroid Injection19.218.718.616.318.5
Umbilical Cord Tissue (UCT) MSCs11.512.815.413.916.4

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Overall MRI Grade of Osteoarthritis

An MRI grade of osteoarthritis was calculated by rating features viewed by MRI (such as cartilage loss) in terms of severity and extent. Total scores range from 0 to 69 with higher values indicating more severe osteoarthritis. (NCT03818737)
Timeframe: Baseline, Month 6, Month 12

,,,
Interventionscore on a scale (Mean)
BaselineMonth 6Month 12
Adipose-derived MSCs39.739.339.8
Bone Marrow Derived MSCs40.540.440.8
Corticosteroid Injection38.939.339.0
Umbilical Cord Tissue (UCT) MSCs38.238.337.6

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Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score

The KOOS questionnaire assesses the participant's opinion about their osteoarthritis and associated problems. It consists of 5 subscales: pain, symptoms, activities of daily living (ADL) function, sport and recreation function, and knee related quality of life (QoL). The KOOS has 42 items across all subscales and response options are given on a 5-point Likert scale where 0 = no problems and 4 = extreme problems. The sum of subscale scores is transformed to a scale ranging from 0 to 100 with 0 indicating extreme symptoms and 100 indicating no symptoms. A negative value means that pain has worsened from what it was at baseline, while a positive value means that pain has improved from baseline. (NCT03818737)
Timeframe: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

,,,
Interventionscore on a scale (Mean)
Change from Baseline at Month 1Change from Baseline at Month 3Change from Baseline at Month 6Change from Baseline at Month 9Change from Baseline at Month 12
Adipose-derived MSCs14.3416.3017.5313.3617.61
Bone Marrow Derived MSCs14.4818.6318.3914.1718.52
Corticosteroid Injection17.7017.2117.44116.3019.27
Umbilical Cord Tissue (UCT) MSCs11.1413.8515.6213.9617.49

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Change in Visual Analog Pain Scale (VAS-pain) Score

"Pain assessment was performed using the Visual Analog Pain Scale (VAS-pain). The VAS-pain is self-completed by the participant. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance in millimeters (mm) on the line between the no pain anchor and the participant's mark, providing a range of scores from 0-100. The recommended cut points for VAS are: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). The change in VAS-pain score is the score from the each follow-up visit subtracted from the baseline score. A negative value means that pain has reduced from what it was at baseline." (NCT03818737)
Timeframe: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

,,,
Interventionunits on a scale (Least Squares Mean)
Absolute Change from Baseline at Month 1Absolute Change from Baseline at Month 3Absolute Change from Baseline at Month 6Absolute Change from Baseline at Month 9Absolute Change from Baseline at Month 12
Adipose-derived MSCs-15.9-17.8-21.6-17.9-19.9
Bone Marrow Derived MSCs-20.2-28.8-23.2-21.9-25.5
Corticosteroid Injection-25.2-21.1-22.7-23.3-22.3
Umbilical Cord Tissue (UCT) MSCs-16.7-17.3-19.7-16.5-20.6

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Cardiovascular Dysfunction

Number of subjects with new and/or worsening right ventricle (RV)/left ventricle (LV) dysfunction (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care1
Biomarker-adjusted Steroid Dosing1

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ICU Admission

Number of subjects admitted to the ICU (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care10
Biomarker-adjusted Steroid Dosing5

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Mortality

Number of subject deaths (NCT03852537)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
Usual Care1
Biomarker-adjusted Steroid Dosing1

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Organ Failure

Organ failures measured by Sequential Organ Failure Assessment (SOFA). The overall score is based on 6 sub-scores respiratory system, neurologic system, cardiovascular system, hepatic system, coagulation, and renal system using an overall scale of 0-24, which 0=no organ failure, 24=complete organ failure. (NCT03852537)
Timeframe: Measured daily for approximately 5 days

,
Interventionscore on a scale (Median)
Day 1Day 2Day 3Day 4Day 5
Biomarker-adjusted Steroid Dosing7.03.03.03.05.5
Usual Care3.03.03.03.03.0

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Timely Initiation of Corticosteroids and Implementation of Biomarker-titrated Corticosteroid Dosing

Number of eligible subjects to adhered to the timely initiation and daily corticosteroid treatment according to ESICM/Society of Critical Care Medicine SCCM clinical practice guideline (control group) or biomarker concordance (intervention group) (NCT03852537)
Timeframe: Within 30 days of enrollment in study.

InterventionParticipants (Count of Participants)
Usual Care20
Biomarker-adjusted Steroid Dosing19

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Need for Invasive Mechanical Ventilation

Assessed by the number of participants that required invasive mechanical ventilation. (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care3
Biomarker-adjusted Steroid Dosing2

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Occurrence of Delirium

Number of participants who develop delirium while receiving corticosteroids. Delirium will be assessed by Confusion Assessment Method for the ICU (CAM-ICU) measurement tool. The CAM-ICU is a binary (yes/no) scale for assessing the presence of delirium. (NCT03852537)
Timeframe: Up to day +5 following study enrollment.

InterventionParticipants (Count of Participants)
Usual Care5
Biomarker-adjusted Steroid Dosing5

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Oxygen-free Days

Number of days subjects did not require oxygen assistance. (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

Interventiondays (Median)
Usual Care21.0
Biomarker-adjusted Steroid Dosing24.0

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Occurrence of Secondary Infection

Number of participants who develop secondary infections during and after steroid therapy. A secondary infection is defined as a new infection that develops after initiation of corticosteroid therapy, until 5 days after steroids are discontinued. (NCT03852537)
Timeframe: Up to day +14 following study enrollment.

InterventionParticipants (Count of Participants)
Usual Care0
Biomarker-adjusted Steroid Dosing0

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Occurrence of Hyperglycemia

Number of participants who have hyperglycemia while receiving corticosteroids. Hyperglycemia is defined as a consistently elevated blood sugar level requiring insulin administration. (NCT03852537)
Timeframe: Up to day +5 following study enrollment.

InterventionParticipants (Count of Participants)
Usual Care11
Biomarker-adjusted Steroid Dosing18

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New Onset Cardiac Arrhythmias

Number of participants who develop arrhythmias identified by electrocardiogram or echocardiogram. (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care0
Biomarker-adjusted Steroid Dosing1

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Need for Noninvasive Mechanical Ventilation

Assessed by the number of participants that required noninvasive mechanical ventilation. (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care4
Biomarker-adjusted Steroid Dosing2

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Need for High Flow Nasal Cannula Oxygen

Number of subjects to need high flow nasal cannula oxygen (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care7
Biomarker-adjusted Steroid Dosing4

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Myocardial Injury

Number of participants with evidence of myocardial injury determined by daily troponin peak and /or new diagnosis of Left Ventricular (LV) dysfunction (LVEF <40%) or new diagnosis of cor pulmonale (NCT03852537)
Timeframe: Up to day +14 following study enrollment.

InterventionParticipants (Count of Participants)
Usual Care8
Biomarker-adjusted Steroid Dosing10

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Percentage of sUA (sUA < 6 mg/dL) Responders During Month 12

Responders are defined as participants achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 12 (Weeks 48, 50 and 52). Month 12 includes pre- and post-infusion sUA Weeks 48 and 50, pre-infusion sUA at Week 52, and any unscheduled sUA assessments done at unscheduled visits between Week 48 and 52. A participant must have had ≥ 2 sUA observations from different visits in order to be eligible as a responder. Participants meeting the stopping rule (those with a pre-infusion sUA >6 mg/dL at 2 consecutive scheduled trial visits beginning with the Week 2 Visit stopped pegloticase dosing) were counted as non-responders. (NCT03994731)
Timeframe: Month 12 (Weeks 48, 50 and 52)

Interventionpercentage of participants (Number)
Pegloticase + MTX60.0
Pegloticase + Placebo30.8

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Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6

Responders are defined as participants achieving and maintaining sUA < 6 mg/dL for at least 80% of the time during Month 6. Month 6 includes pre- and post-infusion sUA assessments at Weeks 20 and 22, non-infusion sUA at Weeks 21 and 23, pre-infusion sUA at Week 24 and any unscheduled sUA between Week 20 and Week 24. A participant must have had ≥ 2 sUA observations from different visits in order to be eligible as a responder. Participants meeting the stopping rule (those with a pre-infusion sUA >6 mg/dL at 2 consecutive scheduled trial visits beginning with the Week 2 Visit stopped pegloticase dosing) were counted as non-responders. (NCT03994731)
Timeframe: Month 6 (Weeks 20, 21, 22, 23 and 24)

Interventionpercentage of participants (Number)
Pegloticase + MTX71.0
Pegloticase + Placebo38.5

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Percentage of Participants With Complete Resolution of ≥ 1 Tophi at Week 52

Percentage of participants with complete resolution of ≥ 1 tophi (using digital photography) at Week 52 in participants with tophi at baseline. Participants with resolution of ≥ 1 tophi at a visit are participants with resolution of ≥ 1 tophi at the visit (i.e. have complete response), and no progressive disease for any other tophi. (NCT03994731)
Timeframe: Baseline, Week 52

Interventionpercentage of participants (Number)
Pegloticase + MTX53.8
Pegloticase + Placebo31.0

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Mean Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52

HAQ-DI is a self-report functional status instrument that is filled out by the participant and measures disability over the past week via 20 questions relating to 8 domains of function: dressing, grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. The HAQ-DI ranges from 0 to 3 with higher values indicating higher disability. A change from baseline value of 0 is imputed at the first post-baseline visit for any participants without post-baseline values. (NCT03994731)
Timeframe: Baseline, Week 52

Interventionscore on a scale (Least Squares Mean)
Pegloticase + MTX-0.35
Pegloticase + Placebo-0.31

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Mean Change From Baseline in HAQ Health Score at Week 52

The HAQ health scale is a self-reported measure of overall health. Participants are asked to rate how they are doing, considering all the ways arthritis affects them, on a scale of 0 to 100, where 0 represents very well and 100 represents very poor. A change from baseline value of 0 is imputed at the first post-baseline visit for any participants without post-baseline values. (NCT03994731)
Timeframe: Baseline, Week 52

Interventionscore on a scale (Least Squares Mean)
Pegloticase + MTX-28.85
Pegloticase + Placebo-18.69

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Mean Change From Baseline HAQ Pain Score at Week 52

The HAQ-Pain score rates the participant's pain over the past week from 0 to 100 with 0 = no pain and 100 = severe pain. A change from baseline value of 0 is imputed at the first post-baseline visit for any participants without post-baseline values. (NCT03994731)
Timeframe: Baseline, Week 52

Interventionscore on a scale (Least Squares Mean)
Pegloticase + MTX-31.02
Pegloticase + Placebo-22.59

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Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Week 24

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. (NCT04046549)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Belatacept+VIB492025.0

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Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR), Graft Loss, Death or Loss to Follow-up (LTFU)

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492025.025.025.0

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Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Weeks 12 and 48

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. (NCT04046549)
Timeframe: Weeks 12 and 48

Interventionpercentage of participants (Number)
Week 12Week 48
Belatacept+VIB492025.025.0

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Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR)

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492025.025.025.0

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Percentage of Participants With Treated Acute Rejections

Acute rejections, per clinical judgement of the investigator followed by confirmatory biopsy, were treated with bolus methylprednisolone (other corticosteroids were acceptable at an equivalent dose) according to local practice. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492025.025.030.0

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Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492025.025.025.0

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Percentage of Participants With Antibody-Mediated Rejection

The diagnosis of antibody-mediated rejection was based on Banff criteria 2017 - a set of standardized guidelines used by pathologists and clinicians to diagnose and classify rejection based on specific features observed in biopsy samples from the transplanted organ, such as the presence of certain types of immune cells, inflammation, and injury patterns. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492010.010.015.0

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Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively

Tear Film Osmolarity as measured on Tear Lab system; validated measure of Tear Film Osmolarity Osmolarity was reported in milliosmoles per liter (mOsmol/L) (NCT04184999)
Timeframe: 3 weeks

InterventionmOsmol/L (Mean)
Intracameral Dexamethasone311.15
Postoperative Prednisolone Acetate316.3

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Number of SLE Patients That Were Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)

Number of of SLE patients that were sampled for RNA-seq differential gene expression analysis in glucocorticoid-treated immune cells. The analysis employed a cutoff value of < 5% false-discovery rate (FDR) to select the transcripts that were considered differentially expressed at each time point. The resulting gene lists were contrasted to determine which genes were uniquely differentially expressed in different cell types. (NCT04233164)
Timeframe: 2 hours and 4 hours post infusion

,
InterventionParticipants (Count of Participants)
2 hours post infusion4 hours post infusion
Group A: Glucocorticoids 1 mg/kg Dose2020
Group B: Glucocorticoids 250 mg Dose2020

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Duration for Achieving Target cPRA

Duration of achieving target cPRA was defined as the time (in weeks) from laboratory sample collection date of achieving target cPRA (defined as the reduction of cPRA required to achieve at least 100% increase of LCD) the first time up to the laboratory sample collection date when no longer achieving target cPRA calculated using OPTN calculator or the date of death due to any cause, whichever occurs first. The duration of achieving target cPRA was assessed using the Kaplan-Meier method. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

Interventionweeks (Median)
Cohort A: Participants With cPRA >=99.90%NA
Cohort B: Participants With cPRA 80.00% to 99.89%7.29

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Duration of Response (DOR)

Duration of response (DOR) was defined as time (in weeks) from laboratory sample collection date used in determining a participant to be a responder (defined as participants meeting at least one of the predefined desensitization efficacy criteria: reduction in cPRA resulting in at least 100% increase of likelihood of finding a compatible donor; reduction in antibody titer [>=75% reduction from Baseline] to achieve target cPRA; elimination of >=1 anti-HLA antibody i.e. MFI reduced to <2000 as measured by a SAB assay, for antibodies with Baseline MFI >=3000) up to the laboratory sample collection date when participant was confirmed as no longer meeting any response criterion (i.e., non-responder) or the date of death due to any cause, whichever occurs first. DOR was analyzed using Kaplan-Meier method. (NCT04294459)
Timeframe: From first dose of study drug until end of follow-up period (maximum duration: up to 39.1 weeks)

Interventionweeks (Median)
Cohort A: Participants With cPRA >=99.90%NA
Cohort B: Participants With cPRA 80.00% to 99.89%NA

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Number of Kidney Transplant Offers

Number of kidney transplants offers received for each participant was reported in the outcome measure. Data on transplant offers were collected and followed up until study cut-off date. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

Interventiontransplant offers (Number)
Cohort A: Participants With cPRA >=99.90%3
Cohort B: Participants With cPRA 80.00% to 99.89%3

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Number of Participants Achieving Target cPRA

Target calculated panel reactive antibodies (cPRA) was defined as the reduction of cPRA required to achieve at least 100% increase of likelihood of compatible donor (LCD). Number of participants who achieved target cPRA was assessed using the Organ Procurement and Transplantation Network (OPTN) calculator during the specified timepoint were reported in this outcome measure. Participants who retained their target cPRA values were censored at the date of the last available laboratory assessment achieving their target cPRA. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

InterventionParticipants (Count of Participants)
Cohort A: Participants With cPRA >=99.90%4
Cohort B: Participants With cPRA 80.00% to 99.89%2

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Number of Participants With Graft Survival at 6 Months Post-Transplant

Number of participants with graft survival status as functioning at 6-months post-transplant was reported in this outcome measure. (NCT04294459)
Timeframe: At 6 Months post-transplant

InterventionParticipants (Count of Participants)
Cohort A: Participants With cPRA >=99.90%1
Cohort B: Participants With Calculated Panel Reactive Antibodies (cPRA) 80.00% to 99.89%0

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Pharmacokinetics (PK) Parameters: Concentration Observed at the End of First Intravenous Infusion (Ceoi) of Isatuximab

Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab. (NCT04294459)
Timeframe: At End of infusion on Cycle 1 Day 1

Interventionmicrograms per milliliter (mcg/mL) (Mean)
Cohort A: Participants With cPRA >=99.90%290
Cohort B: Participants With cPRA 80.00% to 99.89%270

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PK Parameters: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 168 Hours Over the Dosing Interval (AUC0-168 Hours) After First Infusion of Isatuximab

AUC0-168 hours was defined as the area under the plasma concentration versus time curve from time 0 to 168 hours post dose calculated using trapezoidal method after first infusion of isatuximab. (NCT04294459)
Timeframe: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

Interventionmicrograms*hours/milliliter (mcg*h/mL) (Mean)
Cohort A: Participants With cPRA >=99.90%29400
Cohort B: Participants With cPRA 80.00% to 99.89%20000

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PK Parameters: Last Concentration Observed Above the Lower Limit of Quantification (Clast) After the First Infusion of Isatuximab

Clast was defined as the last concentration of isatuximab observed above the lower limit of quantification calculated using non-compartmental analysis after the first infusion of isatuximab. (NCT04294459)
Timeframe: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

Interventionmcg/mL (Mean)
Cohort A: Participants With cPRA >=99.90%104
Cohort B: Participants With cPRA 80.00% to 99.89%76.3

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PK Parameters: Maximum Concentration Observed (Cmax) After the First Infusion of Isatuximab

Cmax was defined as the maximum concentration observed after the first administration calculated using the noncompartmental analysis after the intravenous infusion of isatuximab. (NCT04294459)
Timeframe: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

Interventionmcg/mL (Mean)
Cohort A: Participants With cPRA >=99.90%295
Cohort B: Participants With cPRA 80.00% to 99.89%285

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PK Parameters: Time of Clast (Tlast) After First Infusion of Isatuximab

Tlast was defined as the time of last concentration observed above the lower limit of quantification, calculated using the non-compartmental analysis after the intravenous infusion of isatuximab. (NCT04294459)
Timeframe: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

Interventionhours (Median)
Cohort A: Participants With cPRA >=99.90%166.00
Cohort B: Participants With cPRA 80.00% to 99.89%167.00

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PK Parameters: Time Taken to Reach Cmax (Tmax) After the First Infusion of Isatuximab

Tmax was defined as the time to reach Cmax, calculated using the non-compartmental analysis after the intravenous infusion of isatuximab. (NCT04294459)
Timeframe: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

Interventionhours (Median)
Cohort A: Participants With cPRA >=99.90%3.67
Cohort B: Participants With cPRA 80.00% to 99.89%3.40

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PK Parameters: Trough Plasma Concentrations (Ctrough) of Isatuximab

Ctrough was the plasma concentration of isatuximab observed just before (pre-dose) treatment administration. (NCT04294459)
Timeframe: Cycle 2 Day 1

Interventionmcg/mL (Mean)
Cohort A: Participants With cPRA >=99.90%308
Cohort B: Participants With cPRA 80.00% to 99.89%246

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Time to First Transplant Offer

Time to first transplant offer was defined as time (in days) from date of first study treatment dose up to date of first kidney transplant offer. Data on transplant status were collected and followed up until study cut-off date. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

Interventiondays (Median)
Cohort A: Participants With cPRA >=99.90%373
Cohort B: Participants With cPRA 80.00% to 99.89%156

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Time to Transplant

Time to transplant was defined as time (in days) from date of first study treatment dose up to date of kidney transplant. Data on transplant status were collected and followed up until study cut-off date. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

Interventiondays (Median)
Cohort A: Participants With cPRA >=99.90%445
Cohort B: Participants With cPRA 80.00% to 99.89%259.5

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Number of Participants With Abnormal Electrolytes Parameters

Abnormal electrolyte parameters assessed were hypernatremia, hyponatremia, hyperkalemia, hypokalemia, hypercalcemia, hypocalcemia, blood bicarbonate decreased, hypermagnesemia, hypomagnesemia and chloride. The abnormal grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Chloride was estimated as per PCSA criteria: <80 millimoles per liter (mmol/L) and >115 mmol/L. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
Hypernatremia: Grade 1Hypernatremia: Grade 2Hypernatremia: Grade 3Hypernatremia: Grade 4Hyponatremia: Grade 1Hyponatremia: Grade 2Hyponatremia: Grade 3Hyponatremia: Grade 4Hyperkalemia: Grade 1Hyperkalemia: Grade 2Hyperkalemia: Grade 3Hyperkalemia: Grade 4Hypokalemia: Grade 1Hypokalemia: Grade 2Hypokalemia: Grade 3Hypokalemia: Grade 4Hypercalcemia: Grade 1Hypercalcemia: Grade 2Hypercalcemia: Grade 3Hypercalcemia: Grade 4Hypocalcemia: Grade 1Hypocalcemia: Grade 2Hypocalcemia: Grade 3Hypocalcemia: Grade 4Hypermagnesemia: Grade 1Hypermagnesemia: Grade 2Hypermagnesemia: Grade 3Hypermagnesemia: Grade 4Hypomagnesemia: Grade 1Hypomagnesemia: Grade 2Hypomagnesemia: Grade 3Hypomagnesemia: Grade 4Chloride (PCSA): <80 mmol/LChloride (PCSA): >115 mmol/L
Cohort A: Participants With cPRA >=99.90%0000400023100001010060002000300000
Cohort B: Participants With cPRA 80.00% to 99.89%0000100061200000100052000000300000

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Number of Participants With Abnormal Metabolism Parameters

Abnormal metabolism parameters assessed were hypoglycemia, hypoalbuminemia and glycated Hemoglobin (HbA1c). The abnormal grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. HbA1c was estimated as per PCSA criteria: >8%. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
Hypoglycemia: Grade 1Hypoglycemia: Grade 2Hypoglycemia: Grade 3Hypoglycemia: Grade 4Hypoalbuminemia: Grade 1Hypoalbuminemia: Grade 2Hypoalbuminemia: Grade 3Hypoalbuminemia: Grade 4
Cohort A: Participants With cPRA >=99.90%11003200
Cohort B: Participants With cPRA 80.00% to 99.89%20000200

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Number of Participants With Anti-drug Antibodies (ADA) Against Isatuximab

ADA responses were categorized as treatment boosted ADA and treatment-induced ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
Treatment-induced ADATreatment boosted ADA
Cohort A: Participants With cPRA >=99.90%00
Cohort B: Participants With cPRA 80.00% to 99.89%00

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Number of Participants With Anti-Human Leukocyte Antigen (HLA)-Antibody Reduction

Number of participants with anti-HLA-antibody (Baseline MFI >=3000) reduced to <2000 as measured using a SAB assay per central laboratory assessment was reported in this outcome measure. Participants were categorized in various categories of number of antibodies which were reduced as: none, 1-5, >5-10, >10-15, and >15. If multiple visits had the same number of total anti-HLA antibody reduction, the last visit data was summarized. (NCT04294459)
Timeframe: From first dose of study drug until end of follow-up period (maximum duration: up to 39.1 weeks)

,
InterventionParticipants (Count of Participants)
None1-5 antibodies>5-10 antibodies>10-15 antibodies>15 antibodies
Cohort A: Participants With cPRA >=99.90%24411
Cohort B: Participants With cPRA 80.00% to 99.89%24401

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Number of Participants With Hematological Abnormalities

Abnormal hematological parameters assessed were anemia, platelet count decreased, neutrophil count decreased, lymphocyte count decreased and monocytes. The hematological abnormality grades were based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Monocytes were assessed as per potentially clinically significant abnormality (PCSA) criteria defined as: greater than (>) 0.7*10^9/L. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
Anemia: Grade 1Anemia: Grade 2Anemia: Grade 3Anemia: Grade 4Platelet count decreased: Grade 1Platelet count decreased: Grade 2Platelet count decreased: Grade 3Platelet count decreased: Grade 4Neutrophil count decreased: Grade 1Neutrophil count decreased: Grade 2Neutrophil count decreased: Grade 3Neutrophil count decreased: Grade 4Lymphocyte count decreased: Grade 1Lymphocyte count decreased: Grade 2Lymphocyte count decreased: Grade 3Lymphocyte count decreased: Grade 4Monocytes (PCSA) > 0.7*10^9/L
Cohort A: Participants With cPRA >=99.90%63002000000041103
Cohort B: Participants With cPRA 80.00% to 99.89%82006000000021003

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Number of Participants With Liver Function Abnormalities

Abnormal liver function parameters assessed were Alanine aminotransferase (ALT) increased, Aspartate aminotransferase (AST) increased, Alkaline phosphatase (ALP) increased, and Total bilirubin (TB) increased. The abnormal grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
ALT increased: Grade 1ALT increased: Grade 2ALT increased: Grade 3ALT increased: Grade 4AST increased: Grade 1AST increased: Grade 2AST increased: Grade 3AST increased: Grade 4ALP increased: Grade 1ALP increased: Grade 2ALP increased: Grade 3ALP increased: Grade 4TB increased: Grade 1TB increased: Grade 2TB increased: Grade 3TB increased: Grade 4
Cohort A: Participants With cPRA >=99.90%1000100030000000
Cohort B: Participants With cPRA 80.00% to 99.89%1000000020000000

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Number of Participants With Renal Function Abnormalities

Abnormal renal parameters assessed were creatinine increased and estimated Glomerular Filtration Rate (eGFR). The renal function abnormality grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. eGFR was assessed as per PCSA criteria: 60 (less than equal to) <= to less than (<) 90 milliliter/minute/1.73 meter square (mL/min/1.73m^2) (Mild), 30<= to <60 mL/min/1.73m^2 (Moderate), 15<=to <30 mL/min/1.73m^2 (Severe), <15 mL/min/1.73m^2 (End Stage Renal Disease). (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
Creatinine increased: Grade 1Creatinine increased: Grade 2Creatinine increased: Grade 3Creatinine increased: Grade 4eGFR: 60<= - <90 mL/min/1.73m^2eGFR: 30<= - <60 mL/min/1.73m^2eGFR: 15<= - <30 mL/min/1.73m^2eGFR: <15 mL/min/1.73m^2
Cohort A: Participants With cPRA >=99.90%0011100012
Cohort B: Participants With cPRA 80.00% to 99.89%003800011

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)

An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious adverse events (SAEs) were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (defined as the time from the first dose of study drug until study cut-off date). (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
TEAEsTESAEs
Cohort A: Participants With cPRA >=99.90%30
Cohort B: Participants With cPRA 80.00% to 99.89%40

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Percentage of Participants With Response

Response was defined as the percentage of participants meeting at least one of the predefined desensitization efficacy criteria as measured by single antigen bead (SAB) assay as follows: reduction in cPRA resulting in at least 100% increase of likelihood of finding a compatible donor; reduction in antibody titer (>=75% reduction from Baseline) to achieve target cPRA; elimination of >=1 human leukocyte antigen (HLA) antibody (i.e., mean fluorescence intensity [MFI] reduced to <2000) as measured by a SAB assay, for antibodies with Baseline MFI >=3000. (NCT04294459)
Timeframe: From first dose of study drug until end of follow-up period (maximum duration: up to 39.1 weeks)

Interventionpercentage of participants (Number)
Cohort A: Participants With cPRA >=99.90%83.3
Cohort B: Participants With cPRA 80.00% to 99.89%81.8

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Admission to Intensive Care Unit (ICU)

We reported below the number of participants admitted to ICU within 28 days. (NCT04323592)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Exposed to Methylprednisolone15
Non-exposed to Methylprednisolone27

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Change in C-reactive Protein (CRP)

Change in C-reactive protein after 7 days from baseline. A reduction of CRP reveals a laboratory improvement. (NCT04323592)
Timeframe: 7 days

Interventionmg/L (Mean)
Exposed to Methylprednisolone-82.08
Non-exposed to Methylprednisolone-34.34

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Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28

We reported below the number of participants meeting at least one of three among death or ICU admission or Invasive mechanical ventilation. (NCT04323592)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Exposed to Methylprednisolone19
Non-exposed to Methylprednisolone40

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Endotracheal Intubation (Invasive Mechanical Ventilation)

We reported below the number of participants who needed endotracheal intubation during ICU admission (NCT04323592)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Exposed to Methylprednisolone15
Non-exposed to Methylprednisolone26

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In-hospital Death Within 28 Days

We reported below the number of participants who died within 28 days, during the hospital stay. (NCT04323592)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Exposed to Methylprednisolone6
Non-exposed to Methylprednisolone21

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Number of Days Free From Mechanical Ventilation

number of days free from mechanical ventilation (both invasive and non-invasive) by day 28 (NCT04323592)
Timeframe: 28 days

Interventiondays (Mean)
Exposed to Methylprednisolone19.11
Non-exposed to Methylprednisolone14.34

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Patient Preference Between Groups

As reported by patients choosing one of five options; Strongly preferred insert, preferred insert, no preference, preferred standard drop regimen, strongly preferred standard drop regimen. (NCT04380857)
Timeframe: Day 7, Day 30 and Day 90

,,
InterventionParticipants (Count of Participants)
Day 7Day 30Day 90
Dexamethasone Ophthalmic Insert 0.4 mg14119
No Preference435
Topical Prednisolone Acetate Ophthalmic Drops233

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Mean Change in Pain

"post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 (0 being no pain and 10 being the worst pain you could imagine)" (NCT04380857)
Timeframe: Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90

,
InterventionScore on a scale from 0-10 (Mean)
Pre-operativeDay 1Day 7Day 30Day 90
Dexamethasone Ophthalmic Insert 0.4 mg0.150.950.470.410
Topical Prednisolone Acetate Ophthalmic Drops0.200.900.370.060

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Loss of Lines in Uncorrected Visual Acuity

All units assessed for uncorrected visual acuity using ETDRS. Number of lines seen was then converted to LogMar to measure changes in uncorrected visual acuity between Baseline and Day 90. (NCT04380857)
Timeframe: Baseline to Day 7, Day 30 and Day 90

,
InterventionlogMAR (Mean)
1 week1 month3 months
Dexamethasone Ophthalmic Insert 0.4 mg-0.010-0.014-0.071
Topical Prednisolone Acetate Ophthalmic Drops0.013-0.026-0.068

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Post op Pain Management Per Eye

Count of participants requiring pain management from Day 0 to Day 90. (NCT04380857)
Timeframe: Day 0 to Day 90

InterventionEyes (Count of Units)
Dexamethasone Ophthalmic Insert 0.4 mg0
Topical Prednisolone Acetate Ophthalmic Drops0

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Number of Lines Lost From Best Corrected Visual Acuity

After manifest refraction all units assessed for best corrected distance visual acuity using ETDRS. Number of lines seen was then converted to LogMar score (on a scale of -0.30 to 1.00 where smaller numbers indicate better vision and larger numbers indicate worse vision) to measure changes in Best Corrected Distance Visual Acuity between Baseline and Day 90 (NCT04380857)
Timeframe: Baseline through Day 90

InterventionScore on a scale (Mean)
Dexamethasone Ophthalmic Insert 0.4 mg0
Topical Prednisolone Acetate Ophthalmic Drops0

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Intensity of Pain

Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever (NCT04900220)
Timeframe: Up to 7 days

,
Interventionscore on a scale (Mean)
BaselineFive MinutesDay 1Day 2Day 3Day 4Day 5Day 6Day 7
Betamethasone2.80.31.41.31.00.70.60.60.5
Methylprednisolone2.10.82.92.11.51.00.80.70.6

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Incidence of Pain

Recorded when subject reports pain. Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever (NCT04900220)
Timeframe: Up to 7 days

InterventionParticipants (Count of Participants)
Betamethasone6
Methylprednisolone11

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Patient Reported Outcome Measures: Post Treatment Pain Scores

"Knee society score (KSS); done standard of care on a scale of 0-100, where 100 means a more functional knee.~**Please note, the study was terminated early, only 4 subjects were enrolled and none were randomized to the placebo group. This is a standard of care survey available on all subjects." (NCT05113901)
Timeframe: 6 weeks post treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper78.75

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Patient Reported Outcome Measures: Post Treatment Pain Scores (6 Weeks)

"Using daily defense and veterans pain rating scale (DVPRS) on a scale of 1 to 10, 10 being the worst.~Please note, only one patient made it to the 6 week post treatment mark of the 4 enrolled. The study was terminated and none of the patients were randomized to the placebo group. All other patients followed up but were not interested in continuing. No range could be provided given only one subject answered and completed this visit" (NCT05113901)
Timeframe: 6 weeks post treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper1.93

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Patient Reported Outcome Measures: Pre Treatment Pain Scores Using Knee Society Scores

"Knee society score (KSS); done standard of care on a scale of 0-100, where 100 means a more functional knee~**Please note, the study was terminated early, only 4 subjects were enrolled and none were randomized to the placebo group." (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper66.25

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Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment

Single Assessment Numeric Evaluation (SANE), a single-question patient rating of 0-100, scoring their function to the area being treated. Zero represents a poor functional knee and 100 is the best functioning. (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper89.5

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Number of Participants With Complications Following Treatment

Manipulations under anesthesia (MUAs) following total knee arthroplasty surgery and treatment (NCT05113901)
Timeframe: within 90 days after initial total knee arthroplasty

InterventionParticipants (Count of Participants)
Methylprednisolone Taper0
Placebo Taper0

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Adverse Events or Outcomes Outside of Manipulations Under Anesthesia

Adverse outcomes including infection, avascular necrosis, and 90-day readmission rates (NCT05113901)
Timeframe: within 90 days after initial total knee arthroplasty

InterventionParticipants (Count of Participants)
Methylprednisolone Taper0
Placebo Taper0

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Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment

UCLA activity score, on a scale of 1 to 10 where 10 is the most active patient with examples of activities (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper5.25

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Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment

VR-12: Assesses physical functioning, physical/ mental limitations. Scored as summary of mental and physical, measure in standard deviations. The scale range is 0 to 100, where a score of 100 represents the best physical and mental health and zero is the worst outcome. (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper50.28

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Patient Reported Outcome Measures: Overall Assessment of Knee 6 Wks After Treatment

Forgotten Joint Score (FJS) is a survey scored ranging from 0 to 100, where a high score indicates a high degree of a forgetting they have an artificial joint, which is an ideal outcome. (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper57.82

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Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment

Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), a survey given to patients standard of care containing 7 questions. The score ranges from 0 to 100 where zero represents total disability and 100 represents a perfect knee health. (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper72.12

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Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment

Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), a survey given to patients standard of care containing 7 questions. The score ranges from 0 to 100 where zero represents total disability and 100 represents a perfect knee health. (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper50.04

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Range of Motion in Degrees at Pre and Post Treatment

"Range of motion (ROM) from pre-treatment to six weeks following treatment. Patients started treatment after total knee replacement surgery and presented to clinic with at least one inclusion criteria to be enrolled. Range of motion in degrees is taken at each visit by a clinician (standard of care), starting at zero degrees (straight leg) to about 135 degrees. The ROM was documented as part of consenting and enrollment into study. Subjects returned to the office at 6 weeks post treatment where ROM was performed in a clinic setting once again and documented. ROM is done using a goniometer by a clinician in each clinic.~This study was terminated early, therefore of the 4 enrolled, zero were randomized to the placebo group. Only 1 of the four subjects completed the 6 weeks, however, ROM was captured on all as standard of care." (NCT05113901)
Timeframe: Baseline, Week 6 Following Treatment

InterventionRange of Motion in Degrees (Mean)
Pre treatmentPost treatment
Methylprednisolone Taper82.5112

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Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment

Veterans Rand 12-Item Health Survey (VR-12), a survey of 12 questions to measure health relating to patient's quality of life. Scored as summary of mental and physical, measure in standard deviations. The scale range is 0 to 100, where a score of 100 represents the best physical and mental health and zero is the worst outcome. (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper38.73

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Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment

Forgotten Joint Score (FJS) is a survey scored ranging from 0 to 100, where a high score indicates a high degree of a forgetting they have an artificial joint, which is an ideal outcome. (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper91.67

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Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment

UCLA activity score, on a scale of 1 to 10 where 10 is the most active patient with examples of activities (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper4.25

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Patient Reported Outcome Measures: Post Treatment Pain Scores

"Knee society score (KSS); done standard of care on a scale of 0-100, where 100 means a more functional knee.~**Please note, the study was terminated early, only 4 subjects were enrolled and none were randomized to the placebo group. At 3 weeks post treatment, only 3 of the 4 subjects enrolled were still part of the study." (NCT05113901)
Timeframe: 3 weeks post treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper68.33

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Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores

"Using Daily Visual Analogue Scale (VAS) pain score, which measures intensity of pain on a scale of 0 (no pain) to 10 (worst pain possible).~**Please note, this study was terminated early, only enrolling 4 patients, none were randomized to the placebo group." (NCT05113901)
Timeframe: Days 1 through 6 following treatment

Interventionscore on a scale (Mean)
Day 1Day 2Day 3Day 4Day 5Day 6
Methylprednisolone Taper2.3331.331.331.672.3

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Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment

Single Assessment Numeric Evaluation (SANE), a single-question patient rating of 0-100, scoring their function to the area being treated. Zero represents a poor functional knee and 100 is the best functioning. (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper29.5

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Incidence of a Flare Reaction

A flare reaction was defined as an increase of two or more points of Visual Analog Score (VAS) score during the first week following injection. The VAS is a patient reported pain score from zero to ten where zero is no pain and ten is the most pain. (NCT05438277)
Timeframe: Post-injection day 1 through 7

,
InterventionPerson-visits (Count of Units)
Flare reaction (Yes)Flare reaction (No)Unknown
Methylprednisolone Acetate (MPA)4414916
Triamcinolone Acetonide (TA)819128

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