Compounds > triamcinolone hexacetonide
Page last updated: 2024-12-06

triamcinolone hexacetonide

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

Triamcinolone hexacetonide is a potent synthetic corticosteroid used primarily as a topical medication. It is a derivative of triamcinolone, modified by adding six acetyl groups. This modification significantly increases its lipophilicity, enhancing its penetration through the skin and extending its duration of action. Triamcinolone hexacetonide exhibits anti-inflammatory and immunosuppressive properties, making it effective in treating various dermatological conditions, including eczema, psoriasis, and allergic contact dermatitis. It works by suppressing the production of inflammatory mediators like cytokines and prostaglandins. The study of triamcinolone hexacetonide is crucial due to its widespread clinical use in dermatology. Researchers are continuously exploring its efficacy and safety profile, investigating potential adverse effects like skin atrophy and other systemic side effects. Additionally, research is being conducted to develop novel formulations and delivery systems to enhance its therapeutic efficacy and minimize potential risks.'

triamcinolone hexacetonide: structure [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID21826
CHEMBL ID1200878
CHEBI ID9670
SCHEMBL ID7543
MeSH IDM0047762

Synonyms (74)

Synonym
(11 beta, 16 alpha)-21-(3,3-dimethyl-1-oxobutoxy)-9-fluoro-11-hydroxy-16,17-((1-methylethylidene)bis(oxy)) pregna-1,4-diene-3,20-dione
9-fluoro-11 beta,16 alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone, 21-(3,3-dimethylbutyrate)
pregna-1,4-diene-3,20-dione, 21-(3,3-dimethyl-1-oxobutoxy)-9-fluoro-11-hydroxy-16,17-((1-methylethylidene)bis(oxy))-, (11beta,16alpha)-
hexacetonide de triamcinolone [inn-french]
triamcinolone esacetonide [dcit]
pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,16-alpha,17,21-tetrahydroxy-, cyclic 16,17-acetal with acetone, 21-(3,3-dimethylbutyrate)
tiamcinoloni hexacetonidum [inn]
tatba
lederspan
aristospan
brn 1413888
9-fluoro-11beta,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone 21-(3,3-dimethylbutyrate)
triamcinoloni hexacetonidum [inn-latin]
einecs 227-031-4
hexacetonido de triancinolona [inn-spanish]
cl 34433
(11beta,16alpha)-21-(3,3-dimethyl-1-oxobutoxy)-9-fluoro-11-hydroxy-16,17-((1-methylethylidene)bis(oxy))pregna-1,4-diene-3,20-dione
5611-51-8
C08185
triamcinolone hexacetonide
aristospan (tn)
triamcinolone hexacetonide (usp/inn)
D00985
cl-34433
CHEMBL1200878
chebi:9670 ,
dtxsid0048634 ,
tox21_112979
dtxcid7028560
cas-5611-51-8
tiamcinoloni hexacetonidum
triamcinolone hexacetonide [usan:usp:inn:ban]
triamcinolone esacetonide
unii-i7gt1u99y9
triamcinoloni hexacetonidum
i7gt1u99y9 ,
hexacetonide de triamcinolone
hexacetonido de triancinolona
5-19-06-00569 (beilstein handbook reference)
triamcinolone hexacetonide [ep monograph]
triamcinolone hexacetonide [vandf]
triamcinolone hexacetonide [usan]
triamcinolone hexacetonide [usp-rs]
triamcinolone hexacetonide [usp impurity]
triamcinolone hexacetonide [mart.]
triamcinolone hexacetonide [who-dd]
triamcinolone hexacetonide [mi]
triamcinolone hexacetonide [usp monograph]
triamcinolone hexacetonide [inn]
pregna-1,4-diene-3,20-dione, 21-(3,3-dimethyl-1-oxobutoxy)-9-fluoro-11-hydroxy-16,17-((1-methylethylidene)bis(oxy))-, (11.beta.,16.alpha.)-
triamcinolone hexacetonide [orange book]
SCHEMBL7543
hexatrione
pregna-1,4-diene-3,20-dione,21-(3,3-dimethyl-1-oxobutoxy)-9-fluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11b,16a)-
CS-7139
HY-U00103
triamcinolone hexace-tonide
[2-[(1s,2s,4r,8s,9s,11s,12r,13s)-12-fluoro-11-hydroxy-6,6,9,13-tetramethyl-16-oxo-5,7-dioxapentacyclo[10.8.0.02,9.04,8.013,18]icosa-14,17-dien-8-yl]-2-oxoethyl] 3,3-dimethylbutanoate
triamcinolonehexacetonide
Q1593246
triamcinolone-hexacetonide
pregna-1,4-diene-3,20-dione,21-(3,3-dimethyl-1-oxobutoxy)-9-fluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11b,16a)-
MS-29848
AKOS040742777
triamcinolone hexacetonide (usp-rs)
hexacetonide de triamcinolone (inn-french)
triamcinolone hexacetonide (usp monograph)
triamcinoloni hexacetonidum (inn-latin)
triamcinolone hexacetonide (usan:usp:inn:ban)
triamcinolone hexacetonide (ep monograph)
hexatrione2%
hexacetonido de triancinolona (inn-spanish)
triamcinolone hexacetonide (mart.)
triamcinolone hexacetonide (usp impurity)

Research Excerpts

Overview

Triamcinolone hexacetonide (THA) is a synthetic glucocorticoid (GC) used by intra-articular (IA) administration.

ExcerptReferenceRelevance
"Triamcinolone hexacetonide (THA) is a synthetic glucocorticoid (GC) used by intra-articular (IA) administration. "( Elimination profile of triamcinolone hexacetonide and its metabolites in human urine and plasma after a single intra-articular administration.
Carbó, ML; Coll, S; Llorente-Onaindia, J; Matabosch, X; Monfort, J; Monfort, N; Pérez-Mañá, C; Ventura, R, 2019)		2.27

Toxicity

ExcerptReferenceRelevance
"The half-life of commercially available TH in the vitreous is double that of TA, but the former is toxic to the retina in this rabbit model."( Safety and pharmokinetics of triamcinolone hexacetonide in rabbit eyes.
Abd-El-Barr, MM; Albini, TA; Carvounis, PE; Chevez-Barrios, P; He, F; Holz, ER; Manzano, RP; Wensel, TG; Wu, SM, 2008)		0.64
" Primary outcome for safety was defined as the occurrence of adverse events (AEs) during the follow up period after IAJI."( The efficacy and safety of intra-articular injection of triamcinolone acetonide versus triamcinolone hexacetonide for treatment of juvenile idiopathic arthritis.
Amarilyo, G; Gendler, Y; Goldberg, O; Habot-Wilner, Z; Harel, L; Levinsky, Y; Ohana, O; Peled, O; Rubin, S; Tal, R, 2022)		0.94

Pharmacokinetics

ExcerptReferenceRelevance
" Plasma levels of the steroids were measured and pharmacokinetic parameters were calculated."( Pharmacokinetics and pharmacodynamics of glucocorticoid suspensions after intra-articular administration.
Derendorf, H; Grüner, A; Gyselby, G; Haack, D; Möllmann, H, 1986)		0.27

Bioavailability

ExcerptReferenceRelevance
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019)		0.51

Dosage Studied

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.

ExcerptRelevanceReference
" THA must be injected with a rigorous technique and with a dosage adapted to the articular volume."( Complications of intra-articular injections of triamcinolone hexacetonide in chronic arthritis in children.
Job-Deslandre, C; Menkes, CJ, )		0.39
" 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
" Twenty-four hours after the administration of triamcinolone hexacetonide condyles incorporated significantly less 35SO4, a feature that followed a dose-response relationship."( Studies on hormonal regulation of the growth of the craniofacial skeleton: II. Effects of a glucocorticoid hormone on sulfate incorporation by neonatal condylar cartilage.
Raz, E; Silbermann, M; Weiss, A, 1982)		0.52
"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)		0.8
" During each flare-up, the patient was housebound and required therapeutic dosing of nonsteroidal anti-inflammatory drugs and codeine to control joint pain."( Carbonated apatite-induced arthropathy: a consideration in cases of polyarthritis.
Blair-Levy, JM, 2006)		0.33
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
corticosteroid hormoneAny of a class of steroid hormones that are produced in the adrenal cortex.
[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]

Protein Targets (4)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
AR proteinHomo sapiens (human)Potency0.02670.000221.22318,912.5098AID743040; AID743042; AID743054
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency0.04440.000214.376460.0339AID720691; AID720692; AID720719
estrogen nuclear receptor alphaHomo sapiens (human)Potency0.17110.000229.305416,493.5996AID743069; AID743075; AID743077; AID743078; AID743080; AID743091
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency0.05310.001723.839378.1014AID743083
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (4)

Assay IDTitleYearJournalArticle
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.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (220)

TimeframeStudies, This Drug (%)All Drugs %
pre-199061 (27.73)18.7374
1990's52 (23.64)18.2507
2000's47 (21.36)29.6817
2010's46 (20.91)24.3611
2020's14 (6.36)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 42.32

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index42.32 (24.57)
Research Supply Index5.71 (2.92)
Research Growth Index4.53 (4.65)
Search Engine Demand Index64.87 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (42.32)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials67 (28.63%)5.53%
Reviews12 (5.13%)6.00%
Case Studies30 (12.82%)4.05%
Observational2 (0.85%)0.25%
Other123 (52.56%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (335)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema [NCT00367133]Phase 3840 participants (Actual)Interventional2004-07-31Completed
The Efficacy of Intra-articular Triamcinolone Acetonide 5mg vs. 10 mg vs. 40 mg in Patients With Knee Osteoarthritis: a Non-inferiority Randomized Controlled Double-blind Study [NCT05806021]Phase 4327 participants (Anticipated)Interventional2023-09-30Not yet recruiting
Active Control,Randomized,Double- Blinded Clinical Trial of BD [NCT03771768]38 participants (Anticipated)Interventional2019-05-25Not yet recruiting
Physiotherapy Alone, in Combination With Corticosteroid Injection or Wait-and-see for Acute Lateral Epicondylitis in General Practice: a Randomised, Placebo-controlled Study With 12 Months Follow-up [NCT00826462]Phase 4177 participants (Actual)Interventional2009-03-31Completed
Analysis of Antalgic Efficacy of an Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis by Perfusion MRI:a Superiority, Randomized, Controlled, Double Blind Study [NCT03726788]Phase 2105 participants (Anticipated)Interventional2019-09-30Not yet recruiting
A Randomized, Open-label Study Comparing the Systemic Exposure to Triamcinolone Acetonide Following a Single Intra-articular Dose of Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension) in Patients With Osteoarthritis of t [NCT03382262]Phase 255 participants (Actual)Interventional2017-12-18Completed
Three Injections of Intravitreal Bevasizumab Versus Two Injections of Intravitreal Triamcinolone in the Management of Branch Retinal Vein Occlusion [NCT01178697]Phase 20 participants Interventional2010-01-31Recruiting
A Randomized Phase II Double-Blinded Study of The Efficacy of Oleogel-S10 (AP101) Gel for the Treatment of Grade 2/3 Radiation Dermatitis in Breast Cancer Patients [NCT05190770]Phase 250 participants (Anticipated)Interventional2021-12-15Recruiting
Combined Intralesional Triamcinolone Injection With Whole Breast Detection Radical Surgery in Treating Refractory Granulomatous Lobular Mastitis: A Randomized Controlled Trial [NCT05281419]100 participants (Anticipated)Interventional2022-05-01Recruiting
The NOR-CACTUS Trial - A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome [NCT05306548]Phase 4258 participants (Anticipated)Interventional2022-04-08Recruiting
Randomized, Double Masked, Controlled Study Comparing the Safety and Efficacy of Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema [NCT03126786]Phase 271 participants (Actual)Interventional2017-07-11Completed
MAGNOLIA: Multi-Center, Non-Interventional Extension Study of the Safety and Efficacy of CLS-TA for the Treatment of Macular Edema Associated With Non-Infectious Uveitis [NCT02952001]33 participants (Actual)Observational2017-12-13Completed
Prospective Randomized Trial of EUS Guided Celiac Plexus Block for Chronic Pancreatitis [NCT02399800]1 participants (Actual)Interventional2014-12-31Terminated(stopped due to Low enrollment)
Comparing the Efficacy of Rotator Interval Steroid Injection Versus Steroid Intraarticular Hydrodilatation in the Treatment of Frozen Shoulder [NCT03678038]64 participants (Actual)Interventional2018-09-28Completed
Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial [NCT04115644]Phase 482 participants (Actual)Interventional2017-05-01Terminated(stopped due to Covid-19 and we failed to submit annual report for 2017 and 2018)
SAPPHIRE: A Randomized, Masked, Controlled Trial To Study The Safety And Efficacy Of Suprachoroidal CLS-TA In Conjunction With Intravitreal Aflibercept In Subjects With Retinal Vein Occlusion [NCT02980874]Phase 3460 participants (Actual)Interventional2017-01-31Terminated(stopped due to Primary, 8-week efficacy endpoint not achieved. No additional benefit for subjects receiving a corticosteroid together with an intravitreal anti-VEGF agent.)
Retrobulbar Triamcinolone Acetonide Injection in the Treatment of Nonarteritic Anterior Ischemic Optic Neuropathy [NCT02329288]Phase 360 participants (Anticipated)Interventional2015-05-31Not yet recruiting
25-Gauge Vitrectomy Combine With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in Chinese Patients [NCT02328118]Phase 2/Phase 3120 participants (Anticipated)Interventional2015-02-28Recruiting
A Randomized, Double-Blind Study of the Efficacy of Platelet-Rich Growth Factor (PRGF) Supplementation Compared to Steroid Supplementation After Temporomandibular Joint (TMJ) Arthrocentesis in Female Patients With TMJ Osteoarthritis (OA) [NCT04731233]Phase 436 participants (Anticipated)Interventional2021-03-30Recruiting
A Randomized, Masked, Controlled Trial To Study The Safety And Efficacy Of Suprachoroidal CLS-TA In Combination With An Intravitreal Anti-VEGF Agent In Subjects With Retinal Vein Occlusion [NCT03203447]Phase 3325 participants (Actual)Interventional2018-03-05Terminated(stopped due to The early termination is due to the results obtained from the sister study, SAPPHIRE (CLS1003-301), which did not meet the 8-week primary efficacy endpoint.)
Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections: a Prospective Double-Blinded Randomized Trial [NCT04895280]Phase 4400 participants (Anticipated)Interventional2024-04-30Not yet recruiting
Outcome Comparison of Ultrasound-guided Hydrodissection Between Normal Saline and Combination of Triamcinolone Acetonide, Normal Saline, and Lidocaine in Mild to Moderate Carpal Tunnel Syndrome: A Single Blinded Randomized Clinical Trial [NCT05577676]62 participants (Anticipated)Interventional2022-09-13Recruiting
A Randomized, Double-blind, Active-controlled Study of Canakinumab Prefilled Syringes or Reconstituted Lyophilizate Versus Triamcinolone Acetonide for Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients [NCT01356602]Phase 3397 participants (Actual)Interventional2011-05-31Completed
Economic Impact of Dropless Therapy Versus Usual Care for Cataract Surgery: A Real-World Study. [NCT03640650]Phase 480 participants (Actual)Interventional2018-08-15Terminated(stopped due to COVID-19 pandemic leading to uncertainty in the recruitement)
A Comparative Study of Betamethasone (Diprospan) and Triamcinolone Acetonide as Single Intra-Articular Injection in Knee Osteoarthritis, A Double-Blinded, Randomized Controlled Trial [NCT05139875]Phase 4120 participants (Anticipated)Interventional2022-01-01Recruiting
Formulated Posterior Subtenon Triamcinolone (PSTA) Injection Versus Posterior Subtenon Triamcinolone Alone in the Management of Macular Edema Secondary to Non-ischemic Retinal Vein Occlusions [NCT05385562]78 participants (Actual)Interventional2020-01-02Completed
Open-label Safety Study of Suprachoroidal Triamcinolone Acetonide Injectable Suspension in Patients With Non-Infectious Uveitis [NCT03097315]Phase 338 participants (Actual)Interventional2017-04-04Completed
A Randomized, Controlled, Double-blind Study to Evaluate the Efficacy of Intralesional Triamcinolone in the Treatment of Hidradenitis Suppurativa. [NCT02781818]32 participants (Actual)Interventional2016-06-30Completed
Intralesional Steroid Injection Versus Accent Method of Voice Therapy in Management of Vocal Nodules: A Randomized Controlled Trial [NCT03914092]Phase 440 participants (Anticipated)Interventional2019-09-29Recruiting
Evaluation of Salivary Levels of miR-155 and IL-10 in Oral Lichen Planus Patients Before and After Treatment With Topical Corticosteroid [NCT03871114]30 participants (Actual)Observational2019-03-10Completed
Three Injections of Intravitreal Bevasizumab Versus Two Injections of Intravitreal Triamcinolone in the Management of Branch Retinal Vein Occlusion [NCT01044329]Phase 290 participants (Anticipated)Interventional2010-01-31Recruiting
A Randomized Single Blinded Prospective Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients [NCT03319784]Phase 40 participants (Actual)Interventional2018-09-05Withdrawn(stopped due to never initiated)
Eco-guided Treatment With Triamcinolone-Acetonide in the Treatment of Medial Plica Syndrome - A Pilot Study [NCT04943341]30 participants (Anticipated)Interventional2021-10-28Recruiting
Combined Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata A Randomized Controlled Trial [NCT03535233]Phase 440 participants (Actual)Interventional2016-03-31Completed
A Prospective Randomized Comparative Trial of Targeted Injection Via a Transforaminal Approach With Dexamethasone Versus an Epidural Catheter Via an Interlaminar Approach With Particulate Steroid for the Treatment of Cervical Radicular Pain [NCT03382821]Phase 4120 participants (Actual)Interventional2017-09-15Completed
Adjunctive Photodynamic Therapy + Aflibercept vs. Afilbercept Alone for PDA in Patients With Neovascular Age-Related Macular Degeneration [NCT02457026]0 participants (Actual)Interventional2016-01-31Withdrawn
Ketorolac Versus Triamcinolone Intra-articular Knee Injections for the Treatment of Osteoarthritis. A Prospective, Double-Blinded Randomized Trial [NCT02295189]36 participants (Actual)Interventional2013-01-31Completed
Effectiveness Evaluation of Mixed Gel of Hydrocortisone and Aluminium Phosphate Preventing Endoscopic Submucosal Dissection Postoperative Stenosis for Patients With Early Esophageal Cancer Invading More Than 2/3 Esophageal Perimeter [NCT03165344]66 participants (Actual)Interventional2017-02-10Completed
Sonographic Evaluation of Patients With Carpal Tunnel Syndrome Following Steroid Injection [NCT03132051]54 participants (Anticipated)Interventional2013-04-30Recruiting
Nasal Allergen Challenge - Reproducibility of Biomarkers and Effect of Topical Steroid Treatment [NCT03431961]20 participants (Anticipated)Interventional2018-03-07Recruiting
Efficacy of Oral Zinc Supplement as an Adjunctive Therapy for Erosive Oral Lichen Planus (a Randomized, Controlled Clinical Trial) [NCT06042010]22 participants (Actual)Interventional2023-01-05Completed
Fractional Laser Assisted Steroid Therapy vs Intralesional Steroids in the Treatment of Keloids [NCT02996097]30 participants (Actual)Interventional2016-04-30Completed
Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis [NCT05005000]Phase 21 participants (Actual)Interventional2022-05-12Terminated(stopped due to Difficulties getting subjects recruited and enrolled.)
Suprachoroidal Triamcinolone Acetonide for the Treatment of Macular Edema Associated With Retinal Vein Occlusion: A Pilot Study [NCT05038072]16 participants (Actual)Interventional2019-07-25Completed
A Double-Blind, Randomized, Parallel Group Comparison of the Effects of FX006 and TCA IR (Triamcinolone Acetonide Suspension) on Blood Glucose in Patients With Osteoarthritis of the Knee and Type 2 Diabetes Mellitus [NCT02762370]Phase 233 participants (Actual)Interventional2016-04-30Completed
Safety and Efficacy of Of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ Fusion Protein In Acute Gout [NCT05925166]100 participants (Anticipated)Interventional2023-09-01Not yet recruiting
Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection With Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger [NCT03131882]Phase 2/Phase 3120 participants (Anticipated)Interventional2016-10-01Recruiting
Cryotherapy Versus Intralesional Corticosteroid Injection In Treatment Of Alopecia Areata: Trichoscopic Evaluation [NCT03473600]Phase 440 participants (Anticipated)Interventional2018-11-30Not yet recruiting
Comparison Between Blind and Ultrasound Guided Injection in Morton Neuroma [NCT03046108]Phase 4100 participants (Anticipated)Interventional2016-01-31Recruiting
Randomized Placebo-controlled Analysis of Superior Laryngeal Nerve Block for Neurogenic Cough [NCT04468542]Phase 365 participants (Anticipated)Interventional2021-01-12Recruiting
Evaluation of the Use of Intraoperative Subconjunctival Injection of Triamcinolone Acetonide and Limited Peritomy During Bare Scleral Pterygium Excision [NCT03377348]30 participants (Actual)Interventional2017-12-01Completed
Efficacy of Neural Prolotherapy Versus Local Corticosteroid Soft Tissue Injection for Treatment of Anserine Bursitis [NCT04509440]43 participants (Actual)Interventional2018-05-01Completed
Open , Randomized Study About Efficacy, Safety and Tolerability od Repeated Dosis of Intravitreous Bevacizumab in Patients With Uveitic Macular Oedema [NCT01095809]Phase 35 participants (Actual)Interventional2010-04-30Terminated(stopped due to New intraocular steroid in the market. Recruitment no longer ethical.)
A Multi-Center Randomized, Double-Blind, Placebo Controlled, Parallel Group Comparison Study of Once Daily Triamcinolone Acetonide 0.5% DuraPeel™ Versus Placebo DuraPeel in the Treatment of Hand Dermatitis [NCT00890968]Phase 256 participants (Actual)Interventional2009-04-30Completed
Triamcinolone Acetonide Injections Compared With Micro Injections (MMP Technique) of Triamcinolone Acetonide for the Treatment of Female Genital Lichen Sclerosus and Atrophic [NCT06079645]Phase 420 participants (Anticipated)Interventional2023-10-20Recruiting
Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa [NCT04582669]Phase 411 participants (Actual)Interventional2022-01-24Terminated(stopped due to This study was administratively closed.)
Acute Pseudophakic Cystoid Macular Edema Treatment Trial: Intravitreal Ranibizumab Versus Triamcinolone Acetonide [NCT02294656]Phase 14 participants (Actual)Interventional2014-11-30Completed
A Randomized, Double-blind, Dose-ranging Trial of Subcutaneous Sodium Deoxycholate Injections With or Without Low Dose Triamcinolone and Low Dose Lidocaine for Reduction of Submental Fat With Reduction of Pain and Swelling [NCT03361176]Phase 430 participants (Actual)Interventional2018-03-26Completed
Open-Label Study of the Safety and Efficacy of Suprachoroidal CLS-TA Alone or in Combination With Intravitreal Aflibercept for the Treatment of Diabetic Macular Edema [NCT02949024]Phase 1/Phase 220 participants (Actual)Interventional2016-11-10Completed
Sub-tenon Triamcinolone Acetonide in Age-Related Macular Degeneration as Adjunct to Ranibizumab [NCT01249937]Phase 230 participants (Anticipated)Interventional2011-01-31Recruiting
Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis [NCT01318590]Phase 32 participants (Actual)Interventional2011-11-18Terminated(stopped due to Closed by CHUM REB for incomplete documentation of research activities.)
Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid Regression: Immunohistochemistry, Histopathology and Imaging Study [NCT04326959]Phase 1/Phase 224 participants (Anticipated)Interventional2020-09-01Not yet recruiting
A 12 Weeks Randomized, Controlled Core Study of ACZ885 (Canakinumab) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective, Including a 12-week D [NCT01029652]Phase 3230 participants (Actual)Interventional2009-12-31Completed
A Phase 3 Multi-centre Double-masked Randomised Controlled Trial of Adjunctive Intraocular and Periocular Steroid (Triamcinolone Acetonide) Versus Standard Treatment in Eyes Undergoing Vitreoretinal Surgery for Open Globe Trauma. [NCT02873026]Phase 3300 participants (Actual)Interventional2014-10-31Completed
Arteriovenous Crossing Sheathotomy Versus Intravitreal Triamcinolone Acetonide Injection for Treatment of Macular Edema Associated With Branch Retinal Vein Occlusion [NCT00612261]40 participants (Actual)Interventional2006-10-31Completed
Subacromial Ultrasound-guided or Systemic Steroid Injection for Rotator Cuff Disease, a Randomized Double Blinded Study [NCT00640575]106 participants (Actual)Interventional2005-03-31Completed
A Randomized, Parallel Group, Masked Clinical Study to Evaluate the Efficacy of Triamcinolone and Bevacizumab Through Intravitreal Injection With Individual or Simultaneous Drugs to Treatment of Diabetic Macular Edema [NCT00737971]Phase 4142 participants (Actual)Interventional2008-08-31Completed
Prospective, Controlled Study of the Efficacy of NdYag for Acne Keloidalis Nuchae [NCT00757315]20 participants (Actual)Interventional2008-09-30Active, not recruiting
Suprachoroidal Triamcinolone Acetonide Injection in Two Chorioretinal Diseases: One Year Results [NCT05337332]Phase 2/Phase 350 participants (Anticipated)Interventional2022-04-14Recruiting
Rotator Interval and Intra-articular Corticosteroid Injection for Adhesive Capsulitis (Frozen Shoulder): a Randomised, Double Blind, Placebo Controlled Trial [NCT00840229]122 participants (Actual)Interventional2009-02-28Completed
Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus: A Pilot, Randomized, Clinical and Immunohistochemical Trial [NCT02858297]Phase 430 participants (Actual)Interventional2015-05-31Completed
Multicenter Randomized Controlled Study of Intravitreal Ranibizumab and Triamcinolone Acetonide Combination Therapy Versus Ranibizumab Monotherapy in Patients With Polypoidal Choroidal Vasculopathy [NCT02806752]Phase 4120 participants (Anticipated)Interventional2017-01-31Active, not recruiting
Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide: an Interventional Prospective Study [NCT02221453]Phase 23 participants (Actual)Interventional2015-09-30Completed
One Year Results for Suprachoroidal Triamcinolone Acetonide Injection in Various Retinal Diseases [NCT05496530]100 participants (Anticipated)Interventional2022-07-10Recruiting
Comparative Study on the Efficacy of Periocular Methotrexate Versus Periocular Triamcinolone Injections in Management of Thyroid Associated Orbitopathy [NCT05429450]Phase 218 participants (Actual)Interventional2020-07-01Completed
Symptom Clusters in Children With Exacerbation-prone Asthma [NCT04002362]Phase 2173 participants (Anticipated)Interventional2019-11-13Recruiting
The Use of Triamcinolone Injection in Treatment of Refractory Benign Esophageal Stricture in Children [NCT04524897]Phase 420 participants (Anticipated)Interventional2020-12-01Not yet recruiting
Management of Pain in Oral Lichen Planus Patients: A Comparative Pilot Study [NCT03572959]Phase 424 participants (Actual)Interventional2016-12-27Completed
Alazher University Dean [NCT05464953]75 participants (Actual)Interventional2020-01-20Completed
Comparison of Triamcinolone Acetonide Mucoadhesive Film With Liquorice Mucoadhesive Film On Radiotherapy-Induced Oral Mucositis: A Randomized Double-Blinded Clinical Trial [NCT02075749]Phase 1/Phase 260 participants (Actual)Interventional2013-05-31Completed
Methotrexate With Microneedling Versus Triamcinilone Acetonide With Microneedling in Treatment of Recalcitrant Alopecia Areata [NCT06088147]34 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Local Betamethasone Versus Triamcinolone Injection in Management of Thyroid-Related Upper Lid Retraction With and Without Proptosis [NCT04976816]Phase 2/Phase 392 participants (Actual)Interventional2021-12-01Completed
Comparison of Different Dose of Steroid Injection in Carpal Tunnel Syndrome [NCT03072290]56 participants (Actual)Interventional2017-02-18Completed
Evaluation of the Effectiveness of Photodynamic Therapy in the Treatment of Lesions of the Lichen Planus Type in the Oral Mucosa and Its Diagnostics With the Use of Autofluorescence, in Various Wavelength Ranges, in Combination With the Use of Texture Ana [NCT04991012]Phase 230 participants (Actual)Interventional2020-02-08Completed
Dosing of Intra-articular Triamcinolone Hexacetonide for Knee Synovitis in Chronic Polyarthritis [NCT02437461]Phase 4159 participants (Actual)Interventional2015-04-30Active, not recruiting
A Phase 3, Randomized, Masked, Controlled Clinical Trial to Study the Safety and Efficacy of Triamcinolone Acetonide Injectable Suspension (CLS-TA) for the Treatment of Subjects With Macular Edema Associated With Non-infectious Uveitis [NCT02595398]Phase 3160 participants (Actual)Interventional2015-11-17Completed
OCTA-Directed PDT Triple Therapy for Treatment-Naïve Patients With Exudative Age-Related Macular Degeneration Versus Standard of Care Anti-VEGF(Anti-vascular Endothelial Growth Factor) Monotherapy [NCT04075136]Phase 4150 participants (Anticipated)Interventional2023-03-30Suspended(stopped due to Deviations)
Safety and Effectiveness of Triamcinolone Acetonide in Patients With Serous Pigment Detachment Associated With Age-Related Macular Degeneration [NCT04292756]63 participants (Actual)Interventional2018-03-27Completed
Subtenons Triamcinolone Acetonide Injections for Treatment of Persistent Choroidal Effusions Post Glaucoma Surgery [NCT02917564]Phase 420 participants (Anticipated)Interventional2020-10-14Recruiting
Efficacy of Fractional CO2 Laser Alone and as Transepidermal Drug Delivery for Different Modalities of Treatment in Alopecia Areata [NCT04003376]Phase 440 participants (Anticipated)Interventional2019-07-26Recruiting
A Comparison of a Single Orbital Floor Injection of Triamcinolone Versus Conventional Steroid and Antibiotic Drops Used Post Operatively in Uneventful Phacoemulsification Surgery [NCT00789971]150 participants (Actual)Interventional2007-03-31Completed
An Adaptive Dose-ranging, Multi-center, Single-blind, Double-dummy, Active-controlled Trial to Determine the Target Dose of Canakinumab (ACZ885) in the Treatment of Acute Flares in Gout Patients Who Are Refractory or Contraindicated to NSAIDs and/or Colch [NCT00798369]Phase 2200 participants (Actual)Interventional2008-11-30Completed
Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars: 3-arm Trial [NCT02823236]Phase 3102 participants (Anticipated)Interventional2016-10-24Recruiting
Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis. [NCT05906433]Phase 175 participants (Anticipated)Interventional2023-06-01Recruiting
Influence of Perception of Patients Suffering of Osteoarthritis of Knee Over the Effectiveness and Tolerance in Intra-articular Injection of Corticoids: a Prospective, Controlled and Randomized Study [NCT02835521]Phase 4100 participants (Anticipated)Interventional2016-08-31Not yet recruiting
Intra-articular Botulinum Toxin Type A Versus Corticosteroids: a Clinical Trial in Osteoarthritis of Knees [NCT02829281]Phase 4105 participants (Anticipated)Interventional2016-07-31Recruiting
Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus: A Randomized Controlled Clinical Trial With Immunohistochemical Analysis [NCT05882864]Phase 428 participants (Anticipated)Interventional2023-08-01Not yet recruiting
Trial Extension Protocol to Add a 39 Week Follow Up to Cingal 16-02, a Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection of Cingal to Provide Symptomatic Relief of Knee Osteoarthritis [NCT03390036]Phase 3526 participants (Actual)Interventional2017-12-07Completed
Comparison Between Anterior and Posterior Approaches for Ultrasound-guided Glenohumeral Steroid Injection: A Randomized Controlled Trial [NCT02461368]50 participants (Actual)Interventional2012-12-31Completed
Triamcinolone Assisted Anterior Vitrectomy in Complicated Cataract Surgery and Anterior Segment Reconstruction [NCT01051648]Phase 210 participants (Actual)Interventional2007-12-31Completed
[NCT00987233]Phase 30 participants InterventionalCompleted
Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays: a Randomized Placebo-controlled Study [NCT00279916]Phase 391 participants (Actual)Interventional2005-09-01Completed
Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination With Laser Photocoagulation for Diabetic Macular Edema [NCT00444600]Phase 3691 participants (Actual)Interventional2007-03-31Completed
The PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy With Clindamycin and Triamcinolone in Glioblastoma Patients Treated With Tumor Treating Fields [NCT04469075]Phase 258 participants (Anticipated)Interventional2020-07-09Recruiting
Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis [NCT00742846]0 participants (Actual)Interventional2008-08-31Withdrawn(stopped due to No enrollment)
Incidence of Flare Reaction Following Shoulder Steroid Injections: Comparison of Depo-medrol (Methylprednisolone) and Kenalog (Triamcinolone) [NCT05438277]Phase 4421 participants (Actual)Interventional2020-01-01Completed
The Effectiveness of Ultrasound Guided Sub-acromial Bursa Injection With Botulinum Toxin A in for Refractory Shoulder Pain After Stroke. [NCT02618603]Phase 450 participants (Anticipated)Interventional2016-02-29Not yet recruiting
Pilot Study of Transforaminal Epidural Injection of Clonidine for the Treatment of Acute Lumbosacral Radiculopathy [NCT00588354]26 participants (Actual)Interventional2006-10-31Terminated(stopped due to Targeted enrollment was not reached.)
Efficacy and Safety of Intra-Articular Injections of Durolane® in the Treatment of Osteoarthritis in the Knee [NCT00731289]Phase 460 participants (Actual)Interventional2003-07-31Completed
Pilot Study of Chinese Medicine Medicated Bath as Complementary Medicine for Mild to Moderate Plaque -Type Psoriasis Patient. [NCT04117919]Phase 230 participants (Anticipated)Interventional2019-10-05Recruiting
Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy [NCT00445003]Phase 3333 participants (Actual)Interventional2007-03-31Completed
A Study to Compare the Efficacy of Triamcinolone 0.1% Cream Occluded With Hydrogel Patch to Triamcinolone 0.1% Cream Without Occlusion in the Treatment of Eczema [NCT00924508]23 participants (Actual)Interventional2008-07-31Terminated(stopped due to Loss of Funding)
Resistant Diabetic Macular Edema and Suprachoroidal Injection [NCT04690608]Early Phase 1100 participants (Anticipated)Interventional2023-12-01Not yet recruiting
Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure [NCT00665977]Phase 344 participants (Anticipated)Interventional2007-09-30Completed
Phase 2 Study of Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema. [NCT00874744]Phase 213 participants (Actual)Interventional2008-03-31Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Pharmacodynamic Effect of a 6-week Treatment With Triamcinolone Acetonide Aqueous Nasal Spray 110 μg and 220 μg Once Daily on Basal Hypothalamic-Pituitary-Adr [NCT01154153]Phase 4140 participants (Actual)Interventional2010-06-30Completed
Efficacy of Dextrose Injections, Corticosteroids Injections and Surgical Release for Treatment of the Carpal Tunnel Syndrome: a Prospective, Randomized, Double-blind Controlled Trial [NCT04014244]100 participants (Anticipated)Interventional2021-03-01Recruiting
Efficacy of Post-Surgical Intralesional Injection With Triamcinolone Versus Triamcinolone Plus Fluorouracil in the Treatment of Keloids [NCT04710719]7 participants (Actual)Interventional2021-02-01Completed
Investigator-Initiated, Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout [NCT03636373]Phase 45 participants (Actual)Interventional2019-10-25Terminated(stopped due to The Sponsor has decided to stop funding this study due to lack of enrollment during COVID-19 pandemic and decreased interest in funding investigator initiated studies pertaining to the study drug)
VITRILASE Study: Prospective Randomized Trial Comparing the Effect of Laser, Vitrectomy and Intravitreal Triamcinolone Injection for Diabetic Macular Edema [NCT00764244]Phase 372 participants (Actual)Interventional2005-01-31Completed
Improvement of Short Term Outcome of Mild to Moderate Atopic Dermatitis Using a Combination Treatment of Crisaborole Ointment, 2% and a Concomitant Topical Corticosteroid Over a 8 Week Period [NCT04008784]16 participants (Actual)Observational2019-09-16Completed
A Multi-Center, Open-label, 24-week Clinical Investigation to Evaluate Safety and Tolerability of Treatment With the Oxulumis®, Suprachoroidal Drug Administration Device Delivering 2.4mg Triesence® With Diabetic Macular Edema [NCT05172401]0 participants (Actual)Interventional2022-09-15Withdrawn(stopped due to unforeseen, continued (>12month) global shortage of study medication. Study Drug Triesence, manufacturer Novartis, not supplied throughout 2022)
The Effectiveness of Selective Nerve Root Injections in Preventing the Need for Surgery in Patients With Lumbar Disc Herniations [NCT01073995]Phase 354 participants (Actual)Interventional2010-03-31Completed
Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat [NCT00908817]150 participants (Actual)Interventional2008-05-31Completed
A Phase IIb, Randomized, Masked, Sham-Controlled, Clinical Trial to Study the Efficacy and Safety of the Helical Triamcinolone Acetonide Implant (MK0140) in Diabetic Patients With Clinically Significant Macular Edema [NCT00692614]Phase 22 participants (Actual)Interventional2008-06-30Terminated
A Randomized Parallel, Masked to Evaluate the Efficacy of Triamcinolone Associated With Nepafenac (Nevanac) Compared With Intravitreal Injection of Triamcinolone for Treatment of Clinically Significant Diabetic Macular Edema [NCT00780780]Phase 340 participants (Actual)Interventional2007-07-31Completed
Injection Treatment of Slow-Release Corticosteroid to the Sacrospinous Ligament Insertions on Women With Long-Lasting Low Back Pain Starting in Pregnancy. [NCT00757016]38 participants (Actual)Interventional2004-10-31Completed
[NCT00801450]Phase 1/Phase 224 participants (Actual)Interventional2007-09-30Active, not recruiting
Comparison Between Steroid and Two Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized Double-blind Active Drug-controlled Pilot Study [NCT02767635]Phase 390 participants (Anticipated)Interventional2012-01-31Recruiting
The Effect of Intra-articular Bilateral Knee Injections of Zilretta on Osteoarthritis Research Society International (OARSI) Recommended Physical Performance Measures in Adults With Knee Osteoarthritis [NCT03895840]Phase 470 participants (Actual)Interventional2018-03-19Completed
Treatment Of Radiation Retinopathy Trial Subtitle: Treatment of Radiation Retinopathy; Influence of Lucentis® and Kenalog® on Radiation Retinopathy After Irradiation of Choroidal Melanoma. [NCT00811200]Phase 2/Phase 3220 participants (Anticipated)Interventional2009-09-30Not yet recruiting
Comparison of Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Experimentally Induced Skin Irritation [NCT00779792]Phase 436 participants (Actual)Interventional2008-09-30Active, not recruiting
Posterior Subtenon Versus Intravitreal Injection of Triamcinolone Acetonide for Treatment of Uveitic Cystoid Macular Edema (CME) [NCT02598869]Phase 40 participants (Actual)Interventional2015-11-30Withdrawn
Role of Conditioning in the Pharmacotherapy of Psoriasis [NCT00005922]138 participants (Actual)Interventional2000-08-31Completed
A Prospective Study Comparison of Clinical Outcome After Different Rate Infusion in Caudal Epidural Steroid Injection [NCT02939482]112 participants (Actual)Interventional2016-10-01Completed
Single Blind RCT to Evaluate the Effect of Ketorolac in Upper Extremity Tendinopathy and Arthropathy [NCT05292339]Phase 4160 participants (Anticipated)Interventional2023-01-31Recruiting
The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata [NCT00999869]20 participants (Anticipated)Interventional2009-11-30Recruiting
A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema [NCT00369486]Phase 2113 participants (Actual)Interventional2004-12-31Completed
Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata [NCT00484679]Phase 218 participants (Actual)Interventional2007-05-31Completed
Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee: A Prospective, Double-blind Randomized Controlled Trial [NCT01874574]Phase 4100 participants (Actual)Interventional2011-01-31Completed
A Randomized Controlled Trial of Systemic and Topical Treatments for Rash Secondary to Erlotinib in Advanced Stage IIIB or IV Non-Small Cell Lung Cancer [NCT00473083]Phase 2150 participants (Actual)Interventional2009-01-31Completed
Steroid Versus Hyaluronic Acid Ultrasound-guided Injection for Trigger Finger: A Comparative Study of Outcomes [NCT01950793]36 participants (Actual)Interventional2012-11-30Completed
Intralesional Vitamin D3 Injection in Treatment of Alopecia Areata: A Novel Approach [NCT04660786]Phase 1/Phase 240 participants (Anticipated)Interventional2021-11-01Not yet recruiting
Ultrasound-Guided Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger: Randomized Controlled Study [NCT04645303]Early Phase 1100 participants (Anticipated)Interventional2020-11-06Recruiting
[NCT01961752]111 participants (Actual)Interventional2012-07-31Completed
A Randomised Open Label Placebo Controlled Study to Evaluate Fractional Collagen Synthesis in Keloids and Identify Biomarkers of Keloid Biology for Potential Application in Future Clinical Trials [NCT01978301]Phase 19 participants (Actual)Interventional2014-04-15Terminated(stopped due to Temporary hold on recruitment during staff changes at the site)
Open-Label, Parallel-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Corticosteroid Intra Articular Injection Given 7 Days Before or 7 Days After Lorecivivint Intra-articular Injection Into the Knee of Healthy Volunteers [NCT04598542]Phase 140 participants (Actual)Interventional2020-10-13Completed
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
Efficacy and Safety of Intravitreal Triamcinolone as Treatment of the Diffuse Diabetic Macular Edema [NCT00309192]Phase 3292 participants (Anticipated)Interventional2006-04-30Completed
Assessment Of Pain Subsidence And Sexual Function Amelioration Using Either Pelvic Rehabilitation Or Trigger Point Injections [NCT02022722]Phase 436 participants (Anticipated)Interventional2013-08-31Recruiting
A Multi-center, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Hydros and Hydros-TA Joint Therapies for Management of Pain Associated With Osteoarthritis in the Knee [NCT02022930]Phase 3510 participants (Anticipated)Interventional2014-01-31Completed
Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study [NCT02025023]Phase 3120 participants (Anticipated)Interventional2013-12-31Recruiting
A Randomized Single-blinded Clinical Trial of the Efficacy of Intra-articular Infiltration of Cingal (Sodium Hyaluronate/Triamcinolone) Versus Cortisone (Triamcinolone) in Patients With Osteoarthritis of the Shoulder. [NCT05408065]84 participants (Anticipated)Interventional2023-09-30Not yet recruiting
Efficacy of Platelet Rich Plasma vs. Corticosteroid Injections for Treating Greater [NCT02031367]Early Phase 150 participants (Anticipated)Interventional2014-03-31Not yet recruiting
The Effect of Intralesian Injection of Umbilical Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide on Type 1:3 Collagen Ratio and Interleukin-10 Levels in Keloid: A Randomised Controlled Trial [NCT05939817]Phase 424 participants (Actual)Interventional2021-10-01Completed
The Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Patients With Dupuytren's Contracture: a Randomized Controlled Study [NCT00565019]Phase 351 participants (Actual)Interventional2007-11-30Completed
A Randomized, Controlled Study of ACZ885 (Canakinumab) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective Including a 12 Weeks Extension Study [NCT01080131]Phase 3226 participants (Actual)Interventional2010-03-31Completed
Topical Erythropoietin Hydrogel in Management of Oral Lichen Planus: A Randomized Controlled Clinical Trial [NCT06135259]Phase 318 participants (Anticipated)Interventional2023-12-20Not yet recruiting
The Effect of Intracameral Triesence (Triamcinolone Acetonide Injectable Suspension) on Ocular Inflammation After Trabeculectomy, Tube Shunt Implantation or Combined Trabeculectomy With Cataract Surgery [NCT00853905]Phase 2/Phase 377 participants (Actual)Interventional2009-02-28Completed
Efficacy of Combined Ultrasound Guided Steroid Injection and Splinting in Patients With Carpal Tunnel Syndrome [NCT02708693]52 participants (Actual)Interventional2013-04-30Completed
The Effect of Ethosomal Gel Bearing Losartan 5% on The Patient and Observer Scar Assessment Scale Score, Degree of Erythema and Pigmentation, Surface Area, Thickness and Pliability of Human Keloids [NCT05893108]Phase 1/Phase 246 participants (Anticipated)Interventional2024-03-30Not yet recruiting
Assessment of the Effectiveness of Ultrasound-guided Acupuncture in the Management of Carpal Tunnel Syndrome [NCT02870673]Phase 2/Phase 372 participants (Anticipated)Interventional2016-08-31Not yet recruiting
Triamcinolone Ketorolac (TriKe) Knee Trial Evaluating the Effectiveness and Possible Superiority of Ketorolac vs. Cortisone When Injected Intra-Articular in Subjects With Osteoarthrosis [NCT05336968]Phase 4150 participants (Anticipated)Interventional2022-09-15Enrolling by invitation
Clinical Trials in Stroke Rehabilitation [NCT00597766]Phase 228 participants (Actual)Interventional2007-12-31Completed
Effect of Intracameral Steroids Injection During Phacoemulsification on Postoperative Corneal Edema and Corneal Endothelium [NCT05271058]Phase 369 participants (Actual)Interventional2019-06-16Completed
Medicated Punctured-Glove-Finger Spacer Study [NCT01420471]Phase 450 participants (Actual)Interventional2011-09-30Completed
Phase I/II Study of Intravitreal Triamcinolone Acetonide Microspheres for Treatment of Diffuse Diabetic Macular Edema Unresponsive to Conventional Laser Photocoagulation Treatment. [NCT00407849]Phase 1/Phase 250 participants (Anticipated)Interventional2006-10-31Active, not recruiting
Comparative Study Between Intralesional Autologous Platelet Rich Plasma and Intralesional Triamcinolone Acetonide in the Oral Erosions of Pemphigus Vulgaris Patients [NCT02828163]Phase 311 participants (Actual)Interventional2016-01-31Completed
Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis: A Randomized Clinical Trial [NCT00554476]Phase 450 participants Interventional2003-01-31Terminated(stopped due to Because the sample volume was completed during three years.)
The Role of Triamcinolone Injection During Cataract Extraction for Diabetic Patients With Pre-Operative Macular Edema [NCT00229931]11 participants (Actual)Interventional2005-11-30Completed
Effectiveness and Tolerance Infiltration Intraarticular Corticosteroid According to Dose [NCT01851278]60 participants (Anticipated)Interventional2013-04-30Recruiting
Additive Effects of Hyaluronidase in Intra-articular Steroid Injection Treating the Initial Stage of Adhesive Capsulitis for Shoulder [NCT04347733]Phase 330 participants (Actual)Interventional2017-05-02Completed
A Randomised, Double-blind, French Multi-centre Study, to Evaluate the Efficacy and Tolerance, in Comparison With Placebo, of Nasacort in Chronic Non Allergic and Non Infectious Rhinitis in Adults [NCT00344942]Phase 377 participants (Actual)Interventional2006-04-30Terminated(stopped due to patient's recruitment too difficult)
Efficacy and Safety of Different Concentrations of Intralesional Triamcinolone Acetonide in Alopecia Areata: A Prospective, Randomized, Double-blind, Placebo-controlled Study [NCT01246284]5 participants (Actual)Interventional2010-12-31Completed
Dosage Dependency of Intravitreal Triamcinolone Acetonide for Treatment of Diabetic Macular Edema [NCT00476918]Phase 160 participants (Anticipated)Interventional2006-07-31Recruiting
Clinical Evaluation of the Safety and Efficacy of Triamcinolone Acetonide Suspension for Visualization During Vitrectomy Surgery [NCT00532415]Phase 360 participants (Actual)Interventional2007-09-30Completed
An Open-Label Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Persistent, Moderate to Severe Atopic Dermatitis [NCT02465606]Phase 255 participants (Actual)Interventional2015-07-30Completed
Biological Response to Platelet-rich Plasma and Corticosteroid Injections [NCT05657496]Phase 1/Phase 270 participants (Anticipated)Interventional2022-12-28Recruiting
Intraarticular Corticosteroid Therapy in Legg-Calve Perthes Disease: a Randomized Controlled Clinical Trial. [NCT01026909]3 participants (Actual)Interventional2009-03-31Terminated(stopped due to low recruitment)
A 24-month Randomized, Double-masked, Sham Controlled, Multicenter, Phase IIIB Study Comparing Photodynamic Therapy With Verteporfin (Visudyne®) Plus Two Different Dose Regimens of Intravitreal Triamcinolone Acetonide (1 mg and 4 mg) Versus Visudyne® Plus [NCT00242580]Phase 3111 participants (Actual)Interventional2005-09-30Completed
Intra-articular Injection of Botulinum Toxin Type A in Hemiplegic Shoulder Pain: a Multicentric, Double Blind Randomised, Versus Steroid Study [NCT01473277]Phase 252 participants (Anticipated)Interventional2012-01-31Not yet recruiting
Combined Posterior Sub-Tenon Injection of Triamcinolone Acetonide and Laser Photocoagulation for the Treatment of Clinically Significant Macular Edema [NCT00229918]Phase 260 participants Interventional2005-09-30Recruiting
Efficacy of Ultrasound-Guided Deep Perineural Platelet Rich Plasma Versus Corticosteroid Injection in Patients With Ulnar Neuropathy at Elbow, a Comparative Study [NCT05567081]Phase 2/Phase 360 participants (Actual)Interventional2021-06-01Completed
Evaluation of the Effect of Triamcinolone at Different Doses on Local Infiltration Anesthesia During Total Knee Arthroplasty [NCT05997238]90 participants (Anticipated)Observational2023-04-25Recruiting
Dropless Pars Plana Vitrectomy Study [NCT05331664]Phase 4168 participants (Anticipated)Interventional2022-07-25Recruiting
Combined Phacoemulsification Surgery and Intravitreal Triamcinolone Injection Versus Stand-alone Surgery in Patients With Type 2 Diabetes: A Randomized Controlled Trial [NCT05413330]Phase 2/Phase 373 participants (Actual)Interventional2020-09-12Completed
Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus (A Randomized Controlled Clinical Trial) [NCT05951361]44 participants (Actual)Interventional2022-02-01Completed
A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema [NCT00105404]Phase 35 participants Interventional2005-03-09Completed
Triamcinolone as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy [NCT00443521]Phase 2/Phase 330 participants Interventional2005-03-31Completed
Intravitreal Bevacizumab Combined With Intravitreal Triamcinolone Acetonide Injection Versus Intravitreal Bevacizumab for Age Related Macular Degeneration [NCT00447031]0 participants (Actual)Interventional2007-03-31Withdrawn(stopped due to Insufficient patients who met inclusion criteria)
Multi-Center, Randomized, Phase II Clinical Trial to Study the Effects of Preservative-Free Triamcinolone Acetonide and Avastin® in Combination With Photodynamic Therapy in Participants With Neovascular Age Related Macular Degeneration [NCT00464347]Phase 2100 participants (Anticipated)Interventional2007-01-31Terminated(stopped due to Study was terminated because of poor enrollment.)
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
Triamcinolone Acetonide as an Adjunctive Treatment to Verteporfin Therapy in Neovascular Age-Related Macular Degeneration: Randomized Placebo-Controlled Clinical Trial. [NCT00148551]Phase 2/Phase 3120 participants (Anticipated)Interventional2004-01-31Active, not recruiting
Comparison of the Short-term Clinical Effects of Anterior Extra-articular and Posterior Intra-articular Administration of Ultrasound-guided Steroid Injection in the Treatment of Adhesive Capsulitis. A Prospective, Randomized and Single-blind Study [NCT05668286]50 participants (Anticipated)Interventional2023-05-24Recruiting
Can Dexmedetomidine With Hyalase Augment Quality and Duration of Analgesia When Added to Lumbar Epidural Steroid in Failed Back Surgery. Randomized Double Blind Study [NCT05349448]Early Phase 1100 participants (Anticipated)Interventional2022-03-28Recruiting
Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy [NCT00411333]Early Phase 1100 participants (Anticipated)Interventional2006-07-31Completed
Intravitreal Bevacizumab Versus Intravitreal Triamcinolone Acetonide for Refractory Diabetic Macular Edema [NCT00468351]Phase 10 participants Interventional2006-04-30Active, not recruiting
[NCT00600301]Phase 30 participants InterventionalRecruiting
Ultrasound-guided Glenohumeral Versus Subacromial Steroid Injections for Impingement Syndrome With Mild Stiffness: A Randomized Controlled Trial [NCT06051370]51 participants (Actual)Interventional2013-01-12Completed
A Randomized, Evaluator Blinded, Within Subject, Single-Centre Evaluation of the Vasoconstriction Properties of MC2-01 Cream, Compared to 5 Other Corticosteroids in Healthy Subjects [NCT03758365]Phase 136 participants (Actual)Interventional2018-11-05Completed
Heated Lidocaine Patch Compared to Subacromial Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome, A Pilot [NCT01544283]Phase 260 participants (Anticipated)Interventional2012-03-31Recruiting
Comparison of Topical Tacrolimus, Triamcinolone and Placebo in the Treatment of Symptomatic Oral Lichen Planus [NCT01544842]28 participants (Actual)Interventional2004-08-31Terminated(stopped due to Lack of resources)
Multi-Center, Randomized, Phase II/III Clinical Trial to Study the Effects of Preservative-Free Triamcinolone Acetonide as an Adjunct to Photodynamic Therapy in Participants With Neovascular Age-Related Macular Degeneration [NCT00100009]Phase 330 participants Interventional2004-12-09Completed
Phase I Study of Intravitreal Injections Versus Anterior Sub-Tenon Injections of Triamcinolone Acetonide Formulation for Macular Edema in Retinal Disorders [NCT00101764]Phase 1120 participants Interventional2005-01-05Completed
The Standard Care vs. Corticosteroid for Retinal Vein Occlusion (SCORE) Study [NCT00106132]Phase 31,260 participants Interventional2005-03-31Completed
Pilot Study of Intravitreal Injection of Triamcinolone Acetonide Formulation for Retinal Vascular Disorders [NCT00071227]Phase 116 participants Interventional2003-10-15Completed
A Comparison of Clinical Efficiency of Photodynamic Therapy and Topical Corticosteroid in Treatment of Oral Lichen Planus- Split-Mouth Randomised [NCT04976673]Phase 230 participants (Actual)Interventional2020-12-10Completed
Injection After Arthroscopic Partial Meniscectomy [NCT04641351]Phase 4150 participants (Anticipated)Interventional2021-05-27Enrolling by invitation
Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis: A Double-Blind Prospective Randomized Clinical Trial [NCT04002037]Phase 4120 participants (Actual)Interventional2019-06-25Terminated(stopped due to Preliminary analysis revealed no difference)
Using Saline for Myofascial Pain Syndromes (USAMPS) [NCT02120261]Phase 451 participants (Actual)Interventional2014-05-31Terminated(stopped due to lack of activity, Primary researcher moved to another institution)
Identifying Variables Associated With Steroid-Induced Hyperglycemia Following Intra-articular Knee Injections Among Diabetic Patients [NCT04317404]11 participants (Actual)Observational2020-11-01Completed
The Effects of Triamcinolone Acetonide With Retrobulbar Anesthesia on Postoperative Pain Control Following Vitreoretinal Surgery [NCT01995045]Phase 458 participants (Actual)Interventional2012-07-31Completed
The Safety and the Efficacy of Combined Vitrectomy, Intravitreal Triamcinolone Acetonide and Macular Focal Laser Photocoagulation for the Treatment of Intractable Diffuse Diabetic Macular Edema [NCT00371410]Phase 10 participants Interventional2005-04-30Completed
Early Anti-inflammatory Treatment in Patients With Acute ACL Tear [NCT01692756]Phase 249 participants (Actual)Interventional2013-03-31Completed
Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema [NCT00231023]Phase 210 participants Interventional2005-09-30Completed
Phase 1 Prospective, Randomized, Double-Masked, Multicenter Study to Evaluate the Safety and Tolerability of Two Dose Levels of the Helical Intravitreal Triamcinolone Implant in Diabetic Macular Edema [NCT00915837]Phase 131 participants (Actual)Interventional2005-06-30Completed
Neovascular Age Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy [NCT00305630]Phase 2/Phase 3100 participants Interventional2002-07-31Completed
Botulinum Toxin Versus Steroid Injection for Basal Joint Arthritis of the Thumb: a Randomized, Double Blind, Placebo-controlled Clinical Trial [NCT01045694]Phase 48 participants (Actual)Interventional2011-03-31Terminated(stopped due to Unable to acquire additional funding needed to continue this study.)
A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study Comparing FX006 to Commercially Available Triamcinolone Acetonide Injectable Suspension in Patients With Osteoarthritis of the Knee [NCT01487161]Phase 2229 participants (Actual)Interventional2012-06-30Completed
Changes Noted After Suprachoroidal Triamcinolone Acetonide Injection. [NCT05288192]30 participants (Anticipated)Interventional2022-02-15Recruiting
Bayesian Non-inferiority Trial of Injection Therapies for Acromioclavicular Joint Pain: a Randomized Clinical Trial [NCT05161468]Phase 4150 participants (Anticipated)Interventional2022-07-01Recruiting
An Open-Label, Follow-On Study to Cingal 13-01 to Evaluate the Safety of a Repeat Injection of Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide to Provide Symptomatic Relief of Osteoarthritis of the Knee [NCT02381652]Phase 3242 participants (Actual)Interventional2015-02-28Completed
An Investigator-Initiated Study to Assess the Cooling Effect of Triamcinolone Acetonide Aerosol When Used for Steroid-Responsive Dermatoses [NCT01736670]30 participants (Actual)Interventional2012-04-30Completed
Evaluation of the Efficacy of Suprascapular Nerve Block in Adhesive Capsulitis: a Randomized Controlled Superiority Trial [NCT06176248]62 participants (Anticipated)Interventional2024-02-29Not yet recruiting
Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System. [NCT05106192]22 participants (Anticipated)Interventional2024-06-01Not yet recruiting
Efficacy and Safety of Intralesional Triamcinolone Acetonide in Vitiligo: A Prospective, Double-Blind Randomized Controlled Trial [NCT01766609]Phase 218 participants (Anticipated)Interventional2013-01-31Recruiting
PRevention of Macular EDema After Cataract Surgery [NCT01774474]Phase 31,127 participants (Actual)Interventional2013-07-10Completed
The Use of Intraocular Triamcinolone in the Perioperative Period of Congenital Cataract Surgery [NCT01800708]60 participants (Actual)Interventional2010-01-31Completed
Quantitative Comparison of the Efficacy of Subtenon 20-mg Triamcinolone Injection With 0.1% Dexamethasone Eye Drop in Controlling Intraocular Inflammation After Phacoemulsification [NCT01801774]Phase 4140 participants (Anticipated)Interventional2012-05-31Recruiting
A Randomized, Intraindividual, Phase 4 Study to Evaluate the Short-Term Efficacy of Triamcinolone Acetonide (Aristocort® C) in Subjects With Atopic Dermatitis [NCT05844618]Phase 420 participants (Anticipated)Interventional2023-05-09Recruiting
[NCT00370539]Phase 30 participants Interventional2006-09-30Recruiting
Safety and Efficacy of Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata [NCT01797432]Phase 214 participants (Actual)Interventional2009-03-31Completed
Open-Label, Safety and Tolerability Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle in Subjects With Non-Infectious Uveitis [NCT01789320]Phase 1/Phase 211 participants (Actual)Interventional2013-02-28Completed
Efficacy and Safety of Intralesional Triamcinolone Acetonide Alone and Its Combination With 5-fluorouracil in Keloids and Hypertrophic Scars [NCT04812626]66 participants (Actual)Interventional2021-01-28Completed
A Randomized, Double-Blind Study of the Efficacy of Steroid Supplementation After Temporomandibular Joint Arthrocentesis [NCT01770912]Phase 224 participants (Actual)Interventional2013-03-31Completed
A Double-Blind, Randomized, Parallel Group, Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee [NCT02468583]Phase 26 participants (Actual)Interventional2015-02-28Terminated
Randomized Prospective Study of Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Steroid Injection [NCT03166761]Phase 441 participants (Actual)Interventional2017-09-14Terminated(stopped due to recruitment and staffing)
The Effect of Epidural Steroid Injections on Glycemic Control in Diabetic Patients According to the Doses of Steroids [NCT01435707]125 participants (Actual)Interventional2011-09-30Completed
Success of Long-acting Anti-inflammatories After Anterior Cruciate Ligament and Meniscal Injury [NCT04331002]Phase 21 participants (Actual)Interventional2020-08-21Terminated(stopped due to Funding Termination)
Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized Controlled Trial [NCT03127137]Phase 4123 participants (Actual)Interventional2018-08-01Completed
A Randomized, Open-label, Parallel Group Study in Patients With Bilateral Knee Osteoarthritis Comparing the Systemic Exposure of Triamcinolone Acetonide Following Administration Into Both Knees of Either Extended-release FX006 or Immediate-release TAcs (T [NCT03378076]Phase 224 participants (Actual)Interventional2017-12-06Completed
Valchlor Therapy in Conjunction With Triamcinolone 0.1% Ointment for the Treatment of Contact Dermatitis in Patients With Early Stage Cutaneous T-cell Lymphoma (Mechlorethamine Induced Dermatitis Avoidance Study) [NCT03380026]Phase 228 participants (Actual)Interventional2017-12-13Completed
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
An Open-Label Study of the Safety and Tolerability of Combining 20089 (Triamcinolone Acetonide Intravitreal Injection) When Used Adjunctively With Lucentis® 0.5 mg Intravitreal Injection in Subjects With Subfoveal Neovascular AMD [NCT01175395]Phase 1/Phase 210 participants (Actual)Interventional2010-09-30Completed
Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases: A Pilot Study [NCT05488860]20 participants (Anticipated)Interventional2022-07-30Recruiting
A Study in Atopic Dermatitis to Determine Serum and Skin Biopsy Biomarkers in Patients Receiving Topical Corticosteroid (TCS) and Following TCS Withdrawal [NCT02317276]Phase 411 participants (Actual)Interventional2014-12-31Terminated(stopped due to Unable to meet the study's recruitment goals)
Intra-Articular Use of Platelet Rich Plasma Versus Corticosteroid: A Clinical Trials in Osteoarthritis of Knee. [NCT03086759]Phase 499 participants (Actual)Interventional2017-01-02Completed
Comparison of the Effects of Ultrasonography-guided Suprascapular Nerve Block and Intra-articular Shoulder Injection on Pain, Functional Status and Range of Motion in Patients With Adhesive Capsulitis; Randomized, Controlled Trial [NCT05909462]60 participants (Actual)Interventional2023-01-21Completed
Steroid and Sodium Hyaluronate Hydrodilatation [NCT05861570]84 participants (Anticipated)Interventional2023-05-18Recruiting
Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis (ADRN-12) [NCT05436535]Phase 4600 participants (Anticipated)Interventional2022-11-21Recruiting
A Prospective Triple-Blinded Single-Center Study of Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid Treatment for Keloids [NCT04786210]Phase 420 participants (Actual)Interventional2021-01-30Completed
Modified SALT Score for Assessment of Alopecia Areata [NCT04412148]Phase 420 participants (Anticipated)Interventional2020-01-01Recruiting
Efficacy of Autologous Adipose Derived Stromal Vascular Fraction in the Treatment of Keloids [NCT04391621]Phase 230 participants (Anticipated)Interventional2021-05-01Recruiting
Subakromiyal sıkışma Sendromunda Hyaluronik Asit, Kortikosteroid ve Elektroterapi [NCT04833738]90 participants (Actual)Interventional2013-09-11Completed
PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial [NCT02374060]Phase 3192 participants (Actual)Interventional2015-06-16Completed
The Effectiveness of Intra-articular Corticosteroid Injection in Patients With Whiplash-related Neck Pain [NCT04959721]32 participants (Anticipated)Interventional2021-07-15Not yet recruiting
Effects of Ultrasound-guide Hypertonic Dextrose Injection for Chronic Subacromial Bursitis [NCT04916353]60 participants (Anticipated)Interventional2021-06-10Recruiting
[NCT00373282]Phase 30 participants Interventional2001-06-30Completed
Comparing Low Dose and High Dose Steroid Injection for Adhesive Capsulitis [NCT04364425]80 participants (Anticipated)Interventional2020-05-04Recruiting
Effect of Combined Ultrasound-guided Subdeltoid Corticosteroid Injections and Physiotherapy in Treatment of Patients With Chronic Subacromial Bursitis [NCT03871465]111 participants (Actual)Interventional2018-08-01Completed
A Randomized, Double-blind, Active-control, Multicenter, Efficacy and Safety Study of 2 Dose Levels of Subcutaneous Anakinra Compared to Intramuscular Triamcinolone in the Treatment of Acute Gouty Arthritis, Followed by an Extension Period of up to 2 Year [NCT03002974]Phase 2165 participants (Actual)Interventional2016-12-31Completed
A Two Different Chemoprophylaxis Approaches After Phacoemulsification Surgery in One Thousand Patients in Iraq :a Clinical Trial [NCT03634852]Phase 41,000 participants (Actual)Interventional2016-10-01Completed
A Clinical and Immunological Study of Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata: A Randomized Controlled Clinical Trial [NCT01559584]40 participants (Actual)Interventional2012-03-31Completed
Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis [NCT04182672]Phase 222 participants (Actual)Interventional2020-08-12Active, not recruiting
Outcome in Shoulder Capsulitis (Frozen Shoulder) Between Corticosteroid and Corticosteroid With Distension Compared to Wait and See Policy, a Randomised Controlled Trial [NCT01570985]Phase 3120 participants (Anticipated)Interventional2010-02-28Active, not recruiting
Randomized Multicenter Clinical Trial of Three Parallel Groups to Estimate the Safety and Efficacy of Triamcinolone Acetonide Combined With Laser, Bevacizumab Combined With Laser Versus Laser Alone for the Treatment of Diffuse Non-tractional Diabetic Macu [NCT01572350]Phase 3105 participants (Anticipated)Interventional2010-10-31Completed
Efficacy of Formulated Posterior Sub Tenon Triamcinolone in Macular Edema Secondary to Non-Ischemic Retinal Vein Occlusions [NCT05345808]46 participants (Actual)Interventional2021-03-01Completed
Needle-Free Injection of Lidocaine for Local Anesthesia Prior to Trigger Digit Injection [NCT02084706]60 participants (Actual)Interventional2014-03-31Completed
Effect of Intra-articular Steroids on Structural Progression of Knee OA: A Randomized Controlled Trial [NCT01230424]Phase 4140 participants (Actual)Interventional2011-03-31Completed
A Double-Blind, Randomized, Single-Dose Study to Assess the Safety and Efficacy of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee [NCT02357459]Phase 3486 participants (Actual)Interventional2015-01-31Completed
Comparing Efficacy of Topical Steroid Cream vs. Ointment Formulations Using Wet Dressings for Treatment of Atopic Dermatitis [NCT02680301]Phase 440 participants (Actual)Interventional2016-03-31Completed
[NCT00369863]Phase 276 participants Interventional2002-06-30Completed
The Effectiveness of Nasal Corticosteroids Versus Placebo in Nasal Obstruction in Patients With Nasal Septal Deviation [NCT02877485]Phase 442 participants (Actual)Interventional2016-08-31Completed
Peripheral Nerve Injections for the Treatment of Upper Extremity Complex Regional Pain Syndrome: A Feasibility Study for a Proposed Randomized Design [NCT04744675]Phase 450 participants (Anticipated)Interventional2021-03-31Not yet recruiting
[NCT00370370]Phase 30 participants Interventional2005-11-30Active, not recruiting
[NCT00370669]Phase 3150 participants Interventional2005-11-30Recruiting
Randomized Controlled Trial Comparing Two Different Bladder Instillation Treatments for Interstitial Cystitis/Bladder Pain Syndrome [NCT03463915]Phase 390 participants (Actual)Interventional2019-01-25Completed
SporTRIA Study: A Multicentre Trial for Excretion Kinetics of Triamcinolone Acetonide Following Sport Related Intra-articular Injections in Knees; Definitions of the Washout Periods [NCT04574232]20 participants (Anticipated)Interventional2023-01-01Recruiting
Transpupillary Thermotherapy (TTT) Alone Versus the Combined Therapy Consisting of TTT and Intravitreal Injection of Triamcinolone to Decrease Exudation in Choroidal Melanoma After Proton Beam Therapy [NCT02379000]Phase 450 participants (Anticipated)Interventional2015-01-31Active, not recruiting
A Stratified Investigation of a Single Injection of ZILRETTA™ (Triamcinolone Acetonide Extended-release Injectable Suspension) for Symptomatic Relief in Patients With Idiopathic Adhesive Capsulitis of the Shoulder [NCT04831255]Phase 150 participants (Anticipated)Interventional2019-06-21Recruiting
An Open-label Extension Study of CACZ885H2356E2 and CACZ885H2357E2 on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective [NCT01470989]Phase 3136 participants (Actual)Interventional2011-11-30Completed
Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome; a Comparative Study [NCT04434105]Phase 2/Phase 390 participants (Actual)Interventional2020-02-01Active, not recruiting
25-Gauge Vitrectomy With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in China: a Randomized, Single Blind Trial [NCT02447185]Phase 3200 participants (Anticipated)Interventional2015-06-30Recruiting
Early Effect of Cingal® Compared to Monovisc® in Patients With Osteoarthritis of the Knee (EEFFEK Study) [NCT03062787]60 participants (Actual)Interventional2017-04-05Completed
Cell Therapy for Patients With Symptomatic Knee Osteoarthritis: Phase I / II, Controlled, Randomized and Double-blind Clinical Trial [NCT04863183]Phase 1/Phase 230 participants (Anticipated)Interventional2021-06-01Not yet recruiting
Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal™) to Provide Symptomatic Relief of Osteoarthritis of the Knee [NCT03191903]Phase 3576 participants (Actual)Interventional2017-05-25Completed
Triamcinolone Acetonide Levels in Cochlear Perilymph, Lateral Canal and CSF in Patients With Vestibular Schwannomas [NCT04658836]Phase 121 participants (Actual)Interventional2020-02-01Completed
Using Intraoperative Triamcinolone Acetonide Irrigation to Reduce Post-Operative Pain From Scleral Buckle Surgery [NCT04701593]Phase 424 participants (Anticipated)Interventional2020-01-03Recruiting
Effect of ZILRETTA Versus CELESTONE on Quality of Life, Pain, Neuromuscular Function, and Physical Performance [NCT05058209]Phase 420 participants (Actual)Interventional2020-11-30Completed
Suprachoroidal Triamcinolone Acetonide Injection A Novel Therapy for Serous Retinal Detachment in Vogt-Koyanagi Harada's Disease [NCT05031143]Phase 2/Phase 36 participants (Actual)Interventional2020-04-01Completed
An Open-label, Single Administration Study to Characterize the Systemic Pharmacokinetics and Local Extent and Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis of the Knee [NCT02637323]Phase 281 participants (Actual)Interventional2015-11-30Completed
Pilot Study of Traditional Chinese Medicine (Qing-Re-Liang-Xue Decoction) as Complementary Medicine for Psoriasis Vulgaris of Blood-heat Syndrome. [NCT04994951]Phase 2200 participants (Anticipated)Interventional2021-09-30Recruiting
Randomized Trial Evaluating Bevacizumabe or Triamcinolone for Persistent Diabetic Macular Edema [NCT02985619]Phase 2/Phase 3100 participants (Actual)Interventional2016-07-21Completed
Efficacy of Corticosteroid Injection Into Coracohumeral Ligament in Patients With Adhesive Capsulitis of the Shoulder [NCT03013205]60 participants (Anticipated)Interventional2017-02-28Not yet recruiting
Comparison of Ultrasound-guided Corticosteroid Injection Versus Corticosteroid Injection and Hydrodissection for Carpal Tunnel Syndrome [NCT04346030]60 participants (Anticipated)Interventional2020-04-17Recruiting
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
[NCT01614509]45 participants (Actual)Interventional2012-01-31Completed
A Randomized, Double-blind, Double-dummy, Active Controlled Study of Canakinumab (ACZ885) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective [NCT01362608]Phase 3136 participants (Actual)Interventional2011-06-20Terminated
A Phase 2, Randomized, Active and Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of Intra-articular Resiniferatoxin to Treat Moderate to Severe Pain From Knee Osteoarthritis [NCT04885972]Phase 2124 participants (Actual)Interventional2021-11-15Active, not recruiting
Benefit of Placebo and Different Concentrations of Triamcinolone Acetonide in Nail Psoriasis [NCT03991936]Phase 410 participants (Actual)Interventional2020-03-11Completed
Pilot Study of Early Postoperative Fractional Ablative Laser Treatment of Skin Grafts for Burns [NCT04176705]9 participants (Actual)Interventional2020-12-14Completed
Transepidermal Delivery of Triamcinolone Acetonide or Platelet Rich Plasma Using Either Fractional Carbon Dioxide Laser or Microneedling in Treatment of Alopecia Areata [NCT04147845]60 participants (Actual)Interventional2019-10-30Completed
A Pilot Study of Intralesional Injection of Triamcinolone Acetonide for Desmoid Tumors [NCT03627741]Phase 110 participants (Actual)Interventional2018-06-07Completed
Strategies Towards Personalised Treatment in Juvenile Idiopathic Arthritis (JIA): The MyJIA Trial. [NCT04614311]Phase 4202 participants (Anticipated)Interventional2020-12-01Recruiting
Comparison of the Efficacy of Intra-articular Hybrid Hyaluronic Acid and Steroid in Patients With Rizoarthrosis [NCT03200886]100 participants (Actual)Observational2017-05-24Active, not recruiting
Ranibizumab (rhuFab V2) and Scatter Laser Photocoagulation in Treatment of Patients With Clinically-significant Diabetic Macular Edema With Peripheral Retinal Nonperfusion (RaScaL) [NCT00815360]Phase 222 participants (Actual)Interventional2008-02-29Completed
An Open-label, Single Administration Study to Characterize the Local Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis (OA) of the Knee [NCT02003365]Phase 250 participants (Actual)Interventional2013-11-30Completed
Comparison of Keloid Volume and Symptoms Reduction Between Intralesional Umbilical-Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide Injection as Keloid Therapy: A Randomised Controlled Trial [NCT05887804]Phase 424 participants (Actual)Interventional2021-10-01Completed
Prospective, Randomized Trial of Intralesional Steroid Injection Versus Oral Prednisolone in Prevention of Esophageal Stricture After Endoscopic Submucosal Dissection [NCT04498260]Phase 430 participants (Anticipated)Interventional2019-01-21Recruiting
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
Evaluation of Systemic Administration of Green Tea Polyphenols as a Supportive Antioxidant Agent in the Management of Oral Lichen Planus [NCT02329600]Phase 340 participants (Actual)Interventional2013-06-30Completed
Implications and Stability of Clinical and Molecular Phenotypes of Severe Asthma [NCT01748175]715 participants (Actual)Observational2013-01-31Completed
Effect of the Combination of Photobiomodulation Therapy and the Intralesional Administration of Corticoid in the Preoperative and Postoperative Periods of Keloid Surgery: a Randomized, Controlled, Double-blind Trial [NCT04824612]58 participants (Anticipated)Interventional2021-08-30Enrolling by invitation
Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study [NCT04207931]Phase 4250 participants (Anticipated)Interventional2018-04-30Recruiting
Bevacizumabe e Acetato de Triancinolona Intra-vítreo Associados à Laserterapia em Pacientes Com Edema Macular diabético (IBeTA) [NCT02310295]45 participants (Actual)Interventional2009-01-31Completed
Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized [NCT03382925]Phase 416 participants (Actual)Interventional2017-12-20Terminated(stopped due to Not enough cervical interlaminar patients who meet criteria in order to meet recruitment goals.)
The Clinical Application of PLT Combined With Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy [NCT05648032]Phase 3180 participants (Anticipated)Interventional2022-10-06Recruiting
A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal®) to Provide Symptomatic Relief of Osteoarthritis of the Knee [NCT04231318]Phase 3231 participants (Actual)Interventional2020-09-11Completed
Effect of ZILRETTA Injection on Neuromuscular Function, Gait Biomechanics and Physical Performance [NCT04261049]Phase 135 participants (Actual)Interventional2020-08-01Completed
The ESCRS EPICAT Study: Effectiveness of Periocular Drug Injection in CATaract Surgery [NCT05158699]Phase 3808 participants (Anticipated)Interventional2021-10-13Recruiting
Comparison of Corticosteroid and Repeated Dextrose Hydro-dissection for Carpal Tunnel Syndrome Patients [NCT04579783]60 participants (Anticipated)Interventional2020-11-27Recruiting
Thoracic Epidural Morphine Versus Triamcinolone Acetonide Analgesia in Flail Chest [NCT03413059]Phase 2/Phase 340 participants (Anticipated)Interventional2018-02-01Not yet recruiting
Evaluation of Triamcinolone's Efficacy on the Ultrasound- Guided Infiltration in the Quadratus Lumborum Syndrome: a Double Blind, Randomized, Controlled Study [NCT03407027]Phase 466 participants (Anticipated)Interventional2017-11-01Enrolling by invitation
Painful Inflammatory Carpometacarpal-1 Osteoarthritis Treated With Intraarticular Steroids, Saline or an Occupational Therapy Intervention: the PICASSO Trial. [NCT06084364]Phase 4354 participants (Anticipated)Interventional2023-11-03Recruiting
Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis: A Randomized Placebo-Controlled Clinical Trial [NCT00746889]79 participants (Actual)Interventional2004-03-31Completed
A Double-Blind, Randomized, Parallel Group, Active Comparator Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects (HPA Axis) of FX006 in Patients With Osteoarthritis of the Knee [NCT01487200]Phase 224 participants (Actual)Interventional2012-07-31Completed
Biologics and Blistering - Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation Through Suction Blistering [NCT05535738]Phase 2/Phase 345 participants (Anticipated)Interventional2022-11-15Recruiting
Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo [NCT03365141]12 participants (Anticipated)Interventional2017-11-14Recruiting
Comparison of Triamcinolone Acetonide Mucoadhesive Film and Licorice Mucoadhesive Film Effect on the Duration and Symptoms of Lesions That Caused by Symptomatic Oral Lichen Planus [NCT02453503]Phase 260 participants (Actual)Interventional2014-01-31Completed
A Short Term Outcomes of Subacromial Injection of Combined Corticosteroid With Low Volume Compared to High Volume of Local Anesthetic for Rotator Cuff Impingement Syndrome: A Randomized Controlled Trials [NCT03120923]Phase 452 participants (Actual)Interventional2015-01-01Completed
A Multi-Center, Randomized, Two-Arm, Parallel-Group, Single-masked, 24-week, Clinical Trial to Evaluate Safety and Tolerability of Two Dose Levels of Suprachoroidal Triamcinolone Acetonide Administered With the Oxulumis® Ophthalmic Administration Device i [NCT05512962]Phase 220 participants (Actual)Interventional2022-08-31Active, not recruiting
Triamcinolone Levels in Cochlear Perilymph [NCT03248856]Phase 140 participants (Actual)Interventional2017-10-02Completed
The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study: Two Randomized Trials to Compare the Efficacy and Safety of Intravitreal Injection(s) of Triamcinolone Acetonide With Standard Care to Treat Macular Edema [NCT00105027]Phase 3682 participants (Actual)Interventional2004-10-31Completed
Efficacy of Intralesional Injection of Autologous Platelet Rich Plasma Versus Intralesional Injection of Corticosteroids on Pain Relief and Ulcers Healing in Patients With Erosive Oral Lichen Planus; Randomized Clinical Trial [NCT03293368]Phase 220 participants (Actual)Interventional2018-01-01Completed
A Phase 4 Multicenter, Randomized, Placebo Controlled Trial of 3 Doses of Intralesional Triamcinolone (KENALOG®) In the Treatment of Mild to Moderate Patch Type Alopecia Areata [NCT01898806]Phase 411 participants (Actual)Interventional2011-09-30Terminated(stopped due to The PI left the Columbia University Medical Center. Study was not Completed.)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00105027 (4) [back to overview]Adverse Ocular Outcomes
NCT00105027 (4) [back to overview]The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit
NCT00105027 (4) [back to overview]Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography
NCT00105027 (4) [back to overview]Changes From Baseline in Best-corrected ETDRS Visual Acuity Score
NCT00242580 (6) [back to overview]Number of Participants Requiring Verteporfin Treatment Throughout the Study
NCT00242580 (6) [back to overview]Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.
NCT00242580 (6) [back to overview]Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12
NCT00242580 (6) [back to overview]Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months
NCT00242580 (6) [back to overview]Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12
NCT00242580 (6) [back to overview]Mean Change From Baseline in Total Area of Lesion at 12 Months
NCT00279916 (8) [back to overview]Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears
NCT00279916 (8) [back to overview]Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears
NCT00279916 (8) [back to overview]Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears
NCT00279916 (8) [back to overview]Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution
NCT00279916 (8) [back to overview]Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment
NCT00279916 (8) [back to overview]Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual
NCT00279916 (8) [back to overview]Per-Ear Treatment Outcome
NCT00279916 (8) [back to overview]Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears
NCT00367133 (14) [back to overview]Central Subfield Thickness < 250 Microns at 2 Years
NCT00367133 (14) [back to overview]Central Subfield Thickness at 2 Years
NCT00367133 (14) [back to overview]Central Subfield Thickness on Optical Coherence Tomography (OCT) at Three Years
NCT00367133 (14) [back to overview]Change in Central Subfield Thickness on OCT Baseline to 3 Years
NCT00367133 (14) [back to overview]Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.
NCT00367133 (14) [back to overview]Change in Visual Acuity From Baseline to 3 Years
NCT00367133 (14) [back to overview]Change in Visual Acuity From Baseline to 3 Years
NCT00367133 (14) [back to overview]Mean Change in Central Subfield Thickness Baseline to 2 Years
NCT00367133 (14) [back to overview]Median Change in Visual Acuity Baseline to 2 Years
NCT00367133 (14) [back to overview]Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years
NCT00367133 (14) [back to overview]Percentage of Eyes With a Change in Central Subfield Thickness on OCT <250 Microns From Baseline to 3 Years
NCT00367133 (14) [back to overview]Distribution of Change in Visual Acuity Baseline to 2 Years
NCT00367133 (14) [back to overview]Distribution of Visual Acuity Change Baseline to 3 Years
NCT00367133 (14) [back to overview]Median Change in Central Subfield Thickness Baseline to 2 Years
NCT00369486 (6) [back to overview]Mean Visual Acuity Letter Score at Each Follow-up Visit
NCT00369486 (6) [back to overview]Change in Visual Acuity Letter Score From Baseline Through 34 Weeks
NCT00369486 (6) [back to overview]Change in Central Subfield Thickening From Baseline Through 34 Weeks
NCT00369486 (6) [back to overview]Central Subfield Thickness <250 Microns From Baseline Through 34 Weeks
NCT00369486 (6) [back to overview]Reduction of ≥ 50% in Retinal Thickening in the Central Subfield From Baseline Through 34 Weeks
NCT00369486 (6) [back to overview]Persistence/Recurrence of Diabetic Macular Edema (DME) Either Retreated or Meeting Criteria for Retreatment at 17 Weeks
NCT00444600 (21) [back to overview]Change in Visual Acuity From Baseline to 1 Year Grouped by Optical Coherence Tomography Central Subfield Thickness
NCT00444600 (21) [back to overview]Distribution of Change in Visual Acuity (Letters) From Baseline to 1 Year
NCT00444600 (21) [back to overview]Change From Moderately Severe Non-proliferative Diabetic Retinopathy or Better From Baseline to 1-year
NCT00444600 (21) [back to overview]Change From Severe Non-proliferative Diabetic Retinopathy or Worse From Baseline to 1-year
NCT00444600 (21) [back to overview]Change in Visual Acuity From Baseline to 1 Year Among Eyes That Had Prior Treatment for Diabetic Macular Edema
NCT00444600 (21) [back to overview]Change in Visual Acuity From Baseline to 1 Year Among Eyes That Were Pseudophakic at Baseline
NCT00444600 (21) [back to overview]Change in Visual Acuity From Baseline to 1 Year Grouped by Baseline Visual Acuity Letter Score
NCT00444600 (21) [back to overview]Change in Visual Acuity From Baseline to 1 Year Grouped by Diabetic Retinopathy Severity
NCT00444600 (21) [back to overview]Change in Visual Acuity From Baseline to 1 Year Grouped by Diffuse vs. Focal Edema as Characterized by the Investigator
NCT00444600 (21) [back to overview]Number of Laser Treatments Received Prior to the 1 Year Visit
NCT00444600 (21) [back to overview]Major Ocular Adverse Events During First Year of Follow-Up
NCT00444600 (21) [back to overview]Eyes With Alternative Treatments Prior to the 1-year Visit
NCT00444600 (21) [back to overview]Distribution of Logarithmic Transformation of Optical Coherence Tomography (LogOCT) Improvement and Worsening
NCT00444600 (21) [back to overview]Central Subfield Thickness < 250 With at Least a 25 Micron Decrease From Baseline to 1 Year
NCT00444600 (21) [back to overview]Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year
NCT00444600 (21) [back to overview]Mean Change in Optical Coherence Tomography Retinal Volume From Baseline to 1 Year
NCT00444600 (21) [back to overview]Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity
NCT00444600 (21) [back to overview]Mean Optical Coherence Tomography Retinal Volume at 1 Year
NCT00444600 (21) [back to overview]Number of Injections in First Year
NCT00444600 (21) [back to overview]Percentage of Eyes Receiving Laser at the 48 Week Visit (%)
NCT00444600 (21) [back to overview]Cardiovascular Events According to Antiplatelet Trialists' Collaboration Through 1 Year
NCT00445003 (8) [back to overview]Change in Optical Coherence Tomography Retinal Volume
NCT00445003 (8) [back to overview]Change in Optical Coherence Tomography Central Subfield Thickness
NCT00445003 (8) [back to overview]Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks
NCT00445003 (8) [back to overview]Number of Eyes With Additional Number of Treatments for Diabetic Macular Edema
NCT00445003 (8) [back to overview]Total Optical Coherence Tomography Retinal Volume
NCT00445003 (8) [back to overview]Additional Treatments for Diabetic Macular Edema
NCT00445003 (8) [back to overview]Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema
NCT00445003 (8) [back to overview]Change in Visual Acuity From Baseline
NCT00473083 (7) [back to overview]Overall Incidence of Grade 3 Rash
NCT00473083 (7) [back to overview]Overall Incidence of Rash
NCT00473083 (7) [back to overview]Overall Survival
NCT00473083 (7) [back to overview]Severity of Rash Caused by Erlotinib
NCT00473083 (7) [back to overview]Time Duration From Onset of Rash Until Resolution
NCT00473083 (7) [back to overview]Time to First Presentation of Rash
NCT00473083 (7) [back to overview]Duration of Treatment
NCT00484679 (1) [back to overview]Mean Change in Cortisol Levels From Baseline to Week 24
NCT00588354 (8) [back to overview]Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)
NCT00588354 (8) [back to overview]Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)
NCT00588354 (8) [back to overview]Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire
NCT00588354 (8) [back to overview]Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire
NCT00588354 (8) [back to overview]Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire
NCT00588354 (8) [back to overview]Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)
NCT00588354 (8) [back to overview]Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)
NCT00588354 (8) [back to overview]Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)
NCT00597766 (4) [back to overview]Pain Free External Rotation Range of Motion (ROM)
NCT00597766 (4) [back to overview]Pain Free Abduction Range of Motion (ROM)
NCT00597766 (4) [back to overview]Fugl-Meyer Motor Assessment, Upper Limb Domain
NCT00597766 (4) [back to overview]BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire
NCT00746889 (2) [back to overview]Change in WOMAC Pain Subscale
NCT00746889 (2) [back to overview]Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale
NCT00798369 (7) [back to overview]The Dose of Canakinumab for Treatment of Acute Flares in Gout Patients That Leads to the Same Efficacy as Triamcinolone Acetonide With Respect to Pain Intensity on a 0-100 mm Visual Analog Scale (VAS)
NCT00798369 (7) [back to overview]Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment
NCT00798369 (7) [back to overview]The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint
NCT00798369 (7) [back to overview]Amount of Rescue Medication Taken for Each Treatment Group
NCT00798369 (7) [back to overview]High Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group
NCT00798369 (7) [back to overview]Serum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group
NCT00798369 (7) [back to overview]The Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide
NCT00815360 (2) [back to overview]Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters From Baseline to Month 6.
NCT00815360 (2) [back to overview]Mean Central Foveal Thickness (CFT) on Optical Coherence Tomography (OCT) in Microns at 6 Months
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
NCT00826462 (33) [back to overview]Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
NCT00826462 (33) [back to overview]Treatment Success - Event Rates in Each Group
NCT00826462 (33) [back to overview]Pain-free Grip Strength Ratio
NCT00826462 (33) [back to overview]Pain-free Grip Strength Ratio
NCT00826462 (33) [back to overview]Pain-free Grip Strength Ratio
NCT00826462 (33) [back to overview]Pain-free Grip Strength Ratio
NCT00826462 (33) [back to overview]Pain Free Function Index of Everyday Activities
NCT00826462 (33) [back to overview]Maximum Grip Strength Ratio
NCT00826462 (33) [back to overview]Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Maximum Grip Strength Ratio
NCT00826462 (33) [back to overview]Pain Free Function Index of Everyday Activities
NCT00826462 (33) [back to overview]Pain Free Function Index of Everyday Activities
NCT00826462 (33) [back to overview]Pain Free Function Index of Everyday Activities
NCT00826462 (33) [back to overview]Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale)
NCT00826462 (33) [back to overview]Maximum Grip Strength Ratio
NCT00826462 (33) [back to overview]Maximum Grip Strength Ratio
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
NCT00826462 (33) [back to overview]Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).
NCT00826462 (33) [back to overview]Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).
NCT00826462 (33) [back to overview]Pain as Recorded by the Study Doctors on a 100 mm VAS-scale
NCT00853905 (5) [back to overview]Anterior Chamber Inflammation (Flare)
NCT00853905 (5) [back to overview]Ocular Hypotensive Medications
NCT00853905 (5) [back to overview]Bleb Appearance
NCT00853905 (5) [back to overview]Patient Comfort
NCT00853905 (5) [back to overview]Intraocular Pressure (IOP)
NCT00924508 (2) [back to overview]Change in Disease Severity: Percent Change in Mean EASI Score
NCT00924508 (2) [back to overview]Number of Adverse Events Associated With Treatment
NCT01026909 (2) [back to overview]Primary Outcome Variable: Function. The Pediatric Outcomes Data Collection Instrument (PODCI) Will be the Primary Endpoint as a Measure of Function and Health Related Quality of Life at 12 Months Post Injection.
NCT01026909 (2) [back to overview]Second Outcome Variable: Ambulatory Activity. It Will be Defined as Average Steps/Day as Measured by the StepWatch Activity Monitor for a 7 Day Sample.
NCT01029652 (33) [back to overview]Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab
NCT01029652 (33) [back to overview]Percentage of Participants Who Took Rescue Medication
NCT01029652 (33) [back to overview]Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale)
NCT01029652 (33) [back to overview]Physician's Assessment of Erythema for Patients Re-treated or Switched to Canakinumab
NCT01029652 (33) [back to overview]Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab
NCT01029652 (33) [back to overview]Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab
NCT01029652 (33) [back to overview]Physician's Assessment of Range of Motion of the Most Affected Joint
NCT01029652 (33) [back to overview]Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint
NCT01029652 (33) [back to overview]Mean Number of New Gout Flares Per Patient
NCT01029652 (33) [back to overview]Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab
NCT01029652 (33) [back to overview]Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab
NCT01029652 (33) [back to overview]Mean Number of New Gout Flares Per Patient During the 24 Weeks of the Study
NCT01029652 (33) [back to overview]Patient's Assessment of Gout Pain Intensity in the Most Affected Joint on a Visual Analog Scale (VAS) in Extension
NCT01029652 (33) [back to overview]Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks
NCT01029652 (33) [back to overview]Percentage of Participants With Complete Resolution of Pain
NCT01029652 (33) [back to overview]Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)
NCT01029652 (33) [back to overview]SF36 Physical Function Score at Week 12
NCT01029652 (33) [back to overview]Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)
NCT01029652 (33) [back to overview]Time to Complete Resolution of Pain
NCT01029652 (33) [back to overview]Time to First Intake of Rescue Medication After the Last Post Baseline Flare.
NCT01029652 (33) [back to overview]Physician's Global Assessment of Response to Treatment
NCT01029652 (33) [back to overview]Time to First New Flare
NCT01029652 (33) [back to overview]Flare Rate Per Year
NCT01029652 (33) [back to overview]Time to First New Flare: Survival Analysis by Treatment (72 Weeks Overall)
NCT01029652 (33) [back to overview]Amount of Rescue Medication Taken
NCT01029652 (33) [back to overview]High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall
NCT01029652 (33) [back to overview]High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab
NCT01029652 (33) [back to overview]Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall)
NCT01029652 (33) [back to overview]Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall)
NCT01029652 (33) [back to overview]Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale)
NCT01029652 (33) [back to overview]Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale)
NCT01029652 (33) [back to overview]Patient's Global Assessment of Response to Treatment
NCT01029652 (33) [back to overview]Time to First New Flare
NCT01080131 (33) [back to overview]Physician's Assessment of Range of Motion of the Most Affected Joint
NCT01080131 (33) [back to overview]Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint
NCT01080131 (33) [back to overview]Physician's Global Assessment of Response to Treatment
NCT01080131 (33) [back to overview]Physician's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab
NCT01080131 (33) [back to overview]Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100 mm VAS)
NCT01080131 (33) [back to overview]Self-assessed Pain Intensity in the Joint Most Affected at Last Post-Baseline Measured on a Visual Analog Scale (VAS)
NCT01080131 (33) [back to overview]Serum Amyloid A Protein (SAA) Levels for Participants Re-treated With or Switched to Canakinumab
NCT01080131 (33) [back to overview]Time to First Intake of Rescue Medication
NCT01080131 (33) [back to overview]Flare Rate Per Year
NCT01080131 (33) [back to overview]Mean Number of New Gout Flares Per Patient During 24 Weeks
NCT01080131 (33) [back to overview]Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks of the Study
NCT01080131 (33) [back to overview]Pharmacokinetic Concentrations
NCT01080131 (33) [back to overview]Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) at 72 Hours Post-dose
NCT01080131 (33) [back to overview]SF 36 Physical Function Score at Week 12
NCT01080131 (33) [back to overview]Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS)
NCT01080131 (33) [back to overview]Time to Complete Resolution of Pain; Survival Analysis
NCT01080131 (33) [back to overview]Time to First New Flare: Survival Analysis by Treatment Over 72 Weeks
NCT01080131 (33) [back to overview]Time to First New Flare: Survival Analysis During the 12 Weeks of Study
NCT01080131 (33) [back to overview]Time to the First New Gout Flare During 24 Weeks
NCT01080131 (33) [back to overview]Amount of Rescue Medication Taken
NCT01080131 (33) [back to overview]High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels
NCT01080131 (33) [back to overview]High-sensitivity C-reactive Protein (hsCRP) Levels for Participants Re-treated With or Switched to Canakinumab
NCT01080131 (33) [back to overview]Number of Participants With Adverse Events, Death and Serious Adverse Events (72 Weeks Overall)
NCT01080131 (33) [back to overview]Number of Participants With Adverse Events, Death and Serious Adverse Events During 24 Weeks
NCT01080131 (33) [back to overview]Patient's Assessment of Gout Pain Intensity for Participants Re-treated or Switched to Canakinumab
NCT01080131 (33) [back to overview]Patient's Assessment of Gout Pain Intensity in the Most Affected Joint
NCT01080131 (33) [back to overview]Patient's Global Assessment of Response to Treatment
NCT01080131 (33) [back to overview]Patient's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab
NCT01080131 (33) [back to overview]Percentage of Participants Who Took Rescue Medication
NCT01080131 (33) [back to overview]Percentage of Patients With Maximum Severity of New Gout Flares as Severe or Extreme
NCT01080131 (33) [back to overview]Physician's Assessment of Erythema for Participants Re-treated or Switched to Canakinumab
NCT01080131 (33) [back to overview]Physician's Assessment of Joint Swelling for Participants Re-treated or Switched to Canakinumab
NCT01080131 (33) [back to overview]Physician's Assessment of Joint Tenderness for Participants Re-treated or Switched to Canakinumab
NCT01154153 (6) [back to overview]The Percent of Days of Rescue Medication Use During the Double-blind Treatment Phase
NCT01154153 (6) [back to overview]Number of Participants Using Rescue Medication
NCT01154153 (6) [back to overview]Number of Participants by Relief Level as Evaluated by the Physician
NCT01154153 (6) [back to overview]Number of Participants by Relief Level as Evaluated by the Participant
NCT01154153 (6) [back to overview]Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline
NCT01154153 (6) [back to overview]Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)
NCT01175395 (2) [back to overview]To Assess the Safety & Tolerability of 20089 TA (6.9 mg or 13.8 mg) When Used Adjunctively With Lucentis 0.5 mg in Subjects With Sub-foveal Neovascular AMD
NCT01175395 (2) [back to overview]To Determine the Number of Retreatments With Lucentis in Eyes Initially Treated With 20089 TA and Lucentis
NCT01230424 (11) [back to overview]Change in Area of Denudation Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).
NCT01230424 (11) [back to overview]Change in Volumetric Cartilage Damage Index (CDI) Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).
NCT01230424 (11) [back to overview]Change in Volume of Peri-articular Bone Marrow Lesions Measured on Knee MRI.
NCT01230424 (11) [back to overview]Change in Time to Complete a Twenty-meter Walk.
NCT01230424 (11) [back to overview]Change in Effusion Volume Measured on Knee MRI.
NCT01230424 (11) [back to overview]Change in Time to Complete 5 Chair Stands.
NCT01230424 (11) [back to overview]Change in Patient's Global Assessment (Visual Analogue Scale).
NCT01230424 (11) [back to overview]Change in Mean Cartilage Thickness in the Index Compartment (Compartment With the Most Damage)
NCT01230424 (11) [back to overview]Change in Knee Stiffness During the Past 48 Hours From the WOMAC LK3.1 Stiffness Score Questionnaire.
NCT01230424 (11) [back to overview]Change in Knee Pain Severity During the Past 48 Hours From the WOMAC LK3.1 Pain Score Questionnaire.
NCT01230424 (11) [back to overview]Change in Function Severity During the Past 48 Hours From the WOMAC LK3.1 Function Score Questionnaire.
NCT01356602 (18) [back to overview]Physician's Assessment of Tenderness
NCT01356602 (18) [back to overview]Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale
NCT01356602 (18) [back to overview]Time to First Rescue Medication Intake
NCT01356602 (18) [back to overview]C-reactive Protein Level
NCT01356602 (18) [back to overview]Number of Patients With at Least One New Gouty Arthritis Flare After Baseline
NCT01356602 (18) [back to overview]Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups
NCT01356602 (18) [back to overview]Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups
NCT01356602 (18) [back to overview]Patient's Assessment of Pain Intensity on a 0-100mm VAS
NCT01356602 (18) [back to overview]Proportion of Patients With Rescue Medication Intake
NCT01356602 (18) [back to overview]Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS
NCT01356602 (18) [back to overview]Time to the First New Gouty Arthritis Flare
NCT01356602 (18) [back to overview]Time to Resolution of Gouty Arthritis Flare as Reported by Patient
NCT01356602 (18) [back to overview]Amount of Rescue Medication Taken (mg)
NCT01356602 (18) [back to overview]Patient's Assessment of Pain Intensity on a 5-point Likert Scale
NCT01356602 (18) [back to overview]Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale
NCT01356602 (18) [back to overview]Physician's Assessment of Erythema
NCT01356602 (18) [back to overview]Physician's Assessment of Range of Motion of the Most Affected Joint
NCT01356602 (18) [back to overview]Physician's Assessment of Swelling
NCT01362608 (16) [back to overview]Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
NCT01362608 (16) [back to overview]Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
NCT01362608 (16) [back to overview]Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
NCT01362608 (16) [back to overview]Percent Patients Who Took Rescue Medication
NCT01362608 (16) [back to overview]The Number of Patients With at Least 1 New Gout Flare
NCT01362608 (16) [back to overview]High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose
NCT01362608 (16) [back to overview]Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
NCT01362608 (16) [back to overview]Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
NCT01362608 (16) [back to overview]Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
NCT01362608 (16) [back to overview]Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
NCT01362608 (16) [back to overview]Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.
NCT01362608 (16) [back to overview]Time to First Rescue Medication Intake
NCT01362608 (16) [back to overview]Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis
NCT01362608 (16) [back to overview]Time to Complete Resolution of Pain: Survival Analysis by Treatment
NCT01362608 (16) [back to overview]Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment
NCT01362608 (16) [back to overview]The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)
NCT01470989 (3) [back to overview]Patient's Assessment of Gout Pain Intensity in the Most Affected Joint
NCT01470989 (3) [back to overview]Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants
NCT01470989 (3) [back to overview]Number of New Flares Per Participant
NCT01487161 (16) [back to overview]Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
NCT01487161 (16) [back to overview]Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.
NCT01487161 (16) [back to overview]WOMAC C (Function Subscale) Change From Baseline at Week 8
NCT01487161 (16) [back to overview]Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
NCT01487161 (16) [back to overview]Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg
NCT01487161 (16) [back to overview]Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.
NCT01487161 (16) [back to overview]WOMAC B (Stiffness Subscale) Change From Baseline at Week 8
NCT01487161 (16) [back to overview]WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8
NCT01487161 (16) [back to overview]WOMAC A (Pain Subscale) Change From Baseline at Week 8
NCT01487161 (16) [back to overview]Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
NCT01487161 (16) [back to overview]Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
NCT01487161 (16) [back to overview]Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
NCT01487161 (16) [back to overview]Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
NCT01487161 (16) [back to overview]Percent of Responders According to OMERACT-OARSI Criteria at Week 8
NCT01487161 (16) [back to overview]Patient Global Impression of Change Scores at Week 8
NCT01487161 (16) [back to overview]Clinical Global Impression of Change Scores at Week 8
NCT01487200 (5) [back to overview]Total 24-hour Urinary Free Cortisol Excretion
NCT01487200 (5) [back to overview]Change From Baseline in 24-hour Urinary Free Cortisol Excretion
NCT01487200 (5) [back to overview]Change From Baseline in 24-hour Weighted Mean Serum Cortisol
NCT01487200 (5) [back to overview]Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol
NCT01487200 (5) [back to overview]Characterize the Pharmacokinetic Profile of FX006 and TCA IR
NCT01614509 (2) [back to overview]Changes of Central Retinal Thickness
NCT01614509 (2) [back to overview]Additional Intravitreal Bevacizumab Injection
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
NCT01692756 (13) [back to overview]Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration
NCT01692756 (13) [back to overview]Synovial Interleukin-1α (IL-1α) Concentration
NCT01692756 (13) [back to overview]Synovial C-terminal Peptide II (CTXII) Concentration
NCT01692756 (13) [back to overview]Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration
NCT01692756 (13) [back to overview]Synovial Glycosaminoglycans (GAG) Concentration
NCT01692756 (13) [back to overview]Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration
NCT01692756 (13) [back to overview]Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration
NCT01692756 (13) [back to overview]Synovial Interleukin-1β (IL-1β) Concentration
NCT01692756 (13) [back to overview]Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration
NCT01692756 (13) [back to overview]Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration
NCT01692756 (13) [back to overview]Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration
NCT01692756 (13) [back to overview]Efficacy of Kenalog to Alleviate Knee Pain
NCT01692756 (13) [back to overview]Participant Pain Assessment
NCT01770912 (15) [back to overview]Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks
NCT01770912 (15) [back to overview]Number of Participants With Change From Pre-Treatment Joint Sounds in 12 Weeks
NCT01770912 (15) [back to overview]Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks
NCT01770912 (15) [back to overview]Number of Participants With Change From Pre-Treatment Joint Sounds in 6 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment Functional Pain (Chewing) at 12 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment Functional Pain (Chewing) at 2 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment Functional Pain (Chewing) at 6 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks
NCT01789320 (4) [back to overview]Change in Intraocular Pressure (IOP)
NCT01789320 (4) [back to overview]Vitreous Haze Grade
NCT01789320 (4) [back to overview]Central Subfield Thickness Using Optical Coherence Tomography (OCT)
NCT01789320 (4) [back to overview]Best Corrected Visual Acuity
NCT01797432 (2) [back to overview]Number of Adverse Events Reported by Subjects
NCT01797432 (2) [back to overview]Change in Alopecia Areata Half Head Severity Score (AAHHSS) at 12 Weeks Compared to Baseline
NCT01898806 (1) [back to overview]Number of Adverse Events
NCT01995045 (4) [back to overview]Mean Pain Score
NCT01995045 (4) [back to overview]Mean Oxycodone Intake
NCT01995045 (4) [back to overview]Mean Hydrocodone Intake
NCT01995045 (4) [back to overview]Mean Acetaminophen Intake
NCT02003365 (2) [back to overview]Plasma Drug Concentrations by Time
NCT02003365 (2) [back to overview]Concentration of Triamcinolone Acetonide in Synovial Fluid
NCT02084706 (1) [back to overview]Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After Injection
NCT02120261 (4) [back to overview]Duration of Pain Relief
NCT02120261 (4) [back to overview]Pain Intensity
NCT02120261 (4) [back to overview]Pain Intensity
NCT02120261 (4) [back to overview]Pain Intensity
NCT02242630 (2) [back to overview]Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale
NCT02242630 (2) [back to overview]Change in Shoulder Function, as Measured by the QuickDASH ®
NCT02329600 (2) [back to overview]Salivary Total Oxidative Capacity
NCT02329600 (2) [back to overview]Pain
NCT02357459 (14) [back to overview]AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo
NCT02357459 (14) [back to overview]Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24
NCT02357459 (14) [back to overview]Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24.
NCT02357459 (14) [back to overview]Change From Baseline Over Time for Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Subscale at Weeks 4, 8, 12 and 24
NCT02357459 (14) [back to overview]Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
NCT02357459 (14) [back to overview]Responder Status as Defined by Proportion of Patients Experiencing >30% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)
NCT02357459 (14) [back to overview]Responder Status as Defined by Proportion of Patients Experiencing >50% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)
NCT02357459 (14) [back to overview]AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR
NCT02357459 (14) [back to overview]Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24
NCT02357459 (14) [back to overview]Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR
NCT02357459 (14) [back to overview]Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo
NCT02357459 (14) [back to overview]Time to Onset of Pain Relief
NCT02357459 (14) [back to overview]Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo
NCT02357459 (14) [back to overview]Change From Baseline to Each Week in Weekly Mean of the ADP Scores
NCT02374060 (15) [back to overview]Cumulative Proportion of Eyes With Severe Vision Loss
NCT02374060 (15) [back to overview]Number of Eyes With Endophthalmitis
NCT02374060 (15) [back to overview]Number of Eyes With Retinal Tear or Detachment
NCT02374060 (15) [back to overview]Number of Eyes With Vitreous Hemorrhage
NCT02374060 (15) [back to overview]Proportion of Baseline Central Subfield Thickness Observed at 24 Weeks
NCT02374060 (15) [back to overview]Proportion of Baseline Central Subfield Thickness Observed at 8 Weeks
NCT02374060 (15) [back to overview]Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 8 Weeks
NCT02374060 (15) [back to overview]Proportion of Eyes With Resolution of Macular Edema at 24 Weeks
NCT02374060 (15) [back to overview]Proportion of Eyes With Resolution of Macular Edema at 8 Weeks
NCT02374060 (15) [back to overview]Change in Best-corrected Visual Acuity at 24 Weeks
NCT02374060 (15) [back to overview]Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 24 Weeks
NCT02374060 (15) [back to overview]Change in Best-corrected Visual Acuity at 8 Weeks
NCT02374060 (15) [back to overview]Cumulative Proportion of Eyes With an IOP Elevation >=24 mm Hg
NCT02374060 (15) [back to overview]Cumulative Proportion of Eyes With an IOP Elevation >=30 mm Hg
NCT02374060 (15) [back to overview]Cumulative Proportion of Eyes With an IOP Elevation of >=10 mm Hg Over Baseline
NCT02381652 (1) [back to overview]Number of Treatment-Emergent Adverse Events: Cingal 13-02 vs. Cingal 13-01
NCT02595398 (3) [back to overview]Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
NCT02595398 (3) [back to overview]Mean Change From Baseline in Central Subfield Thickness
NCT02595398 (3) [back to overview]Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks
NCT02637323 (4) [back to overview]Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
NCT02637323 (4) [back to overview]Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
NCT02637323 (4) [back to overview]Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid
NCT02637323 (4) [back to overview]Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid
NCT02680301 (2) [back to overview]Efficacy of 0.1% Triamcinolone Containing Wet Wrap as an Ointment or as a Cream Formulation in Patients With Moderate to Severe Atopic Dermatitis
NCT02680301 (2) [back to overview]Number of Patients Adhering to Treatment Protocol
NCT02762370 (7) [back to overview]Glycemic Variability Coeffecient of Variation (CV)
NCT02762370 (7) [back to overview]Change in Average Blood Glucose From Baseline (Hour -48 to Hour -1) to Hour 1 to Hour 48 for FX006 32 mg Relative to TCA IR 40 mg.
NCT02762370 (7) [back to overview]Percent Time Blood Glucose Less Than 70 mg/dl, 70 - 180 mg/dl, 180.1 - 250.0 mg/dl, 250.1 - 350.0 mg/dl, and Greater Than 350.0 mg/dl
NCT02762370 (7) [back to overview]Percent Time Blood Glucose Less Than 70 mg/dl, 70 - 180 mg/dl, 180.1 - 250.0 mg/dl, 250.1 - 350.0 mg/dl, and Greater Than 350.0 mg/dl
NCT02762370 (7) [back to overview]Area Under the Effect (AUE) Curves for Average Blood Glucose - FX006 Versus TCA IR
NCT02762370 (7) [back to overview]Change From Baseline for Maximum Blood Glucose: Baseline Average Blood Glucose (Hour -72 to Hour -1) to Maximum Blood Glucose (Hour 1 to Hour 72) for FX006 32 mg Relative to TCA IR 40 mg
NCT02762370 (7) [back to overview]Change From Baseline for Average Blood Glucose (mg/dL)
NCT02781818 (3) [back to overview]Change in Pain From Baseline to Day 5
NCT02781818 (3) [back to overview]Patient Rating of Impression of Treatment at Day 14
NCT02781818 (3) [back to overview]Number of Days to Lesion Resolution in Combined Treatment Arms Compared to the Placebo Arm.
NCT02877485 (2) [back to overview]Nasal Obstruction Symptom Evaluation (NOSE) Score Following Surgery in Subset of Patients Who Elect to Undergo Surgery.
NCT02877485 (2) [back to overview]Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray)
NCT02949024 (5) [back to overview]Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
NCT02949024 (5) [back to overview]Mean Change From Baseline in Intraocular Pressure
NCT02949024 (5) [back to overview]Mean Change From Baseline in Central Subfield Thickness
NCT02949024 (5) [back to overview]Best Corrected Visual Acuity
NCT02949024 (5) [back to overview]CLS-TA Injections
NCT02952001 (4) [back to overview]Mean Change From Baseline in Best Corrected Visual Acuity
NCT02952001 (4) [back to overview]Mean Change From Baseline in Central Subfield Thickness
NCT02952001 (4) [back to overview]Time to Additional Therapy for Uveitis
NCT02952001 (4) [back to overview]Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
NCT02980874 (3) [back to overview]Mean Change From Baseline in Central Subfield Thickness
NCT02980874 (3) [back to overview]Mean Change From Baseline in Best Corrected Visual Acuity
NCT02980874 (3) [back to overview]Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)
NCT02996097 (2) [back to overview]Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)
NCT02996097 (2) [back to overview]Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS)
NCT03002974 (25) [back to overview]Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
NCT03002974 (25) [back to overview]Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
NCT03002974 (25) [back to overview]Physician's Assessment of Clinical Signs in Index Joint: Erythema
NCT03002974 (25) [back to overview]Physician's Assessment of Clinical Signs in Index Joint: Tenderness
NCT03002974 (25) [back to overview]Physician's Assessment of Clinical Signs in Index Joint: Swelling
NCT03002974 (25) [back to overview]Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale
NCT03002974 (25) [back to overview]Proportion of Patients With Neutralizing Antibodies
NCT03002974 (25) [back to overview]The Percent of Patients With at Least One Adverse Event
NCT03002974 (25) [back to overview]Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
NCT03002974 (25) [back to overview]The Percent of Patients With at Least One Serious Adverse Event, Including Death
NCT03002974 (25) [back to overview]Physician's Assessment of Global Response to Treatment
NCT03002974 (25) [back to overview]Median Time to First Intake of Rescue Medication From First Investigational Drug Administration
NCT03002974 (25) [back to overview]Median Time to Onset of Effect
NCT03002974 (25) [back to overview]Median Time to Resolution of Pain
NCT03002974 (25) [back to overview]Median Time to Response
NCT03002974 (25) [back to overview]Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
NCT03002974 (25) [back to overview]Change From Baseline in the Inflammatory Biomarker Serum Amyloid A
NCT03002974 (25) [back to overview]Health Care Resource Utilization Due to a Gouty Arthritis Flare
NCT03002974 (25) [back to overview]Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
NCT03002974 (25) [back to overview]Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
NCT03002974 (25) [back to overview]Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
NCT03002974 (25) [back to overview]Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
NCT03002974 (25) [back to overview]Change From Baseline in the Inflammatory Biomarker C Reactive Protein
NCT03002974 (25) [back to overview]Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score
NCT03002974 (25) [back to overview]Change in Patient-assessed Pain Intensity in the Index Joint From Baseline to 24-72 Hours for the First Gout Flare Treated in the Study as Measured by VAS
NCT03097315 (5) [back to overview]Mean Intraocular Pressure in the Study Eye
NCT03097315 (5) [back to overview]Number of Patients With a Grade of 0 in Vitreous Haze in the Study Eye
NCT03097315 (5) [back to overview]Number of Patients With a Grade of 0 in Anterior Chamber Cells in the Study Eye
NCT03097315 (5) [back to overview]Adverse Events
NCT03097315 (5) [back to overview]Number of Patients With a Grade of 0 in Anterior Chamber Flare in the Study Eye
NCT03126786 (2) [back to overview]Mean Change From Baseline in Central Subfield Thickness
NCT03126786 (2) [back to overview]Mean Change From Baseline in Best Corrected Visual Acuity Letter Score
NCT03127137 (1) [back to overview]Change in Strength in Both Groups After CESI.
NCT03191903 (11) [back to overview]Change From Baseline in Total WOMAC Score at 26 Weeks (ITT Population)
NCT03191903 (11) [back to overview]Change From Baseline in WOMAC Pain Score at 1 Week (ITT Population)
NCT03191903 (11) [back to overview]Change From Baseline in WOMAC Pain Score at 26 Weeks (ITT Population)
NCT03191903 (11) [back to overview]Change From Baseline in WOMAC Pain Score at 3 Weeks (ITT Population)
NCT03191903 (11) [back to overview]Change From Baseline in WOMAC Pain Score at 3 Weeks in the Per-Protocol Population
NCT03191903 (11) [back to overview]Change From Baseline in WOMAC Physical Function Score at 26 Weeks (ITT Population)
NCT03191903 (11) [back to overview]Change From Baseline in WOMAC Stiffness Score at 26 Weeks (ITT Population)
NCT03191903 (11) [back to overview]OMERACT-OARSI Responder Index at 26 Weeks Post Treatment Comparing the Cingal Group to the TH Group (ITT Population)
NCT03191903 (11) [back to overview]The Usage of Rescue Medication (Acetaminophen) Through 26 Weeks (ITT Population)
NCT03191903 (11) [back to overview]Change From Baseline in Patient Global Assessment at 26 Weeks (ITT Population)
NCT03191903 (11) [back to overview]Change From Baseline in the Evaluator Global Assessment at 26 Weeks (ITT Population)
NCT03203447 (3) [back to overview]Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)
NCT03203447 (3) [back to overview]Mean Change From Baseline in Central Subfield Thickness
NCT03203447 (3) [back to overview]Mean Change From Baseline in Best Corrected Visual Acuity
NCT03378076 (2) [back to overview]Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma
NCT03378076 (2) [back to overview]Incidence of Treatment Emergent Adverse Events
NCT03380026 (3) [back to overview]Severity of Dermatitis
NCT03380026 (3) [back to overview]Efficacy of Valchlor vs Valchlor Plus Triamcinolone
NCT03380026 (3) [back to overview]Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring
NCT03382262 (2) [back to overview]Concentration of Triamcinolone Acetonide (TA) in Blood Plasma
NCT03382262 (2) [back to overview]Total Number of Treatment Emergent Adverse Events
NCT03382821 (4) [back to overview]Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III
NCT03382821 (4) [back to overview]Neck Disability Index-5
NCT03382821 (4) [back to overview]"The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved)"
NCT03382821 (4) [back to overview]The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score
NCT03390036 (8) [back to overview]Change From Baseline in Patient Global Assessment at 39 Weeks
NCT03390036 (8) [back to overview]Change From Baseline in Total WOMAC Score at 39 Weeks
NCT03390036 (8) [back to overview]Change From Baseline in WOMAC Pain Score at 39 Weeks
NCT03390036 (8) [back to overview]Change From Baseline in WOMAC Physical Function Score at 39 Weeks
NCT03390036 (8) [back to overview]Change From Baseline in WOMAC Stiffness Score at 39 Weeks
NCT03390036 (8) [back to overview]OMERACT-OARSI Responder Rate at 39 Weeks
NCT03390036 (8) [back to overview]The Usage of Rescue Medication (Acetaminophen) at Week 39
NCT03390036 (8) [back to overview]Change From Baseline in Evaluator Global Assessment at 39 Weeks
NCT03463915 (7) [back to overview]Number of Participants With at Least One Adverse Event
NCT03463915 (7) [back to overview]Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire
NCT03463915 (7) [back to overview]Pelvic Floor Distress Inventory (PFDI)
NCT03463915 (7) [back to overview]Change From Baseline in Treatment Response as Measured by the Visual Analogue Scale (VAS) for Pain
NCT03463915 (7) [back to overview]Overactive Bladder Questionnaire (OAB-q)
NCT03463915 (7) [back to overview]Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire
NCT03463915 (7) [back to overview]Pelvic Pain and Urgency/Frequency (PUF) Questionnaire
NCT03636373 (4) [back to overview]Patient's Assessment of Response to Treatment
NCT03636373 (4) [back to overview]Joint Pain Intensity in the Most Affected Joint
NCT03636373 (4) [back to overview]Joint Pain on Numeric Pain Scale
NCT03636373 (4) [back to overview]Physician's Assessment of Response to Treatment
NCT03758365 (2) [back to overview]Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
NCT03758365 (2) [back to overview]Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle
NCT03797872 (1) [back to overview]Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study
NCT03895840 (6) [back to overview]30 Second Chair Standing Test
NCT03895840 (6) [back to overview]40m Fast Paced Walking Test (40m FPWT)
NCT03895840 (6) [back to overview]KOOS-PS (Knee Osteoarthritis Outcome Score - Physical Function Short Form)
NCT03895840 (6) [back to overview]KOOS-QoL (Knee Osteoarthritis Outcome Score - Quality of Life)
NCT03895840 (6) [back to overview]NRS for Pain
NCT03895840 (6) [back to overview]Timed Stair Climb
NCT04115644 (8) [back to overview]Visual Analog Scale
NCT04115644 (8) [back to overview]Visual Analog Scale
NCT04115644 (8) [back to overview]Visual Analog Scale
NCT04115644 (8) [back to overview]Visual Analog Scale
NCT04115644 (8) [back to overview]Visual Analog Scale
NCT04115644 (8) [back to overview]Visual Analog Scale
NCT04115644 (8) [back to overview]Visual Analog Scale
NCT04115644 (8) [back to overview]Visual Analog Scale
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness Score
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score
NCT04231318 (15) [back to overview]The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
NCT04231318 (15) [back to overview]The Usage of Rescue Medication (Acetaminophen/Paracetamol) at 26 Weeks
NCT04231318 (15) [back to overview]Change From Baseline in Knee Pain as Measured by Numerical Rating Scale (NRS) Pain Score
NCT04231318 (15) [back to overview]Change From Baseline in Knee Pain as Measured by Visual Analog Scale (VAS) Pain Score
NCT04231318 (15) [back to overview]Change From Baseline in the Evaluator Global Assessment (EGA) Score
NCT04231318 (15) [back to overview]Change From Baseline in the Patient Global Assessment (PGA) Score
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Score
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score
NCT04582669 (5) [back to overview]Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
NCT04582669 (5) [back to overview]Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
NCT04582669 (5) [back to overview]Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
NCT04582669 (5) [back to overview]Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
NCT04582669 (5) [back to overview]Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
NCT05438277 (1) [back to overview]Incidence of a Flare Reaction

Adverse Ocular Outcomes

(NCT00105027)
Timeframe: 12 months

,,,,,
Interventionevents (Number)
Initiation of IOP-lowering medicationsIOP > 35 mm HGIOP > 10 mm HG above baselineLaser peripheral iridotomyTrabeculectomyTube shuntCataract: lens opacity onset or progressionCataract surgeryInfectious endophthalmitisNoninfectious endophthalmitisRetinal detachmentIris neovascularizationRetinal neovascularizationVitreous hemorrhageYAG capsulotomySector or panretinal photocagulationPars plana vitrectomy
BRVO 1 mg Dose Triamcinolone Acetonide11212000270001111010
BRVO 4 mg Dose Triamcinolone Acetonide571450100384100233141
BRVO Standard Care311000153001152151
CRVO 1 mg Dose Triamcinolone Acetonide18515002200000924092
CRVO 4 mg Dose Triamcinolone Acetonide32824100254000420030
CRVO Observation712000120000244151

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The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit

Visual acuity testing was done using electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity testing at 3 meters using the Electronic Visual Acuity Tester by a SCORE certified technician. A masked visual acuity examiner with no knowledge of treatment assignments performed visual acuity testing at the 4-month, 12-month, 24-month and 36-month visits. An E-ETDRS visual acuity score of 85 is approximately 20/20, and a score of 20 letters is approximately 20/400. A visual acuity letter score change of 15 is about three lines on a vision chart. (NCT00105027)
Timeframe: Change from baseline to 12 months

InterventionParticipants (Number)
CRVO Observation5
CRVO 1 mg Dose Triamcinolone Acetonide22
CRVO 4 mg Dose Triamcinolone Acetonide21
BRVO Standard Care35
BRVO 1 mg Dose Triamcinolone Acetonide31
BRVO 4 mg Dose Triamcinolone Acetonide34

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Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography

(NCT00105027)
Timeframe: 12 months

Interventionum (Median)
CRVO Observation-277
CRVO 1 mg Dose Triamcinolone Acetonide-196
CRVO 4 mg Dose Triamcinolone Acetonide-261
BRVO Standard Care-224
BRVO 1 mg Dose Triamcinolone Acetonide-149
BRVO 4 mg Dose Triamcinolone Acetonide-170

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Changes From Baseline in Best-corrected ETDRS Visual Acuity Score

(NCT00105027)
Timeframe: 12 months

Interventionletters read (Mean)
CRVO Observation-12.1
CRVO 1 mg Dose Triamcinolone Acetonide-1.2
CRVO 4 mg Dose Triamcinolone Acetonide-1.2
BRVO Standard Care4.2
BRVO 1 mg Dose Triamcinolone Acetonide5.7
BRVO 4 mg Dose Triamcinolone Acetonide4.0

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Number of Participants Requiring Verteporfin Treatment Throughout the Study

Participants received study drug at the Baseline visit and subsequent retreatment at 3 month intervals if leakage was detected on the fluorescein angiogram. The cumulative distribution of the number of treatments is shown per arm. (NCT00242580)
Timeframe: Baseline to Month 12

,,
InterventionParticipants (Number)
Participants who received 1 treatmentParticipants who received 2 treatmentsParticipants who received 3 treatmentsParticipants who received 4 treatments
Verteporfin + 1 mg Triamcinolone111092
Verteporfin + 4 mg Triamcinolone1215122
Verteporfin + Pegaptanib101954

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Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decrease in score indicates worsening of vision. This outcome assessed the percentage of participants who lost less than 15 letters of visual acuity at 12 months as compared with baseline. (NCT00242580)
Timeframe: Baseline to Month 12

InterventionPercentage of Participants (Number)
Verteporfin + 1 mg Triamcinolone59.4
Verteporfin + 4 mg Triamcinolone63.4
Verteporfin + Pegaptanib71.1

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Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 5 or more letters of visual acuity at 12 months compared with baseline. (NCT00242580)
Timeframe: Baseline to Month 12

InterventionPercentage of Participants (Number)
Verteporfin + 1 mg Triamcinolone31.3
Verteporfin + 4 mg Triamcinolone12.2
Verteporfin + Pegaptanib28.9

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Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 10 or more letters of visual acuity at 12 months as compared with baseline. (NCT00242580)
Timeframe: Baseline to Month 12

InterventionPercentage of Participants (Number)
Verteporfin + 1 mg Triamcinolone18.8
Verteporfin + 4 mg Triamcinolone2.4
Verteporfin + Pegaptanib23.7

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Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15 or more letters of visual acuity at 12 months as compared with baseline. (NCT00242580)
Timeframe: Baseline to Month 12

InterventionPercentage of Participants (Number)
Verteporfin + 1 mg Triamcinolone6.3
Verteporfin + 4 mg Triamcinolone0
Verteporfin + Pegaptanib13.2

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Mean Change From Baseline in Total Area of Lesion at 12 Months

Fluorescein angiography (FA) was used to assess total lesion area. All angiographs were sent to the Central Reading Center (CRC) for analysis. (NCT00242580)
Timeframe: Baseline to Month 12

,,
Interventionmm^2 (Mean)
Baseline12 MonthsChange from Baseline
Verteporfin + 1 mg Triamcinolone6.91786.8959-0.0219
Verteporfin + 4 mg Triamcinolone5.64005.81490.1749
Verteporfin + Pegaptanib6.30118.62452.3234

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Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears

As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse. (NCT00279916)
Timeframe: baseline, 6 weeks

,
Interventionparticipants (Number)
Frequency - MissingFrequency - BetterFrequency - SameFrequency - WorseSeverity - MissingSeverity - BetterSeverity - SameSeverity - Worse
Placebo114214114169
Triamcinolone Acetonide0101315015815

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Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears

As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse. (NCT00279916)
Timeframe: baseline, 6 weeks

,
Interventionparticipants (Number)
Frequency - BetterFrequency - SameFrequency - WorseSeverity - BetterSeverity - SameSeverity - Worse
Placebo82396259
Triamcinolone Acetonide11171091910

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Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears

As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse. (NCT00279916)
Timeframe: baseline, 6 weeks

,
Interventionparticipants (Number)
Frequency - BetterFrequency - SameFrequency - WorseSeverity - BetterSeverity - SameSeverity - Worse
Placebo1817518139
Triamcinolone Acetonide111710131411

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Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution

For this outcome measure, the subjects treated with antibiotics or oral decongestants while enrolled in the study were handled as having treatment failures. For this outcome measure, subjects with complete normalization of abnormal tympanometry at 6 weeks had a Type A tympanogram and did not take antibiotics, oral decongestants, nasal spray or a combination. (NCT00279916)
Timeframe: 6 weeks

Interventionparticipants (Number)
Triamcinolone Acetonide5
Placebo9

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Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment

Number of subjects with resolution of eustachian tube dysfunction symptoms, as determined by the change in tympanogram type in both ears from an initial Type B or C result to Type A result at 6 weeks. Type A; peaked pressure measurement under -100 kilo Pascals (kPa). Type B; non-peaked, or flat tympanogram, Type C; peaked pressure measurements more negative than -100 kPa. A Pascal is a unit used to quantify internal pressure. (NCT00279916)
Timeframe: 6 weeks

Interventionparticipants (Number)
Triamcinolone Acetonide7
Placebo12

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Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual

As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse. (NCT00279916)
Timeframe: baseline, 6 weeks

,
Interventionparticipants (Number)
Frequency - MissingFrequency - BetterFrequency - SameFrequency - WorseSeverity - MissingSeverity - BetterSeverity - SameSeverity - Worse
Placebo1161581141510
Triamcinolone Acetonide0161480151310

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Per-Ear Treatment Outcome

Initial Tympanogram Type at baseline was compared to Follow-Up Tympanogram Type at 6 weeks. Type A is considered to be normal. Type A; peaked pressure measurement under -100 kilo Pascals (kPa). Type B; non-peaked, or flat tympanogram, Type C; peaked pressure measurements more negative than -100 kPa. A Pascal is a unit used to quantify internal pressure. (NCT00279916)
Timeframe: baseline, 6 weeks

,
Interventionears (Number)
Initial Tympanogram of Type B or C6 weeks Complete Normalization (Type A)
Placebo5720
Triamcinolone Acetonide5512

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Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears

As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse. (NCT00279916)
Timeframe: baseline, 6 weeks

,
Interventionparticipants (Number)
Frequency - MissingFrequency - BetterFrequency - SameFrequency - WorseSeverity - MissingSeverity - BetterSeverity - SameSeverity - Worse
Placebo181813261913
Triamcinolone Acetonide0111413091712

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Central Subfield Thickness < 250 Microns at 2 Years

Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. (NCT00367133)
Timeframe: 2 Years

InterventionPercentage of Eyes (Number)
Focal/Grid Laser Photocoagulation53
1mg Intravitreal Triamcinolone34
4 mg Intravitreal Triamcinolone38

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Central Subfield Thickness at 2 Years

Median central subfield thickness at two-years. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. (NCT00367133)
Timeframe: 2 Years

InterventionMicrons (Median)
Focal/Grid Laser Photocoagulation243
1mg Intravitreal Triamcinolone305
4 mg Intravitreal Triamcinolone279

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Central Subfield Thickness on Optical Coherence Tomography (OCT) at Three Years

Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. (NCT00367133)
Timeframe: 3 years

InterventionMicrons (Median)
Focal/Grid Laser Photocoagulation211
1mg Intravitreal Triamcinolone269
4 mg Intravitreal Triamcinolone248

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Change in Central Subfield Thickness on OCT Baseline to 3 Years

Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement. (NCT00367133)
Timeframe: baseline to 3 years

InterventionMicrons (Mean)Microns (Median)
Focal/Grid Laser Photocoagulation-175
1mg Intravitreal Triamcinolone-124
4 mg Intravitreal Triamcinolone-126
Focal/Grid Laser Photocoagulation-158
1mg Intravitreal Triamcinolone-103
4 mg Intravitreal Triamcinolone-114

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Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.

Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0. (NCT00367133)
Timeframe: Baseline to 2 Years

InterventionLetter score (Mean)
Focal/Grid Laser Photocoagulation1
1mg Intravitreal Triamcinolone-2
4 mg Intravitreal Triamcinolone-3

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Change in Visual Acuity From Baseline to 3 Years

Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. (NCT00367133)
Timeframe: Baseline to 3 year

InterventionLetter Score (Mean)
Focal/Grid Laser Photocoagulation5
1mg Intravitreal Triamcinolone0
4 mg Intravitreal Triamcinolone0

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Change in Visual Acuity From Baseline to 3 Years

Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best Value on the scale=97, Worst Value=0 (NCT00367133)
Timeframe: Baseline to 3 year

InterventionLetter Score (Median)
Focal/Grid Laser Photocoagulation8
1mg Intravitreal Triamcinolone2
4 mg Intravitreal Triamcinolone4

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Mean Change in Central Subfield Thickness Baseline to 2 Years

Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes and improvement. (NCT00367133)
Timeframe: Baseline to 2 years

InterventionMicrons (Mean)
Focal/Grid Laser Photocoagulation-139
1mg Intravitreal Triamcinolone-86
4 mg Intravitreal Triamcinolone-77

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Median Change in Visual Acuity Baseline to 2 Years

Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. (NCT00367133)
Timeframe: Baseline to 2 Years

InterventionLetter score (Median)
Focal/Grid Laser Photocoagulation4
1mg Intravitreal Triamcinolone1
4 mg Intravitreal Triamcinolone2

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Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years

Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. (NCT00367133)
Timeframe: Baseline to 2 Years

InterventionPercentage of Eyes (Number)
Focal/Grid Laser Photocoagulation67
1mg Intravitreal Triamcinolone46
4 mg Intravitreal Triamcinolone48

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Percentage of Eyes With a Change in Central Subfield Thickness on OCT <250 Microns From Baseline to 3 Years

Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement. (NCT00367133)
Timeframe: Baseline to 3 years

InterventionPercentage of Eyes (Number)
Focal/Grid Laser Photocoagulation68
1mg Intravitreal Triamcinolone43
4 mg Intravitreal Triamcinolone51

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Distribution of Change in Visual Acuity Baseline to 2 Years

Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. (NCT00367133)
Timeframe: baseline to 2 years

,,
InterventionPercentage of Eyes (Number)
>= 15 letter improvement14 to 10 letter improvement9 to 5 letter improvementsame +- 4 letters5-9 letters worse10-14 letters worse>=15 letters worse
1mg Intravitreal Triamcinolone141114279620
4 mg Intravitreal Triamcinolone171115236820
Focal/Grid Laser Photocoagulation1813162410514

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Distribution of Visual Acuity Change Baseline to 3 Years

Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale=97, worst=0 (NCT00367133)
Timeframe: Baseline to 3 years

,,
InterventionPercentage of Eyes (Number)
>= 15 letters better10-14 letters better5-9 letters betterno change, + - 4 letters5-9 letters worse10-14 letters worse>=15 letters worse
1mg Intravitreal Triamcinolone204172310917
4 mg Intravitreal Triamcinolone21169246616
Focal/Grid Laser Photocoagulation26181821448

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Median Change in Central Subfield Thickness Baseline to 2 Years

Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement. (NCT00367133)
Timeframe: Baseline to 2 Years

InterventionMicrons (Median)
Focal/Grid Laser Photocoagulation-131
1mg Intravitreal Triamcinolone-74
4 mg Intravitreal Triamcinolone-76

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Mean Visual Acuity Letter Score at Each Follow-up Visit

Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) mean visual acuity letter score: best value = 97; letter score worst value = 0 (NCT00369486)
Timeframe: 4, 8, 17, and 34 weeks

,,,,
Interventionletter score (Mean)
4 Weeks8 Weeks17 Weeks34 Weeks
Anterior Peribulbar Injection of 20 mg Triamcinolone80807980
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser77777777
Focal Laser Photocoagulation79797878
Posterior Peribulbar Injection of 40 mg Triamcinolone79797876
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser77807977

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Change in Visual Acuity Letter Score From Baseline Through 34 Weeks

Change in visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. Letter score best value = 97 and worst value = 0; an increase in a letter score by 10 is considered clinically significant. Negative changes represent a worsening in visual acuity. (NCT00369486)
Timeframe: 4, 8, 17, and 34 weeks

,,,,
Interventionletter score (Mean)
4 Weeks8 Weeks17 Weeks34 Weeks
Anterior Peribulbar Injection of 20 mg Triamcinolone-1-1-2-1
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser-10-1-1
Focal Laser Photocoagulation-1-1-2-2
Posterior Peribulbar Injection of 40 mg Triamcinolone10-1-4
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser-20-1-3

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Change in Central Subfield Thickening From Baseline Through 34 Weeks

Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. Negative changes represent a decrease in retinal thickening. (NCT00369486)
Timeframe: 4, 8, 17, 34 weeks

,,,,
Interventionmicrons (Mean)
4 Weeks8 Weeks17 Weeks34 Weeks
Anterior Peribulbar Injection of 20 mg Triamcinolone-27-38-50-45
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser-37-44-49-68
Focal Laser Photocoagulation-10-27-30-54
Posterior Peribulbar Injection of 40 mg Triamcinolone-47-29-24-31
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser-16-25-52-45

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Central Subfield Thickness <250 Microns From Baseline Through 34 Weeks

Primary criterion for retreatment is central subfield thickness >=250 microns. Central subfield thickness of <250 microns indicates no need for retreatment. Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. (NCT00369486)
Timeframe: 4, 8, 17, 34 weeks

,,,,
Interventioneyes (Number)
4 Weeks8 Weeks17 Weeks34 Weeks
Anterior Peribulbar Injection of 20 mg Triamcinolone3362
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser891113
Focal Laser Photocoagulation591119
Posterior Peribulbar Injection of 40 mg Triamcinolone5478
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser261010

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Reduction of ≥ 50% in Retinal Thickening in the Central Subfield From Baseline Through 34 Weeks

Number of eyes that had a reduction in central subfield retinal thickness by ≥ 50% at each follow-up. Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. (NCT00369486)
Timeframe: 4, 8, 17, 34 weeks

,,,,
Interventioneyes (Number)
4 Weeks8 Weeks17 Weeks34 Weeks
Anterior Peribulbar Injection of 20 mg Triamcinolone2685
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser8101313
Focal Laser Photocoagulation581122
Posterior Peribulbar Injection of 40 mg Triamcinolone8769
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser4479

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Persistence/Recurrence of Diabetic Macular Edema (DME) Either Retreated or Meeting Criteria for Retreatment at 17 Weeks

Number of eyes that were retreated at 17 weeks. According to the protocol, primary criterion for retreatment was central subfield thickness >=250 microns or macular edema was still present according to the investigator's judgment. (NCT00369486)
Timeframe: 17 weeks

,,,,
Interventioneyes (Number)
Eyes that were retreatedEyes with ≥ 250 central subfield thickness
Anterior Peribulbar Injection of 20 mg Triamcinolone1416
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser913
Focal Laser Photocoagulation2226
Posterior Peribulbar Injection of 40 mg Triamcinolone1514
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser911

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Change in Visual Acuity From Baseline to 1 Year Grouped by Optical Coherence Tomography Central Subfield Thickness

Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0. (NCT00444600)
Timeframe: from baseline to 1 Year

,,,
InterventionLetters (Mean)
<400 microns≥400 microns
0.5 mg Ranibizumab+Deferred Laser711
0.5 mg Ranibizumab+Prompt Laser711
4 mg Triamcinolone+Prompt Laser36
Sham+Prompt Laser33

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Distribution of Change in Visual Acuity (Letters) From Baseline to 1 Year

Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. (NCT00444600)
Timeframe: from baseline to 1 Year

,,,
InterventionEyes (Number)
≥15 letter improvement14-10 letter improvement9-5 letter improvementSame ±4 letters5-9 letters worse10-14 letters worse≥15 letters worse
0.5 mg Ranibizumab+Deferred Laser52365435524
0.5 mg Ranibizumab+Prompt Laser573834381433
4 mg Triamcinolone+Prompt Laser39223254121215
Sham+Prompt Laser43386786201623

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Change From Moderately Severe Non-proliferative Diabetic Retinopathy or Better From Baseline to 1-year

113 eyes had missing or ungradable photos at 1 year. Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833 (NCT00444600)
Timeframe: from baseline to 1 Year

,,
InterventionEyes (Number)
Improved by 2 or more levelsWorsened by 2 or more levels
Ranibizumab465
Sham611
Triamcinolone202

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Change From Severe Non-proliferative Diabetic Retinopathy or Worse From Baseline to 1-year

Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833, ETDRS Severity Scale = Diabetic retinopathy absent, minimal non-proliferative diabetic retinopathy (PDR), mild to moderately severe non-PDR, severe non-PDR, scars of full pr partial panretinal photocoagulation present PDR absent, mild to moderate PDR, high risk PDR, cannot grade, missing. (NCT00444600)
Timeframe: from baseline to 1 Year

,,
InterventionEyes (Number)
Improved by 2 or more levelsWorsened by 2 or more levels
Ranibizumab181
Sham107
Triamcinolone62

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Change in Visual Acuity From Baseline to 1 Year Among Eyes That Had Prior Treatment for Diabetic Macular Edema

(NCT00444600)
Timeframe: from baseline to 1 Year

,,,
InterventionLetters (Mean)
NoYes
0.5 mg Ranibizumab+Deferred Laser118
0.5 mg Ranibizumab+Prompt Laser99
4 mg Triamcinolone+Prompt Laser35
Sham+Prompt Laser23

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Change in Visual Acuity From Baseline to 1 Year Among Eyes That Were Pseudophakic at Baseline

(NCT00444600)
Timeframe: from baseline to 1 Year

,,,
InterventionLetters (Mean)
Not pseudophakic at baselinePseudophakic at baseline
0.5 mg Ranibizumab+Deferred Laser107
0.5 mg Ranibizumab+Prompt Laser98
4 mg Triamcinolone+Prompt Laser28
Sham+Prompt Laser24

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Change in Visual Acuity From Baseline to 1 Year Grouped by Baseline Visual Acuity Letter Score

Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0. (NCT00444600)
Timeframe: from baseline to 1 Year

,,,
InterventionLetters (Mean)
≥66 (better than 20/50)≤65 (20/50 or worse)
0.5 mg Ranibizumab+Deferred Laser513
0.5 mg Ranibizumab+Prompt Laser612
4 mg Triamcinolone+Prompt Laser17
Sham+Prompt Laser15

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Change in Visual Acuity From Baseline to 1 Year Grouped by Diabetic Retinopathy Severity

Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0. (NCT00444600)
Timeframe: from baseline to 1 Year

,,,
InterventionLetters (Mean)
Moderately severe non-proliferative DR or betterSevere non-proliferative DR or worse
0.5 mg Ranibizumab+Deferred Laser99
0.5 mg Ranibizumab+Prompt Laser108
4 mg Triamcinolone+Prompt Laser35
Sham+Prompt Laser32

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Change in Visual Acuity From Baseline to 1 Year Grouped by Diffuse vs. Focal Edema as Characterized by the Investigator

Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0. (NCT00444600)
Timeframe: from baseline to 1 Year

,,,
InterventionLetters (Mean)
Typical/predominantly focalNeither predominantly focal nor diffuseTypical/predominantly diffuse
0.5 mg Ranibizumab+Deferred Laser8810
0.5 mg Ranibizumab+Prompt Laser8109
4 mg Triamcinolone+Prompt Laser335
Sham+Prompt Laser323

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Number of Laser Treatments Received Prior to the 1 Year Visit

One eye in the sham+prompt laser group did not receive laser until post 1-year due to an adverse event unrelated to study treatment. One eye in the triamcinolone+prompt laser did not receive laser until after 1-year due to missing 2 consecutive visits at the time of required laser treatment. (NCT00444600)
Timeframe: 1 Year

,,,
InterventionEyes (Number)
01234
0.5 mg Ranibizumab+Deferred Laser124361710
0.5 mg Ranibizumab+Prompt Laser053544618
4 mg Triamcinolone+Prompt Laser146534927
Sham+Prompt Laser1357510756

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Major Ocular Adverse Events During First Year of Follow-Up

(NCT00444600)
Timeframe: 1 Year

,,,
InterventionEyes (Number)
EndophthalmitisPseudoendophthalmitisOcular vascular eventRetinal detachmentVitrectomyVitreous hemorrhageIncrease in intraocular pressure >=10 mmHgIntraocular pressure >=30 mmHgInitiation of intraocular lowering medicationGlaucoma surgeryCataract surgery
0.5 mg Ranibizumab+Deferred Laser10013454708
0.5 mg Ranibizumab+Prompt Laser1010031021206
4 mg Triamcinolone+Prompt Laser012002704679019
Sham+Prompt Laser111071516323011

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Eyes With Alternative Treatments Prior to the 1-year Visit

Each combination of treatment only counted once. (NCT00444600)
Timeframe: 1 Year

,,,
InterventionEyes (Number)
Intravitreal bevacizumabIntravitreal triamcinolone acetonideVitrectomyIntravitreal bevacizumab+triamcinolone acetonideTotal number of eyes with alternative treatmentsTotal number of treatments appliedTotal per protocol treatments appliedTotal deviations from protocol treatments applied
0.5 mg Ranibizumab+Deferred Laser00000000
0.5 mg Ranibizumab+Prompt Laser00001110
4 mg Triamcinolone+Prompt Laser10001110
Sham+Prompt Laser3524142559

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Distribution of Logarithmic Transformation of Optical Coherence Tomography (LogOCT) Improvement and Worsening

Logarithmic transformation of optical coherence tomography central subfield thickness is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values. (NCT00444600)
Timeframe: 1 Year

,,,
InterventionEyes (Number)
≥2 step improvement≥2 step worsening
0.5 mg Ranibizumab+Deferred Laser710
0.5 mg Ranibizumab+Prompt Laser721
4 mg Triamcinolone+Prompt Laser654
Sham+Prompt Laser816

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Central Subfield Thickness < 250 With at Least a 25 Micron Decrease From Baseline to 1 Year

(NCT00444600)
Timeframe: 1 Year

InterventionEyes (Number)
Sham+Prompt Laser72
0.5 mg Ranibizumab+Prompt Laser91
0.5 mg Ranibizumab+Deferred Laser74
4 mg Triamcinolone+Prompt Laser82

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Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year

Negative change denotes an improvement. (NCT00444600)
Timeframe: from baseline to 1 year

Interventionmicrons (Mean)
Sham+Prompt Laser-102
0.5 mg Ranibizumab+Prompt Laser-131
0.5 mg Ranibizumab+Deferred Laser-137
4 mg Triamcinolone+Prompt Laser-127

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Mean Change in Optical Coherence Tomography Retinal Volume From Baseline to 1 Year

(NCT00444600)
Timeframe: from baseline to 1 Year

Interventionmm^3 (Mean)
Sham+Prompt Laser-1.0
0.5 mg Ranibizumab+Prompt Laser-1.4
0.5 mg Ranibizumab+Deferred Laser-1.5
4 mg Triamcinolone+Prompt Laser-1.4

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Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity

Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0. (NCT00444600)
Timeframe: from baseline to 1 Year

InterventionLetters (Mean)
Sham+Prompt Laser3
0.5 mg Ranibizumab+Prompt Laser9
0.5 mg Ranibizumab+Deferred Laser9
4 mg Triamcinolone+Prompt Laser4

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Mean Optical Coherence Tomography Retinal Volume at 1 Year

(NCT00444600)
Timeframe: 1 Year

Interventionmm^3 (Mean)
Sham+Prompt Laser8.1
0.5 mg Ranibizumab+Prompt Laser7.3
0.5 mg Ranibizumab+Deferred Laser7.4
4 mg Triamcinolone+Prompt Laser7.5

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Number of Injections in First Year

Maximum possible number of injections for each of the following groups: sham+prompt laser=13 sham injections;ranibizumab+prompt laser=13 ranibizumab injections; ranibizumab+deferred laser=13 ranibizumab injections; triamcinolone+prompt laser=4 triamcinolone injections and 9 sham injections. (NCT00444600)
Timeframe: from baseline to 1 year

InterventionInjections (Median)
Sham+Prompt Laser11
0.5 mg Ranibizumab+Prompt Laser8
0.5 mg Ranibizumab+Deferred Laser9
4 mg Triamcinolone+Prompt Laser3

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Percentage of Eyes Receiving Laser at the 48 Week Visit (%)

(NCT00444600)
Timeframe: 1 Year

InterventionEyes (Number)
Sham+Prompt Laser26
0.5 mg Ranibizumab+Prompt Laser16
0.5 mg Ranibizumab+Deferred Laser8
4 mg Triamcinolone+Prompt Laser21

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Cardiovascular Events According to Antiplatelet Trialists' Collaboration Through 1 Year

Antiplatelet Trialists' Collaboration is a collaborative overview of randomised trials of antiplatelet therapy - I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. Antiplatelet Trialists' Collaboration. MBJ 1994; 308:81-106. Nonfatal cerebrovascular accident includes ischemic or hemorrhagic or unknown events. Vascular death includes death from any potential vascular or unknown cause. (NCT00444600)
Timeframe: 1 Year

,,
InterventionParticipants (Number)
Nonfatal myocardial infarctionNonfatal cerebrovascular accidentVascular deathAny ATC cardiovascular event
Ranibizumab13711
Sham35410
Triamcinolone2125

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Change in Optical Coherence Tomography Retinal Volume

Missing or un-gradable data as follows for the sham plus focal/grid/panretinal photocoagulation laser, triamcinolone plus focal/grid panretinal photocoagulation laser, and Ranibizumab groups were 49, 37, and 39, respectively (NCT00445003)
Timeframe: Baseline to 14 weeks

Interventionmm^3 (Mean)
Sham Injection0.1
0.5mg Ranibizumab-0.4
4-mg Triamcinolone Acetonided-1.3

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Change in Optical Coherence Tomography Central Subfield Thickness

(NCT00445003)
Timeframe: Baseline to 14 weeks

InterventionMicrons (Median)
Sham Injection362
0.5mg Ranibizumab312
4-mg Triamcinolone Acetonided265

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Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks

Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best. (NCT00445003)
Timeframe: baseline to 14 weeks

InterventionLetter Score (Mean)
Sham Injection-4
0.5mg Ranibizumab1
4-mg Triamcinolone Acetonided2

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Number of Eyes With Additional Number of Treatments for Diabetic Macular Edema

Treatments include any type or combination of treatment for diabetic macular edema. Eyes were only counted once, when receiving a combination of treatments. (NCT00445003)
Timeframe: 14 weeks to 56-weeks

InterventionEyes (Number)
Sham Injection71
0.5mg Ranibizumab48
4-mg Triamcinolone Acetonided45

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Total Optical Coherence Tomography Retinal Volume

Missing/ungradable as follows: Sham = 49, Ranibizumab = 37, Triamcinolone = 39. Visits occured between 70 days and 153 days from randomization adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes. Confidence intervals are adjusted for multiple comparisons. (NCT00445003)
Timeframe: Baseline to 14-weeks

Interventionmm^3 (Mean)
Sham Injection9.7
0.5mg Ranibizumab9.3
4-mg Triamcinolone Acetonided7.9

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Additional Treatments for Diabetic Macular Edema

Each combination of treatment is only counted once per treatment eye. Participants could have 2 study eyes, with random assignments to different treatments. (NCT00445003)
Timeframe: 14 weeks to 56-weeks

,,
InterventionEyes (Number)
BevacizumabRanibizumabTriamcinolonePegaptanibLaserVitrectomyBevacizumab plus TriamcinoloneRanibizumab plus TriamcinoloneBevacizumab plus laserRanibizumab plus laserTriamcinolone plus laserPegaptanib plus laserTriamcinolone plus vitrectomyPegaptanib plus vitrectomyTriamcinolone plus laser plus vitrectomyBevacizumab plus triamcinolone plus laser
0.5mg Ranibizumab120801010153401111
4-mg Triamcinolone Acetonided93232102000500000
Sham Injection141303122080710002

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Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema

(NCT00445003)
Timeframe: 14 weeks to 56-weeks

InterventionEyes (Number)
Sham Injection28
0.5mg Ranibizumab23
4-mg Triamcinolone Acetonided17

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Change in Visual Acuity From Baseline

Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best. (NCT00445003)
Timeframe: baseline to 56-weeks

InterventionLetter Score (Mean)
Sham Injection-6
0.5mg Ranibizumab-4
4-mg Triamcinolone Acetonided-5

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Overall Incidence of Grade 3 Rash

"The overall incidence of grade 3 erlotinib-induced rash among the three treatment arms.~For overall incidence of rash a binary variable will be designed. Data will be summarized with percentages by treatment group." (NCT00473083)
Timeframe: From onset of rash until resolution, up to 4 weeks following progression, on average of 1 year

Interventionpercentage of participants (Number)
Arm 1: Prophylactic Treatment14.3
Arm 2: Reactive Treatment9.5
Arm 3: No Treatment Unless Severe (Grade 3)34.1

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Overall Incidence of Rash

"The overall incidence of any grade of erlotinib-induced rash among the three treatment arms.~For overall incidence of rash a binary variable will be designed. Data will be summarized with percentages by treatment group." (NCT00473083)
Timeframe: From onset of rash until resolution, up to 4 weeks following progression, an average of 1 year

Interventionpercentage of participants (Number)
Arm 1: Prophylactic Treatment84
Arm 2: Reactive Treatment84
Arm 3: No Treatment Unless Severe (Grade 3)82

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Overall Survival

(NCT00473083)
Timeframe: Until death

Interventionmonths (Median)
Arm 1: Prophylactic Treatment7.6
Arm 2: Reactive Treatment8.0
Arm 3: No Treatment Unless Severe (Grade 3)6.0

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Severity of Rash Caused by Erlotinib

The maximum severity of rash per subject will be summarized by treatment group. The summary will include only subjects who indicated any occurrence of rash. (NCT00473083)
Timeframe: Onset until resolution, up to 4 weeks following progression, on average of 1 year

,,
Interventionpercentage of participants (Number)
Maximal Rash Grade 1Maximal Rash Grade 2aMaximal Rash Grade 2bMaximal Rash Grade 3
Arm 1: Prophylactic Treatment40.526.219.014.3
Arm 2: Reactive Treatment47.633.39.59.5
Arm 3: No Treatment Unless Severe (Grade 3)46.314.64.934.1

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Time Duration From Onset of Rash Until Resolution

"To investigate if the rash caused by erlotinib is self-limiting.~A time variable will be defined to identify the duration from onset of rash until resolution. Resolution will be defined as resolution to severity Grade 1 for patients with rash of maximum severity grade >1 and resolution to Grade 0 for patients with maximum rash severity = 1. For patients where resolution is not observed the time considered will be the maximum time from onset of rash until end of the study.~The analyses will be performed using the following two sub-populations: subjects with maximum severity of rash of Grade 1, 2a and 2b will constitute one sub-population and Grade 3 will be considered the second sub-population.~The comparisons will be performed primarily for Group 1 vs. Group 3 and Group 2 vs. Group 3 and secondly for Group 1 vs. Group 2." (NCT00473083)
Timeframe: From onset of rash until resolution, up to 4 weeks following progression, an average of 1 year

,,
Interventiondays (Median)
Patients With Max Severity of Rash Gr 1, 2a and 2bPatients With Maximum Severity of Rash Grade 3
Arm 1: Prophylactic Treatment133.0201.0
Arm 2: Reactive Treatment92.076.0
Arm 3: No Treatment Unless Severe (Grade 3)98.054.0

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Time to First Presentation of Rash

(NCT00473083)
Timeframe: Up to onset of rash while on study treatment

Interventiondays (Mean)
Arm 1: Prophylactic Treatment17.4
Arm 2: Reactive Treatment13.3
Arm 3: No Treatment Unless Severe (Grade 3)12.0

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Duration of Treatment

(NCT00473083)
Timeframe: Up to one year

Interventionmonths (Median)
Arm 1: Prophylactic Treatment3.6
Arm 2: Reactive Treatment1.8
Arm 3: No Treatment Unless Severe (Grade 3)1.8

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Mean Change in Cortisol Levels From Baseline to Week 24

Mean change in cortisol levels from baseline to week 24 after four triamcinolone acetonide 10 ml injections 6 weeks apart. (NCT00484679)
Timeframe: baseline, week 24

Interventionmg/dL (Mean)
(Kenalog-10) Intralesional Injections for Alopecia Areata0.187

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Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)

The MPI is a comprehensive instrument comprised of 12 scales divided into three parts for assessing a number of dimensions of the chronic pain experience including pain intensity, emotional distress, cognitive and functional adaptation, and social support. Reference: Kearns RO, Turk DC, Rudy TC. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain 1985; 23:345-356. Subscales were not used; the DOS WHYMPI computer program version 2.1 was used to score the instrument. Scores range from 0 (no pain) to 100 (highest pain). A score of 50 is the mean for patients with chronic pain. (NCT00588354)
Timeframe: 2 weeks

InterventionUnits on a scale (Mean)
2% Lidociane and Clonidine (200 or 400 ug)51.6
2% Lidocaine and Triamcinolone (40 mg)56.0

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Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)

11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain). (NCT00588354)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
2% Lidociane and Clonidine (200 or 400 ug)4.1
2% Lidocaine and Triamcinolone (40 mg)2.7

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Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire

This scale measures functional disability due to back pain. The score of the scale is the total number of items checked, from a minimum of 0 (no disability) to a maximum of 24 (great disability). Roland MO, Morris RW. A study of the natural history of back Pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8:141-144. (NCT00588354)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
2% Lidociane and Clonidine (200 or 400 ug)9.4
2% Lidocaine and Triamcinolone (40 mg)3.5

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Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire

This questionnaire measures a patient's permanent functional disability. The questionnaire consists of 10 sections with 6 statements each of increasing point value (from 0 to 5). The score is a percentage of the total, with higher score showing greater disability. Minimum detectable change is 10%, with a 90% CI. Change of less than this may be attributable to error in measurement. (NCT00588354)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
2% Lidociane and Clonidine (200 or 400 ug)23.9
2% Lidocaine and Triamcinolone (40 mg)17.0

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Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire

This scale measures functional disability due to back pain. The score of the scale is the total number of items checked, from a minimum of 0 (no disability) to a maximum of 24 (great disability). Roland MO, Morris RW. A study of the natural history of back Pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8:141-144. (NCT00588354)
Timeframe: 2 weeks

InterventionUnits on a scale (Mean)
2% Lidociane and Clonidine (200 or 400 ug)9.6
2% Lidocaine and Triamcinolone (40 mg)5.7

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Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)

This questionnaire measures a patient's permanent functional disability. The questionnaire consists of 10 sections with 6 statements each of increasing point value (from 0 to 5). The score is a percentage of the total, with higher score showing greater disability. Minimum detectable change is 10%, with a 90% CI. Change of less than this may be attributable to error in measurement. (NCT00588354)
Timeframe: 2 weeks

InterventionUnits on a scale (Mean)
2% Lidocaine and Clonidine (200 or 400 ug)27.0
2% Lidocaine and Triamcinolone (40 mg)21.3

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Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)

11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain). (NCT00588354)
Timeframe: 2 weeks

InterventionUnits on a scale (Mean)
2% Lidociane and Clonidine (200 or 400 ug)4.1
2% Lidocaine and Triamcinolone (40 mg)4.0

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Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)

The MPI is a comprehensive instrument comprised of 12 scales divided into three parts for assessing a number of dimensions of the chronic pain experience including pain intensity, emotional distress, cognitive and functional adaptation, and social support. Reference: Kearns RO, Turk DC, Rudy TC. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain 1985; 23:345-356. Subscales were not used; the DOS WHYMPI computer program version 2.1 was used to score the instrument. Scores range from 0 (no pain) to 100 (highest pain). A score of 50 is the mean for patients with chronic pain. (NCT00588354)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
2% Lidociane and Clonidine (200 or 400 ug)56.7
2% Lidocaine and Triamcinolone (40 mg)56.9

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Pain Free External Rotation Range of Motion (ROM)

Differences in least-mean squares (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions. (NCT00597766)
Timeframe: Baseline, weeks 4, 8, 12 (4 times)

Interventionunits on a scale (Least Squares Mean)
20mg Triamcinolone26.7
40mg Triamcinolone12.7
60mg Triamcinolone10.3

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Pain Free Abduction Range of Motion (ROM)

Difference in least-squares means (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions. (NCT00597766)
Timeframe: Baseline, weeks 4, 8, 12 (4 times)

Interventionunits on a scale (Least Squares Mean)
20mg Triamcinolone33.3
40mg Triamcinolone15.2
60mg Triamcinolone28.0

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Fugl-Meyer Motor Assessment, Upper Limb Domain

"Evaluates and measures recovery in post-stroke hemiplegic patients. Items are scored on a 3-point ordinal scale:~0 = cannot perform~= performs partially~= performs fully Scores for 33 motor function items are summed to arrive at a total score ranging from 0 to 66, where higher scores indicate greater motor function Differences baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions." (NCT00597766)
Timeframe: Baseline, weeks 4, 8, 12 (4 times)

Interventionunits on a scale (Least Squares Mean)
20mg Triamcinolone5.1
40mg Triamcinolone4.5
60mg Triamcinolone2.3

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BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire

Change in BPI-12, Worst pain in the last week on 0 (No Pain) to 10 (Worst Pain Possible) scale, from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions. (NCT00597766)
Timeframe: Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times)

Interventionunits on a scale (Least Squares Mean)
20mg Triamcinolone-1.7
40mg Triamcinolone-2.2
60mg Triamcinolone-4.7

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Change in WOMAC Pain Subscale

WOMAC pain subscale range 0-20 (0=best, 20=worst) (NCT00746889)
Timeframe: baseline to 12 weeks

Interventionunits on a scale (Mean)
Inflammatory Patients Who Received Corticosteroid Injections-0.1
Noninflammatory Patients Who Received Corticosteroid Injection-2.0

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Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale

WOMAC pain subscale range 0-20 (0=best, 20=worst) (NCT00746889)
Timeframe: baseline to 4 weeks

Interventionunits on a scale (Mean)
Corticosteroid Injection-2.1
Placebo-0.1

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The Dose of Canakinumab for Treatment of Acute Flares in Gout Patients That Leads to the Same Efficacy as Triamcinolone Acetonide With Respect to Pain Intensity on a 0-100 mm Visual Analog Scale (VAS)

Mean target dose at 24, 48 and 72 hours. Four models: Emax, Logistic, Linear in log-dose, Linear were selected to describe the potential dose-response curve and hence estimate the target dose of canakinumab using baseline Visual Analog Scale (VAS) and Body Mass Index (BMI) as covariates. Target dose was defined as the dose for which the efficacy is equivalent to the efficacy of triamcinolone acetonide 40 mg and was identified by assessing the dose response relationship with regards to the pain intensity in the target joint measured on a 0- 100 mm VAS (0= no pain and 100= unbearable pain). (NCT00798369)
Timeframe: at 24,48 and 72 hours post-baseline

Interventionmg (Number)
Target dose at 24 hrs post-baselineTarget dose at 48 hrs post-baselineTarget dose at 72 hrs post-baseline
Linear Model3723NA

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Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment

Participants scored their global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Slight and Poor. (NCT00798369)
Timeframe: at 72 hours post-baseline

InterventionPercentage of Participants (Number)
Canakinumab 10 mg64
Canakinumab 25 mg62
Canakinumab 50 mg71
Canakinumab 90 mg66
Canakinumab 150 mg89
Triamcinolone Acetonide 40 mg54

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The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint

The median time in days to at least 50% reduction in Pain intensity from baseline as measured by Visual Analog Scale (VAS) for each treatment group. Participants scored their pain intensity in the target joint on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). (NCT00798369)
Timeframe: Baseline, within 7 days after randomization

InterventionDays (Median)
Canakinumab 10 mg2.9
Canakinumab 25 mg2.9
Canakinumab 50 mg1.0
Canakinumab 90 mg1.0
Canakinumab 150 mg1.0
Triamcinolone Acetonide 40 mg2.0

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Amount of Rescue Medication Taken for Each Treatment Group

Participants who had difficulty in tolerating their pain after the 6-hour post-dose pain assessments and during the first 7 study days were allowed to take a maximum of 30 mg prednisolone (or equivalent dose of prednisone [30 mg]) orally once a day for a maximum of 5 days. In addition, participants could use 500 mg acetaminophen (paracetamol) and/or 30 mg codeine as needed during the first 7 study days. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/dose or 180 mg/day of codeine was allowed during the first 7 days of the study. (NCT00798369)
Timeframe: 7 days after study drug administration

,,,,,
Interventionmg (Mean)
AcetaminophenCodeinePrednisolone/Prednisone
Canakinumab 10 mg1414.342.913.4
Canakinumab 150 mg607.44.46.2
Canakinumab 25 mg1656.978.623.8
Canakinumab 50 mg2178.649.324.1
Canakinumab 90 mg1646.627.913.1
Triamcinolone Acetonide 40 mg1614.352.013.3

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High Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group

"High sensitivity C-reactive protein (hsCRP) was determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.~ANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates." (NCT00798369)
Timeframe: at 72 hours and 7 days, 4 and 8 weeks post-dose

,,,,,
Interventionmg/L (Least Squares Mean)
72 hrs post-dose (n= 27, 28, 26, 28, 25, 53)7 days post-dose (n= 28, 29, 28, 28, 27, 55)4 week post-dose (n= 27, 28, 27, 28, 27, 55)8 weeks post-dose (n= 26, 28, 27, 28, 27, 54)
Canakinumab 10 mg16.78.03.03.8
Canakinumab 150 mg9.23.74.82.9
Canakinumab 25 mg7.92.52.92.0
Canakinumab 50 mg11.74.32.92.6
Canakinumab 90 mg13.46.34.85.2
Triamcinolone Acetonide 40 mg13.413.79.28.6

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Serum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group

"Serum amyloid A (SAA) were determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.~ANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates." (NCT00798369)
Timeframe: at 72 hours and 7 days, 4 and 8 weeks post-dose

,,,,,
Interventionmg/L (Least Squares Mean)
72 hrs post-dose (n= 26, 28, 28, 28, 27, 50)7 days post-dose (n= 28, 28, 28, 28, 26, 49)4 week post-dose (n= 27, 28, 27, 28, 27, 50)8 weeks post-dose (n= 26, 26, 26, 27, 27, 48)
Canakinumab 10 mg50.110.64.45.5
Canakinumab 150 mg26.910.36.24.1
Canakinumab 25 mg27.65.44.24.6
Canakinumab 50 mg70.711.94.95.7
Canakinumab 90 mg29.410.514.38.2
Triamcinolone Acetonide 40 mg52.539.412.918.0

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The Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide

The change in pain intensity from baseline to 72 hours and 7 days post dose as measured on a 0-100 mm Visual Analog Scale(VAS): 0= no pain and 100= severe pain. Analysis of Covariance (ANCOVA) with treatment group, VAS at baseline and Body mass Index (BMI) at baseline as covariates. Change from baseline = (post-baseline measurement - baseline). (NCT00798369)
Timeframe: Baseline,at 72 hrs post-dose and 7 days post-dose

,,,,,
InterventionUnits on a scale (Least Squares Mean)
72 hrs post-dose (n= 28, 28, 26, 28, 27, 53)7 days post-dose (n= 26, 28, 27, 27, 26, 51)
Canakinumab 10 mg-48.6-57.6
Canakinumab 150 mg-62.5-66.4
Canakinumab 25 mg-46.6-53.9
Canakinumab 50 mg-48.6-63.4
Canakinumab 90 mg-52.7-61.2
Triamcinolone Acetonide 40 mg-43.3-56.0

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Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters From Baseline to Month 6.

(NCT00815360)
Timeframe: 6 months

InterventionLetters of visual acuity on ETDRS chart (Mean)
Treatment Group 113
Comparative Group 110

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Mean Central Foveal Thickness (CFT) on Optical Coherence Tomography (OCT) in Microns at 6 Months

(NCT00815360)
Timeframe: 6 months

Interventionunits on a scale (microns) (Mean)
Treatment Group 1270
Comparative Group 1350

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No Pain on Three Point Likert Scale on Dorsiflexion of Wrist

"Percentage of patients reporting no pain on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 6 weeks

Interventionpercentage of participants (Number)
Corticosteroid Injection in Combination With Physical Therapy36
Placebo Injection in Combination With Physical Therapy3
Control Group: Wait-and-see Treatment8

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No Pain on Three Point Likert Scale on Isometric Extension of Third Finger

"Percentage of patients reporting no pain on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 12 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy36
Placebo Injection in Combination With Physical Therapy24
Control Group: Wait-and-see Treatment22

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No Pain on Three Point Likert Scale on Isometric Extension of Third Finger

"Percentage of patients reporting no pain on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 26 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy31
Placebo Injection in Combination With Physical Therapy53
Control Group: Wait-and-see Treatment58

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No Pain on Three Point Likert Scale on Isometric Extension of Third Finger

"Percentage of patients reporting no pain on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 52 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy53
Placebo Injection in Combination With Physical Therapy76
Control Group: Wait-and-see Treatment63

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No Pain on Three Point Likert Scale on Isometric Extension of Third Finger

"Percentage of patients reporting no pain on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 6 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy44
Placebo Injection in Combination With Physical Therapy16
Control Group: Wait-and-see Treatment17

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Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors

Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 12 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy43
Placebo Injection in Combination With Physical Therapy35
Control Group: Wait-and-see Treatment36

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Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors

Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 26 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy36
Placebo Injection in Combination With Physical Therapy19
Control Group: Wait-and-see Treatment18

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Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors

Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 52 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy20
Placebo Injection in Combination With Physical Therapy9
Control Group: Wait-and-see Treatment12

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Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors

Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 6 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy32
Placebo Injection in Combination With Physical Therapy50
Control Group: Wait-and-see Treatment51

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No Pain on Three Point Likert Scale on Dorsiflexion of Wrist

"Percentage of patients reporting no pain on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 26 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy19
Placebo Injection in Combination With Physical Therapy29
Control Group: Wait-and-see Treatment38

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Treatment Success - Event Rates in Each Group

Unadjusted event rates of treatment success, defined as participants rating themselves 'much improved' or 'completely recovered' on a six point scale. Percentage with 99% confidence interval. (NCT00826462)
Timeframe: 6 - 52 weeks

,,
Interventionpercentage of participants (Number)
6 weeks12 weeks26 weeks52 weeks
Control Group: Wait-and-see Treatment15486778
Corticosteroid Injection in Combination With Physical Therapy59424275
Placebo Injection in Combination With Physical Therapy24456978

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Pain-free Grip Strength Ratio

Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint. (NCT00826462)
Timeframe: 52 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy100
Placebo Injection in Combination With Physical Therapy90
Control Group: Wait-and-see Treatment91

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Pain-free Grip Strength Ratio

Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint. (NCT00826462)
Timeframe: 26 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy82
Placebo Injection in Combination With Physical Therapy76
Control Group: Wait-and-see Treatment74

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Pain-free Grip Strength Ratio

Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint. (NCT00826462)
Timeframe: 12 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy64
Placebo Injection in Combination With Physical Therapy55
Control Group: Wait-and-see Treatment63

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Pain-free Grip Strength Ratio

Pain free grip strength registered with hand held dynamometer . Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint. (NCT00826462)
Timeframe: 6 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy58
Placebo Injection in Combination With Physical Therapy50
Control Group: Wait-and-see Treatment57

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Pain Free Function Index of Everyday Activities

Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment. (NCT00826462)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Corticosteroid Injection in Combination With Physical Therapy2.78
Placebo Injection in Combination With Physical Therapy4.40
Control Group: Wait-and-see Treatment4.82

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Maximum Grip Strength Ratio

Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain. (NCT00826462)
Timeframe: 52 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy96
Placebo Injection in Combination With Physical Therapy102
Control Group: Wait-and-see Treatment104

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Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors

To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 12 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy37
Placebo Injection in Combination With Physical Therapy32
Control Group: Wait-and-see Treatment34

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Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors

To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 26 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy28
Placebo Injection in Combination With Physical Therapy17
Control Group: Wait-and-see Treatment16

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Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors

To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 6 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy25
Placebo Injection in Combination With Physical Therapy45
Control Group: Wait-and-see Treatment38

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Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors

To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 52 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy16
Placebo Injection in Combination With Physical Therapy9
Control Group: Wait-and-see Treatment10

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Maximum Grip Strength Ratio

Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain. (NCT00826462)
Timeframe: 12 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy83
Placebo Injection in Combination With Physical Therapy88
Control Group: Wait-and-see Treatment89

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Pain Free Function Index of Everyday Activities

Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment. (NCT00826462)
Timeframe: 52 weeks

Interventionscore on a scale (Mean)
Corticosteroid Injection in Combination With Physical Therapy1.64
Placebo Injection in Combination With Physical Therapy1.03
Control Group: Wait-and-see Treatment1.40

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Pain Free Function Index of Everyday Activities

Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment. (NCT00826462)
Timeframe: 26 weeks

Interventionscore on a scale (Mean)
Corticosteroid Injection in Combination With Physical Therapy2.97
Placebo Injection in Combination With Physical Therapy1.83
Control Group: Wait-and-see Treatment2.00

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Pain Free Function Index of Everyday Activities

Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment. (NCT00826462)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
Corticosteroid Injection in Combination With Physical Therapy3.42
Placebo Injection in Combination With Physical Therapy3.62
Control Group: Wait-and-see Treatment3.37

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Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale)

Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. (NCT00826462)
Timeframe: 6 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy29
Placebo Injection in Combination With Physical Therapy45
Control Group: Wait-and-see Treatment44

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Maximum Grip Strength Ratio

Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain. (NCT00826462)
Timeframe: 26 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy89
Placebo Injection in Combination With Physical Therapy99
Control Group: Wait-and-see Treatment99

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Maximum Grip Strength Ratio

Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain. (NCT00826462)
Timeframe: 6 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy87
Placebo Injection in Combination With Physical Therapy80
Control Group: Wait-and-see Treatment74

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No Pain on Three Point Likert Scale on Dorsiflexion of Wrist

"Percentage of patients reporting no pain on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 12 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy22
Placebo Injection in Combination With Physical Therapy12
Control Group: Wait-and-see Treatment17

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No Pain on Three Point Likert Scale on Dorsiflexion of Wrist

"Percentage of patients reporting no pain on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 52 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy36
Placebo Injection in Combination With Physical Therapy60
Control Group: Wait-and-see Treatment50

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Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).

Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. (NCT00826462)
Timeframe: 26 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy38
Placebo Injection in Combination With Physical Therapy21
Control Group: Wait-and-see Treatment19

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Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).

Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. (NCT00826462)
Timeframe: 12 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy41
Placebo Injection in Combination With Physical Therapy33
Control Group: Wait-and-see Treatment33

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Pain as Recorded by the Study Doctors on a 100 mm VAS-scale

Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. (NCT00826462)
Timeframe: 52 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy19
Placebo Injection in Combination With Physical Therapy9
Control Group: Wait-and-see Treatment13

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Anterior Chamber Inflammation (Flare)

Inflammation in the anterior chamber (called flare), is measured 10 times per eye using the flare meter, a non-invasive measurement. Flare meter measures inflammation in photon counts per millisecond (p/msec). (NCT00853905)
Timeframe: 1 month, 3 month and 6 month post-op visits

,
Interventionphoton counts per millisecond (p/msec) (Mean)
Month 1Month 3Month 6
Treatment 1(Triesence)0.40.60.3
Treatment 2 (Balanced Salt Solution BSS)1.00.40.2

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Ocular Hypotensive Medications

Number of ocular hypotensive ophthalmic solutions (eye drops) needed, if any, to maintain lower eye pressure. (NCT00853905)
Timeframe: 1 week, 1 month, 3 month, and or 6 month post-op visits

,
Interventioneye drops (Mean)
Week 1Month 1Month 3Month 6
Treatment 1(Triesence)0.030.10.080.22
Treatment 2 (Balanced Salt Solution BSS)0.060.030.220.22

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Bleb Appearance

A bleb is a blister on the white part of the eye (sclera) intentionally formed during some glaucoma surgeries. The Indiana Bleb Appearance Grading Scale (IBAGS) measures the bleb appearance in elevation (height), extent and vascularity. The height range is flat, low, moderate and high with 0 to 3 units on a scale. Zero is a flat bleb and 3 is a high bleb. Elevated functioning blebs increase the success of glaucoma surgery. (NCT00853905)
Timeframe: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits

,
Interventionunits on a scale (Mean)
Day 1Week 1Month 1Month 3Month 6
Balanced Salt Solution (BSS Treatment 2)2.11.91.91.82.1
Triesence (Treatment 1)1.71.72.22.01.9

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Patient Comfort

Questionnaire administered to capture feeling of dry eye. Dry eye was graded on a scale of absent, mild, moderate and severe with 0 to 3 units on a scale. (NCT00853905)
Timeframe: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits

,
InterventionPatient comfort questionnaire score (Mean)
Day 1Week 1Month 1Month 3Month 6
Treatment 1(Triesence)0.30.60.30.40.7
Treatment 2 (Balanced Salt Solution BSS)0.10.30.60.40.7

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Intraocular Pressure (IOP)

Intraocular pressure (IOP) was measured by applanation tonometry in millimeters of mercury (mmHg). Surgical success was determined if IOP was <21mmHg and 20% less than baseline IOP. Failure was defined as inability to meet criteria for success or IOP was less than 5mmHg. (NCT00853905)
Timeframe: 1 day, 1week, 1 month, 3 month and 6 month post-op visits

,
Interventionmm Hg (Mean)
Day 1Week 1Month 1Month 3Month 6
Treatment 1(Triesence)16.111.716.115.114.6
Treatment 2 (Balanced Salt Solution BSS)12.811.814.412.813.6

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Change in Disease Severity: Percent Change in Mean EASI Score

Percent change in mean EASI score week 0 to week 6: Each lesion was scored using a 12-point modified Eczema Area and Severity Index (EASI) at baseline and 2 weeks after the 4-week treatment period (week6). An experienced evaluator assessed each lesion on the severity of 4 domains, with higher scores indicating more severity: 1) intensity of redness (erythema), 2) thickness (induration, papulation, oedema), 3) scratching (excoriation) and 4) lichenification (lined skin) as as none (0), mild (1), moderate (2) and severe (3). Pictorial and descriptive instructions guided the evaluator in scoring the lesions based on visual appearance. (NCT00924508)
Timeframe: Baseline, 6 weeks

Interventionpercentage change (Mean)
Hydrogel Patch-47
TAC 0.1%-56
Patch + TAC-61

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Number of Adverse Events Associated With Treatment

(NCT00924508)
Timeframe: 6 weeks

InterventionAdverse events (Number)
Hydrogel Patch Alone, TAC 0.1%, TAC + Patch0

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Primary Outcome Variable: Function. The Pediatric Outcomes Data Collection Instrument (PODCI) Will be the Primary Endpoint as a Measure of Function and Health Related Quality of Life at 12 Months Post Injection.

"The Pediatric Outcomes Data Collection Instrument (PODCI) is designed to be completed by the parent/guardian of a child ten years of age or younger who has knowledge of the child's conditions. The eight scales generated from these instruments are:~Upper Extremity and Physical Function Scale; Transfer and Basic Mobility Scale; Sports/Physical Functioning Scale; Pain/Comfort; Treatment Expectations Scale; Happiness Scale; Satisfaction with Symptoms Scale and Global Functioning Scale. The results of each scale are standardized into a scale of 0-100 where 0 indicates the worst outcome and 100 the best.~We decided to report Global Functioning only due to space limitations. Also the Global Functioning scale encompasses items from other scales." (NCT01026909)
Timeframe: This exam is to be administered at time of enrollment and at 4 and 12 months follow up visits.

,
Interventionunits on a scale (Mean)
After Treatment (12 months) Global Functioning ScaBefore treatment - Global Functioning Scale
Control97.579
Injection9764

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Second Outcome Variable: Ambulatory Activity. It Will be Defined as Average Steps/Day as Measured by the StepWatch Activity Monitor for a 7 Day Sample.

(NCT01026909)
Timeframe: StepWatch monitor will be used 7 days prior to treatment and 4 weeks, 4 months and 12 months follow up visits

,
Interventionsteps/day (Mean)
Baseline- Average Number of steps per day4 weeks Follow Up- Average Number of steps per d4 months follow up- average # of steps per day12 months follow up- average # of steps per day
Control1448.042521.912687.572158.7
Injection62871782.196985.896990

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Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab

Patients made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. Percentage of participants in each category for both core and extension periods were measured. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab. (NCT01029652)
Timeframe: 72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)

,
InterventionPercentage of participants (Number)
Excellent (72 hours post dose) (n=60, 36)Good (72 hours post dose) (n=60, 36)Acceptable (72 hours post dose) (n=60, 36)Slight (72 hours post dose) (n=60, 36)Poor (72 hours post dose) (n=60, 36)Excellent (7 days post dose) (n=68, 36)Good (7 days post dose) (n=68, 36)Acceptable (7 days post dose) (n=68, 36)Slight (7 days post dose) (n=68, 36)Poor (7 days post dose) (n=68, 36)
Randomized to Canakinumab and Re-treated With Canakinumab15.026.750.06.71.723.541.227.97.40.0
Randomized to Triamcinolone and Switched to Canakinumab19.444.427.82.85.627.852.816.72.80.0

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Percentage of Participants Who Took Rescue Medication

Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments. Permitted rescue medications included acetaminophen 500 mg and/ or codeine 30 mg as needed. If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as needed per day for 2 days followed by up to 20 mg of prednisolone as needed per day for 3 subsequent days within 7 days after randomization or after re-dose/injection administration. (NCT01029652)
Timeframe: during 12 weeks core, 24 weeks overall

,
InterventionPercentage of participants (Number)
12 weeks :Core (N=113, 115)24 weeks: Overall (N=35, 43)
Canakinumab 150 mg31.048.6
Triamcinolone Acetonide 40 mg52.244.2

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Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale)

Maximum severity is the maximum Likert score recorded after the start of the flare. Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme). (NCT01029652)
Timeframe: Last post-baseline flare (during 24 weeks overall)

,
InterventionPercentage of participants (Number)
NoneMildModerateSevereExtreme
Canakinumab 150 mg0.00.014.377.18.6
Triamcinolone Acetonide 40 mg0.02.316.360.520.9

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Physician's Assessment of Erythema for Patients Re-treated or Switched to Canakinumab

The study physician assessed the most affected joint for Erythema: Present or absent. The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab. (NCT01029652)
Timeframe: 72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)

,
InterventionPercentage of participants (Number)
Absent (72 hours post dose) (n=61, 35)Present (72 hours post dose) (n=61, 35)Absent (7 days post dose) (n=67, 36)Present (7 days post dose) (n=67, 36)
Randomized to Canakinumab and Re-treated With Canakinumab82.018.095.54.5
Randomized to Triamcinolone and Switched to Canakinumab80.020.094.45.6

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Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab

The study physician assessed the most affected joint for: Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab. (NCT01029652)
Timeframe: 72 hours post-dose , 7 days post dose last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)

,
InterventionPercentage of participants (Number)
No Pain (72 hours post dose) (n=61, 35)Pain (72 hours post dose) (n=61, 35)Pain and winces (72 hours post dose) (n=61, 35)Pain, winces, withdraw(72 hrs post dose)(n=61, 35)No pain (7 days post dose) (n=68, 36)Pain (7 days post dose) (n=68, 36)Pain and winces (7 days post dose) (n=68, 36)Pain, winces, withdraw(72 hrs post dose)(n=68, 36)
Randomized to Canakinumab and Re-treated With Canakinumab29.542.624.63.364.725.07.42.9
Randomized to Triamcinolone and Switched to Canakinumab42.948.68.60.075.016.75.62.8

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Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab

"The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that there is pain, patient states there is pain and winces, and patient states there is pain, winces, and withdraws on palpation or passive movement of the affected study joint; The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab." (NCT01029652)
Timeframe: 72 hours post-dose , 7 days post dose last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)

,
InterventionPercentage of participants (Number)
No Pain (72 hours post dose) (n=61, 35)Pain (72 hours post dose) (n=61, 35)Pain and winces (72 hours post dose) (n=61, 35)Pain, winces, withdraw(72 hrs post dose)(n=61, 35)No pain (7 days post dose) (n=68, 36)Pain (7 days post dose) (n=68, 36)Pain and winces (7 days post dose) (n=68, 36)Pain, winces, withdraw(72 hrs post dose)(n=61, 36)
Randomized to Canakinumab and Re-treated With Canakinumab27.954.116.41.652.944.12.90.0
Randomized to Triamcinolone and Switched to Canakinumab28.668.62.90.069.427.82.80.0

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Physician's Assessment of Range of Motion of the Most Affected Joint

The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of patients in each category is reported. (NCT01029652)
Timeframe: 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (24 weeks overall)

,
InterventionPercentage of participants (Number)
Normal (Core) [N=113, 111]Mildly restricted (Core) [N=113, 111]Moderately restricted (Core) [N=113, 111]Severely restricted (Core) [N=113, 111]Immobilized (Core) [N=113, 111]Normal (24 weeks) [N=87, 79]Mildly restricted (24 weeks) [N=87, 79]Moderately Restricted (24 weeks) [N=87, 79]Severely Restricted (24 weeks) [N=87, 79]Immobilized (24 weeks) [N=87, 79]
Canakinumab 150 mg25.750.421.22.70.066.731.02.30.00.0
Triamcinolone Acetonide 40 mg31.529.727.08.13.665.829.13.81.30.0

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Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint

"The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that there is pain, patient states there is pain and winces, and patient states there is pain, winces, and withdraws on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of patients in each category is reported." (NCT01029652)
Timeframe: 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

,
InterventionPercentage of participants (Number)
TENDERNESS - No pain (Core) [N=113, 110]Pain (Core) [N=113, 110]Pain and winces (Core) [N=113, 110]Pain,winces,withdraws (Core) [N=113,110]SWELLING - No swelling (Core) [N=113, 110]Palpable (Core) [N=113, 110]Visible (Core) [N=113, 110]Bulging beyond joint margin (Core) [N=113, 110]ERYTHEMA - Absent (Core) [N=112, 109]Present (Core) [N=112, 109]TENDERNESS - No pain (24 weeks) [N=87, 80]Pain (24 weeks) [N=87, 80]Pain and winces (24 weeks) [N=87, 80]Pain,winces,withdraws (24 weeks) [N=87, 80]SWELLING - No swelling (24 weeks) [N=87, 80]Palpable (24 weeks) [N=87, 80]Visible (24 weeks) [N=87, 80]Bulging beyond joint margin (24 week)[N=87,80]ERYTHEMA - Absent (24 weeks) [N=87, 80]Present (24 weeks) [N=87, 80]
Canakinumab 150 mg33.656.68.01.838.138.921.21.878.621.482.817.20.00.088.58.03.40.098.91.1
Triamcinolone Acetonide 40 mg26.451.817.34.530.035.529.15.565.134.985.013.81.30.093.85.01.30.01000.0

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Mean Number of New Gout Flares Per Patient

"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely." (NCT01029652)
Timeframe: 12 weeks

InterventionNew flares/patient/12 weeks (Mean)
Canakinumab 150 mg0.21
Triamcinolone Acetonide 40 mg0.53

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Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab

The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's assessments (pain intensity [Visual Analog Scale and Likert scale] and patient's global assessment of response to treatment). The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab. (NCT01029652)
Timeframe: 72 hours post-dose , 7 days post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)

,
InterventionPercentage of participants (Number)
Very good (72 hours post dose) (n=61, 34)Good (72 hours post dose) (n=61, 34)Fair (72 hours post dose) (n=61, 34)Poor (72 hours post dose) (n=61, 34)Very poor (72 hours post dose) (n=61, 34)Very Good (7 days post dose) (n=68, 34)Good (7 days post dose) (n=68, 34)Fair (7 days post dose) (n=68, 34)Poor (7 days post dose) (n=68, 34)Very Poor (7 days post dose) (n=68, 34)
Randomized to Canakinumab and Re-treated With Canakinumab21.341.031.16.60.036.852.910.30.00.0
Randomized to Triamcinolone and Switched to Canakinumab22.957.117.12.90.033.363.90.00.02.8

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Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab

Serum Amyloid A Protein (SAA) levels were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab. (NCT01029652)
Timeframe: 24 hours, 72 hours, 7 days, 4 weeks, 8 weeks and 12 weeks post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)

,
Interventionmg/L (Mean)
24 hours post dose (n= 45, 27)72 hours post dose (n=45, 36)7 days post dose (n=67, 39)4 weeks post dose (n=52, 35)8 weeks post dose (n=45, 37)12 weeks post dose (n=42, 33)
Randomized to Canakinumab and Re-treated With Canakinumab151.442.55.431.04.210.7
Randomized to Triamcinolone and Switched to Canakinumab86.526.94.98.55.47.8

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Mean Number of New Gout Flares Per Patient During the 24 Weeks of the Study

"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely." (NCT01029652)
Timeframe: 24 weeks

InterventionNew flares/patient/24 weeks (Mean)
Canakinumab 150 mg0.40
Triamcinolone Acetonide 40 mg0.87

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Patient's Assessment of Gout Pain Intensity in the Most Affected Joint on a Visual Analog Scale (VAS) in Extension

Patients scored their pain intensity in the joint most affected at baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates. (NCT01029652)
Timeframe: 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

Interventionmm (Least Squares Mean)
Canakinumab 150 mg34.6
Triamcinolone Acetonide 40 mg44.9

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Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks

"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely." (NCT01029652)
Timeframe: 12 weeks

InterventionPercentage of participants (Number)
Canakinumab 150 mg18.6
Triamcinolone Acetonide 40 mg34.8

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Percentage of Participants With Complete Resolution of Pain

Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. The Kaplan-Meier estimates of cumulative event rate = percentage of participants with event up to the end of the time interval. (NCT01029652)
Timeframe: 7 days post-dose (randomization)

InterventionPercentage of participants (Number)
Canakinumab 150 mg34.5
Triamcinolone Acetonide 40 mg31.3

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Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)

Patients scored their pain intensity in the joint most affected at baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates. (NCT01029652)
Timeframe: 72 hours post-dose (randomization)

Interventionmm (Least Squares Mean)
Canakinumab 150 mg28.1
Triamcinolone Acetonide 40 mg39.5

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SF36 Physical Function Score at Week 12

The SF-36 measures the impact of disease on overall quality of life (QoL). This 36-item survey has 8 subscales that can be aggregated into physical- and mental-component summary scores. Scores are standardized with the use of norm-based methods based on an assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. A negative change score indicates improvement. An ANCOVA model was used with treatment group and baseline SF-36 physical function subscore as covariates. (NCT01029652)
Timeframe: Week 12

InterventionUnits on a scale (Least Squares Mean)
Canakinumab 150 mg71.76
Triamcinolone Acetonide 40 mg71.48

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Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)

The Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at baseline was determined along with the 95% confidence interval. Patients scored their pain intensity on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. (NCT01029652)
Timeframe: From baseline to 7 days post dose (randomization)

InterventionHours (Median)
Canakinumab 150 mg48.0
Triamcinolone Acetonide 40 mg72.0

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Time to Complete Resolution of Pain

Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. The Kaplan-Meier estimates of time to complete resolution of self-assessed pain intensity in the joint most affected and their confidence intervals were determined. (NCT01029652)
Timeframe: 7 days post-dose (randomization)

InterventionHours (Median)
Canakinumab 150 mgNA
Triamcinolone Acetonide 40 mgNA

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Time to First Intake of Rescue Medication After the Last Post Baseline Flare.

The Kaplan-Meier estimates of medians and 95% confidence intervals were used to calculate the endpoint. (NCT01029652)
Timeframe: 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

InterventionHours (Median)
Canakinumab 150 mgNA
Triamcinolone Acetonide 40 mgNA

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Physician's Global Assessment of Response to Treatment

The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's assessments (pain intensity [Visual Analog Scale and Likert scale] and patient's global assessment of response to treatment). (NCT01029652)
Timeframe: 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

,
InterventionPercentage of participants (Number)
Very good (Core) [N=113,110]Good (Core) [N=113, 110]Fair (Core) [N= 113, 110]Poor (Core) [N= 113, 110]Very poor (Core) [N=113, 110]Very Good ( 24 weeks) [N=87, 79]Good (24 weeks) [N=87, 79]Fair (24 weeks) [N=87, 79]Poor (24 weeks) [N=87, 79]Very Poor (24 weeks) [N=87, 79]
Canakinumab 150 mg16.847.826.57.11.843.750.65.70.00.0
Triamcinolone Acetonide 40 mg15.530.032.714.57.327.850.617.73.80.0

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Time to First New Flare

"Kaplan-Meier (KM) estimates of time to first new flare and confidence intervals were determined. Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely." (NCT01029652)
Timeframe: 24 weeks

InterventionDays (Median)
Canakinumab 150 mgNA
Triamcinolone Acetonide 40 mg119

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Flare Rate Per Year

"Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab.~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely." (NCT01029652)
Timeframe: 72 weeks overall

InterventionNew flares per patient per year (Mean)
Canakinumab 150 mg1.16
Triamcinolone Acetonide 40 mg2.81

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Time to First New Flare: Survival Analysis by Treatment (72 Weeks Overall)

"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1).~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before flare has resolved completely." (NCT01029652)
Timeframe: 72 weeks overall

Interventiondays (Median)
Canakinumab 150 mg222.0
Triamcinolone Acetonide 40 mg119.0

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Amount of Rescue Medication Taken

"Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolon as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare." (NCT01029652)
Timeframe: 7 days last post-baseline flare (during 24 weeks)

,
Interventionmg (Mean)
AcetaminophenCodeinePrednisolone/Prednisone
Canakinumab 150 mg1931.47.74.1
Triamcinolone Acetonide 40 mg2058.146.021.6

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High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall

High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates. (NCT01029652)
Timeframe: 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

,
Interventionmg/L (Least Squares Mean)
hsCRP : Core(n= 109, 107)SAA protein : Core (n=105, 106)hsCRP : 24 weeks(n= 31, 32)SAA protein : 24 weeks (n=28, 33)
Canakinumab 150 mg4.506.775.1811.43
Triamcinolone Acetonide 40 mg7.0817.007.1821.11

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High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab

High sensitivity C-reactive protein (hsCRP) levels were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab. (NCT01029652)
Timeframe: 24 hours, 72 hours, 7 days, 4 weeks, 8 weeks and 12 weeks post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)

,
Interventionmg/L (Mean)
24 hours post dose (n= 45, 24)72 hours post dose (n=45, 34)7 days post dose (n=67, 39)4 weeks post dose (n=52, 35)8 weeks post dose (n=45, 37)12 weeks post dose (n=42, 33)
Randomized to Canakinumab and Re-treated With Canakinumab28.910.63.39.22.66.5
Randomized to Triamcinolone and Switched to Canakinumab26.07.03.23.23.04.3

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Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall)

This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. (NCT01029652)
Timeframe: 24 weeks overall

,
InterventionParticipants (Number)
Adverse EventDeathSerious Adverse Event
Canakinumab 150 mg71011
Triamcinolone Acetonide 40 mg5616

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Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall)

This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. (NCT01029652)
Timeframe: 72 weeks overall

,,,,,
InterventionParticipants (Number)
Adverse EventDeathSerious Adverse Event
All Randomized to Canakinumab76119
Randomized to Canakinumab :After Re-treated With Canakinumab3818
Randomized to Canakinumab :Before Re-treated With Canakinumab4106
Randomized to Triam: After Switched to Canakinumab1900
Randomized to Triam: Before Switched to Canakinumab2002
Randomized to Triamcinolone Acetonide (Triam)60211

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Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale)

Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme). The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab. (NCT01029652)
Timeframe: 72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)

,
InterventionPercentage of participants (Number)
None (72 hours post dose) (n=66, 39)Mild (72 hours post dose) (n=66, 39)Moderate (72 hours post dose) (n=66, 39)Severe (72 hours post dose) (n=66, 39)Extreme (72 hours post dose) (n=66, 39)None (7 days post dose) (n=65, 35)Mild (7 days post dose) (n=65, 35)Moderate (7 days post dose) (n=65, 35)Severe (7 days post dose) (n=65, 35)Extreme (7 days post dose) (n=65, 35)
Randomized to Canakinumab and Re-treated With Canakinumab19.730.045.54.50.041.538.518.51.50.0
Randomized to Triamcinolone and Switched to Canakinumab20.561.515.40.02.657.134.35.70.02.9

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Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale)

Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme). (NCT01029652)
Timeframe: 7 days post dose (randomization), 24 weeks post-dose

,
InterventionPercentage of participants (Number)
None (7 days post-dose) [N= 110, 107]Mild (7 days post-dose) [N= 110, 107]Moderate (7 days post-dose) [N= 110, 107]Severe (7 days post-dose) [N= 110, 107]Extreme (7 days post-dose) [N= 110, 107]None (24 weeks post-dose) [N= 85, 78]Mild (24 weeks post-dose) [N= 85, 78]Moderate (24 weeks post-dose) [N= 85, 78]Severe (24 weeks post-dose) [N= 85, 78]Extreme (24 weeks post-dose) [N= 85, 78]
Canakinumab 150 mg32.748.216.42.70.047.138.812.91.20.0
Triamcinolone Acetonide 40 mg28.041.116.812.11.946.237.215.41.30.0

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Patient's Global Assessment of Response to Treatment

Patients made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. Percentage of participants in each category for both core and extension periods were measured. (NCT01029652)
Timeframe: 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

,
InterventionPercentage of participants (Number)
Excellent (Core) [N=113, 111]Good (Core) [N=113, 111]Acceptable (Core) [N=113, 111]Slight (Core) [N=113, 111]Poor (Core) [N=113, 111]Excellent (24 weeks) [N=87, 78]Good (24 weeks) [N=87, 78]Acceptable (24 weeks) [N=87, 78]Slight (24 weeks) [N=87, 78]Poor (24 weeks) [N=87, 78]
Canakinumab 150 mg12.438.937.28.82.7314620.71.11.1
Triamcinolone Acetonide 40 mg12.628.830.612.615.317.944.925.69.02.6

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Time to First New Flare

"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1).~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before flare has resolved completely." (NCT01029652)
Timeframe: 12 weeks

InterventionDays (Median)
Canakinumab 150 mgNA
Triamcinolone Acetonide 40 mgNA

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Physician's Assessment of Range of Motion of the Most Affected Joint

The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of participants in each category is reported. (NCT01080131)
Timeframe: 72 hours post-dose and 24 weeks post-dose

,
Interventionpercentage of participants (Number)
72 hours - Normal [N=107,109]72 hours - Mildly restricted [N=107,109]72 hours - Moderately restricted [N=107,109]72 hours - Severely restricted [N=107,109]72 hours - Immobilized [N=107,109]24 weeks - Normal [N=79, 71]24 weeks - Mildly restricted [N=79, 71]24 weeks - Moderately restricted [N=79, 71]24 weeks - Severely restricted [N=79, 71]24 weeks - Immobilized [N=79, 71]
Canakinumab 150 mg47.737.413.11.90.086.110.12.51.30.0
Triamcinolone Acetonide 40 mg28.445.920.25.50.097.22.80.00.00.0

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Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint

"The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that there is pain, patient states there is pain and winces, and patient states there is pain, winces, and withdraws on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of participants in each category is reported." (NCT01080131)
Timeframe: 72 hours post-dose and 24 weeks post-dose

,
Interventionpercentage of participants (Number)
72 hours - Tenderness: No pain [N=107, 109]72 hours - Tenderness: Pain [N=107, 109]72 hours - Tenderness: Pain & winces [N=107, 109]72 hours - Tenderness:Winces/withdraws [N=107,109]24 weeks - Tenderness: No pain [N=79, 71]24 weeks - Tenderness: Pain [N=79, 71]24 weeks - Tenderness: Pain and winces [N=79, 71]24 weeks - Tenderness: Winces/withdraws [N=79, 71]72 hours - Swelling: No swelling [N=107,109]72 hours - Swelling: Palpable [N=107,109]72 hours - Swelling: Visible [N=107,109]72 hours - Swelling: Bulging [N=107,109]24 weeks - Swelling: No swelling [N=79, 71]24 weeks - Swelling: Palpable [N=79, 71]24 weeks - Swelling: Visible [N=79, 71]24 weeks - Swelling: Bulging [N=79, 71]72 hours - Erythema: Absent [N=107, 108]72 hours - Erythema: Present [N=107, 108]24 weeks - Erythema: Absent [N=79, 71]24 weeks - Erythema: Present [N=79, 71]
Canakinumab 150 mg47.743.94.73.788.68.91.31.347.728.022.41.993.75.11.30.074.825.297.52.5
Triamcinolone Acetonide 40 mg30.346.814.78.391.55.61.41.435.829.428.46.494.44.21.40.066.733.397.22.8

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Physician's Global Assessment of Response to Treatment

The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's own assessments (pain intensity and patient's global assessment of response to treatment). (NCT01080131)
Timeframe: 72 hours post-dose and 24-weeks post-dose.

,
Interventionpercentage of participants (Number)
72 hours - Very good [N= 107, 109]72 hours - Good [N= 107, 109]72 hours - Fair [N= 107, 109]72 hours - Poor [N= 107, 109]72 hours - Very poor [N= 107, 109]24 weeks - Very good [N=79, 71]24 weeks - Good [N=79, 71]24 weeks - Fair [N=79, 71]24 weeks - Poor [N=79, 71]24 weeks - Very poor [N=79, 71]
Canakinumab 150 mg43.043.011.22.80.077.216.55.11.30.0
Triamcinolone Acetonide 40 mg25.735.826.66.45.566.229.64.20.00.0

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Physician's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab

"The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: very good, good, fair, poor or very poor.~The physician completed the physician's global assessment of response to treatment without viewing any of the patient's assessments.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2." (NCT01080131)
Timeframe: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

,
Interventionpercentage of participants (Number)
72 hours - Very good [N=56, 38]72 hours - Good [N=56, 38]72 hours - Fair [N=56, 38]72 hours - Poor [N=56, 38]72 hours - Very poor [N=56, 38]7 days - Very good [N=58, 39]7 days - Good [N=58, 39]7 days - Fair [N=58, 39]7 days - Poor [N=58, 39]7 days - Very poor [N=58, 39]
Re-treated With Canakinumab 150 mg39.339.316.15.40.056.925.915.51.70.0
Triam Switched to Canakinumab42.139.518.40.00.059.038.52.60.00.0

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Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100 mm VAS)

Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), from 6 hours to 7 days post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates. (NCT01080131)
Timeframe: 6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose (randomization)

,
Interventionmm (Least Squares Mean)
6 hours post-dose12 hours post-dose24 hours post-dose48 hours post-dose72 hours post-dose4 days post-dose5 days post-dose6 days post-dose7 days post-dose
Canakinumab 150 mg58.750.839.129.522.119.216.414.314.0
Triamcinolone Acetonide 40 mg60.352.045.038.931.927.725.422.319.5

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Self-assessed Pain Intensity in the Joint Most Affected at Last Post-Baseline Measured on a Visual Analog Scale (VAS)

Patient's assessment of gout pain intensity in the most affected joint (on a 0-100 mm VAS) for the last post-baseline flare, ranging from no pain (0) to unbearable pain (100), was summarized up to 7 days after receiving a re-dose of study drug by time point. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The covariance analysis included treatment group, Baseline VAS score at that flare, and body mass index (BMI) at Baseline as covariates. (NCT01080131)
Timeframe: 6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose for last post-baseline flare that occurred up until the end of the first extension study (24 weeks).

,
Interventionmm (Least Squares Mean)
6 hours post-dose12 hours post-dose24 hours post-dose48 hours post-dose72 hours post-dose4 days post-dose5 days post-dose6 days post-dose7 days post-dose
Canakinumab 150 mg57.450.746.242.337.031.329.028.124.1
Triamcinolone Acetonide 40 mg59.153.343.834.226.123.421.620.519.1

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Serum Amyloid A Protein (SAA) Levels for Participants Re-treated With or Switched to Canakinumab

"Serum Amyloid A Protein (SAA) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2." (NCT01080131)
Timeframe: 24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

,
Interventionmg/L (Mean)
24-hours post-dose [N=47, 36]72-hours post-dose [N=54, 37]7 days post-dose [N=56, 39]4 weeks post-dose [N=47, 37]8 weeks post-dose [N=38, 35]12 weeks post-dose [N=38, 29]
Re-treated With Canakinumab 150 mg129.045.65.73.43.53.4
Triam Switched to Canakinumab145.945.45.95.05.34.8

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Time to First Intake of Rescue Medication

"Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.~Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication.~Kaplan-Meier estimates of the time to first intake of rescue medication, in hours, and the confidence interval were determined for the flare experienced at study entry (Baseline flare) and the last new flare (last post-baseline flare) that occurred up until the end of the first extension period (24 weeks)." (NCT01080131)
Timeframe: For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).

,
Interventionhours (Median)
Baseline flare [N= 112, 114]Last post-baseline flare [N=25, 46]
Canakinumab 150 mgNA32
Triamcinolone Acetonide 40 mg37.5NA

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Flare Rate Per Year

"Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab.~Participants met the definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Participants did not meet criterion of having new gout flare if:~• Increasing/renewed gout pain in an affected joint before the flare has resolved completely.~Flare rates were estimated from a negative binomial model with body mass index at baseline as a covariate." (NCT01080131)
Timeframe: From randomization to the end of the second extension period (72 weeks).

Interventionflares per patient per year (Mean)
Canakinumab 150 mg1.18
Triamcinolone Acetonide 40 mg2.02

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Mean Number of New Gout Flares Per Patient During 24 Weeks

"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint(at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely." (NCT01080131)
Timeframe: 24 weeks

Interventionnew flares per patient (Mean)
Canakinumab 150 mg0.35
Triamcinolone Acetonide 40 mg0.80

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Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks of the Study

The percentage of participants who experienced at least 1 new gout flare during the 12 week study treatment period. (NCT01080131)
Timeframe: Baseline to Week 12

Interventionpercentage of participants (Number)
Canakinumab 150 mg13.4
Triamcinolone Acetonide 40 mg36.8

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Pharmacokinetic Concentrations

Canakinumab concentration was analyzed in serum by means of a competitive Enzyme-linked immunosorbent assay (ELISA) assay with a lower limit of quantification (LOQ) at 100 ng/mL. (NCT01080131)
Timeframe: 12 weeks post-dose

Interventionµg/mL (Mean)
Canakinumab 150 mg2.16

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Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) at 72 Hours Post-dose

Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The analysis of covariance (ANCOVA) analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates. (NCT01080131)
Timeframe: 72 hours post-dose (randomization)

Interventionmm (Least Squares Mean)
Canakinumab 150 mg22.1
Triamcinolone Acetonide 40 mg31.9

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SF 36 Physical Function Score at Week 12

SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales that can be aggregated into physical and mental component summary scores. Scores are standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. Analysis of covariance (ANCOVA) model was used with treatment group and baseline SF-36 physical function subscore as covariates. (NCT01080131)
Timeframe: Week 12

InterventionUnits on a scale (Least Squares Mean)
Canakinumab 150 mg81.46
Triamcinolone Acetonide 40 mg78.75

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Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS)

Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at Baseline and the confidence intervals were determined along with 95% confidence interval. Patients scored their pain intensity on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. (NCT01080131)
Timeframe: Baseline to 7 days post-dose (randomization)

Interventionhours (Median)
Canakinumab 150 mg25.0
Triamcinolone Acetonide 40 mg48.0

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Time to Complete Resolution of Pain; Survival Analysis

Kaplan-Meier estimates of the time to complete resolution of self-assessed pain intensity in the joint most affected and the confidence interval was determined. Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; 6 and 12 hours; 1, 2, 3, 4, 5, 6, and 7 days post-dose. (NCT01080131)
Timeframe: Baseline to 7 days post-dose (randomization)

Interventionhours (Number)
Canakinumab 150 mg144.0
Triamcinolone Acetonide 40 mgNA

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Time to First New Flare: Survival Analysis by Treatment Over 72 Weeks

"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1).~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~• Increasing/renewed gout pain in an affected joint before flare has resolved completely." (NCT01080131)
Timeframe: From randomization to the end of the second extension period (72 weeks).

Interventiondays (Median)
Canakinumab 150 mg254.0
Triamcinolone Acetonide 40 mg146.0

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Time to First New Flare: Survival Analysis During the 12 Weeks of Study

Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1). Patients met definition of new flare if they had: •Flare in joint, not a previously affected joint (at baseline or during study) •Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Patients did not meet criterion of having new gout flare if: • Increasing/renewed gout pain in an affected joint before flare has resolved completely. (NCT01080131)
Timeframe: Baseline to 12 weeks

InterventionDays (Median)
Canakinumab 150 mgNA
Triamcinolone Acetonide 40 mgNA

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Time to the First New Gout Flare During 24 Weeks

"Kaplan-Meier (KM) estimates of the time to first new flare and confidence intervals were determined. Participants met the definition of a new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely." (NCT01080131)
Timeframe: From randomization to the end of the first extension period (24 weeks).

Interventiondays (Median)
Canakinumab 150 mgNA
Triamcinolone Acetonide 40 mg146

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Amount of Rescue Medication Taken

"Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare." (NCT01080131)
Timeframe: For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).

,
Interventionmg (Mean)
Baseline flare: Acetaminophen [N=112, 114]Baseline flare: Codeine [N=112, 114]Baseline flare: Prednisone/Predinisone [N=112,114]Last flare: Acetaminophen [N=25, 46]Last flare: Codeine [N= 25, 46]Last flare: Prednisolone/Predinisone [N= 25, 46]
Canakinumab 150 mg1375.027.29.22292.064.85.6
Triamcinolone Acetonide 40 mg2526.560.619.31541.365.218.3

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High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels

High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analyses were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates. (NCT01080131)
Timeframe: 72 hours after the first dose for the baseline flare and 72 hours post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).

,
Interventionmg/L (Least Squares Mean)
Baseline flare: hsCRP [N=107, 110]Baseline flare: SAA [N=95, 104]Last post-baseline flare: hsCRP [N= 22, 42]Last post-baseline flare: SAA, [N= 19, 39]
Canakinumab 150 mg3.846.313.696.74
Triamcinolone Acetonide 40 mg6.3815.854.3211.04

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High-sensitivity C-reactive Protein (hsCRP) Levels for Participants Re-treated With or Switched to Canakinumab

"High sensitivity C-reactive protein (hsCRP) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2." (NCT01080131)
Timeframe: 24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

,
Interventionmg/L (Mean)
24-hours post-dose [N=48, 36]72-hours post-dose [N=56, 38]7 days post-dose [N=55, 40]4 weeks post-dose [N=46, 37]8 weeks post-dose [N=37, 35]12 weeks post-dose [N=38, 31]
Re-treated With Canakinumab 150 mg30.110.42.81.62.11.3
Triam Switched to Canakinumab39.412.63.52.22.42.9

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Number of Participants With Adverse Events, Death and Serious Adverse Events (72 Weeks Overall)

This was the primary endpoint of extension study 2. An adverse event was defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. (NCT01080131)
Timeframe: 72 weeks

,,,,,
Interventionparticipants (Number)
Any adverse eventDeathSerious adverse event
All Canakinumab85112
All Triamcinolone Acetonide7004
Canakinumab: After Retreatment3905
Canakinumab: Before Retreatment4401
Triam: After Switch to Canakinumab2703
Triam: Before Switch to Canakinumab2900

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Number of Participants With Adverse Events, Death and Serious Adverse Events During 24 Weeks

This was primary endpoint of extension study 1. Adverse event is defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. A serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. (NCT01080131)
Timeframe: During 24 weeks overall

,
InterventionParticipants (Number)
Adverse eventDeathSerious adverse event
Canakinumab 150 mg7817
Triamcinolone Acetonide 40 mg6502

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Patient's Assessment of Gout Pain Intensity for Participants Re-treated or Switched to Canakinumab

"Participants scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe or extreme).~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2." (NCT01080131)
Timeframe: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

,
Interventionpercentage of participants (Number)
72 hours - None [N=59, 40]72 hours - Mild [N=59, 40]72 hours - Moderate [N=59, 40]72 hours - Severe [N=59, 40]72 hours - Extreme [N=59, 40]7 days - None [N=57, 37]7 days - Mild [N=57, 37]7 days - Moderate [N=57, 37]7 days - Severe [N=57, 37]7 days - Extreme [N=57, 37]
Re-treated With Canakinumab 150 mg30.544.122.03.40.064.921.110.53.50.0
Triam Switched to Canakinumab25.062.512.50.00.059.535.15.40.00.0

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Patient's Assessment of Gout Pain Intensity in the Most Affected Joint

Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). (NCT01080131)
Timeframe: 72 hours post-dose and 24 weeks post-dose

,
Interventionpercentage of participants (Number)
72 hours - None [N=108, 111]72 hours - Mild [N=108, 111]72 hours - Moderate [N=108, 111]72 hours - Severe [N=108, 111]72 hours - Extreme [N=108, 111]24 weeks - None [N=79, 70]24 weeks - Mild [N=79, 70]24 weeks - Moderate [N=79, 70]24 weeks - Severe [N=79, 70]24 weeks - Extreme [N=79, 70]
Canakinumab 150 mg30.648.120.40.90.072.219.06.32.50.0
Triamcinolone Acetonide 40 mg18.045.027.08.11.867.125.77.10.00.0

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Patient's Global Assessment of Response to Treatment

Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. The percentage of participants in each category is reported. (NCT01080131)
Timeframe: 72 hours post-dose and 24 weeks post-dose

,
Interventionpercentage of participants (Number)
72 hours - Excellent [N=108, 108]72 hours - Good [N=108, 108]72 hours - Acceptable [N=108, 108]72 hours - Slight [N=108, 108]72 hours - Poor [N=108, 108]24 weeks - Excellent [N=79, 72]24 weeks - Good [N=79, 72]24 weeks - Acceptable [N=79, 72]24 weeks - Slight [N=79, 72]24 weeks - Poor [N=79, 72]
Canakinumab 150 mg36.137.018.54.63.759.526.66.36.31.3
Triamcinolone Acetonide 40 mg19.432.413.925.09.340.344.413.91.40.0

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Patient's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab

Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight or poor. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2. (NCT01080131)
Timeframe: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

,
Interventionpercentage of participants (Number)
72 hours - Excellent [N=58, 38]72 hours - Good [N=58, 38]72 hours - Acceptable [N=58, 38]72 hours - Slight [N=58, 38]72 hours - Poor [N=58, 38]7 days - Excellent [N=56, 39]7 days - Good [N=56, 39]7 days - Acceptable [N=56, 39]7 days - Slight [N=56, 39]7 days - Poor [N=56, 39]
Re-treated With Canakinumab 150 mg41.432.812.113.80.051.826.810.77.13.6
Triam Switched to Canakinumab36.839.521.12.60.051.333.37.77.70.0

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Percentage of Participants Who Took Rescue Medication

"Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.~Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication." (NCT01080131)
Timeframe: For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).

,
Interventionpercentage of participants (Number)
Baseline flare [N= 112, 114]Last post-baseline flare [N=25, 46]
Canakinumab 150 mg43.856.0
Triamcinolone Acetonide 40 mg57.041.3

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Percentage of Patients With Maximum Severity of New Gout Flares as Severe or Extreme

For each new flare, participants scored the maximum amount of acute gout pain in the most affected joint since the onset of the new flare and the time they were re-dosed on a 5 point Likert scale as None, Mild, Moderate, Severe or Extreme. The percentage of participants with a maximum new flare severity of severe or extreme is reported for the first post-baseline flare that occurred during the 12-week core study and for the last post-baseline flare that occurred up until the end of the first extension period. (NCT01080131)
Timeframe: From the onset of a new flare until re-dosing. First post-baseline new flare during 12 week core study and the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).

,
InterventionPercentage of participants (Number)
First post-baseline flare [N= 12, 37]Last post-baseline flare [N= 25, 46]
Canakinumab 150 mg66.764.0
Triamcinolone Acetonide 40 mg78.478.3

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Physician's Assessment of Erythema for Participants Re-treated or Switched to Canakinumab

"The study physician assessed the most affected joint for erythema (redness of the skin) as either present, absent or not assessable.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2." (NCT01080131)
Timeframe: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

,
Interventionpercentage of participants (Number)
72 hours - Absent [N=56, 38]72 hours - Present [N=56, 38]7 days - Absent [N=58, 39]7 days - Present [N=58, 39]
Re-treated With Canakinumab 150 mg73.226.884.515.5
Triam Switched to Canakinumab92.17.994.95.1

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Physician's Assessment of Joint Swelling for Participants Re-treated or Switched to Canakinumab

"The study physician assessed the most affected joint for swelling on the following 4-point scale:~no swelling;~palpable;~visible;~bulging beyond the joint margins.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2." (NCT01080131)
Timeframe: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

,
Interventionpercentage of participants (Number)
72 hours - No swelling [N=56, 38]72 hours - Palpable [N=56, 38]72 hours - Visible [N=56, 38]72 hours - Bulging beyond joint margins [N=56, 38]7 days - No swelling [N=58, 39]7 days - Palpable [N=58, 39]7 days - Visible [N=58, 39]7 days - Bulging beyond joint margins [N=58, 39]
Re-treated With Canakinumab 150 mg55.426.812.55.470.717.210.31.7
Triam Switched to Canakinumab47.434.215.82.679.517.92.60.0

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Physician's Assessment of Joint Tenderness for Participants Re-treated or Switched to Canakinumab

"The study physician assessed the most affected joint for tenderness on the following 4-point scale:~no pain;~participant states that there is pain;~participant states there is pain and winces;~participant states there is pain, winces and withdraws on palpation or passive movement of the affected study joint.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2." (NCT01080131)
Timeframe: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

,
Interventionpercentage of participants (Number)
72 hours - No pain [N=56, 38]72 hours - Pain [N=56, 38]72 hours - Pain and winces [N=56, 38]72 hours - Pain, winces and withdraws [N=56, 38]7 days - No pain [N=58, 39]7 days - Pain [N=58, 39]7 days - Pain and winces [N=58, 39]7 days - Pain, winces and withdraws [N=58, 39]
Re-treated With Canakinumab 150 mg51.837.55.45.474.122.43.40.0
Triam Switched to Canakinumab42.150.05.32.679.520.50.00.0

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The Percent of Days of Rescue Medication Use During the Double-blind Treatment Phase

The percent of days of rescue medication used during the double-blind treatment phase was calculated. For participants who did not use any rescue medication, the percentage of days using rescue medication was set to be 0. (NCT01154153)
Timeframe: From randomization to 43-50 days postrandomization

InterventionPercentage of days (Mean)
Placebo4.02
TAA-AQ3.07

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Number of Participants Using Rescue Medication

The number of participants using the rescue medication (Claritin®) during the single-blind screening phase (the time from 8-24 days before randomization up to the day before randomization) and during the double-blind treatment phase (the time from randomization to end of study). (NCT01154153)
Timeframe: From 8 to 24 days prerandomization and randomization to end of study (43-50 days postrandomization)

,
InterventionParticipants (Number)
Prerandomization periodPostrandomization period
Placebo824
TAA-AQ819

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Number of Participants by Relief Level as Evaluated by the Physician

Efficacy of treatment was assessed by the physician using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present). (NCT01154153)
Timeframe: At end of study (43-50 days after randomization)

,
InterventionParticipants (Number)
Relief Level 0 (No relief)Relief Level 1 (Slight relief)Relief Level 2 (Moderate relief)Relief Level 3 (Marked relief)Relief Level 4 (Complete relief)
Placebo111816133
TAA-AQ91320176

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Number of Participants by Relief Level as Evaluated by the Participant

Efficacy of treatment was assessed by the participant using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present). (NCT01154153)
Timeframe: At end of study (43-50 days after randomization)

,
InterventionParticipants (Number)
Relief level 0 (No relief)Relief level 1 (Slight relief)Relief level 2 (Moderate relief)Relief level 3 (Marked relief)Relief level 4 (Complete relief)
Placebo91716145
TAA-AQ52213169

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Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline

"Blood samples were collected over a 24-hour period (at 0, 2, 4, 8, 12, 20, and 24 hours), with 0 hour being between 8:00AM to 9:00AM, immediately prior to investigational product (IP) administration. AUC (0-24hr) was calculated using the trapezoid rule, and was normalized by dividing the AUC(0-24 hr) by the actual sample collection interval between 0-hour and 24-hour blood draw times.~Ratio in Serum Cortisol AUC(0-24 hr) = (Serum Cortisol AUC[0-24 hr] at 6 weeks postrandomization)/(Serum Cortisol AUC[0-24 hr] at 1-3 days prerandomization). Log transformation was used for the analysis." (NCT01154153)
Timeframe: 1-3 days prerandomization and 6 weeks postrandomization

InterventionRatio (Geometric Mean)
Placebo0.938
TAA-AQ0.898

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Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)

"Every morning, participants rated the severity of symptoms experienced over the previous 24 hours using scale from 0-3, where 0=symptoms absent, 1=mild, 2=moderate, and 3=severe symptoms (interfere with daily living or sleep) for each symptom (nasal congestion, nasal itching, sneezing, and runny nose). The rTNSS was the sum of the individual symptom scores, ranged from 0-12 (where 12 reflected the worst symptoms).~Change from baseline in the rTNSS = mean rTNSS (double-blind treatment phase) - mean rTNSS (screening phase)." (NCT01154153)
Timeframe: From 8-24 days prerandomization up to 6 weeks postrandomization

InterventionScore on a scale (Mean)
Placebo-0.22
TAA-AQ-1.07

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To Assess the Safety & Tolerability of 20089 TA (6.9 mg or 13.8 mg) When Used Adjunctively With Lucentis 0.5 mg in Subjects With Sub-foveal Neovascular AMD

"The primary objective is to assess the ocular safety of 20089 TA (6.9 mg or 13.8 mg)treatment in combination with Lucentis.~The ocular safety endpoints to be assessed include the number of participants with ocular Adverse Events such as: evidence of endophthalmitis, uveitis, ocular hemorrhage, retinal tear or detachment to be assessed during ophthalmic examinations. Elevated IOP as measured by an applanation tonometer at every visit." (NCT01175395)
Timeframe: 360 Days

InterventionNumber-participants with adverse events (Number)
IBI-20089/Lucentis0

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To Determine the Number of Retreatments With Lucentis in Eyes Initially Treated With 20089 TA and Lucentis

Because of the combination - 20089/Lucentis - treatment, patients may not require monthly Lucentis injections as is the current standard of care practice for AMD. (NCT01175395)
Timeframe: 30 to 360 days

Interventionretreatments (Median)
IBI-20089/Lucentis2

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Change in Area of Denudation Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).

Change in area of denudation measured on knee MRI in the index compartment (compartment with the most damage). Missing data were imputed. (NCT01230424)
Timeframe: Baseline to 2 years

Interventionmm^2 (Mean)
Triamcinolone Acetonide0.4
Sodium Chloride0.4

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Change in Volumetric Cartilage Damage Index (CDI) Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).

Change in volumetric cartilage damage index (CDI) measured on knee MRI in the index compartment (compartment with the most damage). Missing data were imputed. (NCT01230424)
Timeframe: Baseline to 2 years

Interventionmm^3 (Mean)
Triamcinolone Acetonide-133.7
Sodium Chloride-72.4

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Change in Volume of Peri-articular Bone Marrow Lesions Measured on Knee MRI.

Change in volume of peri-articular bone marrow lesions measured on knee MRI on the log scale. Missing data were imputed. (NCT01230424)
Timeframe: Baseline to 2 years.

Interventionlog mm^3 (Mean)
Triamcinolone Acetonide0.9
Sodium Chloride1.1

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Change in Time to Complete a Twenty-meter Walk.

Change in time (seconds) to complete a twenty-meter walk. Missing data were imputed. (NCT01230424)
Timeframe: Baseline to 2 years

Interventionseconds (Mean)
Triamcinolone Acetonide-0.3
Sodium Chloride0.1

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Change in Effusion Volume Measured on Knee MRI.

Change in effusion volume measured on knee MRI on the log scale. Missing data were imputed. (NCT01230424)
Timeframe: Baseline to 2 years

Interventionlog mm^3 (Mean)
Triamcinolone Acetonide-0.1
Sodium Chloride-0.3

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Change in Time to Complete 5 Chair Stands.

Change in time (seconds) to complete 5 chair stands. Missing data were imputed. (NCT01230424)
Timeframe: Baseline to 2 years

Interventionseconds (Mean)
Triamcinolone Acetonide-1.1
Sodium Chloride-1.2

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Change in Patient's Global Assessment (Visual Analogue Scale).

"The response to the question, Considering all the ways your knee affects you, how much pain are you having today?, was measured and the change in the scoring was evaluated. The Patient's Global Assessment (PGA) is measured on a scale of 0 to 100 millimeters. Higher scores represent a higher level of disease activity or a worse global health. Missing data were imputed." (NCT01230424)
Timeframe: Baseline to 2 years

Interventionmm (Mean)
Triamcinolone Acetonide-2.7
Sodium Chloride-7.6

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Change in Mean Cartilage Thickness in the Index Compartment (Compartment With the Most Damage)

Mean cartilage thickness was measured on knee MRI (Philips Achieva X-Series 3.0 Tesla scanner). Missing data were imputed. (NCT01230424)
Timeframe: Baseline to 2 years

Interventionmm (Mean)
Triamcinolone Acetonide 40mg-0.21
0.9% Sodium Chloride-0.10

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Change in Knee Stiffness During the Past 48 Hours From the WOMAC LK3.1 Stiffness Score Questionnaire.

"Stiffness subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Stiffness subscale score was used for this outcome measure. The Stiffness subscale consists of two items, each ranging from 0 to 4, making the total Stiffness subscore 0 to 8. Higher scores represent higher levels of stiffness, whereas lower scores represent lower levels of stiffness.~Missing data were imputed." (NCT01230424)
Timeframe: Baseline to 2 years

Interventionunits on a scale (Mean)
Triamcinolone Acetonide-0.6
Sodium Chloride-0.5

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Change in Knee Pain Severity During the Past 48 Hours From the WOMAC LK3.1 Pain Score Questionnaire.

"Pain subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Pain subscale score was used for this outcome measure. The Pain subscale consists of five items, each ranging from 0 to 4, making the total Pain subscore 0 to 20. Higher scores represent higher levels of pain, whereas lower scores represent lower levels of pain.~Missing data were imputed." (NCT01230424)
Timeframe: Baseline to 2 years

Interventionunits on a scale (Mean)
Triamcinolone Acetonide-1.2
Sodium Chloride-1.9

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Change in Function Severity During the Past 48 Hours From the WOMAC LK3.1 Function Score Questionnaire.

"Physical Function subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Physical Function subscale score was used for this outcome measure. The Physical Function subscale consists of 17 items, each ranging from 0 to 4, making the total Function subscore 0 to 68. Higher scores represent higher levels of difficulty performing daily activities, whereas lower scores represent lower levels of difficulty performing daily activities.~Missing data were imputed." (NCT01230424)
Timeframe: Baseline to 2 years

Interventionunits on a scale (Mean)
Triamcinolone Acetonide-4.1
Sodium Chloride-5.1

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Physician's Assessment of Tenderness

"The study physician assessed the most affected joint for tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 0 = no pain, 1 = patient states that there is pain, 2 = patient states there is pain and winces and 3 = patient states there is pain, winces and withdraws on palpation or passive movement of the affected study joint." (NCT01356602)
Timeframe: 72 hours

,,
InterventionPercentage of Participants (Number)
No painThere is painThere is pain and wincesThere is pain, winces and withdraws
Canakinumab, Lyophilizate (LYO)40.052.86.40.8
Canakinumab, Pre-filled Syringes (PFS)50.043.15.41.5
Triamcinolone Acetonide29.847.114.09.1

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Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale

A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor). (NCT01356602)
Timeframe: 72 hours

,,
InterventionPercentage of Participants (Number)
Very goodGoodFairPoorVery poor
Canakinumab, Lyophilizate (LYO)33.648.816.01.60.0
Canakinumab, Pre-filled Syringes (PFS)46.235.415.41.51.5
Triamcinolone Acetonide21.533.923.114.07.4

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Time to First Rescue Medication Intake

Patients used a diary to record the time of intake of rescue medication and the amount taken. (NCT01356602)
Timeframe: 14 days

InterventionHours (Median)
Canakinumab, Pre-filled Syringes (PFS)11
Canakinumab, Lyophilizate (LYO)7.5
Triamcinolone Acetonide11

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C-reactive Protein Level

A central laboratory was used for analysis of all blood samples collected. (NCT01356602)
Timeframe: 72 hours

Interventionmg / L (Least Squares Mean)
Canakinumab, Pre-filled Syringes (PFS)3.65
Canakinumab, Lyophilizate (LYO)3.37
Triamcinolone Acetonide5.2

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Number of Patients With at Least One New Gouty Arthritis Flare After Baseline

Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. (NCT01356602)
Timeframe: 12 weeks

InterventionParticpants (Number)
Canakinumab, Pre-filled Syringes (PFS)12
Canakinumab, Lyophilizate (LYO)12
Triamcinolone Acetonide52

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Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups

The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method. (NCT01356602)
Timeframe: 72 hours post dose

InterventionMillimeters (Least Squares Mean)
Canakinumab, Pre-filled Syringes (PFS)17.1
Canakinumab, Lyophilizate (LYO)19.7

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Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups

The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method. (NCT01356602)
Timeframe: 72 hours post dose

InterventionMillimeters (Least Squares Mean)
Canakinumab, Pre-filled Syringes (PFS)17.1
Triamcinolone Acetonide32

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Patient's Assessment of Pain Intensity on a 0-100mm VAS

The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity VAS measurements up to 14 days. (NCT01356602)
Timeframe: 14 days

InterventionMillimeters (Least Squares Mean)
Canakinumab, Pre-filled Syringes (PFS)7.9
Canakinumab, Lyophilizate (LYO)8.2
Triamcinolone Acetonide14.8

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Proportion of Patients With Rescue Medication Intake

Patients used a diary to record the time of intake of rescue medication and the amount taken. (NCT01356602)
Timeframe: 12 weeks

InterventionPercentage of Particpants (Number)
Canakinumab, Pre-filled Syringes (PFS)29.0
Canakinumab, Lyophilizate (LYO)31.8
Triamcinolone Acetonide45.7

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Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS

The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported. (NCT01356602)
Timeframe: 14 days

InterventionHours (Median)
Canakinumab, Pre-filled Syringes (PFS)24
Canakinumab, Lyophilizate (LYO)25
Triamcinolone Acetonide48

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Time to the First New Gouty Arthritis Flare

Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated. (NCT01356602)
Timeframe: 12 weeks

InterventionDays (Median)
Canakinumab, Pre-filled Syringes (PFS)NA
Canakinumab, Lyophilizate (LYO)NA
Triamcinolone AcetonideNA

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Time to Resolution of Gouty Arthritis Flare as Reported by Patient

Patients completed diary entries at 6, 12, 24, 48 and 72 hours post dose and then daily up to 7 days post-dose and/or daily until resolution of the flare. Kaplan Meier estimate of time to resolution of gouty flare as reported by patient, along with associated 95% confiedence interval, were reported. (NCT01356602)
Timeframe: 14 days

InterventionHours (Median)
Canakinumab, Pre-filled Syringes (PFS)142
Canakinumab, Lyophilizate (LYO)120
Triamcinolone Acetonide170

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Amount of Rescue Medication Taken (mg)

Patients used a diary to record the time of intake of rescue medication and the amount taken. (NCT01356602)
Timeframe: 14 days

,,
Interventionmilligrams (mg) (Mean)
AcetaminophenCodeinePrednisolone / Prednisone
Canakinumab, Lyophilizate (LYO)1108.323.96.7
Canakinumab, Pre-filled Syringes (PFS)609.212.75.8
Triamcinolone Acetonide2323.160.824.7

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Patient's Assessment of Pain Intensity on a 5-point Likert Scale

A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days. (NCT01356602)
Timeframe: 72 hours

,,
InterventionPercentage of Patients (Number)
NoneMildModerateSevereExtreme
Canakinumab, Lyophilizate (LYO)32.644.221.71.60
Canakinumab, Pre-filled Syringes (PFS)35.945.815.32.30.8
Triamcinolone Acetonide23.436.721.914.13.9

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Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale

A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their response to treatment on a 5-point Likert scale (excellent, good, acceptable, slight, poor). This outcome measure shows the number of patients indicating each score on the scale. (NCT01356602)
Timeframe: 72 hours

,,
InterventionPercentage of Participants (Number)
ExcellentGoodAcceptableSlightPoor
Canakinumab, Lyophilizate (LYO)34.836.520.07.80.9
Canakinumab, Pre-filled Syringes (PFS)36.043.210.46.44.0
Triamcinolone Acetonide20.431.921.214.212.4

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Physician's Assessment of Erythema

The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable. (NCT01356602)
Timeframe: 72 hours

,,
InterventionPercentage of Participants (Number)
AbsentPresent
Canakinumab, Lyophilizate (LYO)82.917.1
Canakinumab, Pre-filled Syringes (PFS)88.311.7
Triamcinolone Acetonide68.631.4

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Physician's Assessment of Range of Motion of the Most Affected Joint

The study physician assessed the patient's range of motion of the most affected joint on a 5 point Likert scale (normal, mildly restricted, moderately restricted, severely restricted and immobilized). (NCT01356602)
Timeframe: 72 hours

,,
InterventionPercentage of Participants (Number)
NormalMildly restrictedModerately restrictedSeverely restrictedImmobilized
Canakinumab, Lyophilizate (LYO)44.840.812.02.40.0
Canakinumab, Pre-filled Syringes (PFS)50.037.711.50.80.0
Triamcinolone Acetonide35.537.214.012.40.8

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Physician's Assessment of Swelling

The study physician assessed the most affected joint for swelling. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins. (NCT01356602)
Timeframe: 72 hours

,,
InterventionPercentage of Partipants (Number)
No swellingPalpableVisibleBulging beyond the joint margins
Canakinumab, Lyophilizate (LYO)55.225.617.61.6
Canakinumab, Pre-filled Syringes (PFS)60.826.910.81.5
Triamcinolone Acetonide51.215.724.88.3

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Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment

Physicians will score their response of erythema on a 4-point Likert scale (absent, present not assessed and not assessable). (NCT01362608)
Timeframe: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose

,
Interventionparticipants (Number)
Baseline AbsentBaseline presentBaseline not assessedBaseline not assessable72 hours post-dose absent72 hours post-dose present72 hours post-dose not assessed72 hrs post-dose not assessable7 days post-dose absent7 days post-dose present7 days post-dose not assessed7 days post-dose not assessable4 weeks post-dose absent4 weeks post-dose present4 weeks post-dose not assessed4 weeks post-dose not assessable8 weeks post-dose absent8 weeks post-dose present8 weeks post-dose not assessed8 weeks post-dose not assessable12 weeks post-dose absent12 weeks post-dose present12 weeks post-dose not assessed12 wks post-dose not assessable
ACZ885 150 mg19480054110162301631016500062101
Triamcinolone Acetonide 40 mg19500041150057800496005630061100

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Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment

Physicians will score their response ofrange of motion on a 5-point Likert scale (normal,mildly restricted, moderately restricted, severely restricted and immolbilized). (NCT01362608)
Timeframe: baseline through week 12

,
Interventionparticipants (Number)
baseline normalbaseline mildly restrictedbaseline moderately restrictedbaseline severely restrictedbaseline immobilzed72 hours post-dose normal72 hours post-dose mildly restricted72 hours post-dose moderately restricted72 hours post-dose severely restricted72 hours post-dose immobilized7 days post-dose normal7 days post-dose mildly restricted7 days post-dose moderately restricted7 days post-dose severely restricted7 days post-dose immobilized4 weeks post-dose normal4 weeks post-dose mildly restricted4 weeks post-dose moderately restricted4 weeks post-dose severely restricted4 weeks post-dose immobilized8 weeks post-dose normal8 weeks post-dose mildly restricted8 weeks post-dose moderately restricted8 weeks post-dose severely restricted8 weeks post-dose immobilized12 weeks post-dose normal12 weeks post-dose mildly restrcted12 weeks post-dose moderately restricted12 weeks post-dose severely restricted12 weeks post-dose immobilized
ACZ885 150 mg033227520331120352541049123105112110501210
Triamcinolone Acetonide 40 mg06243901519147126201531252271032186303023630

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Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment

Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed). (NCT01362608)
Timeframe: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose

,
Interventionparticipants (Number)
Baseline no painBaseline painBaseline pain and wincesBaseline pain, winces and withdrawsBaseline not assessed72 hours post-dose no pain72 hours post-dose pain72 hours post-dose pain and winces72 hours post-dose pain, winces and withdraws72 hours post-dose not assessed7 days post-dose no pain7 days post-dose pain7 days post-dose pain and winces7 days post-dose pain , winces and withdraws7 days post-dose not assessed4 weeks post-dose no pain4 weeks post-dose pain4 weeks post-dose pain and winces4 weeks post-dose pain, winces and withdraws4 weeks post-dose not assessed8 weeks post-dose no pain8 weeks post-dose pain8 weeks post-dose pain and winces8 weeks post-dose pain winces and withdraws8 weeks post-dose not assessed12 weeks post-dose no pain12 weeks post-dose pain12 weeks post-dose pain and winces12 weeks post-dose pain, winces and withdraws12 weeks post-dose not assessed
ACZ885 150 mg015312102337510412320054101005411000537220
Triamcinolone Acetonide 40 mg016292401626113026271020301933038191103922100

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Percent Patients Who Took Rescue Medication

(NCT01362608)
Timeframe: 12 weeks

,
Interventionpercentage (Number)
Baseline flare (n= 29,42)Last post-baseline flare (n=3,4)
ACZ885 150 mg43.375.0
Triamcinolone Acetonide 40 mg60.944.4

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The Number of Patients With at Least 1 New Gout Flare

(NCT01362608)
Timeframe: 12 weeks

,
Interventionparticipants (Number)
1 new flare2 new flares3 new flares> 3 new flares
ACZ885 150 mg3002
Triamcinolone Acetonide 40 mg15101

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High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose

(NCT01362608)
Timeframe: 72 hours post dose

Interventionmg/L (Mean)
ACZ885 150 mg5.5
Triamcinolone Acetonide 40 mg7.2

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Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment

Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed). (NCT01362608)
Timeframe: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose

,
Interventionparticipants (Number)
Baseline No swellingBaseline PalpableBaseline VisibleBaseline Bulging beyond the joint marginsBaseline not assessed72 hours post-dose No swelling72 hours post-dose Palpable72 hours post-dose Visible72 hrs post-dose Bulging beyond the joint margins72 hours post-dose not assessed7 days post-dose No swelling7 days post-dose Palpable7 days post-dose Visible7 days post-dose Bulging beyond the joint margins7 days post-dose not assessed04 weeks post-dose No swelling4 weeks post-dose Palpable4 weeks post-dose Visible4 weeks post-dose Bulging beyond the joint margins4 weeks post-dose not assessed8 weeks post-dose No swelling8 weeks post-dose Palpable8 weeks post-dose Visible8 weeks post-dose Bulging beyond the joint margins8 weeks post-dose not assessed12 weeks post-dose No swelling12 weeks post-dose Palpable12 weeks post-dose Visible12 wks post-dose Bulging beyond the joint margins12 weeks post-dose not assessed
ACZ885 150 mg1132924038151210539310602300630200611200
Triamcinolone Acetonide 40 mg31239150221518103518930409420496400526220

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Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment

A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm) (NCT01362608)
Timeframe: baseline through 12 weeks

,
Interventionunit on a scale (Mean)
baseline6 hours post-dose12 hours post-dose24 hours post-dose48 hours post-dose72 hours post-dose7 days post-dose4 weeks post-dose8 weeks post-dose12 weeks post-dose
ACZ885 150 mg72.353.041.730.922.017.410.19.56.86.8
Triamcinolone Acetonide 40 mg74.558.851.848.643.936.624.017.916.013.0

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Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.

Patients will score their response to pain on a 7-point Likert scale (excellent, good ,acceptable, slight,poor,very poor,not done). (NCT01362608)
Timeframe: 72 hours through week 12

,
Interventionparticipants (Number)
72 hours post-dose excellent72 hours post-dose good72 hours post-dose acceptable72 hours post-dose slight72 hours post-dose poor72 hours post-dose very poor72 hours post-dose not done7 days post-dose excellent7 days post-dose good7 days post-dose acceptable7 days post-dose slight7 days post-dose poor7 days post-dose very poor7 days post-dose not done4 weeks post-dose excellent4 weeks post-dose good4 weeks post-dose acceptable4 weeks post-dose slight4 weeks post-dose poor4 weeks post-dose very poor4 weeks post-dose not done8 weeks post-dose excellent8 weeks post-dose good8 weeks post-dose acceptable8 weeks post-dose slight8 weeks post-dose poor8 weeks post-dose very poor8 weeks post-dose not done12 weeks post-dose excellent12 weeks post-dose good12 weeks post-dose acceptable12 weeks post-dose slight12 weeks post-dose poor12 weeks post-dose very poor12 weeks post-dose not done
ACZ885 150 mg740144100163891100153313400018351020001637100103
Triamcinolone Acetonide 40 mg317181110014201871601619147902816189801421217903

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Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment

Patients will score their current pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). (NCT01362608)
Timeframe: baseline through week 12

,
Interventionparticipants (Number)
baseline nonebaseline mildbaseline moderatebaseline severebaseline extreme6 hours post-dose none6 hours post-dose mild6 hours post-dose moderate6 hours post-dose severe6 hours post-dose extreme12 hours post-dose none12 hours post-dose mild12 hours post-dose moderate12 hours post-dose severe12 hours post-dose extreme24 hours post-dose none24 hours post-dose mild24 hours post-dose moderate24 hours post-dose severe24 hours post-dose extreme48 hours post-dose none48 hours post-dose mild48 hours post-dose moderate48 hours post-dose severe48 hours post-dose extreme72 hours post-dose none72 hours post-dose mild72 hours post-dose moderate72 hours post-dose severe72 hours post-dose extreme4 days post-dose none4 days post-dose mild4 days post-dose moderate4 days post-dose severe4 days post-dose extreme7 days post-dose none7 days post-dose mild7 days post-dose moderate7 days post-dose severe7 days post-dose extreme4 weeks post-dose none4 weeks post-dose mild4 weeks post-dose moderate4 weeks post-dose severe4 weeks post-dose extreme8 weeks post-dose none8 weeks post-dose mild8 weeks post-dose moderate8 weeks post-dose severe8 weeks post-dose extreme12 weeks post-dose none12 weeks post-dose mild12 weeks post-dose moderate12 weeks post-dose severe12 weeks post-dose extreme
ACZ885 150 mg022537301828172128287134019211048720144580021397003229510431741039222204118320
Triamcinolone Acetonide 40 mg03184440142629021926211420252001021201421226169414291310023251080242560030216202528811

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Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.

Paracetamol / acetaminophen, Prednisolone and Prednisone taken at baseline flare and post baseline flare. (NCT01362608)
Timeframe: 12 weeks

,
Interventionmg (Mean)
Baseline flare Paracetamol / acetaminophenBaseline flare PrednisololBaseline Flare PrednisoneBaseline flare CodeineLast post-baseline flare Paraceta/acetamin n=4,9Last post-baseline flare Prednisolone n=4,9Last post-baseline flare Prednisone n=4,9
ACZ885 150 mg342.51.10.70.0287.55.00.0
Triamcinolone Acetonide 40 mg451.45.05.20.4222.24.40.6

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Time to First Rescue Medication Intake

(NCT01362608)
Timeframe: 12 weeks

Interventionhours (Mean)
ACZ885 150 mg31.8
Triamcinolone Acetonide 40 mg41.5

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Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis

Measure canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks (NCT01362608)
Timeframe: 12 weeks

InterventionParticipants (Number)
ACZ885 150 mg5
Triamcinolone Acetonide 40 mg17

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Time to Complete Resolution of Pain: Survival Analysis by Treatment

Kaplan Meier estimate (NCT01362608)
Timeframe: 12 weeks

Interventionhours (Median)
ACZ885 150 mg168.0
Triamcinolone Acetonide 40 mg168.0

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Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment

Kaplan Meier estimate (NCT01362608)
Timeframe: 12 weeks

Interventionhours (Median)
ACZ885 150 mg24.0
Triamcinolone Acetonide 40 mg48.0

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The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)

A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm) (NCT01362608)
Timeframe: at 72 hours post-dose

Interventionunits on a scale (Least Squares Mean)
ACZ885 150 mg18.2
Triamcinolone Acetonide 40 mg37.9

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Patient's Assessment of Gout Pain Intensity in the Most Affected Joint

Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none or mild). (NCT01470989)
Timeframe: up to 7 days post-dose

,
InterventionParticipants (Count of Participants)
Baseline FlareLast New Flare
Canakinumab Retreatment102104
Triamcinolone Acetonide- Randomized to Canakinumab Treatment7269

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Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants

Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline,or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. (NCT01470989)
Timeframe: From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)

,
InterventionIR/100 patient-years (Number)
Adverse EventsNon Fatal SAEsDeath
Canakinumab 150 mg873592
Triamcinolone Acetonide 40 mg451252

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Number of New Flares Per Participant

Flare rate was calculated as the number of new flares over the period of observation in years. New flares occurred before first study medication dose in extension 3 study were considered. (NCT01470989)
Timeframe: From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)

Interventionflares (Mean)
Canakinumab 150 mg1.109
Triamcinolone Acetonide 40 mg2.459

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Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT01487161)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
FX006 60 mg-3.9
TCA IR 40 mg-3.4

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Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.

(NCT01487161)
Timeframe: 8 weeks

Interventiontablets (1tablet= 500 mg) (Least Squares Mean)
FX006 10 mg1.0
FX006 40 mg1.0
FX006 60 mg1.1
TCA IR 40 mg1.2

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WOMAC C (Function Subscale) Change From Baseline at Week 8

The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT01487161)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
FX006 10 mg-1.22
FX006 40 mg-1.31
FX006 60 mg-1.13
TCA IR 40 mg-0.94

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Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT01487161)
Timeframe: 10 weeks

Interventionunits on a scale (Least Squares Mean)
FX006 60 mg-3.6
TCA IR 40 mg-3.3

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Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT01487161)
Timeframe: Weeks 8, 10 and 12

,,
Interventionunits on a scale (Least Squares Mean)
8 Weeks10 Weeks12 Weeks
FX006 10 mg-3.9-3.8-3.6
FX006 40 mg-4.3-4.1-3.7
TCA IR 40 mg-3.4-3.3-3.3

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Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT01487161)
Timeframe: Weeks 1-7 and Week 9 and 11

,,,
Interventionunits on a scale (Least Squares Mean)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 9Week 11
FX006 10 mg-2.7-3.6-3.7-3.8-3.9-4.0-3.9-3.8-3.7
FX006 40 mg-3.0-3.9-4.1-4.3-4.3-4.3-4.4-4.2-3.9
FX006 60 mg-3.0-3.8-4.2-4.2-4.2-4.2-3.9-3.7-3.2
TCA IR 40 mg-3.1-3.5-3.5-3.7-3.5-3.4-3.3-3.3-3.4

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WOMAC B (Stiffness Subscale) Change From Baseline at Week 8

The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT01487161)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
FX006 10 mg-1.37
FX006 40 mg-1.49
FX006 60 mg-1.24
TCA IR (40 mg)-0.99

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WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8

The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT01487161)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
FX006 10 mg-1.2
FX006 40 mg-1.2
FX006 60 mg-1.1
TCA IR 40 mg-0.8

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WOMAC A (Pain Subscale) Change From Baseline at Week 8

The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT01487161)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
FX006 10 mg-1.23
FX006 40 mg-1.33
FX006 60 mg-1.16
TCA IR 40 mg-0.96

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Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT01487161)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
FX006 10 mg35
FX006 40 mg40
FX006 60 mg34
TCA IR 40 mg23

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Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT01487161)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
FX006 10 mg42
FX006 40 mg47
FX006 60 mg45
TCA IR 40 mg27

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Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT01487161)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
FX006 10 mg47
FX006 40 mg49
FX006 60 mg48
TCA IR 40 mg30

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Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT01487161)
Timeframe: 12 weeks

Interventionunits on a scale (Least Squares Mean)
FX006 60 mg-3.2
TCA IR 40 mg-3.3

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Percent of Responders According to OMERACT-OARSI Criteria at Week 8

Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. Responders are defined as participants with high improvement in pain or function. (NCT01487161)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
FX006 10 mg52
FX006 40 mg53
FX006 60 mg47
TCA IR 40 mg32

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Patient Global Impression of Change Scores at Week 8

The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. (NCT01487161)
Timeframe: Week 8

Interventionunits on a scale (Least Squares Mean)
FX006 10 mg1.9
FX006 40 mg1.8
FX006 60 mg2.4
TCA IR 40 mg2.5

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Clinical Global Impression of Change Scores at Week 8

The Clinical Global Impression of Change is a scale that the clinician uses to assess the participants' global function and determine if there has been an improvement or not. The clinician selects one response from the response options that gives the most accurate description of the participant's state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. (NCT01487161)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
FX006 10 mg1.9
FX006 40 mg1.8
FX006 60 mg2.5
TCA IR 40 mg2.6

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Total 24-hour Urinary Free Cortisol Excretion

(NCT01487200)
Timeframe: Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)

,,,
Interventionnmol/24h (Geometric Mean)
Day 1 to 2Day 14 to 15Day 42 to 43
FX006 10mg75.6657.1455.74
FX006 40mg29.9430.9134.62
FX006 60 mg29.3626.4651.16
TCA IR 40 mg18.7736.2236.38

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Change From Baseline in 24-hour Urinary Free Cortisol Excretion

(NCT01487200)
Timeframe: Baseline to Days 1-2, Baseline to Days 14-15 (Week 2) and Baseline to Days 42-43 (Week 6)

,,,
Interventionnmol/24h (Least Squares Mean)
Day 1 to 2Day 14 to 15Day 42 to 43
FX006 10mg47.913.07.7
FX006 40mg-43.8-42.4-38.3
FX006 60 mg-50.1-59.0-13.1
TCA IR 40 mg-58.5-14.7-21.3

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Change From Baseline in 24-hour Weighted Mean Serum Cortisol

The primary pharmacodynamic endpoint was change from baseline (pre-dose) to Day 1-2, Day 14-15 (Week 2) and Day 42-43 (Week 6) in 24-hour weighted mean serum cortisol. This is defined as AUC over the 0-24 hour measurement period divided by 24 (NCT01487200)
Timeframe: Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)

,,,
Interventionweighted mean serum cortisol (nmol/L) (Least Squares Mean)
Change from BL to Days 1 to 2Change from BL to Days 14 to 15Change in BL to Days 42 to 43
FX006 10mg-7.7-11.1-9.0
FX006 40mg-42.7-33.4-18.0
FX006 60 mg-62.2-49.5-11.8
TCA IR 40 mg-59.0-19.7-4.8

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Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol

Least square mean difference against TCA IR 40 mg (NCT01487200)
Timeframe: Baseline to Days 2, 3, 4, 5, 8, 14, 15, 22, 29, 36, 42 and 43

,,,
Interventionnmol/L (Least Squares Mean)
Day 2Day 3Day 4Day 5Day 8Day 14Day 15Day 22Day 29Day 36Day 42Day 43
FX006 10mg-30.2-24.9-13.9-12.4-29.8-7.6-24.43.3-4.5-6.4-18.3-22.1
FX006 40mg-42.3-40.8-37.1-35.1-37.4-35.5-28.1-28.5-21.1-19.5-27.0-14.9
FX006 60 mg-78.2-80.2-77.2-73.0-61.7-40.4-46.4-14.4-6.3-3.0-19.1-13.4
TCA IR 40 mg-85.4-86.2-73.1-49.8-8.6-27.3-8.3-11.30.811.7-21.43.0

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Characterize the Pharmacokinetic Profile of FX006 and TCA IR

Concentrations below the limit of quantification of 50 pg/mL were treated as 0. (NCT01487200)
Timeframe: Day 1 (1, 2, 4, 6, 8, 12 and 24 hours post dose) and Days 3, 4, 5, 8, 15, 22, 29, 36 and 43

,,,
Interventionpg/mL (Geometric Mean)
1 hour postdose2 hours postdose4 hours postdose6 hours postdose8 hours postdose12 hours postdoseDay 2 (24 hrs post dose)Day 3 (48 hrs post dose)Day 4 (72 hrs post dose)Day 5 (96 hrs post dose)Day 8 (168 hrs post dose)Day 15 (336 hrs post dose)Day 22 (504 hrs post dose)Day 29 (672 hrs post dose)Day 36 (840 hrs post dose)Day 43 (1008 hrs post dose)
FX006 10mg140.941226.058280.406261.231249.298230.506242.764233.138224.987242.533185.257113.0020.0000.0000.0000.000
FX006 40mg638.447779.819860.476814.647748.962691.962763.568743.344675.086690.857586.977365.970238.529189.4220.000138.660
FX006 60 mg862.5741164.0131251.7761182.9251227.6581127.4761309.2601294.0421270.9531252.0211070.823718.787521.843369.683246.176187.435
TCA IR 40 mg12268.83514243.60416282.65914560.88613543.42710112.8635421.8942371.7781310.061822.243235.9380.0000.0000.0000.0000.000

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Changes of Central Retinal Thickness

Changes of central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection (NCT01614509)
Timeframe: baseline, 1, 3, 6 months after injection

,
Interventionmicrometer (Mean)
at baseline1 month after injection3 months after injection6 months after injection
Combined Group468.22233.33233.22217.83
Monotherapy Group510.35291.48265.35246.48

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Additional Intravitreal Bevacizumab Injection

Comparison of the additional intravitreal bevacizumab injection of intravitreal bevacizumab monotherapy or combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab during 6 months (NCT01614509)
Timeframe: 6 months

Interventiontimes of injection (Mean)
Monotherapy Group0.96
Combined Group0.44

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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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Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-9 concentration using an immunoassay. Data will be presented as the change in MMP-9 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionng/mL (Mean)
Kenalog or Placebo-71.1
Kenalog Then Placebo-28.9
Kenalog Only-17.7
Placebo-14.0

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Synovial Interleukin-1α (IL-1α) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1α concentration using an immunoassay. Data will be presented as the change in IL-1α concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionpg/mL (Mean)
Kenalog or Placebo4.30
Kenalog Then Placebo7.68
Kenalog Only1.77
Placebo3.11

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Synovial C-terminal Peptide II (CTXII) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure CTXII concentration using an immunoassay. Data will be presented as the change in CTXII concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionng/mL (Mean)
Kenalog or Placebo0.32
Kenalog Then Placebo0.23
Kenalog Only0.19
Placebo1.32

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Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure COMP concentration using an immunoassay. Data will be presented as the change in COMP concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionμg/mL (Mean)
Kenalog or Placebo-4.9
Kenalog Then Placebo-21.7
Kenalog Only-11.7
Placebo-22.1

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Synovial Glycosaminoglycans (GAG) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure GAG concentration using an immunoassay. Data will be presented as the change in GAG concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionμg/mL (Mean)
Kenalog or Placebo-73.1
Kenalog Then Placebo155.8
Kenalog Only-49.0
Placebo-167.4

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Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure NTX-I concentration using an immunoassay. Data will be presented as the change in NTX-I concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionµg/mL (Mean)
Kenalog or Placebo3.5
Kenalog Then Placebo0.6
Kenalog Only2.6
Placebo5.8

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Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1ra concentration using an immunoassay. Data will be presented as the change in IL-1ra concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionpg/mL (Mean)
Kenalog or Placebo-3352.5
Kenalog Then Placebo-4955.6
Kenalog Only-7278.4
Placebo-6888.5

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Synovial Interleukin-1β (IL-1β) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1β concentration using an immunoassay. Data will be presented as the change in IL-1β concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionpg/mL (Mean)
Kenalog or Placebo-1.08
Kenalog Then Placebo0.75
Kenalog Only-0.28
Placebo-0.19

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Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure TSG-6 concentration using an immunoassay. Data will be presented as the change in TSG-6 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionng/ml (Mean)
Kenalog or Placebo68.0
Kenalog Then Placebo57.6
Kenalog Only111.4
Placebo-4.9

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Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-1 concentration using an immunoassay. Data will be presented as the change in MMP-1 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionng/mL (Mean)
Kenalog or Placebo249.0
Kenalog Then Placebo-183.0
Kenalog Only-395.5
Placebo-100.4

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Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-3 concentration using an immunoassay. Data will be presented as the change in MMP-3 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionng/mL (Mean)
Kenalog or Placebo2702.9
Kenalog Then Placebo504.0
Kenalog Only-512.4
Placebo1295.9

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Efficacy of Kenalog to Alleviate Knee Pain

The efficacy of Kenalog with be determined using the Knee Injury and Osteoarthritis Outcome Score (KOOS) instrument. Participants will self-report knee pain and function through the KOOS questionnaire during the initial orthopedic consult and during the pre-op assessment prior to surgery, between 1 and 7 days later. The scale scores range from 100 (no symptoms) to zero (extreme symptoms). (NCT01692756)
Timeframe: Up to seven days

Interventionunits on a scale (Mean)
Kenalog or Placebo37.37
Kenalog Then Placebo18.94
Kenalog Only30.56
Placebo28.93

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Participant Pain Assessment

Participants with be given a Visual Analog Scale (VAS) pain assessment questionnaire which scores the participant's perceived pain on a scale of 0-10 were zero is no pain and 10 is the worst pain imaginable. The scale will be administered during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionunits on a scale (Mean)
Kenalog or Placebo-3.9
Kenalog Then Placebo-2.2
Kenalog Only-3.6
Placebo-4.3

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Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks

Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score. (NCT01770912)
Timeframe: Baseline and 12 weeks post-treatment

Interventionunits on a scale (Median)
Lactated Ringers0
Triamcinolone Acetonide-2

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Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks

Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score. (NCT01770912)
Timeframe: Baseline and 2 weeks post-treatment

Interventionunits on a scale (Median)
Lactated Ringers-2
Triamcinolone Acetonide-1

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Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks

Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score. (NCT01770912)
Timeframe: Baseline and 6 weeks post-treatment

Interventionunits on a scale (Median)
Lactated Ringers-1
Triamcinolone Acetonide-1

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Number of Participants With Change From Pre-Treatment Joint Sounds in 12 Weeks

Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face. (NCT01770912)
Timeframe: Baseline and 12 weeks post-treatment

InterventionParticipants (Count of Participants)
Lactated Ringers4
Triamcinolone Acetonide5

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Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks

Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face. (NCT01770912)
Timeframe: Baseline and 2 weeks post-treatment

InterventionParticipants (Count of Participants)
Lactated Ringers1
Triamcinolone Acetonide5

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Number of Participants With Change From Pre-Treatment Joint Sounds in 6 Weeks

Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face. (NCT01770912)
Timeframe: Baseline and 6 weeks post-treatment

InterventionParticipants (Count of Participants)
Lactated Ringers3
Triamcinolone Acetonide6

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Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks

Mandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement. (NCT01770912)
Timeframe: Baseline and 2 weeks post-treatment

Interventionmm (Mean)
Lactated Ringers3.9
Triamcinolone Acetonide9.7

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Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks

Mandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement. (NCT01770912)
Timeframe: Baseline and 12 weeks post-treatment

Interventionmm (Mean)
Lactated Ringers5.3
Triamcinolone Acetonide10.0

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Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks

TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity). (NCT01770912)
Timeframe: Baseline and 12 weeks post-treatment

Interventionunits on a scale (Median)
Lactated Ringers-1
Triamcinolone Acetonide-2

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Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks

TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity). (NCT01770912)
Timeframe: Baseline and 2 weeks post-treatment

Interventionunits on a scale (Median)
Lactated Ringers-1
Triamcinolone Acetonide-2

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Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks

TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity). (NCT01770912)
Timeframe: Baseline and 6 weeks post-treatment

Interventionunits on a scale (Median)
Lactated Ringers-1
Triamcinolone Acetonide-2

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Change From Pre-Treatment Functional Pain (Chewing) at 12 Weeks

"Pain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing no pain and 100 representing the most intense chewing pain imaginable." (NCT01770912)
Timeframe: Baseline and 12 weeks post-treatment

Interventionunits on a scale (Mean)
Lactated Ringers-26
Triamcinolone Acetonide-43

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Change From Pre-Treatment Functional Pain (Chewing) at 2 Weeks

"Pain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing no pain and 100 representing the most intense chewing pain imaginable." (NCT01770912)
Timeframe: Baseline and 2 weeks post-treatment

Interventionunits on a scale (Mean)
Lactated Ringers-30
Triamcinolone Acetonide-37

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Change From Pre-Treatment Functional Pain (Chewing) at 6 Weeks

"Pain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing no pain and 100 representing the most intense chewing pain imaginable." (NCT01770912)
Timeframe: Baseline and 6 weeks post-treatment

Interventionunits on a scale (Mean)
Lactated Ringers-33
Triamcinolone Acetonide-47

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Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks

Mandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement. (NCT01770912)
Timeframe: Baseline and 6 weeks post-treatment

Interventionmm (Mean)
Lactated Ringers6.9
Triamcinolone Acetonide7.4

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Change in Intraocular Pressure (IOP)

Intraocular pressure is the fluid pressure inside the eye. Intraocular pressure change from baseline at week 8 was measured by Goldmann applanation tonometry. Tonometry is the method eye care professionals use to determine this pressure. Intraocular pressure is typically measured in millimeters of mercury. A higher pressure inside the eye can be a risk factor for developing glaucoma or glaucoma progression leading to optic nerve damage. A negative change indicates a reduction in intraocular pressure. (NCT01789320)
Timeframe: Change from baseline in IOP at 8 weeks

Interventionmm Hg (Mean)
Triamcinolone Acetonide (Triesence®)-0.1

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Vitreous Haze Grade

Vitreous haze scale (Nussenblatt 1985 as modified in Lowder 2011). Scores include value 0 (no inflammation), +0.5 (trace inflammation), +1 (mild blurring of the retinal vessels and optic nerve), +1.5 (optic nerve head and posterior retina view obscuration greater than +1 but less than +2), +2 (moderate blurring of the optic nerve head), +3 (marked blurring of the optic nerve head), and +4 (optic nerve head not visible) A higher score indicates a worse outcome. (NCT01789320)
Timeframe: Change from baseline at 8 weeks and 26 weeks

Interventionscore on a scale (Mean)
Week 8Week 26
Triamcinolone Acetonide (Triesence®)-0.75-0.75

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Central Subfield Thickness Using Optical Coherence Tomography (OCT)

Central subfield thickness (CST) is a measure of the thickness of the retina in the 1 mm diameter circle centered on the fovea or center of the macular where eyesight is the sharpest. CST change from baseline at 8 and 26 weeks was measured using optical coherence tomography (OCT). OCT is a diagnostic imaging technique used to capture 2 and 3 dimensional images within biological tissue, e.g., for determining the amount of edema contained in the retina. CST is typically measured in microns. A negative change represents a reduction in retinal thickness and an improvement in cases of retinal edema. (NCT01789320)
Timeframe: Change from baseline at 8 weeks and 26 weeks.

InterventionMicrons (Mean)
Week 8Week 26
Triamcinolone Acetonide (Triesence®)-153.7-107.0

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Best Corrected Visual Acuity

Visual acuity (VA) rates a person's ability to recognize small details with precision. Best corrected VA refers to this measurement when the best vision has be achieved following refraction. Visual acuity change from baseline at 8 and 26 weeks was measured following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol using standardized lighting and lanes and an ETDRS eye chart. This eye chart comprises rows of letters, with 5 letters per row, and with the letter size from line to line varying logarithmically and is used to estimate visual acuity. Visual acuity is scored with reference to the logarithm of the minimum angle of resolution or logMAR. Zero logMAR indicates standard vision, positive values indicate poor vision and negative values indicate good vision. A negative changes indicates an improvement in visual acuity. (NCT01789320)
Timeframe: Change from baseline at 8 weeks and 26 weeks.

InterventionlogMAR (Mean)
Week 8Week 26
Triamcinolone Acetonide (Triesence®)-0.25-0.28

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Number of Adverse Events Reported by Subjects

To assess the safety of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA. (NCT01797432)
Timeframe: 12 weeks

Interventionadverse events (Number)
Combined IL Kenalog and Restylane25

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Change in Alopecia Areata Half Head Severity Score (AAHHSS) at 12 Weeks Compared to Baseline

The primary endpoint of evaluating the efficacy of administration of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA is the alopecia areata half head severity score (AAHHSS) comparing week 12 with baseline hair loss. Four discreet areas of the scalp are examined. The percent of terminal hair loss in each area is measured by visual estimation. Those percent figures are multiplied by the total area on one half of the scalp represented by the four respective areas. 1) Left parietal scalp (18% of area), right parietal scalp (18% of area), frontal scalp (40% of area), and occipital scalp (24% of area). Scores range from 0 to 50, with higher scores indicating more hair loss. (NCT01797432)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
Combined IL Kenalog and Restylane-17.75

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Number of Adverse Events

Incidence and severity of adverse events (AEs) including the presence and degree of skin atrophy, as well as incidence of treatment-emergent laboratory abnormalities. (NCT01898806)
Timeframe: 48 weeks

Interventionadverse events (Number)
All Participants0

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Mean Pain Score

The mean pain score assessed by the Visual Analog Pain Scale ranging from 0-10; 10 being the worst possible pain. (NCT01995045)
Timeframe: Post-Operative Day 1 (Up to 24 hours)

Interventionunits on a scale (Mean)
Bupivicaine & Triamcinolone2.9
Salt Solution, Bupivacaine, and Cefazolin3.8

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Mean Oxycodone Intake

The mean oxycodone use post surgery in milligrams(mg). (NCT01995045)
Timeframe: Post Surgery (Up to 24 hours)

Interventionmilligrams (Mean)
Bupivicaine & Triamcinolone6.7
Salt Solution, Bupivacaine, and Cefazolin9.0

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Mean Hydrocodone Intake

The mean hydrocodone use post surgery in milligrams(mg). (NCT01995045)
Timeframe: Post Surgery (Up to 24 hours)

Interventionmilligrams (Mean)
Bupivicaine & Triamcinolone.7
Salt Solution, Bupivacaine, and Cefazolin2.8

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Mean Acetaminophen Intake

The mean acetaminophen use post surgery in milligrams(mg). (NCT01995045)
Timeframe: Post Surgery (Up to 24 hours)

Interventionmilligrams (Mean)
Bupivicaine & Triamcinolone819
Salt Solution, Bupivacaine, and Cefazolin962

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Plasma Drug Concentrations by Time

"Plasma Drug Concentration Population. Analyses of plasma drug concentrations were performed using the Plasma Drug Concentration Population.~Values recorded as lower limit of quantification (LLOQ) (< 10 pg/mL) were counted as half the value below limit of quantification (BLQ)." (NCT02003365)
Timeframe: Weeks 6, 12, 16 and 20

,,
Interventionpg/mL (Geometric Mean)
Week 6Week 12Week 16Week 20
FX006 10 mg26.56.6NANA
FX006 40 mg100.18.926.410.1
TCA IR 40 mg21.19.4NANA

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Concentration of Triamcinolone Acetonide in Synovial Fluid

"Analyses of synovial fluid drug concentrations were performed using the Synovial Fluid Drug Concentration Population.~Values recorded as lower limit of quantification (LLOQ) (< 50 pg/mL) were counted as half the value below limit of quantification (BLQ)." (NCT02003365)
Timeframe: 12 to 20 weeks

,,
Interventionpg/mL (Geometric Mean)
Week 12Week 16Week 20
FX006 10 mg477.5NANA
FX006 40 mg923.7224.333.3
TCA IR 40 mg250.1NANA

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Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After Injection

Members of both study groups completed the Visual Analog Scale (VAS) pain assessment both prior for anticipated pain and after injection for actual pain; these recorded scores were the primary study endpoint and were later compared to determine the difference in anticipated pain versus actual pain experienced. The VAS ranges from 0-10, where 0 is no pain and 10 is worst possible pain. The outcome measure is the mean anticipated pain minus the actual pain experienced. (NCT02084706)
Timeframe: Our outcome measure was collected within the 60 seconds before and following the steroid injection.

Interventionunits on a scale (Mean)
Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley1.6
J-tip Lidocaine Administration, Then Steroid Injection2.8

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Duration of Pain Relief

If the patient experienced pain relief with the trigger point injection and the pain came back later, the number of days after the injection at which the pain had returned was recorded. (NCT02120261)
Timeframe: 16 days

Interventiondays (Median)
TPI With Normal Saline3
TPI With Lidocaine & Triamcinolone Acetonide1

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Pain Intensity

The level of pain intensity is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain. (NCT02120261)
Timeframe: 2 weeks

Interventionunits on a scale (Mean)
TPI With Normal Saline4.29
TPI With Lidocaine & Triamcinolone Acetonide4.14

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Pain Intensity

The level of pain intensity is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain. (NCT02120261)
Timeframe: at discharge (a few minutes after receiving intervention)

Interventionunits on a scale (Mean)
TPI With Normal Saline1.52
TPI With Lidocaine & Triamcinolone Acetonide1.76

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Pain Intensity

The level of pain intensity is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain. (NCT02120261)
Timeframe: baseline

Interventionunits on a scale (Mean)
TPI With Normal Saline7.69
TPI With Lidocaine & Triamcinolone Acetonide7.44

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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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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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Salivary Total Oxidative Capacity

total oxidative capacity was assessed in whole unstimulated saliva by ezyme-linked immunosorbent assay (umol/L) at 1 month after treatment (NCT02329600)
Timeframe: one month after treatment

Interventionumol/L (Mean)
Control Subjects6.37
OLP and Corticosteroid58.41
OLP and Corticosteroid and Green Tea23.27

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Pain

pain was assessed by visual analogue scale (1-10) 1 indicates better and 10 worse, 1 month after treatment (NCT02329600)
Timeframe: one month after treatment

Interventionunits on a scale (Mean)
Control Subjects0
OLP and Corticosteroid4
OLP and Corticosteroid and Green Tea4.4

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AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine." (NCT02357459)
Timeframe: Baseline to 24 Weeks

InterventionADP Pain Scores * Week (Least Squares Mean)
FX006 32mg-432.5
Placebo-297.0

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Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24

The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT02357459)
Timeframe: Weeks 4, 8, 12, 16, 20 and 24

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
FX006 32 mg-1.11-1.09-0.93-0.69-0.65-0.59
Placebo-0.51-0.53-0.56-0.59-0.56-0.51
TCA IR 40 mg-0.87-0.80-0.72-0.62-0.57-0.54

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Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24.

The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT02357459)
Timeframe: Weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
FX006 32 mg-1.10-1.02-0.88-0.67-0.61-0.63
Placebo-0.50-0.48-0.50-0.54-0.51-0.49
TCA IR 40 mg-0.87-0.81-0.70-0.64-0.60-0.56

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Change From Baseline Over Time for Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Subscale at Weeks 4, 8, 12 and 24

"The Knee injury and Osteoarthritis Outcome Score (KOOS) is a participant (patient)-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury and also consequences of primary osteoarthritis (OA). It holds 42 items in five separately scored subscales: KOOS Pain, KOOS Symptoms, Function in daily living (KOOS ADL), Function in Sport and Recreation (KOOS Sport/Rec), and knee-related Quality of Life (KOOS QOL).~A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). 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 as is common in orthopaedic assessment scales and generic measures. Higher scores indicate better quality of life." (NCT02357459)
Timeframe: Weeks 4, 8, 12, and 24

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week 24
FX006 32 mg23.5023.3021.1911.95
Placebo8.9310.7012.2210.25
TCA IR 40 mg15.6018.0215.7711.44

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Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)

(NCT02357459)
Timeframe: Weeks 1-24

,,
Interventiontablets (1 tablet = 500 mg) (Least Squares Mean)
Week1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12Week 13Week 14Week 15Week 16Week 17Week 18Week 19Week 20Week 21Week 22Week 23Week 24
FX006 32 mg1.010.690.690.580.600.560.600.630.660.670.730.620.680.670.670.710.820.870.710.690.920.980.940.95
Placebo1.311.391.351.281.211.241.191.241.111.211.121.131.141.181.251.151.171.151.231.221.231.211.201.18
TCA IR 40 mg1.101.001.020.900.830.870.890.850.911.010.890.930.970.980.900.930.951.080.980.941.020.980.971.04

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Responder Status as Defined by Proportion of Patients Experiencing >30% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT02357459)
Timeframe: Weeks 1-24

,,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12Week 13Week 14Week 15Week 16Week 17Week 18Week 19Week 20Week 21Week 22Week 23Week 24
FX006 32 mg6699109107106113112109107107107103979588918481868482797770
Placebo426361646973757479787880818079818275787976747974
TCA IR 40 mg819610110810911111210710910910510410610097978693888783788474

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Responder Status as Defined by Proportion of Patients Experiencing >50% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)

(NCT02357459)
Timeframe: Weeks 1-24

,,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12Week 13Week 14Week 15Week 16Week 17Week 18Week 19Week 20Week 21Week 22Week 23Week 24
FX006 32 mg397381868592979791878380797673716966646056565147
Placebo213740475151495355576056575455595952545454525449
TCA IR 40 mg576777808084858283848075777270706766676261576356

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AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine." (NCT02357459)
Timeframe: Baseline to 12 Weeks

InterventionADP Pain Scores * Week (Least Squares Mean)
FX006 32 mg-247.3
TCA IR 40 mg-231.9

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Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24

The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT02357459)
Timeframe: Weeks 4, 8, 12, 16, 20 and 24

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
FX006 32 mg-1.23-1.24-1.03-0.80-0.66-0.67
Placebo-0.51-0.54-0.59-0.64-0.64-0.58
TCA IR 40 mg-1.00-0.92-0.80-0.71-0.58-0.57

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Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine." (NCT02357459)
Timeframe: Baseline through 12 Weeks

Interventionunits on a scale (Least Squares Mean)
FX006 32 mg-3.12
TCA IR 40 mg-2.86

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Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine." (NCT02357459)
Timeframe: Baseline and 12 Weeks

Interventionunits on a scale (Least Squares Mean)
FX006 32mg-3.12
Placebo-2.14

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Time to Onset of Pain Relief

Time to onset of pain relief is defined as the time from administration of study drug to the first daily pain assessment showing >30% improvement from the weekly mean of the ADP scores at baseline (NCT02357459)
Timeframe: Baseline to >30% improvement (measured up to 30 days)

Interventiondays (Median)
FX006 32 mg4
Placebo11
TCA IR 40 mg3

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Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine." (NCT02357459)
Timeframe: Baseline to 12 Weeks

InterventionADP Pain Scores * Week (Least Squares Mean)
FX006 32mg-247.3
Placebo-145.3

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Change From Baseline to Each Week in Weekly Mean of the ADP Scores

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine." (NCT02357459)
Timeframe: Weeks 1-11 & Weeks 13-24

,,
Interventionunits on a scale (Least Squares Mean)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 13Week 14Week 15Week 16Week 17Week 18Week 19Week 20Week 21Week 22Week 23Week 24
FX006 32 mg-1.9-2.95-3.20-3.23-3.34-3.48-3.48-3.48-3.45-3.31-3.21-2.96-2.91-2.84-2.73-2.66-2.60-2.57-2.44-2.27-2.18-2.14-1.99
Placebo-1.04-1.61-1.66-1.84-1.87-1.95-2.01-1.96-2.06-2.08-2.13-2.21-2.18-2.12-2.22-2.18-2.13-2.19-2.18-2.16-2.20-2.12-2.16
TCA IR 40 mg-2.13-2.69-2.93-3.11-3.11-3.20-3.03-3.04-3.06-3.07-3.01-2.87-2.73-2.75-2.67-2.57-2.55-2.48-2.46-2.27-2.29-2.30-2.18

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Cumulative Proportion of Eyes With Severe Vision Loss

Cumulative proportion of eyes with uveitic macular edema who experience severe vision loss (>= 15 standard letters) during the 24 weeks of follow-up. (NCT02374060)
Timeframe: During 24 weeks of follow-up

InterventionCumulative proportion of eyes at 24 wks (Number)
Periocular Triamcinolone 40mg0.11
Intravitreal Triamcinolone 4mg0.10
Dexamethasoneintravitreal Implant0.05

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Number of Eyes With Endophthalmitis

Count of eyes with an occurrence of endophthalmitis (NCT02374060)
Timeframe: During 24 weeks of folllow-ip

InterventionEyes with uveitic macular edema (Number)
Periocular Triamcinolone 40mg1
Intravitreal Triamcinolone 4mg0
Dexamethasoneintravitreal Implant0

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Number of Eyes With Retinal Tear or Detachment

Count of eyes with retinal tears or detachments during the course of follow-up. (NCT02374060)
Timeframe: During 24 weeks of follow-up

InterventionEyes with uveitic macular edema (Number)
Periocular Triamcinolone 40mg1
Intravitreal Triamcinolone 4mg0
Dexamethasoneintravitreal Implant0

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Number of Eyes With Vitreous Hemorrhage

Count of eyes with vitreous hemorrhage as an immediate complication of injection. (NCT02374060)
Timeframe: During 24 weeks of follow-up

InterventionEyes with uveitic macular edema (Number)
Periocular Triamcinolone 40mg1
Intravitreal Triamcinolone 4mg0
Dexamethasoneintravitreal Implant1

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Proportion of Baseline Central Subfield Thickness Observed at 24 Weeks

The primary outcome is the change in central subfield thickness from baseline to 24 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better.The time point of 24 weeks was chosen to evaluate the duration of response and the need for additional injections.Retinal thickness was evaluated using masked assessments of OCT images. (NCT02374060)
Timeframe: At baseline and the 24 week visit

Interventionproportion of baseline retinal thickness (Mean)
Periocular Triamcinolone 40mg0.68
Intravitreal Triamcinolone 4mg0.64
Dexamethasoneintravitreal Implant0.61

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Proportion of Baseline Central Subfield Thickness Observed at 8 Weeks

"The primary outcome is the change in central subfield thickness from baseline to 8 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better.~The time point of 8 weeks was chosen for assessment of the primary outcome because it encompasses the window for maximum benefit for all three treatment strategies. Retinal thickness was evaluated using masked assessments of OCT images." (NCT02374060)
Timeframe: At baseline and 8 weeks

Interventionproportion of baseline retinal thickness (Mean)
Periocular Triamcinolone 40mg.77
Intravitreal Triamcinolone 4mg.61
Dexamethasoneintravitreal Implant.54

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Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 8 Weeks

Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 8 weeks. (NCT02374060)
Timeframe: Over 8 weeks of follow-up

InterventionProportion of eyes (Number)
Periocular Triamcinolone 40mg0.41
Intravitreal Triamcinolone 4mg0.79
Dexamethasoneintravitreal Implant0.84

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Proportion of Eyes With Resolution of Macular Edema at 24 Weeks

Proportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., <260 um on the standard scale) at 24 weeks. (NCT02374060)
Timeframe: Over 24 weeks of follow-up

InterventionProportion of eyes (Number)
Periocular Triamcinolone 40mg0.35
Intravitreal Triamcinolone 4mg0.36
Dexamethasoneintravitreal Implant0.41

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Proportion of Eyes With Resolution of Macular Edema at 8 Weeks

Proportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., < 260 um on the standardized scale) at 8 weeks. The greater the proportion the more eyes achieved resolution of macular edema. (NCT02374060)
Timeframe: Over 8 weeks of follow-up

InterventionProportion of eyes (Number)
Periocular Triamcinolone 40mg0.20
Intravitreal Triamcinolone 4mg0.47
Dexamethasoneintravitreal Implant0.61

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Change in Best-corrected Visual Acuity at 24 Weeks

Mean change in best-corrected visual acuity from baseline to 24 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity. (NCT02374060)
Timeframe: Over 24 weeks of follow-up

InterventionStandard letters (Mean)
Periocular Triamcinolone 40mg4.07
Intravitreal Triamcinolone 4mg9.60
Dexamethasoneintravitreal Implant9.21

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Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 24 Weeks

Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 24 weeks (NCT02374060)
Timeframe: Over 24 weeks of follow-up

InterventionProportion of eyes (Number)
Periocular Triamcinolone 40mg0.61
Intravitreal Triamcinolone 4mg0.73
Dexamethasoneintravitreal Implant0.74

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Change in Best-corrected Visual Acuity at 8 Weeks

Mean change in best-corrected visual acuity from baseline to 8 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity. (NCT02374060)
Timeframe: Over 8 weeks of follow-up

InterventionStandard letters (Mean)
Periocular Triamcinolone 40mg4.37
Intravitreal Triamcinolone 4mg9.70
Dexamethasoneintravitreal Implant9.53

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Cumulative Proportion of Eyes With an IOP Elevation >=24 mm Hg

Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=24 mm Hg during 24 weeks of follow-up. (NCT02374060)
Timeframe: During 24 weeks of follow-up

InterventionCumulative proportion of eyes at 24 wks (Number)
Periocular Triamcinolone 40mg0.20
Intravitreal Triamcinolone 4mg0.30
Dexamethasoneintravitreal Implant0.41

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Cumulative Proportion of Eyes With an IOP Elevation >=30 mm Hg

Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=30 mm Hg during 24 weeks of follow-up. (NCT02374060)
Timeframe: During 24 weeks of follow-up

InterventionCumulative proportion of eyes at 24 wks (Number)
Periocular Triamcinolone 40mg0.06
Intravitreal Triamcinolone 4mg0.06
Dexamethasoneintravitreal Implant0.04

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Cumulative Proportion of Eyes With an IOP Elevation of >=10 mm Hg Over Baseline

Cumulative proportion of eyes with uveitic macular edema that experience an IOP elevation of >=10 mm Hg higher than the baseline level during 24 weeks of follow-up. (NCT02374060)
Timeframe: During 24 weeks of follow-up

InterventionCumulative proportion of eyes at 24 wks (Number)
Periocular Triamcinolone 40mg0.14
Intravitreal Triamcinolone 4mg0.26
Dexamethasoneintravitreal Implant0.39

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Number of Treatment-Emergent Adverse Events: Cingal 13-02 vs. Cingal 13-01

The primary outcome measure will compare safety results (all adverse events, whether related to the study injection or not) for Cingal 13-01 and Cingal 13-02. (NCT02381652)
Timeframe: Baseline through 6 weeks post-injection

InterventionAdverse events (Number)
Cingal 13-02 Adverse Events73

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Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Number of subjects with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) reported between the first dose of study drug and study exit. (NCT02595398)
Timeframe: Baseline to 24 weeks

,
InterventionParticipants (Count of Participants)
Experiencing at least one TEAEExperiencing at least one SAE
4mg CLS-TA Suprachoriodal Injection673
Sham Procedure450

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Mean Change From Baseline in Central Subfield Thickness

Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. Only images that were gradable by the central reading center were included in the analysis. (NCT02595398)
Timeframe: Baseline, 24 weeks

Interventionmicrons (Mean)
4mg CLS-TA Suprachoriodal Injection-152.6
Sham Procedure-17.9

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Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on electronic Visual Acuity (eVA). An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement. (NCT02595398)
Timeframe: Baseline, 24 weeks

InterventionParticipants (Count of Participants)
4mg CLS-TA Suprachoriodal Injection45
Sham Procedure10

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Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort

All baseline (pre-treatment) values and all post-baseline values that are recorded as below LLOQ were set to zero for analysis and were included in the descriptive mean calculations. Values below LLOQ were not included in geometric mean calculations. (NCT02637323)
Timeframe: Up to 20 Weeks

Interventionpg/mL (Geometric Mean)
Day 1 - Hour 1Day 1 - Hour 2Day 1 - Hour 4Day 1 - Hour 6Day 1 - Hour 8Day 1 - Hour 10Day 1 - Hour 12Day 2 - Hour 24Week 6
TCA IR 40 mg6968.88494.79628.89314.38421.37439.36678.74991.1149.4

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Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort

All baseline (pre-treatment) values and all post-baseline values that are recorded as below LLOQ were set to zero for analysis and were included in the descriptive mean calculations. Values below LLOQ were not included in geometric mean calculations. (NCT02637323)
Timeframe: Up to 20 Weeks

Interventionpg/mL (Geometric Mean)
Day 1 - Hour 1Day 1 - Hour 2Day 1 - Hour 4Day 1 - Hour 6Day 1 - Hour 8Day 1 - Hour 10Day 1 - Hour 12Day 2 - Hour 24Week 1Week 6Week 12Week 16Week 20
FX006 32 mg670.0736.5759.5747.1740.2720.7706.6836.4600.9118.653.773.8108.2

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Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid

All baseline (pre-treatment) values and all post-baseline values recorded as below LLOQ (<50 pg/mL) were set to zero. Geometric mean summary statistics were computed on adjusted concentration values. One (1) was added to each concentration value observed. BLQ values for the computation of geometric mean are included in the summary with a value of 1 (0+1). (NCT02637323)
Timeframe: Up to 20 Weeks

Interventionpg/mL (Geometric Mean)
Baseline (pre-treatment)Week 1Week 6Week 12Week 16Week 20
FX006 32 mg1.0231328.93590.0290.61.01.0

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Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid

All baseline (pre-treatment) values and all post-baseline values recorded as below LLOQ (<50 pg/mL) were set to zero. Geometric mean summary statistics were computed on adjusted concentration values. One (1) was added to each concentration value observed. BLQ values for the computation of geometric mean are included in the summary with a value of 1 (0+1). (NCT02637323)
Timeframe: Up to 20 Weeks

Interventionpg/mL (Geometric Mean)
Baseline (pre-treatment)Week 6
TCA IR 40 mg1.07.7

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Efficacy of 0.1% Triamcinolone Containing Wet Wrap as an Ointment or as a Cream Formulation in Patients With Moderate to Severe Atopic Dermatitis

"Change in atopic dermatitis based on physician global assessment scale: 0=clear; 1=almost clear; 2=mild disease; 3=moderate disease; 4=severe disease; 5- very severe disease~Lower scores represent a better outcome." (NCT02680301)
Timeframe: 3-5 days

Interventionunits on a scale (Mean)
Cream0.717
Ointment0.589

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Number of Patients Adhering to Treatment Protocol

Patient-reported adherence to wet-wrap protocol. Medication logs were used to evaluate adherence to the treatment protocol for both steroid formulations. Patents were determined to be adhering to the protocol if the number of wet-wraps for each study arm (cream or ointment) were the same. Because the total number of wraps varied between patients (the protocol required 1-2 wraps per day for 3-5 days), we reviewed medication logs to determine that each patient completed an equivalent number of ointment and cream wraps. (NCT02680301)
Timeframe: 3-5 days

InterventionParticipants (Count of Participants)
All Subjects39

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Glycemic Variability Coeffecient of Variation (CV)

The glycemic variability was calculated as the coefficient of variation (CV) of the hourly averages in each of these time periods: Hour 1-24, Hour 1-48, Hour 1-72, Hour 1-168, and Hour 1-360. The % CV for each patient was derived using the formula: (SD/mean)*100, using the values for each hourly average glucose measurement over the time period. Average % CV in the FX006 40 mg group was compared to the TCA IR 40 mg group using a linear model (ANCOVA) with fixed effects for treatment group. Model covariates were study center and baseline (72-hour) blood glucose average. (NCT02762370)
Timeframe: Baseline to 72 hours post injection (hourly average blood glucose measurement over the time period)

Interventionmg/dL (Least Squares Mean)
FX006 32 mg22.43
TCA IR 40 mg27.05

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Change in Average Blood Glucose From Baseline (Hour -48 to Hour -1) to Hour 1 to Hour 48 for FX006 32 mg Relative to TCA IR 40 mg.

(NCT02762370)
Timeframe: Baseline (Hour -48 to Hour -1) to Hour 1 to Hour 48

Interventionmg/dL (Least Squares Mean)
FX006 32 mg16.33
TCA IR 40 mg43.62

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Percent Time Blood Glucose Less Than 70 mg/dl, 70 - 180 mg/dl, 180.1 - 250.0 mg/dl, 250.1 - 350.0 mg/dl, and Greater Than 350.0 mg/dl

The glycemic variability was calculated as the coefficient of variation (CV) of the hourly averages in each of these time periods: Hour 1-24, Hour 1-48, Hour 1-72, Hour 1-168, and Hour 1-360. The % CV for each patient was derived using the formula: (SD/mean)*100, using the values for each hourly average glucose measurement over the time period. Average % CV in the FX006 40 mg group was compared to the TCA IR 40 mg group using a linear model (ANCOVA) with fixed effects for treatment group. Model covariates were study center and baseline (72-hour) blood glucose average. (NCT02762370)
Timeframe: Baseline to Days 1-3

,
InterventionPercentage of time (Number)
Less than 7070 - 180180.1 - 250.0250.1 - 350.0Greater than 350.0
FX006 32 mg2.263.323.79.51.3
TCA IR 40 mg0.449.724.521.14.3

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Percent Time Blood Glucose Less Than 70 mg/dl, 70 - 180 mg/dl, 180.1 - 250.0 mg/dl, 250.1 - 350.0 mg/dl, and Greater Than 350.0 mg/dl

(NCT02762370)
Timeframe: Baseline to Days 1-2

,
InterventionPercentage of time (Number)
Less than 70.070.0 - 180.0180.1 - 250.0250.1 - 350.0Greater than 350.0
FX006 32 mg1.264.123.09.91.7
TCA IR 40 mg0.342.727.425.24.4

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Area Under the Effect (AUE) Curves for Average Blood Glucose - FX006 Versus TCA IR

(NCT02762370)
Timeframe: Baseline to 72 hours post injection (-72 hr, 0 hr, and 1, 2, 3, 7, and 15 days post-dose)

,
Interventionhr*mg/dL (Least Squares Mean)
Baseline (Hour -72 to Hour -1)Day 1Days 1-2Days 1-3Days 1-7Days 1-15
FX006 32 mg22089.03703.37902.611772.327245.752112.8
TCA IR 40 mg23669.14483.29251.712950.925987.049532.2

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Change From Baseline for Maximum Blood Glucose: Baseline Average Blood Glucose (Hour -72 to Hour -1) to Maximum Blood Glucose (Hour 1 to Hour 72) for FX006 32 mg Relative to TCA IR 40 mg

(NCT02762370)
Timeframe: Baseline (Hour -72 to Hour -1) to Hour 1 to Hour 72

Interventionmg/dL (Least Squares Mean)
FX006 32 mg110.04
TCA IR 40 mg158.46

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Change From Baseline for Average Blood Glucose (mg/dL)

Average blood glucose was analyzed with a mixed model for repeated measures (MMRM) (NCT02762370)
Timeframe: Baseline and 72 Hours post intra-articular (IA) injection

Interventionmg/dL (Least Squares Mean)
FX006 32 mg14.66
TCA IR 40 mg33.88

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Change in Pain From Baseline to Day 5

Patients will rate pain on a scale of 1-10 (1 being no pain, 10 being the worst possible pain) at the baseline visit and on day 5. A secondary outcome will compare reduction in pain on day 5 in the combined treatment groups compared to the placebo group, and between the two treatment arms. (NCT02781818)
Timeframe: Baseline, Day 5

Interventionunits on a scale (Mean)
Triamcinolone Acetonide 10mg/mL2
Triamcinolone Acetonide 40mg/mL2.3
Normal Saline Placebo2.6

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Patient Rating of Impression of Treatment at Day 14

"Patients will rate their impression of the treatment for each site as follows:~0. Made it worse;~Not helpful;~A little bit helpful;~Moderately helpful;~Very helpful~Comparison of rating of impression of treatment between the combined treatment groups and placebo will be performed. Similar comparison will be performed between the triamcinolone 10mg/ml and triamcinolone 40mg/ml treatment arms." (NCT02781818)
Timeframe: 14 days

Interventionunits on a scale (Mean)
Triamcinolone Acetonide 10mg/mL2.5
Triamcinolone Acetonide 40mg/mL2.5
Normal Saline Placebo2.4

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Number of Days to Lesion Resolution in Combined Treatment Arms Compared to the Placebo Arm.

Mean number of days that patient reports it takes for a lesion to resolve. This is defined as a return of the skin to baseline in the treated area and an absence of pain. (NCT02781818)
Timeframe: 1-14 days

InterventionDays (Mean)
Triamcinolone Acetonide 10mg/mL10.8
Triamcinolone Acetonide 40mg/mL10.9
Normal Saline Placebo9.35

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Nasal Obstruction Symptom Evaluation (NOSE) Score Following Surgery in Subset of Patients Who Elect to Undergo Surgery.

"Nasal Obstruction Symptom Evaluation (NOSE) scale:~A quality of life (QOL) instrument developed to assess nasal obstruction symptoms in patients undergoing septoplasty. It consists of a 5-item questionnaire, scored on a 5-point (0-4) Likert scale. The raw score ranges from 0-20, which is scaled to a score of 0-100 by multiplying the raw score by 5, where '0' represents 'no problem' and, and '100' represent 'worst problem.'" (NCT02877485)
Timeframe: Postoperative time interval (months): 1-2 , 3-5 , 6-9, 9-12, >12.

Interventionscore on a scale (Mean)
Baseline NOSE scorePostoperative period: 1-2 monthsPostoperative period:3-5 monthsPostoperative period:6-9 monthsPostoperative period: 9-12 monthsPostoperative period: >12 months
Surgery Patients7016.217.617.222.220

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Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray)

"Nasal Obstruction Symptom Evaluation (NOSE) scale:~A quality of life (QOL) instrument developed to assess nasal obstruction symptoms in patients undergoing septoplasty. It consists of a 5-item questionnaire, scored on a 5-point (0-4) Likert scale. The raw score ranges from 0-20, which is scaled to a score of 0-100 by multiplying the raw score by 5, where '0' represents 'no problem' and, and '100' represent 'worst problem.'" (NCT02877485)
Timeframe: Pre-spray NOSE score - 6 weeks Post spray NOSE score- 2 weeks washout - Pre spray Pre-spray NOSE score - 6 weeks Post spray NOSE score

,
Interventionscore on a scale (Mean)
Baseline: Pre - spray 1 NOSE scorePost - spray 1 / pre- spray 2 NOSE scorePost - spray 2 NOSE score
Ayr Spray Then Triamcinolone Acetonide68.565.861.5
Triamcinolone Acetonide Then Ayr Spray69.165.264.1

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Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

Number of participants with treatment emergent adverse events and serious adverse events reported over 6 months of follow-up (NCT02949024)
Timeframe: Over 6 months of follow-up

,
InterventionParticipants (Count of Participants)
Number of participants with treatment emergent adverse eventsNumber of participants with serious adverse events
Previous TX Arm90
TX Naïve Arm80

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Mean Change From Baseline in Intraocular Pressure

Baseline and change from baseline at 6 months in intraocular pressure as measured by applanation tonometry (NCT02949024)
Timeframe: Baseline and 6 months

,
Interventionmm Hg (Mean)
BaselineMonth 6
Previous TX Arm13.32.8
TX Naïve Arm14.2-0.3

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Mean Change From Baseline in Central Subfield Thickness

Baseline and change from baseline at 6 months in central subfield thickness. Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. (NCT02949024)
Timeframe: Baseline and 6 months

,
InterventionMicrons (Mean)
BaselineMonth 6
Previous TX Arm421.6-90.9
TX Naïve Arm472.7-119.6

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Best Corrected Visual Acuity

Baseline and Change from baseline at 6 months in best corrected visual acuity before and after treatment Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured as the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision. (NCT02949024)
Timeframe: Baseline and 6 months

,
InterventionLetters (Mean)
BaselineMonth 6
Previous TX Arm67.21.1
TX Naïve Arm67.28.5

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CLS-TA Injections

After the initial treatment with CLS-TA, with or without intravitreal aflibercept, at Baseline, retreatment with CLS-TA was allowed in either treatment group from Month 2 through Month 6 if pre-defined retreatment criteria were met. Number of patients receiving 0, 1, 2, 3, 4 or 5 retreatments with CLS-TA. (NCT02949024)
Timeframe: 2 to 6 months following initial treatment with study drug

,
InterventionParticipants (Count of Participants)
0 additional injections1 additional injection2 additional injections3 additional injections4 additional injections
Previous TX Arm13204
TX Naïve Arm42022

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Mean Change From Baseline in Best Corrected Visual Acuity

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement. (NCT02952001)
Timeframe: 6 months following exit from Parent study

Interventionletters (Mean)
4 mg CLS-TA Suprachoriodal Injection12.1
Sham Procedure14.0

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Mean Change From Baseline in Central Subfield Thickness

Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. (NCT02952001)
Timeframe: 6 months following exit from Parent study

Interventionmicrons (Mean)
4 mg CLS-TA Suprachoriodal Injection-174.5
Sham Procedure19.5

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Time to Additional Therapy for Uveitis

This time to event outcome was calculated as the number of days between the date of initiation of additional therapy for uveitis and the date of first treatment in the Parent study CLS1001-301 (NCT02595398). (NCT02952001)
Timeframe: 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year

Interventiondays (Median)
4 mg CLS-TA Suprachoriodal Injection344.0
Sham Procedure332.0

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Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

Number of participants with treatment emergent adverse events and serious adverse events reported during the extension study. (NCT02952001)
Timeframe: 6 months following exit from Parent study

,
InterventionParticipants (Count of Participants)
Treatment-emergent adverse eventsSerious adverse events
4 mg CLS-TA Suprachoriodal Injection161
Sham Procedure30

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Mean Change From Baseline in Central Subfield Thickness

Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. (NCT02980874)
Timeframe: 6 months

InterventionMicrons (Least Squares Mean)
Active-354.3
Control-416.2

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Mean Change From Baseline in Best Corrected Visual Acuity

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision. (NCT02980874)
Timeframe: 6 months

InterventionLetters (Least Squares Mean)
Active15.5
Control20.5

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Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement. (NCT02980874)
Timeframe: 2 months

InterventionParticipants (Count of Participants)
Active114
Control127

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Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)

Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score. (NCT02996097)
Timeframe: Once every 4 weeks for 16 weeks

Interventionscore on a scale (Mean)
CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide-22.6
Intralesional Triamcinolone Acetonide Only-18.8

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Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS)

Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score. (NCT02996097)
Timeframe: Once every 4 weeks for 16 weeks

Interventionscore on a scale (Mean)
CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide-9.5
Intralesional Triamcinolone Acetonide Only-8.9

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Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra

This endpoint represents the level of of endogenous interleukin-1 receptor antagonist /anakinra (NCT03002974)
Timeframe: Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated during the extension period

,
Interventionng/mL (Mean)
First flare : BaselineFirst flare : 72 hoursFirst flare : Day 8First flare : Day 15First flare : Day 28First flare : Week 12Second flare : BaselineSecond flare : 72 hoursSecond flare : Day 8Second flare : Day 15Second flare : Day 28Second flare : Week 12Third flare : BaselineThird flare : 72 hoursThird flare : Day 8Third flare : Day 15Third flare : Day 28Third flare : Week 12Fourth flare : BaselineFourth flare : 72 hoursFourth flare : Day 8Fourth flare : Day 15Fourth flare : Day 28Fourth flare : Week 12Fifth flare : BaselineFifthe flare : 72 hoursFifthe flare : Day 8Fifthe flare : Day 15Fifthe flare : Day 28Fifth flare : Week 12
Anakinra 200 mg1.950628.05334.7771.5741.7791.7191.500719.66748.7851.5001.5001.6921.50431.6310.701.502.471.501.50916.6220.621.501.501.501.50292.356.391.501.501.50
Triamcinolone 40 mg2.0321.9741.6921.5331.6351.5001.7481.6283.1411.8451.9752.9202.051.851.501.501.852.851.501.501.501.501.501.501.501.501.501.501.501.50

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Physician's Assessment of Clinical Signs in Index Joint: Erythema

Physicians assessment of clinical signs with 2 outcomes: Absent=no erythema, present=erythema (NCT03002974)
Timeframe: at 72 hours, Day 8 and Day 15 for the first flare treated in the study

,,
InterventionParticipants (Count of Participants)
Baseline : AbsentBaseline : PresentBaseline : Missing72 hours : Absent72 hours : Present72 hours : MissingDay 8 : AbsentDay 8 : PresentDay 8 : MissingDay 15 : AbsentDay 15 : PresentDay 15 : Missing
Anakinra 100 mg84803914343944754
Anakinra 200 mg84513714340954095
Triamcinolone 40 mg35112922443664726

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Physician's Assessment of Clinical Signs in Index Joint: Tenderness

4-point Likert scale (0=no pain, 1= mild/patient states there is pain when touched, 2= moderate/patient states there is pain and Winces, 3=severe/patient states there is pain, winces and withdraws (NCT03002974)
Timeframe: at 72 hours, Day 8 and Day 15 for the first flare treated in the study

,,
InterventionParticipants (Count of Participants)
72 hours : None72 hours : Mild72 hours : Moderate72 hours : Severe72 hours : MissingDay 8 : NoneDay 8 : MildDay 8 : ModerateDay 8 : SevereDay 8 : MissingDay 15 : NoneDay 15 : MildDay 15 : ModerateDay 15 : SevereDay 15 : Missing
Anakinra 100 mg18284332819243389513
Anakinra 200 mg162591330171153212505
Triamcinolone 40 mg822174419254163710116

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Physician's Assessment of Clinical Signs in Index Joint: Swelling

4-point Likert scale (0=no swelling, 1= mild swelling, 2=moderate swelling, 3=severe swelling or bulging beyond joint margins) (NCT03002974)
Timeframe: at 72 hours, Day 8 and Day 15 for the first flare treated in the study

,,
InterventionParticipants (Count of Participants)
Baseline : NoneBaseline : MildBaseline : ModerateBaseline : SevereBaseline : Missing72 hours : None72 hours : Mild72 hours : Moderate72 hours : Severe72 hours : MissingDay 8 : NoneDay 8 : MildDay 8 : ModerateDay 8 : SevereDay 8 : MissingDay 15 : NoneDay 15 : MildDay 15 : ModerateDay 15 : SevereDay 15 : Missing
Anakinra 100 mg0142715027187133713213446303
Anakinra 200 mg072818117267133892053414105
Triamcinolone 40 mg0923230142210542516716379216

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Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale

"Patients will score their pain intensity in the joint most affected at baseline (index joint) on a 5-point Likert scale (0-4 point scale: none, mild, moderate, severe, extreme) at time points baseline (pre-dose) and at 6, 12, 18, 24, 36, 48 and 72 hours and Day 5, 6, 7 and 8." (NCT03002974)
Timeframe: At baseline (pre-dose) and at 6, 12, 18, 24, 36, 48 and 72 hours and Day 5, 6, 7 and 8 for the first gout flare treated in the study

,,
InterventionScore on a scale (Mean)
6 hours12 hours18 hours24 hours36 hours48 hours72 hoursDay 5Day 6Day 7Day 8
Anakinra 100 mg-0.8-1.1-1.2-0.9-1.3-1.4-1.6-1.8-2.2-2.2-2.1
Anakinra 200 mg-0.4-0.5-0.8-1.1-1.1-1.5-1.7-1.8-1.9-1.9-2.1
Triamcinolone 40 mg-0.6-0.9-0.8-1.0-1.3-1.5-1.6-1.8-1.9-2.4-1.9

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Proportion of Patients With Neutralizing Antibodies

Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies (NCT03002974)
Timeframe: Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated during the extension period

,,
Interventionparticipants (Number)
First flare : BaselineFirst flare : Day 8First flare : Day 15First flare : Day 28First flare : Week 12Second flare : Study baselineSecond flare : Flare baselineSecond flare : Day 8Second flare : Day 15Second flare : Day 28Second flare : Week 12Third flare : Study baselineThird flare : Flare baselineThird flare : Day 8Third flare : Day 15Third flare : Day 28Third flare : Week 12Fourth flare : Study baselineFourth flare : Flare baselineFourth flare : Day 8Fourth flare : Day 15Fourth flare : Day 28Fourth flare : Week 12Fifth flare : Study baselineFifth flare : Flare baselineFifth flare : Day 8Fifth flare : Day 15Fifth flare : Day 28Fifth flare : Week 12
Anakinra 100 mg00000000000000000001000000000
Anakinra 200 mg00000000000000000000100000000
Triamcinolone 40 mg00000000000000000000000000000

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The Percent of Patients With at Least One Adverse Event

All adverse events to be recorded Day 1 - Day 28 for each flare. Serious adverse events (SAE) will be collected from informed consent until week 12 for each flare. Any SAE with suspected causal relationship should be reported irrespective of the time of occurrence. (NCT03002974)
Timeframe: Through study completion, at 12 weeks after last flare treated during the extension period

InterventionPercent (Number)
Triamcinolone 40 mg40.7
Anakinra 100 mg38.2
Anakinra 200 mg55.8

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Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra

Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies (NCT03002974)
Timeframe: Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated treated during the extension period

,,
Interventionparticipants (Number)
First flare : BaselineFirst flare : Day 8First flare : Day 15First flare : Day 28First flare : Week 12Second flare : BaselineSecond flare : Day 8Second flare : Day 15Second flare : Day 28Second flare : Week 12Third flare : BaselineThird flare : Day 8Third flare : Day 15Third flare : Day 28Third flare : Week 12Fourth flare : BaselineFourth flare : Day 8Fourth flare : Day 15Fourth flare : Day 28Fourth flare : Week 12Fifth flare : BaselineFifth flare : Day 8Fifth flare : Day 15Fifth flare : Day 28Fifth flare : Week 12
Anakinra 100 mg5454401110011100111101210
Anakinra 200 mg2342022011244002341012220
Triamcinolone 40 mg2100000000000000000000000

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The Percent of Patients With at Least One Serious Adverse Event, Including Death

Serious Adverse Events (SAE) will be collected from informed consent until week 12 for each flare. Any SAE with suspected causal relationship should be reported irrespective of the time of occurrence. (NCT03002974)
Timeframe: Through study completion, at 12 weeks after last flare treated during the extension period

InterventionPercent (Number)
Triamcinolone 40 mg0
Anakinra 100 mg7.3
Anakinra 200 mg0

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Physician's Assessment of Global Response to Treatment

"5-point Likert scale (0- to 4-point scale: none, mild, moderate, severe, extreme) where higher score mean worse outcome" (NCT03002974)
Timeframe: At 72 hours, Day 8 and Day 15 for the first flare treated in the study

,,
InterventionScore on a scale (Mean)
72 hoursDay 8Day 15
Anakinra 100 mg1.250.900.80
Anakinra 200 mg1.250.810.78
Triamcinolone 40 mg1.541.261.04

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Median Time to First Intake of Rescue Medication From First Investigational Drug Administration

Time to first intake of rescue medication for acute gout, measured in hours from first investigational drug administration (NCT03002974)
Timeframe: From Day 1 to Day 15 for the first flare treated

InterventionHours (Median)
Triamcinolone 40 mgNA
Anakinra 100 mgNA
Anakinra 200 mgNA

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Median Time to Onset of Effect

Onset of effect defined as 20% change from baseline pain intensity in the index joint on a visual analogue scale (VAS) (NCT03002974)
Timeframe: From baseline (predose) up to Day15 of the first flare treated in the study

InterventionHours (Median)
Triamcinolone 40 mg22.3
Anakinra 100 mg11.8
Anakinra 200 mg19.8

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Median Time to Resolution of Pain

Resolution of pain defined as <10 mm on VAS, a continuous 0 to 100 mm visual analogue scale, ranging from no pain (0) to unbearable pain (100), in the index joint (NCT03002974)
Timeframe: From baseline (predose) up to Day15 of the first flare

InterventionHours (Median)
Triamcinolone 40 mg167.5
Anakinra 100 mg131.8
Anakinra 200 mg119.8

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Median Time to Response

Response defined as 50% change from baseline pain intensity on a visual analogue scale (VAS) (NCT03002974)
Timeframe: From baseline (predose) up to Day15 of the first flare treated in the study

InterventionHours (Median)
Triamcinolone 40 mg47.6
Anakinra 100 mg43.0
Anakinra 200 mg46.9

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Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra

This endpoint represents the level of of endogenous interleukin-1 receptor antagonist /anakinra (NCT03002974)
Timeframe: Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated during the extension period

Interventionng/mL (Mean)
First flare : BaselineFirst flare : 72 hoursFirst flare : Day 8First flare : Day 15First flare : Day 28First flare : Week 12Second flare : BaselineSecond flare : 72 hoursSecond flare : Day 8Second flare : Day 15Second flare : Day 28Second flare : Week 12Third flare : BaselineThird flare : 72 hoursThird flare : Day 8Third flare : Day 15Third flare : Day 28Third flare : Week 12Fourth flare : BaselineFourth flare : 72 hoursFourth flare : Day 8Fourth flare : Day 15Fourth flare : Day 28Fourth flare : Week 12Fifth flare : BaselineFifthe flare : 72 hoursFifthe flare : Day 8Fifthe flare : Day 15Fifthe flare : Day 28
Anakinra 100 mg4.883267.7446.7501.5881.6591.6251.718254.9307.0481.5951.6921.6811.50196.675.561.631.501.501.50184.401.891.501.502.661.50129.201.501.503.31

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Change From Baseline in the Inflammatory Biomarker Serum Amyloid A

This endpoint represents the change from baseline, mg/L, of the inflammatory biomarker Serum amyloid A (NCT03002974)
Timeframe: baseline (predose) and at 72 hours, Day 8 and Day 15 for the first flare treated in the study

,,
Interventionmg/L (Mean)
72 hoursDay 8Day 15
Anakinra 100 mg-45.160-46.561-25.328
Anakinra 200 mg-34.510-35.88714.370
Triamcinolone 40 mg8.950-6.363-50.524

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Health Care Resource Utilization Due to a Gouty Arthritis Flare

Exploratory objective: number of days with hospitalization and un-scheduled outpatient visits (NCT03002974)
Timeframe: Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period

,,
Interventiondays (Mean)
Hospitalization : First flare : Day 1-7Hospitalization : First flare : Day 8-15Hospitalization : First flare : Day 1-15Hospitalization : Second flare : Day 1-7Hospitalization : Second flare : Day 8-15Hospitalization : Second flare : Day 1-15Hospitalization : Third flare : Day 1-7Hospitalization : Third flare : Day 8-15Hospitalization : Third flare : Day 1-15Hospitalization : Fourth flare : Day 1-7Hospitalization : Fourth flare : Day 8-15Hospitalization : Fourth flare : Day 1-15Hospitalization : Fifth flare : Day 1-7Hospitalization : Fifth flare : Day 8-15Hospitalization : Fifth flare : Day 1-15Unscheduled outpatient visits:First flare: Day 1-7Unscheduled outpatient visits:First flare:Day 8-15Unscheduled outpatient visits:First flare:Day 1-15Unscheduled outpatient visits:Second flare:Day 1-7Unscheduled outpatient visit:Second flare:Day 8-15Unscheduled outpatient visit:Second flare:Day 1-15Unscheduled outpatient visits:Third flare:Day 1-7Unscheduled outpatient visits:Third flare:Day 8-15Unscheduled outpatient visits:Third flare:Day 1-15Unscheduled outpatient visitstFourth flare:Day 1-7Unscheduled outpatient visitsFourth flare:Day 8-15Unscheduled outpatient visitsFourth flare:Day 1-15Unscheduled outpatient visit:Fifth flare : Day 1-7Unscheduled outpatient visitFifth flare : Day 8-15Unscheduled outpatient visit Fifth flare:Day 1-15
Anakinra 100 mg00000000000000000.10.1000000000000
Anakinra 200 mg0000000000000000.100.1000000000000
Triamcinolone 40 mg0000000000000000.10.30.40.20.20.50.40.40.8000000

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Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)

5-point Likert scale (0- to 4-point scale: 0=excellent, 1=very good, 2=good, 3=fair, 4=poor response to treatment) where lower rate indicates better response to treatment (NCT03002974)
Timeframe: at 72 hours, Day 8 and Day 15 for the first flare treated in the study

,,
InterventionParticipants (Count of Participants)
72 hours : Excellent72 hours : Very good72 hours : Good72 hours : Fair72 hours : Poor72 hours : MissingDay 8 : ExcellentDay 8 : Very goodDay 8 : GoodDay 8 : FairDay 8 : PoorDay 8 : MissingDay 15 : ExcellentDay 15 : Very goodDay 15 : GoodDay 15 : FairDay 15 : PoorDay 15 : Missing
Anakinra 100 mg10191441816216607191385011
Anakinra 200 mg18915318191372112211110318
Triamcinolone 40 mg11137741391685512149106313

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Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares

"The WPAI yeilds four types of scores of which Work productivity loss is one.~SHP is derived from WPAI as follows:~The WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity as follows:~Questions:~Q1 = currently employed Q2 = hours missed due to specified problem Q3 = hours missed other reasons Q4 = hours actually worked Q5 = degree problem affected productivity while working Q6 = degree problem affected regular activities~Scores:~Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10 The answer on Q5 is given on a scale from 0 (PROBLEM had no effect on work) to 10 (PROBLEM completely prevented me from working).~Thus the analysis values from which mean and SD have been calculated and reported are the outcomes from Q5 (ranging from 0 to 10) multiplied with 100 and divided by 10." (NCT03002974)
Timeframe: Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period

Interventionpercent (Mean)
First flare : Day 8First flare : Day 15Second flare : Day 8Second flare : Day 15Third flare : Day 8Third flare : Day 15Fourth flare : Day 8Fourth flare : Day 15Fifth flare : Day 8Fifth flare : Day 15
Anakinra 200 mg20.521.624.013.810.023.320.05.026.713.3

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Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares

"The WPAI yeilds four types of scores of which Work productivity loss is one.~SHP is derived from WPAI as follows:~The WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity as follows:~Questions:~Q1 = currently employed Q2 = hours missed due to specified problem Q3 = hours missed other reasons Q4 = hours actually worked Q5 = degree problem affected productivity while working Q6 = degree problem affected regular activities~Scores:~Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10 The answer on Q5 is given on a scale from 0 (PROBLEM had no effect on work) to 10 (PROBLEM completely prevented me from working).~Thus the analysis values from which mean and SD have been calculated and reported are the outcomes from Q5 (ranging from 0 to 10) multiplied with 100 and divided by 10." (NCT03002974)
Timeframe: Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period

Interventionpercent (Mean)
First flare : Day 8First flare : Day 15Second flare : Day 8Second flare : Day 15Third flare : Day 8Third flare : Day 15Fifth flare : Day 15
Anakinra 100 mg32.612.624.020.05.020.040.0

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Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares

"The WPAI yeilds four types of scores of which Work productivity loss is one.~SHP is derived from WPAI as follows:~The WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity as follows:~Questions:~Q1 = currently employed Q2 = hours missed due to specified problem Q3 = hours missed other reasons Q4 = hours actually worked Q5 = degree problem affected productivity while working Q6 = degree problem affected regular activities~Scores:~Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10 The answer on Q5 is given on a scale from 0 (PROBLEM had no effect on work) to 10 (PROBLEM completely prevented me from working).~Thus the analysis values from which mean and SD have been calculated and reported are the outcomes from Q5 (ranging from 0 to 10) multiplied with 100 and divided by 10." (NCT03002974)
Timeframe: Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period

Interventionpercent (Mean)
First flare : Day 8First flare : Day 15Second flare : Day 8Second flare : Day 15Third flare : Day 8Third flare : Day 15Fourth flare : Day 8Fifth flare : Day 8Fifth flare : Day 15
Triamcinolone 40 mg36.123.342.916.010.010.030.060.020.0

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Change From Baseline in the Inflammatory Biomarker C Reactive Protein

This endpoint represents the change from baseline, mg/dL, of the inflammatory biomarker C reactive protein (NCT03002974)
Timeframe: baseline (predose) and at 72 hours, Day 8 and Day 15 for the first flare treated in the study

,,
Interventionmg/dL (Mean)
72 hoursDay 8Day 15
Anakinra 100 mg-1.435-1.334-0.724
Anakinra 200 mg-1.3621.406-0.607
Triamcinolone 40 mg-0.362-0.321-1.102

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Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score

SF-36® measures the impact of disease on overall quality of life. It consists of 8 individual domains. Score range from 0 to 100, where 0 represents the worst possible health and 100 is perfect health. (NCT03002974)
Timeframe: at baseline, Day 8 and Day 15 for the first flare treated in the study

,,
Interventionunits on a scale (Mean)
Day 8Day 15
Anakinra 100 mg10.512.2
Anakinra 200 mg10.49.4
Triamcinolone 40 mg8.011.8

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Change in Patient-assessed Pain Intensity in the Index Joint From Baseline to 24-72 Hours for the First Gout Flare Treated in the Study as Measured by VAS

Patients will score their pain intensity in the joint most affected at baseline (index joint) on a 0-100 mm visual analogue scale (VAS), ranging from no pain (0) to unbearable pain (100). Average of the assessments performed at 24, 48 and 72 hours. (NCT03002974)
Timeframe: At baseline (pre-dose) and at 24, 48 and 72 hours for the first gout flare treated in the study

,,
InterventionUnits on a scale (Mean)
24 hours48 hours72 hours
Anakinra 100 mg-32.5-42.9-51.6
Anakinra 200 mg-31.1-43.6-49.1
Triamcinolone 40 mg-26.1-43.4-45.2

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Mean Intraocular Pressure in the Study Eye

Intraocular pressure is the fluid pressure inside the eye. Tonometry is the method eye care professionals use to determine this. IOP is an important aspect in the evaluation of patients at risk of glaucoma. Tonometers in this study were calibrated to measure pressure in millimeters of mercury. (NCT03097315)
Timeframe: Baseline, 24 Weeks

InterventionmmHg (Mean)
BaselineWeek 24
4 mg CLS-TA Suprachoriodal Injection13.315.2

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Number of Patients With a Grade of 0 in Vitreous Haze in the Study Eye

The vitreous body is that part of the eye that fills the space in the center of the eye. The primary purpose of the vitreous body is to keep the center of the eye clear so that light can get to the retina and vision can begin. Vitreous haze involves the obstruction of the back of the eye by vitreous cells and protein exudation. In this study, vitreous haze was graded following a standardized photographic scale ranging from 0 to 4. The following scale was used to grade the vitreous haze: 0 = no inflammation, +0.5 = trace inflammation, +1 = mild blurring of the retinal vessels and optic nerve, +1.5 = optic nerve head and posterior retina view obscuration greater than +1 but less than +2, +2 = moderate blurring of the optic nerve head, +3 = marked blurring of the optic nerve head, +4 = optic nerve head not visible. A lower grade represents less inflammation in the eye. (NCT03097315)
Timeframe: Baseline, 24 Weeks

InterventionParticipants (Count of Participants)
BaselineWeek 24
4 mg CLS-TA Suprachoriodal Injection1734

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Number of Patients With a Grade of 0 in Anterior Chamber Cells in the Study Eye

The anterior chamber is the aqueous humor-filled space inside the eye between the iris and the cornea's innermost surface, the endothelium. The grading of cellular reaction in the anterior chamber helps in the assessment of the severity of uveitis. In this study, anterior chamber cells were graded following the Standardization of Uveitis Nomenclature working group recommendations. The following scale was used to grade the cells in the field: 0 = <1, 0.5+ = 1-5, 1+ = 6-15, 2+ = 16-25, 3+ = 26-50, and 4+ = >50 cells. A lower grade represents less inflammation in the eye. (NCT03097315)
Timeframe: Baseline, 24 Weeks

InterventionParticipants (Count of Participants)
BaselineWeek 24
4 mg CLS-TA Suprachoriodal Injection1731

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Adverse Events

Number of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a preexisting medical condition after or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A TEAE is an AE occurring on or after the date of the first dose of study drug or worsening relative to the pre-treatment state. An SAE is an AE that fulfils one or more of the following: results in death; is immediately life-threatening; requires hospitalization nor prolongation of hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event that may jeopardize the subject or may require medical intervention to present one of the outcomes listed above. (NCT03097315)
Timeframe: Baseline to 24 weeks

InterventionParticipants (Count of Participants)
Treatment-Emergent Adverse EventsSerious Adverse Events
4 mg CLS-TA Suprachoriodal Injection271

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Number of Patients With a Grade of 0 in Anterior Chamber Flare in the Study Eye

The anterior chamber is the aqueous humor-filled space inside the eye between the iris and the cornea's innermost surface, the endothelium. The grading of intraocular inflammation or flare in the anterior chamber helps in the assessment of the severity of uveitis. In this study, anterior chamber flare was graded following the Standardization of Uveitis Nomenclature working group recommendations. The following scale was used to grade the flare: 0 = none, 1+ = faint, 2+ moderate (iris and lens details clear), 3+ = marked (iris and lens details hazy), 4+ = intense (fibrin or plastic aqueous). A lower grade represents less inflammation in the eye. (NCT03097315)
Timeframe: Baseline, 24 Weeks

InterventionParticipants (Count of Participants)
BaselineWeek 24
4 mg CLS-TA Suprachoriodal Injection2734

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Mean Change From Baseline in Central Subfield Thickness

Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. (NCT03126786)
Timeframe: Baseline, 6 months

Interventionmicrons (Least Squares Mean)
Active-212.1
Control-178.6

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Mean Change From Baseline in Best Corrected Visual Acuity Letter Score

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement. (NCT03126786)
Timeframe: Baseline, 6 months

Interventionletters (Least Squares Mean)
Active11.4
Control13.8

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Change in Strength in Both Groups After CESI.

Change in strength in both groups greater than or equal to 20% weakness in one or more myotomes 30 minutes after CESI using a hand held Dynamometer. (NCT03127137)
Timeframe: 30 minutes after the CESI procedure

,
InterventionParticipants (Count of Participants)
Yes, greater or equal to 20% weakness in greater or equal to 1 or more myotomeNo, greater or equal to 20% weakness in greater or equal to 1 or more myotome
Experimental Group 1 With Lidocaine2535
Experimental Group 2 With Saline3030

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Change From Baseline in Total WOMAC Score at 26 Weeks (ITT Population)

The change from baseline in Total Score as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) comparing the Cingal group to the TH group. The Total WOMAC Score combines the three 0-to-100 point scores from the WOMAC Pain Score, the WOMAC Stiffness Score, and the WOMAC Physical Function Score for a Total Score from 0 = no symptoms to 300 = highest degrees of pain, stiffness, and functional limitation symptoms. A negative number for the change from baseline indicates reduction in pain, stiffness and function limitations. A greater negative difference from baseline means a better outcome. (NCT03191903)
Timeframe: 26 weeks

Interventionscore on a scale (Mean)
Cingal-128.3
Monovisc-130.1
Triamcinolone Hexacetonide (TH)-125.9

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Change From Baseline in WOMAC Pain Score at 1 Week (ITT Population)

The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal group to the Monovisc group. The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the change from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome. (NCT03191903)
Timeframe: 1 week

Interventionscore on a scale (Mean)
Cingal-35.3
Monovisc-33.0
Triamcinolone Hexacetonide-34.5

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Change From Baseline in WOMAC Pain Score at 26 Weeks (ITT Population)

The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal group to the TH group. The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the change from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome. (NCT03191903)
Timeframe: 26 weeks

Interventionunits on a scale (Mean)
Cingal-46.4
Monovisc-46.6
Triamcinolone Hexacetonide (TH)-45.0

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Change From Baseline in WOMAC Pain Score at 3 Weeks (ITT Population)

The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal group to the Monovisc group. The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the change from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome. (NCT03191903)
Timeframe: 3 weeks

Interventionscore on a scale (Mean)
Cingal-42.6
Monovisc-39.5
Triamcinolone Hexacetonide (TH)-41.3

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Change From Baseline in WOMAC Pain Score at 3 Weeks in the Per-Protocol Population

The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal group to the Monovisc group. The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the change from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome. (NCT03191903)
Timeframe: 3 Weeks

Interventionscore on a scale (Mean)
Cingal-43.4
Monovisc-39.8
Triamcinolone Hexacetonide (TH)-42.5

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Change From Baseline in WOMAC Physical Function Score at 26 Weeks (ITT Population)

The change from baseline of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score comparing the Cingal and TH arms (ITT Population). The WOMAC Physical Function Score is a validated visual analog scale from 0 = no limitations in function to 100 mm = highest limitations in function. A negative number for the change from baseline indicates improvement in physical function. A greater negative difference from baseline means a better outcome. (NCT03191903)
Timeframe: 26 weeks

Interventionunits on a scale (Mean)
Cingal-42.6
Monovisc-42.4
Triamcinolone Hexacetonide (TH)-42.4

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Change From Baseline in WOMAC Stiffness Score at 26 Weeks (ITT Population)

The change from baseline in knee stiffness as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score comparing the Cingal group to the TH group. The WOMAC Stiffness Score is a validated visual analog scale from 0 = no stiffness to 100 = highest stiffness level. A negative number for the change from baseline indicates reduction in knee stiffness. A greater negative difference from baseline means a better outcome. (NCT03191903)
Timeframe: 26 weeks

Interventionunits on a scale (Mean)
Cingal-39.4
Monovisc-41.1
Triamcinolone Hexacetonide (TH)-38.5

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OMERACT-OARSI Responder Index at 26 Weeks Post Treatment Comparing the Cingal Group to the TH Group (ITT Population)

The responder rate as identified by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) responder index at 26 weeks post treatment comparing the Cingal® group to the TH group. The OMERACT-OARSI responder index is a proportion of subjects that met the criteria to be a responder. (NCT03191903)
Timeframe: 26 weeks

Interventionpercentage of subjects (Number)
Cingal91.24
Monovisc93.63
Triamcinolone Hexacetonide (TH)94.59

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The Usage of Rescue Medication (Acetaminophen) Through 26 Weeks (ITT Population)

The usage of rescue medication (acetominophen) through 26 weeks post treatment in the Cingal group compared to the TH group using the ITT population. (NCT03191903)
Timeframe: 26 weeks

Interventionpills (Mean)
Cingal5.4
Monovisc5.9
Triamcinolone Hexacetonide (TH)6.3

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Change From Baseline in Patient Global Assessment at 26 Weeks (ITT Population)

"The change from baseline in the Patient Global Assessment (PGA) between the Cingal and TH arms (ITT population). The PGA is completed by the subject answering the question Considering all the ways the osteoarthritis in your index knee bothers you, what is your assessment of how much your knee is bothering you today? The PGA is scored on a visual analog scale, where 0 = the patient is not bothered to 100 mm = the patient is bothered to the highest degree. A negative number for the change from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome." (NCT03191903)
Timeframe: 26 weeks

Interventionscore on a scale (Mean)
Cingal-37.2
Monovisc-37.3
Triamcinolone Hexacetonide (TH)-37.9

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Change From Baseline in the Evaluator Global Assessment at 26 Weeks (ITT Population)

"The change from baseline in the Evaluator Global Assessment between the Cingal and TH arms (ITT population). The Evaluator Global Assessment is completed by the Blinded Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the change from baseline indicates improvement in the assessment. A greater negative difference means a better outcome." (NCT03191903)
Timeframe: 26 weeks

Interventionscore on a scale (Mean)
Cingal-37.4
Monovisc-36.4
Triamcinolone Hexacetonide (TH)-38.8

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Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement. (NCT03203447)
Timeframe: 2 months

InterventionParticipants (Count of Participants)
Active64
Control76

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Mean Change From Baseline in Central Subfield Thickness

Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. (NCT03203447)
Timeframe: 6 months

Interventionmicrons (Least Squares Mean)
Active-353.6
Control-374.7

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Mean Change From Baseline in Best Corrected Visual Acuity

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision. (NCT03203447)
Timeframe: 6 months

Interventionletters (Least Squares Mean)
Active13.8
Control20.7

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Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma

"Plasma drug concentrations (pg/mL) by Time Point across FX006 and TAcs treatment arms in plasma.~For the PK analysis and individual concentration vs. time plots, a concentration that is BLOQ is assigned a value of zero if it occurs in a profile before the first measurable concentration. If a BLOQ value occurs after a measurable concentration in a profile and is followed by a value above the lower limit of quantification, then the BLOQ is treated as missing data. If a BLOQ value occurs at the end of the collection interval (after the last quantifiable concentration) it is set to zero. If two BLOQ values occur in succession after Cmax, the profile is deemed to have terminated at the first BLOQ value and any subsequent concentrations are set to zero for PK calculations" (NCT03378076)
Timeframe: 43 days

,
Interventionpg/mL (Geometric Mean)
Day 1- Hour 1Day 1 - Hour 2Day 1 - Hour 3Day 1 - Hour 4Day 1 - Hour 5Day 1 - Hour 6Day 1 - Hour 8Day 1 - Hour 10Day 1 - Hour 12Day 2 - Hour 24Day 8Day 15Day 29Day 43
FX006 32 mg1801.51893.61958.12013.81914.41900.21928.11839.81793.91948.81397.0956.2445.8265.8
TAcs 40 mg4507.95140.15443.85454.25338.95430.65199.04948.84507.84185.4450.8428.7334.6241.0

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Incidence of Treatment Emergent Adverse Events

"Safety analyses were conducted using the safety population.~Analyses of adverse events will be performed for those events that are considered treatment emergent, where treatment emergent is defined as any adverse event with onset after the administration of study medication in the first knee through the end of the study or any event that was present at baseline but worsened in intensity through the end of the study. Severity of Adverse events were graded by the Principal Investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The grading went from Grade 1 (Mild) to Grade 5 (Death related to AE)." (NCT03378076)
Timeframe: 43 days

,
Interventionparticipants (Number)
Patients with TEAE Grade 1Patients with TEAE Grade 2Patients with TEAE Grade 3Patients with TEAE Grade 4Patients with TEAE Grade 5
FX006 32 mg61100
TAcs 40 mg32000

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Severity of Dermatitis

"Scoring Atopic Dermatitis (SCORAD) differences between lesions treated with Valchlor and Triamcinolone versus lesions treated with Valchlor only. SCORAD measures the extent and severity of dermatitis. The percentage of total body surface area (0-100) covered by a lesion is measured by an investigator, and this number corresponds to score A. The intensity criteria are met by scoring erythema, edema/papulation, oozing/crusting, excoriation, xerosis, and thickness on a scale of 0-3 (0=none, 1=mild, 2=Moderate, 3=Severe). These values are summed to give a total score, B. Subjective symptoms of pruritus and insomnia are then scored using visual analogue scales ranging from 0-10 (0=none, 10=worst imaginable), and the result of each is summed to give score C. The final score is then calculated by the formula A/5 + 7B/2 + C. The lowest possible score is 0, and the highest possible score is 103. A higher score indicates a worse outcome.~A lower score would be a better outcome." (NCT03380026)
Timeframe: 4 months

Interventionscore on a scale (Mean)
Valchlor 0.016% Topical Gel24.8
Valchlor Plus Triamcinolone12.7

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Efficacy of Valchlor vs Valchlor Plus Triamcinolone

Efficacy of Valchlor therapy with Triamcinolone compared to Valchlor using a composite assessment of index lesion severity (CAILS). CAILS is an objective, quantitative, method to assess the extent of skin lesions. Skin lesions and erythema will be evaluated using CAILS. A Composite Assessment will be generated for each time point by a summation of the grades for each index lesion's erythema, scaling, plaque elevation, hypopigmentation or hyperpigmentation, and area of involvement. The index lesion grade at baseline will be divided into the grade at each subsequent study visit to determine the subject's response to treatment. Any ratio of the grade obtained at the visit vs. the one obtained at baseline that is >1.0 will indicate worsening of disease. (NCT03380026)
Timeframe: 4 months

,
InterventionCAILS score (Mean)
Average CAILS score at BaselineAverage CAILS score at Month 4
Valchlor 0.016% Topical Gel8.611.4
Valchlor Plus Triamcinolone7.012.0

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Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring

Incidence of moderate to severe contact dermatitis in patients treated concurrently with Triamcinolone 0.1% ointment versus those that are not. Dermatitis will be defined as a finding of cutaneous inflammatory reaction occurring as a result of treatment. This will be assessed by the SCORD (SCORing Dermatitis) tool and may be confirmed by biopsy of the specimen. Moderate to Severe Contact dermatitis is defined as >25 by SCORD. (NCT03380026)
Timeframe: 4 months

Interventionpatients (Number)
Valchlor 0.016% Topical Gel16
Valchlor Plus Triamcinolone11

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Concentration of Triamcinolone Acetonide (TA) in Blood Plasma

"Characterize the Pharmacokinetic Profile of FX006 and TCA IR [Time Frame: Day 1 (pre-treatment,1, 2, 3, 4, 5, 6, 8,10, and 12 hrs. post-dose) and Days 2, 3, 5, 8, 15, 22, 29, 57,and 85]~For the PK analysis and individual concentration vs. time plots, a concentration that is BLOQ is assigned a value of zero if it occurs in a profile before the first measurable concentration. If a BLOQ value occurs after a measurable concentration in a profile and is followed by a value above the lower limit of quantification, then the BLOQ is treated as missing data. If a BLOQ value occurs at the end of the collection interval (after the last quantifiable concentration) it is set to zero. If two BLOQ values occur in succession after Cmax, the profile is deemed to have terminated at the first BLOQ value and any subsequent concentrations are set to zero for PK calculations" (NCT03382262)
Timeframe: 12 Weeks

,,,
Interventionpg/mL (Geometric Mean)
Day 1 - Hour 1Day 1 - Hour 2Day 1 - Hour 3Day 1 - Hour 4Day 1 - Hour 5Day 1 - Hour 6Day 1 - Hour 8Day 1 - Hour 10Day 1 - Hour 12Day 2 - Hour 24Day - 3Day - 5Day - 8Day - 15Day - 22Day - 29Day - 57Day - 85
FX006 32 mg Hip681.8752.2748.0776.1792.9743.5705.0698.2675.1791.0682.1562.4472.3382.6235.0256.3225.1112.0
FX006 32 mg Shoulder1061.81117.61140.01142.41093.81052.81016.2951.4903.8943.4903.4754.6678.1397.6268.3201.0151.8100.1
TAcs 40 mg Hip3862.34052.44519.34557.84672.64469.84102.33615.63276.23218.81723.6897.3525.3444.7331.6281.8133.192.5
TAcs 40 mg Shoulder1104.11344.81501.81594.11662.71689.61668.31506.31531.31467.01413.11038.2857.8722.7476.7418.7200131.4

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Total Number of Treatment Emergent Adverse Events

Analyses of adverse events (AE) were performed for events considered treatment-emergent (TE). TE was defined as any AE with onset after administration of the 1st dose of study drug or any event present at baseline but worsened in intensity through the study. Severity was graded by the PI using the Common Terminology Criteria for AEs Version 4.0. Grading went from Grade 1 (Mild) to Grade 5 (Death Related to AE). (NCT03382262)
Timeframe: 12 Weeks

InterventionEvents (Number)
FX006 32 mg Shoulder10
TAcs 40 mg Shoulder7
FX006 32 mg Hip8
TAcs 40 mg Hip17

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Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III

The Medication Quantification Scale (MQS) is an instrument used for clinical and research applications for quantifying medication regimen use in chronic pain populations. A 6.8 point reduction is considered equivalent to 10 morphine eqivalents. (NCT03382821)
Timeframe: 1 month, 3 month, 6 month, and 1 year follow up

,
Interventionpercentage of participants (Number)
One monthThree monthSix monthOne year
Transforaminal Catheter-targeted ESI With Triamcinolone1917198
Transforaminal ESI With Dexamethasone1620157

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Neck Disability Index-5

Percentage of patients with >30% improvement in Neck Disability Index-5 score. (NCT03382821)
Timeframe: 1 month, 3 month, 6 month, and 1 year follow up

,
Interventionpercentage of participants (Number)
One monthThree monthSix monthOne year
Transforaminal Catheter-targeted ESI With Triamcinolone62585660
Transforaminal ESI With Dexamethasone48565547

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"The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved)"

"Patient Global Impression of Change is a scale which measures participant reported satisfaction after an intervention. The outcome was measured as the percent of patients reporting a PGIC score of 6-7 (indicating much improved and very much improved)" (NCT03382821)
Timeframe: 1 month, 3 month, 6 month, and 1 year follow up

,
Interventionpercentage of participants (Number)
One monthThree monthsSix monthsOne year
Transforaminal Catheter-targeted ESI With Triamcinolone59575361
Transforaminal ESI With Dexamethasone41425557

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The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score

The Percentage of Participants with Reduction of 50% or More of Neck and Arm Pain NRS score (NCT03382821)
Timeframe: 1 month follow up

Interventionpercentage of participants (Number)
Transforaminal ESI With Dexamethasone49.1
Interlaminar Catheter-targeted ESI With Triamcinolone68.5

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Change From Baseline in Patient Global Assessment at 39 Weeks

"Comparison of the change of the Patient Global Assessment from baseline to 39 weeks between the Cingal and Triamcinolone Hexacetonide arms (ITT population). The Patient Global Assessment is done by the subject, and answers the question Considering all the ways the osteoarthritis in your index knee bothers you, what is your assessment of how much your knee is bothering you today? The Patient Global Assessment is scored on a 0 to 100 mm visual analog scale, where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment." (NCT03390036)
Timeframe: 39 Weeks

,,
InterventionMillimeters (mm) (Mean)
Change from Baseline in Patient Global 39 weeksBaseline Patient Global in mm39 Week Patient Global in mm
Cingal-38.657.018.4
Monovisc-38.256.017.8
Triamcinolone Hexacetonide (TH)-36.758.221.5

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Change From Baseline in Total WOMAC Score at 39 Weeks

The change from baseline as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The Total WOMAC Score is determined from the SUM of the scores from the WOMAC Pain Score, the WOMAC Stiffness Score, and the WOMAC Physical Function Score, resulting in a final range for Total Score from 0 mm to 240 mm. A higher Total WOMAC Score indicates a higher overall degree of pain, stiffness and functional limitations. A negative number for the change from baseline indicates improvement in the Total WOMAC Score. (NCT03390036)
Timeframe: 39 Weeks

,,
InterventionMillimeters (mm) (Mean)
Change from Baseline in Total WOMAC 39 WeeksBaseline Total WOMAC in mm39 Week Total WOMAC in mm
Cingal-128.4181.853.4
Monovisc-132.6183.450.8
Triamcinolone Hexacetonide (TH)-122.7183.560.8

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Change From Baseline in WOMAC Pain Score at 39 Weeks

The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The WOMAC Pain Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher pain level. A negative number for the difference from baseline indicates improvement in pain. A greater negative difference from baseline indicates a better outcome. (NCT03390036)
Timeframe: 39 Weeks

,,
InterventionMillimeters (mm) (Mean)
Change from Baseline in WOMAC Pain 39 WeeksBaseline WOMAC Pain in mm39 Week WOMAC Pain in mm
Cingal-46.363.317.0
Monovisc-47.263.316.0
Triamcinolone Hexacetonide (TH)-43.663.820.1

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Change From Baseline in WOMAC Physical Function Score at 39 Weeks

This endpoint compares the change of the WOMAC Physical Function Score from baseline to Week 39 between the Cingal and Triamcinolone Hexacetonide arms. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher degree of functional limitation. A negative number for the change from baseline indicates improvement in physical function. (NCT03390036)
Timeframe: 39 Weeks

,,
InterventionMillimeters (mm) (Mean)
Change from Baseline WOMAC Function 39 WeeksBaseline WOMAC Function39 Week WOMAC Function
Cingal-42.560.818.4
Monovisc-43.560.817.3
Triamcinolone Hexacetonide (TH)-41.161.820.7

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Change From Baseline in WOMAC Stiffness Score at 39 Weeks

The change from baseline in knee stiffness as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The WOMAC Stiffness Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher degree of stiffness. A negative number for the change from baseline indicates improvement in knee stiffness. (NCT03390036)
Timeframe: 39 Weeks

,,
InterventionMillimeters (mm) (Mean)
Change from Baseline in WOMAC Stiffness 39 WeeksBaseline WOMAC Stiffness in mm39 Week WOMAC Stiffness in mm
Cingal-39.857.717.9
Monovisc-42.059.217.2
Triamcinolone Hexacetonide (TH)-38.057.919.9

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OMERACT-OARSI Responder Rate at 39 Weeks

"The post treatment Responder Rate at 39 weeks is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder. The criteria for response are (1) improvement in pain or physical function ≥50% and an absolute change ≥20 mm; or (2) improvement of ≥20% with an absolute change ≥10 mm in at least two of the following three categories: pain, physical function, and patient's global assessment.~A higher percentage of subjects responding indicates a better outcome." (NCT03390036)
Timeframe: 39 weeks

InterventionPercentage of subjects (Number)
Cingal91.2
Monovisc92.4
Triamcinolone Hexacetonide (TH)93.2

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The Usage of Rescue Medication (Acetaminophen) at Week 39

The usage of rescue medication (number of pills of acetominophen) at Week 39 weeks post treatment in the Cingal group compared to the Triamcinolone Hexacetonide group. (NCT03390036)
Timeframe: 39 Weeks

InterventionNumber of pills (Mean)
Cingal7.9
Monovisc6.0
Triamcinolone Hexacetonide (TH)6.9

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Change From Baseline in Evaluator Global Assessment at 39 Weeks

"Comparison of the change of the Evaluator Global Assessment from baseline to 39 weeks between the Cingal and Triamcinolone Hexacetonide arms (ITT population). The Evaluator Global Assessment is done by the Blinded Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a 0 to 100 mm visual analog scale, where a higher number means the Evaluator assesses that the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment." (NCT03390036)
Timeframe: 39 Weeks

,,
InterventionMillimeters (mm) (Mean)
Change from Baseline in Evaluator Global 39 eeksBaseline Evaluator Global in mm39 Week Evaluator Global in mm
Cingal-37.152.915.8
Monovisc-37.752.314.6
Triamcinolone Hexacetonide (TH)-39.156.617.4

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Number of Participants With at Least One Adverse Event

Adverse events will only be those determined to be related to the study drug (NCT03463915)
Timeframe: End of study (6 weeks)

InterventionParticipants (Count of Participants)
Bladder Instillation WITH Triamcinolone Acetonide1
Bladder Instillation WITHOUT Triamcinolone Acetonide5

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Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire

Total scores range: 0-36 (0= no symptoms to 36= the most severe symptoms) (NCT03463915)
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

Interventionscores on a scale (Mean)
Bladder Instillation WITH Triamcinolone Acetonide-6.7
Bladder Instillation WITHOUT Triamcinolone Acetonide-5.8

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Pelvic Floor Distress Inventory (PFDI)

20 question self-administered questionnaire on the presence and absence of pelvic floor symptoms. Score ranges from 0 (least distress) to 300 (most distress). (NCT03463915)
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

Interventionscore on a scale (Mean)
Bladder Instillation WITH Triamcinolone Acetonide-5.3
Bladder Instillation WITHOUT Triamcinolone Acetonide-6.4

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Change From Baseline in Treatment Response as Measured by the Visual Analogue Scale (VAS) for Pain

VAS is measured on marking on a 10-centimeter (cm) ruler (measured in cm, 0= no pain and 10= most severe pain possible) (NCT03463915)
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

Interventionscore on a scale (Mean)
Bladder Instillation WITH Triamcinolone Acetonide-1.9
Bladder Instillation WITHOUT Triamcinolone Acetonide-1.8

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Overactive Bladder Questionnaire (OAB-q)

Total scores range: 0-100 (higher scores on the symptom-severity scale suggestive of greater severity of symptoms and higher scores on the quality-of-life scale suggestive of better quality of life) (NCT03463915)
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

Interventionscore on a scale (Mean)
Bladder Instillation WITH Triamcinolone Acetonide-24.2
Bladder Instillation WITHOUT Triamcinolone Acetonide-18.8

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Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire

Measures sexual function in women with pelvic floor disorders. Queries about arousal, orgasm, partner-related issues, sexual quality, and desire. The tool also takes into account those who are not sexually active. The questionnaire was used in the study solely to determine if patients had improved dyspareunia (as a categorical variable). (NCT03463915)
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

Interventionparticipants (Number)
Bladder Instillation WITH Triamcinolone Acetonide4
Bladder Instillation WITHOUT Triamcinolone Acetonide4

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Pelvic Pain and Urgency/Frequency (PUF) Questionnaire

Total scores range: 0-35 (0= no symptoms to 35= the most severe symptoms) (NCT03463915)
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

Interventionscore on a scale (Mean)
Bladder Instillation WITH Triamcinolone Acetonide-5.3
Bladder Instillation WITHOUT Triamcinolone Acetonide-2.7

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Patient's Assessment of Response to Treatment

Patient's global assessment of response to treatment (Likert), options are None, Poor, Acceptable, Good, Excellent (NCT03636373)
Timeframe: Day 4, 7 and 14

InterventionParticipants (Count of Participants)
Visit 2 (Day 4)72266691Visit 2 (Day 4)72266690Visit 3 (Day 7)72266690Visit 3 (Day 7)72266691Visit 4 (Day 14)72266691Visit 4 (Day 14)72266690
NoneAcceptableGoodExcellentPoor
Etanercept1
Triamcinolone Acetonide0
Etanercept0
Triamcinolone Acetonide2
Triamcinolone Acetonide1

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Joint Pain Intensity in the Most Affected Joint

Pain intensity in the most affected baseline joint measured by the numeric 0-10 Visual Analog Scale at 72 hours with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome. (NCT03636373)
Timeframe: 72 hours

Interventionscore on a scale (Mean)
Etanercept5
Triamcinolone Acetonide1.5

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Joint Pain on Numeric Pain Scale

Patient's assessment of joint pain intensity in the most affected baseline joint on a numeric 0-10 Visual Analog Scale at Baseline and post-dose Days with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome. (NCT03636373)
Timeframe: Baseline, Days 4, 7, and 14

,
Interventionscore on a scale (Mean)
Visit 1 (Baseline)Visit 2 (Day 4)Visit 3 (Day 7)Visit 4 (Day 14)
Etanercept7.67530.5
Triamcinolone Acetonide61.511

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Physician's Assessment of Response to Treatment

Physician's global assessment of response to treatment None, Poor, Acceptable, Good, Excellent (NCT03636373)
Timeframe: Post-dose days 4, 7 and 14

InterventionParticipants (Count of Participants)
Visit 2 (Day 4)72266692Visit 2 (Day 4)72266693Visit 3 (Day 7)72266693Visit 3 (Day 7)72266692Visit 4 (Day 14)72266692Visit 4 (Day 14)72266693
NonePoorAcceptableGoodExcellent
Triamcinolone Acetonide0
Etanercept1
Etanercept0
Triamcinolone Acetonide1
Etanercept2
Triamcinolone Acetonide2

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Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle

The local tolerability of the creams will be assesed using a predefined scale: 0 = No reaction; 0.5 = Only slight erythema; 1 = Only erythema; 2 = Erythema with papules or oedema; 3 = Erythema, oedema with papules, oedema with vesicle; 4 = Blisters (NCT03758365)
Timeframe: Day 2

InterventionParticipants (Count of Participants)
MC2-01 Cream72211385Clobetasol Propionate 0.05% Lotion72211385Betamethasone Dipropionate 0.05% Cream72211385Triamcinolone Acetonide 0.1% Cream72211385Hydrocortisone Butyrate 0.1% Cream72211385Desonide 0.05% Cream72211385Vehicle Cream72211385
Erythema with papules or oedemaNo reactionOnly Slight reactionOnly erythemaErythema, oedema with papules, oedema with vesicleBlisters
MC2-01 Cream + Comparators0
MC2-01 Cream + Comparators36

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Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle

Blanching of the skin will be assessed individually by two trained observers blinded to treatment. The observers will score the blanching of the skin from 0-4 (0 = No change in color skin; 1 = Slight (barely visible) blanching; 3 = Obvious blanching; 4 = Blanching judged to be maximal). The results is presented as Mean ± SD. (NCT03758365)
Timeframe: Day 2

Interventionscore on a scale (Mean)
MC2-01 CreamClobetasol Propionate 0.05% LotionBetamethasone Dipropionate 0.05% CreamTriamcinolone Acetonide 0.1% CreamHydrocortisone Butyrate 0.1% CreamDesonide 0.05% CreamVehicle Cream
MC2-01 Cream + Comparators1.663.052.451.922.062.110.14

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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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30 Second Chair Standing Test

The 30 second Chair Standing Test is one of three Osteoarthritis Research Society International (OARSI) recommended minimal core set of performance-based outcome measures in OA research and clinical practice.In this test, the subject will stand up completely from the sitting position so hips and knees are fully extended, then completely back in the seated position. This will be repeated for 30 seconds and the total number of chair stands will be recorded (up and down equals one stand). (NCT03895840)
Timeframe: 12 weeks

Interventionstands (Least Squares Mean)
Intra-articular Zilretta Injection9.5

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40m Fast Paced Walking Test (40m FPWT)

The 40-meter fast paced walk test is one of the three Osteoarthritis Research Society International recommended minimal core set of performance-based outcome measures in OA research and clinical practice.The subjects will be timed to complete a 40 m track course. (NCT03895840)
Timeframe: 12 weeks

Interventionseconds (Least Squares Mean)
Intra-articular Zilretta Injection35.9

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KOOS-PS (Knee Osteoarthritis Outcome Score - Physical Function Short Form)

KOOS-Physical Function (KOOS-PS) Short Form is a parsimonious measure of physical function derived from the KOOS, which is a self-reported outcome score. The KOOS-Physical Function Short Form ranges from 0 to 100 where higher values represents a worse outcome. (NCT03895840)
Timeframe: 12 weeks

Interventionscore on a scale (Least Squares Mean)
Intra-articular Zilretta Injection70.0

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KOOS-QoL (Knee Osteoarthritis Outcome Score - Quality of Life)

KOOS-QoL a self-reported measure consisting of 4 questions assessing quality of life, which is part of the five patient-relevant subscales of KOOS.The sub scale ranges from 0 to 100 where higher values represents a better outcome (NCT03895840)
Timeframe: 12 weeks

Interventionscore on a scale (Least Squares Mean)
Intra-articular Zilretta Injection51.9

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NRS for Pain

The Numeric Rating Scale for Pain (NRS for Pain) is a measure of pain intensity. The subject will rate their knee pain bilaterally on a scale from no pain (0) to worst pain imaginable (10). (NCT03895840)
Timeframe: 12 weeks

Interventionunits on a scale (Least Squares Mean)
Intra-articular Zilretta Injection3.3

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Timed Stair Climb

The stair climb test is one of the three Osteoarthritis Research Society International recommended minimal core set of performance-based outcome measures in OA research and clinical practice. The subject will be timed while ascending and descending 9 steps of stairs. (NCT03895840)
Timeframe: 12 weeks

Interventionseconds (Least Squares Mean)
Intra-articular Zilretta Injection15.0

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Visual Analog Scale

Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. (NCT04115644)
Timeframe: Week 4

Interventionscore on a scale (Mean)
Group 1 (Control)3.547
Group 2 (Ketorolac)2.67
Group 3 (Kenalog)2.317

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Visual Analog Scale

Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. (NCT04115644)
Timeframe: Week 1

Interventionscore on a scale (Mean)
Group 1 (Control)3.397
Group 2 (Ketorolac)3.7
Group 3 (Kenalog)3.257

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Visual Analog Scale

Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. (NCT04115644)
Timeframe: Week 12

Interventionscore on a scale (Mean)
Group 1 (Control)3.447
Group 2 (Ketorolac)1.417
Group 3 (Kenalog)2.027

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Visual Analog Scale

Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. (NCT04115644)
Timeframe: Week 2

Interventionscore on a scale (Mean)
Group 1 (Control)3.547
Group 2 (Ketorolac)2.67
Group 3 (Kenalog)2.57

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Visual Analog Scale

Pain as measured by the Visual Analog Scale after first injection. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. (NCT04115644)
Timeframe: Baseline - immediately after the injection

Interventionscore on a scale (Mean)
Group 1 (Control)3.197
Group 2 (Ketorolac)3.577
Group 3 (Kenalog)3.677

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Visual Analog Scale

Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. (NCT04115644)
Timeframe: Week 6

Interventionscore on a scale (Mean)
Group 1 (Control)3.357
Group 2 (Ketorolac)2.757
Group 3 (Kenalog)2.687

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Visual Analog Scale

Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. (NCT04115644)
Timeframe: Day 2

Interventionscore on a scale (Mean)
Group 1 (Control)2.347
Group 2 (Ketorolac)2.837
Group 3 (Kenalog)2.67

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Visual Analog Scale

Pain as measured by the Visual Analog Scale prior to first injection. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. (NCT04115644)
Timeframe: Baseline - pre-injection

Interventionscore on a scale (Mean)
Group 1 (Control)5.77
Group 2 (Ketorolac)4.57
Group 3 (Kenalog)4.67

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score

The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative number for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment. (NCT04231318)
Timeframe: 12 Weeks

Interventionscore on a scale (Mean)
Cingal-44.1
Triamcinolone Hexacetonide (TH)-38.9
Placebo-37.4

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score

The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative number for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment. (NCT04231318)
Timeframe: 18 Weeks

Interventionscore on a scale (Mean)
CINGAL-44.5
Triamcinolone Hexacetonide (TH)-40.2
Placebo-36.7

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score

The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative number for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment. (NCT04231318)
Timeframe: 3 Weeks

Interventionscore on a scale (Mean)
Cingal-45.1
Triamcinolone Hexacetonide (TH)-37.7
Placebo-34.0

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score

The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative number for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment. (NCT04231318)
Timeframe: 6 Weeks

Interventionscore on a scale (Mean)
Cingal-46.0
Triamcinolone Hexacetonide (TH)-40.4
Placebo-36.2

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness Score

The change from Baseline in knee stiffness post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score comparing the Cingal, TH, and Placebo arms. WOMAC Stiffness Score records participant responses regarding the sensation of ease in moving their joint. The WOMAC Stiffness Score is a validated 100 mm visual analog scale (VAS) from 0 mm = No Stiffness to 100 mm = Extreme Stiffness. A negative value for the change from Baseline indicates improvement in WOMAC Stiffness Score. A larger negative value indicates less stiffness, and a better outcome. (NCT04231318)
Timeframe: 26 Weeks

Interventionscore on a scale (Mean)
Cingal-39.4
Triamcinolone Hexacetonide (TH)-34.6
Placebo-32.1

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score

"The change from Baseline in overall clinical improvement in the knee post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score comparing the Cingal, TH, and Placebo arms. WOMAC Total Score combines the three 0-to-100 point scores from the WOMAC Pain Score, the WOMAC Stiffness Score, and the WOMAC Function Score to calculate a TOTAL Score from 0 = No Symptoms to 100 = Highest Degrees of Pain, Stiffness and Functional Limitation Symptoms.~A negative value for the change from Baseline in WOMAC Total Score indicates reduction in pain, stiffness, and improved function. A larger negative value indicates a better overall clinical outcome." (NCT04231318)
Timeframe: 26 Weeks

Interventionscore on a scale (Mean)
Cingal-41.4
Triamcinolone Hexacetonide (TH)-37.3
Placebo-35.6

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The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index

"The post-treatment responder rate is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder to treatment. The criteria for response are (1) improvement in pain or physical function >50% and an absolute change >20 mm; or (2) improvement of >20% with an absolute change >10 mm in at least of the following three categories: pain, physical function, and patient's global assessment.~A higher percentage of subjects responding indicates a better outcome.~OMERACT-OARSI responder rates were compared between the Cingal, TH and Placebo arms." (NCT04231318)
Timeframe: 26 Weeks

Interventionpercentage of participants (Number)
Cingal89.9
Triamcinolone Hexacetonide (TH)80.8
Placebo78.8

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The Usage of Rescue Medication (Acetaminophen/Paracetamol) at 26 Weeks

"The usage of Rescue Medication (RM) as based on the average number of acetominophen/paracetamol pills taken among participants at 26 Weeks post treatment comparing between the Cingal, Triamcinolone Hexacetonide (TH) and Placebo arms.~A smaller value in average RM indicates that fewer pills were taken by the participants, which may correlate to a better clinical outcome in terms of pain." (NCT04231318)
Timeframe: 26 Weeks

InterventionPills (Mean)
Cingal8.5
Triamcinolone Hexacetonide (TH)14.2
Placebo19.1

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Change From Baseline in Knee Pain as Measured by Numerical Rating Scale (NRS) Pain Score

Change in knee pain was obtained from participant responses using a Numerical Rating Scale (NRS) Pain Score. This NRS Pain Score ranged from 0 = No Pain to 10 = Highest Pain Level. A negative value for the change in Pain Score indicates less pain post-treatment. A larger negative value indicates a higher level of improvement, and a better outcome. (NCT04231318)
Timeframe: 26 Weeks

Interventionscore on a scale (Mean)
Cingal-3.5
Triamcinolone Hexacetonide (TH)-3.3
Placebo-2.3

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Change From Baseline in Knee Pain as Measured by Visual Analog Scale (VAS) Pain Score

Change in knee pain was obtained from participant responses using a 100 mm Visual Analog Scale (VAS) Pain Score at each time point. This VAS scale ranged from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative value for the change in pain indicates less pain post-treatment. A larger negative value indicates a higher level of improvement, and a better outcome. (NCT04231318)
Timeframe: 26 Weeks

Interventionscore on a scale (Mean)
Cingal-35.1
Triamcinolone Hexacetonide (TH)-31.9
Placebo-27.1

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Change From Baseline in the Evaluator Global Assessment (EGA) Score

"The change from Baseline in knee pain post-treatment as measured by the Evaluator Global Assessment (EGA) Score comparing the Cingal, TH, and Placebo arms. EGA Score records the Study Evaluator's assessment of how much the patient's STUDY (treated) knee is bothering them today . The EGA Score is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Extreme Pain.~A negative value for the change from Baseline indicates improvement in EGA Score. A larger negative value indicates less pain, and a better clinical outcome." (NCT04231318)
Timeframe: 26 Weeks

Interventionscore on a scale (Mean)
Cingal-40.1
Triamcinolone Hexacetonide (TH)-33.3
Placebo-32.6

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Change From Baseline in the Patient Global Assessment (PGA) Score

"The change from Baseline in knee pain post-treatment as measured by the Patient Global Assessment (PGA) Score comparing the Cingal, TH, and Placebo arms. PGA Score records participant responses to their assessment of how much their STUDY (treated) knee is bothering them today . The PGA Score is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Extreme Pain.~A negative value for the change from Baseline indicates improvement in PGA Score. A larger negative value indicates less pain, and a better clinical outcome." (NCT04231318)
Timeframe: 26 Weeks

Interventionscore on a scale (Mean)
Cingal-42.3
Triamcinolone Hexacetonide (TH)-37.6
Placebo-34.0

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Score

The change from Baseline in knee function post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Score comparing the Cingal, TH, and Placebo arms. WOMAC Function Score records participant responses regarding the difficulty they have performing daily activities. The WOMAC Function Score is a validated 100 mm visual analog scale (VAS) from 0 mm = No Difficulty to 100 mm = Extreme Difficulty. A negative value for the change from Baseline indicates improvement in WOMAC Function Score. A larger negative value indicates improvement in performing daily activities, and a better outcome. (NCT04231318)
Timeframe: 26 Weeks

Interventionscore on a scale (Mean)
Cingal-40.8
Triamcinolone Hexacetonide (TH)-37.5
Placebo-35.2

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score

The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative value for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment. A larger negative value indicates lower pain levels and a better outcome. (NCT04231318)
Timeframe: 26 Weeks

Interventionscore on a scale (Mean)
Cingal-44.3
Triamcinolone Hexacetonide (TH)-37.5
Placebo-36.1

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score

The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative number for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment. (NCT04231318)
Timeframe: 1 Week

Interventionscore on a scale (Mean)
Cingal-40.9
Triamcinolone Hexacetonide (TH)-35.6
Placebo-24.8

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Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.

"Evaluate the morphologic changes in participant's skin from baseline, specifically assessing~Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris~Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.~Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules." (NCT04582669)
Timeframe: Baseline

InterventionParticipants (Count of Participants)
Sodium Chloride 0.9%0
Intralesional Triamcinolone 10 mg/mL0
Intralesional Triamcinolone 20 mg/mL0
Intralesional Triamcinolone 40 mg/mL0

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Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.

"Evaluate the morphologic changes in participant's skin from baseline, specifically assessing~Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris~Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.~Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules." (NCT04582669)
Timeframe: Day 2

InterventionParticipants (Count of Participants)
Sodium Chloride 0.9%0
Intralesional Triamcinolone 10 mg/mL0
Intralesional Triamcinolone 20 mg/mL0
Intralesional Triamcinolone 40 mg/mL0

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Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.

"Evaluate the morphologic changes in participant's skin from baseline, specifically assessing~Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris~Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.~Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules." (NCT04582669)
Timeframe: Day 28

InterventionParticipants (Count of Participants)
Sodium Chloride 0.9%0
Intralesional Triamcinolone 10 mg/mL0
Intralesional Triamcinolone 20 mg/mL0
Intralesional Triamcinolone 40 mg/mL0

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Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.

"Evaluate the morphologic changes in participant's skin from baseline, specifically assessing~Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris~Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.~Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules." (NCT04582669)
Timeframe: Day 6

InterventionParticipants (Count of Participants)
Sodium Chloride 0.9%0
Intralesional Triamcinolone 10 mg/mL0
Intralesional Triamcinolone 20 mg/mL0
Intralesional Triamcinolone 40 mg/mL0

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Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.

"Evaluate the morphologic changes in participant's skin from baseline, specifically assessing~Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris~Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.~Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules." (NCT04582669)
Timeframe: Day 14

InterventionParticipants (Count of Participants)
Sodium Chloride 0.9%0
Intralesional Triamcinolone 10 mg/mL0
Intralesional Triamcinolone 20 mg/mL0
Intralesional Triamcinolone 40 mg/mL0

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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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SubstanceRelationship StrengthStudiesTrialsClassesRoles
acetaminophen
Acetaminophen: Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.. paracetamol : A member of the class of phenols that is 4-aminophenol in which one of the hydrogens attached to the amino group has been replaced by an acetyl group.		3.811acetamides;
phenols		antipyretic;
cyclooxygenase 1 inhibitor;
cyclooxygenase 2 inhibitor;
cyclooxygenase 3 inhibitor;
environmental contaminant;
ferroptosis inducer;
geroprotector;
hepatotoxic agent;
human blood serum metabolite;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug;
xenobiotic
carbamazepine
Carbamazepine: A dibenzazepine that acts as a sodium channel blocker. It is used as an anticonvulsant for the treatment of grand mal and psychomotor or focal SEIZURES. It may also be used in the management of BIPOLAR DISORDER, and has analgesic properties.. carbamazepine : A dibenzoazepine that is 5H-dibenzo[b,f]azepine carrying a carbamoyl substituent at the azepine nitrogen, used as an anticonvulsant.		2.0210dibenzoazepine;
ureas		analgesic;
anticonvulsant;
antimanic drug;
drug allergen;
EC 3.5.1.98 (histone deacetylase) inhibitor;
environmental contaminant;
glutamate transporter activator;
mitogen;
non-narcotic analgesic;
sodium channel blocker;
xenobiotic
diclofenac
Diclofenac: A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.. diclofenac : A monocarboxylic acid consisting of phenylacetic acid having a (2,6-dichlorophenyl)amino group at the 2-position.		1.9710amino acid;
aromatic amine;
dichlorobenzene;
monocarboxylic acid;
secondary amino compound		antipyretic;
drug allergen;
EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor;
environmental contaminant;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug;
xenobiotic
pentetic acid
Pentetic Acid: An iron chelating agent with properties like EDETIC ACID. DTPA has also been used as a chelator for other metals, such as plutonium.		1.9810pentacarboxylic acidcopper chelator
lidocaine
Lidocaine: A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of PROCAINE but its duration of action is shorter than that of BUPIVACAINE or PRILOCAINE.. lidocaine : The monocarboxylic acid amide resulting from the formal condensation of N,N-diethylglycine with 2,6-dimethylaniline.		8.1386benzenes;
monocarboxylic acid amide;
tertiary amino compound		anti-arrhythmia drug;
drug allergen;
environmental contaminant;
local anaesthetic;
xenobiotic
iothalamic acid
Iothalamic Acid: A contrast medium in diagnostic radiology with properties similar to those of diatrizoic acid. It is used primarily as its sodium and meglumine (IOTHALAMATE MEGLUMINE) salts.		3.4511organic molecular entity
mepivacaine
Mepivacaine: A local anesthetic that is chemically related to BUPIVACAINE but pharmacologically related to LIDOCAINE. It is indicated for infiltration, nerve block, and epidural anesthesia. Mepivacaine is effective topically only in large doses and therefore should not be used by this route. (From AMA Drug Evaluations, 1994, p168). mepivacaine : A piperidinecarboxamide in which N-methylpipecolic acid and 2,6-dimethylaniline have combined to form the amide bond. It is used as a local amide-type anaesthetic.		3.3711piperidinecarboxamidedrug allergen;
local anaesthetic
phenylmethylsulfonyl fluoride
Phenylmethylsulfonyl Fluoride: An enzyme inhibitor that inactivates IRC-50 arvin, subtilisin, and the fatty acid synthetase complex.. phenylmethanesulfonyl fluoride : An acyl fluoride with phenylmethanesulfonyl as the acyl group.		2.1710acyl fluorideserine proteinase inhibitor
iodoacetic acid
Iodoacetic Acid: A derivative of ACETIC ACID that contains one IODINE atom attached to its methyl group.. iodoacetic acid : A haloacetic acid that is acetic acid in which one of the hydrogens of the methyl group is replaced by an iodine atom.		1.9610haloacetic acid;
organoiodine compound		alkylating agent
tiaprofenic acid
tiaprofenic acid: RN given refers to parent cpd; structure. tiaprofenic acid : An aromatic ketone that is thiophene substituted at C-2 by benzoyl and at C-4 by a 1-carboxyethyl group.		1.9710aromatic ketone;
monocarboxylic acid;
thiophenes		drug allergen;
non-steroidal anti-inflammatory drug
hydrocortisone acetate
hydrocortisone acetate: RN given refers to cpd without isomeric designation		1.9710cortisol ester;
tertiary alpha-hydroxy ketone
prednisolone
Prednisolone: A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states.. prednisolone : A glucocorticoid that is prednisone in which the oxo group at position 11 has been reduced to the corresponding beta-hydroxy group. It is a drug metabolite of prednisone.		9.336011beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
C21-steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		adrenergic agent;
anti-inflammatory drug;
antineoplastic agent;
drug metabolite;
environmental contaminant;
immunosuppressive agent;
xenobiotic
thymidine
[no description available]		1.9610pyrimidine 2'-deoxyribonucleosideEscherichia coli metabolite;
human metabolite;
metabolite;
mouse metabolite
prednisolone acetate
prednisolone acetate: RN given refers to cpd with locant for acetate group in position 21 & (11 beta)-isomer		2.3820corticosteroid hormone
fluprednisolone
Fluprednisolone: A synthetic glucocorticoid with anti-inflammatory properties.		3.0610fluorinated steroid
methylprednisolone acetate
Methylprednisolone Acetate: Methylprednisolone derivative that is used as an anti-inflammatory agent for the treatment of ALLERGY and ALLERGIC RHINITIS; ASTHMA; and BURSITIS; and for the treatment of ADRENAL INSUFFICIENCY.. methylprednisolone acetate : An acetate ester resulting from the formal condensation of the 21-hydroxy function of 6alpha-methylprednisolone compound with acetic acid.		7.256211beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
3-oxo-Delta(1),Delta(4)-steroid;
acetate ester;
glucocorticoid;
steroid ester;
tertiary alpha-hydroxy ketone		anti-inflammatory drug
desoxycorticosterone
Desoxycorticosterone: A steroid metabolite that is the 11-deoxy derivative of CORTICOSTERONE and the 21-hydroxy derivative of PROGESTERONE		1.961020-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(4) steroid;
mineralocorticoid;
primary alpha-hydroxy ketone		human metabolite;
mouse metabolite
triamcinolone diacetate
triamcinolone diacetate: lysyl oxidase antagonist; Polcortolon may also refers to triamcinolone		1.9610corticosteroid hormone
alizarin
[no description available]		2.0310dihydroxyanthraquinonechromophore;
dye;
plant metabolite
ethyl chloride
Ethyl Chloride: A gas that condenses under slight pressure. Because of its low boiling point ethyl chloride sprayed on skin produces an intense cold by evaporation. Cold blocks nerve conduction. Ethyl chloride has been used in surgery but is primarily used to relieve local pain in sports medicine.. chloroethane : The simplest and least toxic member of the class of chloroethanes, that is ethane in which a single hydrogen is substituted by a chlorine. A colourless gas at room temperature and pressure (boiling point 12degreeC), it is used as a mild topical anaesthetic to numb the skin prior to ear piercing, skin biopsies, etc., and is also used in the treatment of sports injuries. It was formerly used in the production of tetraethyllead.		6.6733chloroethanesantipruritic drug;
inhalation anaesthetic;
local anaesthetic
triamcinolone acetonide
Triamcinolone Acetonide: An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.. triamcinolone acetonide : A synthetic glucocorticoid that is the 16,17-acetonide of triamcinolone. Used to treat various skin infections.		19.322237011beta-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(4) steroid;
cyclic ketal;
fluorinated steroid;
glucocorticoid;
primary alpha-hydroxy ketone		anti-allergic agent;
anti-inflammatory drug
methylprednisolone
Methylprednisolone: A PREDNISOLONE derivative with similar anti-inflammatory action.. 6alpha-methylprednisolone : The 6alpha-stereoisomer of 6-methylprednisolone.		9.841336-methylprednisolone;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		adrenergic agent;
anti-inflammatory drug;
antiemetic;
environmental contaminant;
neuroprotective agent;
xenobiotic
1,2-dihydroxybenzene-3,5-disulfonic acid disodium salt
Chymopapain: A cysteine endopeptidase isolated from papaya latex. Preferential cleavage at glutamic and aspartic acid residues. EC 3.4.22.6.		1.9710organosulfur compound;
sulfonic acid derivative
citrulline
citrulline : The parent compound of the citrulline class consisting of ornithine having a carbamoyl group at the N(5)-position.		3.4611amino acid zwitterion;
citrulline		Daphnia magna metabolite;
EC 1.14.13.39 (nitric oxide synthase) inhibitor;
Escherichia coli metabolite;
human metabolite;
micronutrient;
mouse metabolite;
nutraceutical;
plant metabolite;
protective agent;
Saccharomyces cerevisiae metabolite
betamethasone
Betamethasone: A glucocorticoid given orally, parenterally, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. Its lack of mineralocorticoid properties makes betamethasone particularly suitable for treating cerebral edema and congenital adrenal hyperplasia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p724)		12.666211beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
fluorinated steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		anti-asthmatic agent;
anti-inflammatory drug;
immunosuppressive agent
durapatite
Durapatite: The mineral component of bones and teeth; it has been used therapeutically as a prosthetic aid and in the prevention and treatment of osteoporosis.. hydroxylapatite : A phosphate mineral with the formula Ca5(PO4)3(OH).		3.4511
methylprednisolone hemisuccinate
Methylprednisolone Hemisuccinate: A water-soluble ester of METHYLPREDNISOLONE used for cardiac, allergic, and hypoxic emergencies.		1.9610corticosteroid hormone;
hemisuccinate
rhenium
Rhenium: A metal, atomic number 75, atomic weight 186.207, symbol Re.		1.9710manganese group element atom
samarium
Samarium: An element of the rare earth family of metals. It has the atomic symbol Sm, atomic number 62, and atomic weight 150.36. The oxide is used in the control rods of some nuclear reactors.		5.544f-block element atom;
lanthanoid atom
technetium
Technetium: The first artificially produced element and a radioactive fission product of URANIUM. Technetium has the atomic symbol Tc, and atomic number 43. All technetium isotopes are radioactive. Technetium 99m (m=metastable) which is the decay product of Molybdenum 99, has a half-life of about 6 hours and is used diagnostically as a radioactive imaging agent. Technetium 99 which is a decay product of technetium 99m, has a half-life of 210,000 years.		1.9810manganese group element atom
erbium
Erbium: Erbium. An element of the rare earth family of metals. It has the atomic symbol Er, atomic number 68, and atomic weight 167.26.		6.9610f-block element atom;
lanthanoid atom
gadolinium
Gadolinium: An element of the rare earth family of metals. It has the atomic symbol Gd, atomic number 64, and atomic weight 157.25. Its oxide is used in the control rods of some nuclear reactors.		2.520f-block element atom;
lanthanoid atom
gold
Gold: A yellow metallic element with the atomic symbol Au, atomic number 79, and atomic weight 197. It is used in jewelry, goldplating of other metals, as currency, and in dental restoration. Many of its clinical applications, such as ANTIRHEUMATIC AGENTS, are in the form of its salts.		7.610copper group element atom;
elemental gold
yttrium
Yttrium: An element of the rare earth family of metals. It has the atomic symbol Y, atomic number 39, and atomic weight 88.91. In conjunction with other rare earths, yttrium is used as a phosphor in television receivers and is a component of the yttrium-aluminum garnet (YAG) lasers.		9.2611d-block element atom;
rare earth metal atom;
scandium group element atom
tricalcium phosphate
tricalcium phosphate: a form of tricalcium phosphate used as bioceramic bone replacement material; see also records for alpha-tricalcium phosphate, beta-tricalcium phosphate, calcium phosphate; apatitic tricalcium phosphate Ca9(HPO4)(PO4)5(OH) is the calcium orthophosphate leading to beta tricalcium phosphate Ca3(PO4)2 (b-TCP). calcium phosphate : A calcium salt composed of calcium and phosphate/diphosphate ions; present in milk and used for the mineralisation of calcified tissues.		2.0310calcium phosphate
stanozolol
Stanozolol: A synthetic steroid that has anabolic and androgenic properties. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1194). stanozolol : An organic heteropentacyclic compound resulting from the formal condensation of the 3-keto-aldehyde moiety of oxymetholone with hydrazine. Like oxymetholone, it is a synthetic anabolic steroid. It has both anabolic and androgenic properties, and has been used to treat hereditary angioedema and various vascular disorders. It has also been widely abused by professional athletes.		8.71117beta-hydroxy steroid;
anabolic androgenic steroid;
organic heteropentacyclic compound;
tertiary alcohol		anabolic agent;
androgen
osmium tetroxide
Osmium Tetroxide: (T-4)-Osmium oxide (OsO4). A highly toxic and volatile oxide of osmium used in industry as an oxidizing agent. It is also used as a histological fixative and stain and as a synovectomy agent in arthritic joints. Its vapor can cause eye, skin, and lung damage.. osmium tetroxide : An osmium coordination entity consisting of four oxygen atoms bound to a central osmium atom via covalent double bonds.		1.9710osmium coordination entityfixative;
histological dye;
oxidising agent;
poison
triamcinolone
Triamcinolone: A glucocorticoid given, as the free alcohol or in esterified form, orally, intramuscularly, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. (From Martindale, The Extra Pharmacopoeia, 30th ed, p739). triamcinolone : A C21-steroid hormone that is 1,4-pregnadiene-3,20-dione carrying four hydroxy substituents at positions 11beta, 16alpha, 17alpha and 21 as well as a fluoro substituent at position 9. Used in the form of its 16,17-acetonide to treat various skin infections.		4.72111beta-hydroxy steroid;
16alpha-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(4) steroid;
C21-steroid hormone;
fluorinated steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		anti-allergic agent;
anti-inflammatory drug
ioxitalamic acid
ioxitalamic acid: RN given refers to parent cpd; Telebrix 38 contains both sodium ioxitalamate & meglumine ioxitalamate; structure. iooxitalamic acid : An organoiodine compound that is 2,4,6-triiodobenzoic acid substituted by an acetylamino group at position 3 and a (2-hydroxyethyl)carbamoyl group at position 5. It is used as a contrast medium.		3.4511acetamides;
benzoic acids;
dicarboxylic acid monoamide;
organoiodine compound		environmental contaminant;
radioopaque medium;
xenobiotic
yttrium citrate
yttrium citrate: RN given refers to unlabeled tri-Na salt; RN for yttrium-90 citrate not in Chemline 8/85		3.4511
simvastatin
Simvastatin: A derivative of LOVASTATIN and potent competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It may also interfere with steroid hormone production. Due to the induction of hepatic LDL RECEPTORS, it increases breakdown of LDL CHOLESTEROL.. simvastatin : A member of the class of hexahydronaphthalenes that is lovastatin in which the 2-methylbutyrate ester moiety has been replaced by a 2,2-dimethylbutyrate ester group. It is used as a cholesterol-lowering and anti-cardiovascular disease drug.		2.520delta-lactone;
fatty acid ester;
hexahydronaphthalenes;
statin (semi-synthetic)		EC 1.1.1.34/EC 1.1.1.88 (hydroxymethylglutaryl-CoA reductase) inhibitor;
EC 3.4.24.83 (anthrax lethal factor endopeptidase) inhibitor;
ferroptosis inducer;
geroprotector;
prodrug
halopredone acetate
halopredone acetate: RN given refers to (6beta,11beta)-isomer; structure		3.0610organic molecular entity
yttrium radioisotopes
Yttrium Radioisotopes: Unstable isotopes of yttrium that decay or disintegrate emitting radiation. Y atoms with atomic weights 82-88 and 90-96 are radioactive yttrium isotopes.		7.6973
methotrexate
[no description available]		11.1743dicarboxylic acid;
monocarboxylic acid amide;
pteridines		abortifacient;
antimetabolite;
antineoplastic agent;
antirheumatic drug;
dermatologic drug;
DNA synthesis inhibitor;
EC 1.5.1.3 (dihydrofolate reductase) inhibitor;
immunosuppressive agent
deflazacort
deflazacort: structure		1.9810corticosteroid hormone
cortisone
[no description available]		3.752111-oxo steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(4) steroid;
C21-steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		human metabolite;
mouse metabolite
cortodoxone
Cortodoxone: 17,21-Dihydroxypregn-4-ene-3,20-dione. A 17-hydroxycorticosteroid with glucocorticoid and anti-inflammatory activities.. 11-deoxycortisol : A deoxycortisol that is cortisol in which the hydroxy group at position 11 has been replaced by a hydrogen.		1.9610deoxycortisol;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		human metabolite;
mouse metabolite
cefoxitin
Cefoxitin: A semisynthetic cephamycin antibiotic resistant to beta-lactamase.. cefoxitin : A semisynthetic cephamycin antibiotic which, in addition to the methoxy group at the 7alpha position, has 2-thienylacetamido and carbamoyloxymethyl side-groups. It is resistant to beta-lactamase.		1.9610beta-lactam antibiotic allergen;
cephalosporin;
cephamycin;
semisynthetic derivative		antibacterial drug
pyrophosphate
Diphosphates: Inorganic salts of phosphoric acid that contain two phosphate groups.		3.3411diphosphate ion
osteoprotegerin
Osteoprotegerin: A secreted member of the TNF receptor superfamily that negatively regulates osteoclastogenesis. It is a soluble decoy receptor of RANK LIGAND that inhibits both CELL DIFFERENTIATION and function of OSTEOCLASTS by inhibiting the interaction between RANK LIGAND and RECEPTOR ACTIVATOR OF NUCLEAR FACTOR-KAPPA B.		2.0310long-chain fatty acid
rimexolone
[no description available]		6.971020-oxo steroid
gadolinium dtpa
Gadolinium DTPA: A complex of gadolinium with a chelating agent, diethylenetriamine penta-acetic acid (DTPA see PENTETIC ACID), that is given to enhance the image in cranial and spinal MRIs. (From Martindale, The Extra Pharmacopoeia, 30th ed, p706)		1.9810gadolinium coordination entityMRI contrast agent
shu 508
SHU 508: intravenous saccharide echo contrast agent with transpulmonary capacity for left heart contrast; appears in Japanese literature as SH/TA-508		2.0210
yttrium silicate
yttrium silicate: RN given refers to cpd with unknown MF		4.2611
technetium tc 99m exametazime
Technetium Tc 99m Exametazime: A gamma-emitting RADIONUCLIDE IMAGING agent used in the evaluation of regional cerebral blood flow and in non-invasive dynamic biodistribution studies and MYOCARDIAL PERFUSION IMAGING. It has also been used to label leukocytes in the investigation of INFLAMMATORY BOWEL DISEASES.		2.3820
cosyntropin
Cosyntropin: A synthetic peptide that is identical to the 24-amino acid segment at the N-terminal of ADRENOCORTICOTROPIC HORMONE. ACTH (1-24), a segment similar in all species, contains the biological activity that stimulates production of CORTICOSTEROIDS in the ADRENAL CORTEX.. cosyntropin : A synthetic peptide that is identical to the 24-amino acid segment at the N-terminal of adrenocorticotropic hormone (corticotropin). A segment similar in all species, it contains the biological activity that stimulates production of corticosteroids in the adrenal cortex. It is used diagnostically to investigate adrenocortical insufficiency.		1.9610
(9R)-9-chloro-11,17-dihydroxy-17-(2-hydroxy-1-oxoethyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one
Beclomethasone: An anti-inflammatory, synthetic glucocorticoid. It is used topically as an anti-inflammatory agent and in aerosol form for the treatment of ASTHMA.. beclomethasone : A 17alpha-hydroxy steroid that is prednisolone in which the hydrogens at the 9alpha and 16beta positions are substituted by a chlorine and a methyl group, respectively.		3.061021-hydroxy steroid
cortisol succinate, sodium salt
hydrocortisone hemisuccinate: RN given refers to (11beta)-isomer; Synonyms Solu-Cortef & sopolcort H refer to Na salt		4.2811organic molecular entity
piroxicam
[no description available]		3.5911benzothiazine;
monocarboxylic acid amide;
pyridines		analgesic;
antirheumatic drug;
cyclooxygenase 1 inhibitor;
EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor;
non-steroidal anti-inflammatory drug
mobiflex
tenoxicam : A thienothiazine-derived monocarboxylic acid amide obtained by formal condensation of the carboxy group of 4-hydroxy-2-methylthieno[2,3-e][1,2]thiazine-3-carboxylic acid 1,1-dioxide with the amino group of 2-aminopyridine. Used for the treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis. It is also indicated for short term treatment of acute musculoskeletal disorders including strains, sprains and other soft-tissue injuries.		3.5911heteroaryl hydroxy compound;
monocarboxylic acid amide;
pyridines;
thienothiazine		antipyretic;
EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug
transforming growth factor beta
Transforming Growth Factor beta: A factor synthesized in a wide variety of tissues. It acts synergistically with TGF-alpha in inducing phenotypic transformation and can also act as a negative autocrine growth factor. TGF-beta has a potential role in embryonal development, cellular differentiation, hormone secretion, and immune function. TGF-beta is found mostly as homodimer forms of separate gene products TGF-beta1, TGF-beta2 or TGF-beta3. Heterodimers composed of TGF-beta1 and 2 (TGF-beta1.2) or of TGF-beta2 and 3 (TGF-beta2.3) have been isolated. The TGF-beta proteins are synthesized as precursor proteins.		5.0231
technetium tc 99m medronate
Technetium Tc 99m Medronate: A gamma-emitting radionuclide imaging agent used primarily in skeletal scintigraphy. Because of its absorption by a variety of tumors, it is useful for the detection of neoplasms.		1.9810
sodium morrhuate
Sodium Morrhuate: The sodium salts of the fatty acids in cod liver oil; an irritant and sclerosing agent used to treat varicose veins and arthritic joints.		8.3711
chondroitin sulfates
Chondroitin Sulfates: Derivatives of chondroitin which have a sulfate moiety esterified to the galactosamine moiety of chondroitin. Chondroitin sulfate A, or chondroitin 4-sulfate, and chondroitin sulfate C, or chondroitin 6-sulfate, have the sulfate esterified in the 4- and 6-positions, respectively. Chondroitin sulfate B (beta heparin; DERMATAN SULFATE) is a misnomer and this compound is not a true chondroitin sulfate.		1.9610
rifampin
Rifampin: A semisynthetic antibiotic produced from Streptomyces mediterranei. It has a broad antibacterial spectrum, including activity against several forms of Mycobacterium. In susceptible organisms it inhibits DNA-dependent RNA polymerase activity by forming a stable complex with the enzyme. It thus suppresses the initiation of RNA synthesis. Rifampin is bactericidal, and acts on both intracellular and extracellular organisms. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p1160)		4.311cyclic ketal;
hydrazone;
N-iminopiperazine;
N-methylpiperazine;
rifamycins;
semisynthetic derivative;
zwitterion		angiogenesis inhibitor;
antiamoebic agent;
antineoplastic agent;
antitubercular agent;
DNA synthesis inhibitor;
EC 2.7.7.6 (RNA polymerase) inhibitor;
Escherichia coli metabolite;
geroprotector;
leprostatic drug;
neuroprotective agent;
pregnane X receptor agonist;
protein synthesis inhibitor
ConditionIndicatedRelationship StrengthStudiesTrials
Recrudescence
[description not available]		07.8284
Arthritis, Juvenile Chronic
[description not available]		011.71458
Arthritis, Juvenile
Arthritis in children, with onset before 16 years of age. The terms juvenile rheumatoid arthritis (JRA) and juvenile idiopathic arthritis (JIA) refer to classification systems for chronic arthritis in children. Only one subtype of juvenile arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.		011.71458
Keloid
A sharply elevated, irregularly shaped, progressively enlarging scar resulting from formation of excessive amounts of collagen in the dermis during connective tissue repair. It is differentiated from a hypertrophic scar (CICATRIX, HYPERTROPHIC) in that the former does not spread to surrounding tissues.		04.7211
Osteoarthritis of Knee
[description not available]		011.231614
Ache
[description not available]		09.191311
Pain
An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.		111.191311
Osteoarthritis, Knee
Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019)		011.231614
Arthritis, Degenerative
[description not available]		012.362913
Osteoarthritis
A progressive, degenerative joint disease, the most common form of arthritis, especially in older persons. The disease is thought to result not from the aging process but from biochemical changes and biomechanical stresses affecting articular cartilage. In the foreign literature it is often called osteoarthrosis deformans.		114.362913
Joint Pain
[description not available]		02.2110
Rheumatoid Arthritis
[description not available]		014.044319
Arthritis, Rheumatoid
A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated.		116.044319
Arthralgia
Pain in the joint.		02.2110
Pyogenic Sacroiliitis
[description not available]		02.2510
Epulides, Giant Cell
[description not available]		02.5220
Granuloma, Giant Cell
A non-neoplastic inflammatory lesion, usually of the jaw or gingiva, containing large, multinucleated cells. It includes reparative giant cell granuloma. Peripheral giant cell granuloma refers to the gingiva (giant cell epulis); central refers to the jaw.		02.5220
Temporomandibular Disorders
[description not available]		04.9681
Temporomandibular Joint Disorders
A variety of conditions affecting the anatomic and functional characteristics of the temporomandibular joint. Factors contributing to the complexity of temporomandibular diseases are its relation to dentition and mastication and the symptomatic effects in other areas which account for referred pain to the joint and the difficulties in applying traditional diagnostic procedures to temporomandibular joint pathology where tissue is rarely obtained and x-rays are often inadequate or nonspecific. Common diseases are developmental abnormalities, trauma, subluxation, luxation, arthritis, and neoplasia. (From Thoma's Oral Pathology, 6th ed, pp577-600)		04.9681
Body Weight
The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms.		02.3110
Disease Models, Animal
Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases.		04.3270
Coxarthrosis
[description not available]		02.3110
Osteoarthritis, Hip
Noninflammatory degenerative disease of the hip joint which usually appears in late middle or old age. It is characterized by growth or maturational disturbances in the femoral neck and head, as well as acetabular dysplasia. A dominant symptom is pain on weight-bearing or motion.		02.3110
Canine Diseases
[description not available]		03.821
Tenosynovitis
Inflammation of the synovial lining of a tendon sheath. Causes include trauma, tendon stress, bacterial disease (gonorrhea, tuberculosis), rheumatic disease, and gout. Common sites are the hand, wrist, shoulder capsule, hip capsule, hamstring muscles, and Achilles tendon. The tendon sheaths become inflamed and painful, and accumulate fluid. Joint mobility is usually reduced.		02.4920
Sensitivity and Specificity
Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)		04.131
Hypertrophy
General increase in bulk of a part or organ due to CELL ENLARGEMENT and accumulation of FLUIDS AND SECRETIONS, not due to tumor formation, nor to an increase in the number of cells (HYPERPLASIA).		03.5911
Plica Syndrome
[description not available]		011.672814
Psoriasis Arthropathica
[description not available]		04.5111
Synovitis
Inflammation of the SYNOVIAL MEMBRANE.		016.672814
Arthritis, Psoriatic
A type of inflammatory arthritis associated with PSORIASIS, often involving the axial joints and the peripheral terminal interphalangeal joints. It is characterized by the presence of HLA-B27-associated SPONDYLARTHROPATHY, and the absence of rheumatoid factor.		04.5111
Adjuvant Arthritis
[description not available]		03.2660
Weight Gain
Increase in BODY WEIGHT over existing weight.		02.0810
Embolus
[description not available]		02.0810
Embolism
Blocking of a blood vessel by an embolus which can be a blood clot or other undissolved material in the blood stream.		02.0810
Ischemia
A hypoperfusion of the BLOOD through an organ or tissue caused by a PATHOLOGIC CONSTRICTION or obstruction of its BLOOD VESSELS, or an absence of BLOOD CIRCULATION.		02.0810
Low Back Ache
[description not available]		04.7421
Low Back Pain
Acute or chronic pain in the lumbar or sacral regions, which may be associated with musculo-ligamentous SPRAINS AND STRAINS; INTERVERTEBRAL DISK DISPLACEMENT; and other conditions.		04.7421
B. burgdorferi Infection
[description not available]		02.110
Lyme Disease
An infectious disease caused by a spirochete, BORRELIA BURGDORFERI, which is transmitted chiefly by Ixodes dammini (see IXODES) and pacificus ticks in the United States and Ixodes ricinis (see IXODES) in Europe. It is a disease with early and late cutaneous manifestations plus involvement of the nervous system, heart, eye, and joints in variable combinations. The disease was formerly known as Lyme arthritis and first discovered at Old Lyme, Connecticut.		02.110
Tendinitis
Inflammation of TENDONS. It is characterized by the degeneration of tendons accompanied by an inflammatory repair response, fibroblastic proliferation, and formation of granulation tissue. Tendinitis is not a clinical diagnosis and can be confirmed only by histopathological findings.		05.6521
Arthropathies
[description not available]		03.9310
Joint Diseases
Diseases involving the JOINTS.		15.9310
Tendinopathy
Clinical syndrome describing overuse tendon injuries characterized by a combination of PAIN, diffuse or localized swelling, and impaired performance.		05.6521
Chronic Illness
[description not available]		09.82129
Innate Inflammatory Response
[description not available]		04.7821
Chronic Disease
Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care (Dictionary of Health Services Management, 2d ed). For epidemiological studies chronic disease often includes HEART DISEASES; STROKE; CANCER; and diabetes (DIABETES MELLITUS, TYPE 2).		09.82129
Inflammation
A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function.		04.7821
Calcification, Pathologic
[description not available]		04.4280
Dermatitis Medicamentosa
[description not available]		02.0410
Chronic Plantar Fasciitis
[description not available]		02.0410
Foot Dermatoses
Skin diseases of the foot, general or unspecified.		02.0410
Calcinosis
Pathologic deposition of calcium salts in tissues.		04.4280
Fasciitis, Plantar
Inflammation of the plantar fascia (APONEUROSIS) on the bottom of the foot causing heel pain. The etiology of plantar fasciitis remains controversial but is likely to involve a biomechanical imbalance. Though often presenting along with HEEL SPUR, they do not appear to be causally related.		02.0410
Incontinentia Pigmenti Achromians
[description not available]		02.0510
Atrophy
Decrease in the size of a cell, tissue, organ, or multiple organs, associated with a variety of pathological conditions such as abnormal cellular changes, ischemia, malnutrition, or hormonal changes.		02.0510
Lipid Metabolism Disorders
Pathological conditions resulting from abnormal anabolism or catabolism of lipids in the body.		02.0510
Chronic Hepatitis C
[description not available]		02.0510
Polyarthritis
[description not available]		08.09164
Arthritis
Acute or chronic inflammation of JOINTS.		08.09164
Hepatitis C, Chronic
INFLAMMATION of the LIVER in humans that is caused by HEPATITIS C VIRUS lasting six months or more. Chronic hepatitis C can lead to LIVER CIRRHOSIS.		02.0510
Jaw Diseases
Diseases involving the JAW.		02.0510
Diabetes Mellitus
A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE.		04.3711
Adhesive Capsulitis
[description not available]		011.782219
Extravasation of Contrast Media
[description not available]		03.4511
Bursitis
Inflammation or irritation of a SYNOVIAL BURSA, the fibrous sac that acts as a cushion between moving structures of bones, muscles, tendons or skin.		011.782219
Shoulder Pain
Unilateral or bilateral pain of the shoulder. It is often caused by physical activities such as work or sports participation, but may also be pathologic in origin.		03.4511
Blood Poisoning
[description not available]		0310
Nervous System Disorders
[description not available]		0310
Nervous System Diseases
Diseases of the central and peripheral nervous system. This includes disorders of the brain, spinal cord, cranial nerves, peripheral nerves, nerve roots, autonomic nervous system, neuromuscular junction, and muscle.		0310
Sepsis
Systemic inflammatory response syndrome with a proven or suspected infectious etiology. When sepsis is associated with organ dysfunction distant from the site of infection, it is called severe sepsis. When sepsis is accompanied by HYPOTENSION despite adequate fluid infusion, it is called SEPTIC SHOCK.		0310
Aseptic Necrosis of Femur Head
[description not available]		05.6321
Anesthesia
A state characterized by loss of feeling or sensation. This depression of nerve function is usually the result of pharmacologic action and is induced to allow performance of surgery or other painful procedures.		02.9310
Acute Disease
Disease having a short and relatively severe course.		03.3120
Lingual Nerve Contusion
[description not available]		02.4220
Cranial Nerve V Injury
[description not available]		02.0210
Epileptiform Neuralgia
[description not available]		02.0210
Cranial Nerve Injuries
Dysfunction of one or more cranial nerves causally related to a traumatic injury. Penetrating and nonpenetrating CRANIOCEREBRAL TRAUMA; NECK INJURIES; and trauma to the facial region are conditions associated with cranial nerve injuries.		02.0210
Trigeminal Neuralgia
A syndrome characterized by recurrent episodes of excruciating pain lasting several seconds or longer in the sensory distribution of the TRIGEMINAL NERVE. Pain may be initiated by stimulation of trigger points on the face, lips, or gums or by movement of facial muscles or chewing. Associated conditions include MULTIPLE SCLEROSIS, vascular anomalies, ANEURYSMS, and neoplasms. (Adams et al., Principles of Neurology, 6th ed, p187)		02.0210
Disc, Herniated
[description not available]		04.6261
Myelopathy
[description not available]		02.3920
Intervertebral Disc Displacement
An INTERVERTEBRAL DISC in which the NUCLEUS PULPOSUS has protruded through surrounding ANNULUS FIBROSUS. This occurs most frequently in the lower lumbar region.		04.6261
Spinal Cord Diseases
Pathologic conditions which feature SPINAL CORD damage or dysfunction, including disorders involving the meninges and perimeningeal spaces surrounding the spinal cord. Traumatic injuries, vascular diseases, infections, and inflammatory/autoimmune processes may affect the spinal cord.		02.3920
Alveolitis, Fibrosing
[description not available]		02.0310
Autoimmune Thyroiditis
[description not available]		02.0310
Pulmonary Fibrosis
A process in which normal lung tissues are progressively replaced by FIBROBLASTS and COLLAGEN causing an irreversible loss of the ability to transfer oxygen into the bloodstream via PULMONARY ALVEOLI. Patients show progressive DYSPNEA finally resulting in death.		02.0310
Bone Loss, Osteoclastic
[description not available]		02.0310
Flexor Tendon Entrapment
[description not available]		03.4211
Asthma, Bronchial
[description not available]		02.8810
Nasal Catarrh
[description not available]		02.8810
Dermatoses
[description not available]		02.8810
Asthma
A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).		02.8810
Rhinitis
Inflammation of the NASAL MUCOSA, the mucous membrane lining the NASAL CAVITIES.		02.8810
Skin Diseases
Diseases involving the DERMIS or EPIDERMIS.		02.8810
Harelip
[description not available]		02.3620
Cleft Palate, Isolated
[description not available]		02.8940
Abnormality, Heart
[description not available]		01.9610
Abnormalities, Drug-Induced
Congenital abnormalities caused by medicinal substances or drugs of abuse given to or taken by the mother, or to which she is inadvertently exposed during the manufacture of such substances. The concept excludes abnormalities resulting from exposure to non-medicinal chemicals in the environment.		02.3620
Cleft Lip
Congenital defect in the upper lip where the maxillary prominence fails to merge with the merged medial nasal prominences. It is thought to be caused by faulty migration of the mesoderm in the head region.		02.3620
Cleft Palate
Congenital fissure of the soft and/or hard palate, due to faulty fusion.		02.8940
Heart Defects, Congenital
Developmental abnormalities involving structures of the heart. These defects are present at birth but may be discovered later in life.		01.9610
Cyst
[description not available]		03.3511
Eyelid Diseases
Diseases involving the EYELIDS.		03.7621
Rheumatism
[description not available]		06.9610
Rheumatic Diseases
Disorders of connective tissue, especially the joints and related structures, characterized by inflammation, degeneration, or metabolic derangement.		01.9610
Cicatrization
The formation of fibrous tissue in the place of normal tissue during the process of WOUND HEALING. It includes scar tissue formation occurring in healing internal organs as well as in the skin after surface injuries.		02.3720
Burns
Injuries to tissues caused by contact with heat, steam, chemicals (BURNS, CHEMICAL), electricity (BURNS, ELECTRIC), or the like.		01.9610
Cicatrix
The fibrous tissue that replaces normal tissue during the process of WOUND HEALING.		02.3720
Synovial Cyst
Non-neoplastic tumor-like lesions at joints, developed from the SYNOVIAL MEMBRANE of a joint through the JOINT CAPSULE into the periarticular tissues. They are filled with SYNOVIAL FLUID with a smooth and translucent appearance. A synovial cyst can develop from any joint, but most commonly at the back of the knee, where it is known as POPLITEAL CYST.		01.9610
Hand Injuries
General or unspecified injuries to the hand.		01.9610
Mandibular Diseases
Diseases involving the MANDIBLE.		02.3620
Pregnancy
The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.		02.8840
Primary Peritonitis
[description not available]		01.9510
Ascites
Accumulation or retention of free fluid within the peritoneal cavity.		01.9510
Peritonitis
INFLAMMATION of the PERITONEUM lining the ABDOMINAL CAVITY as the result of infectious, autoimmune, or chemical processes. Primary peritonitis is due to infection of the PERITONEAL CAVITY via hematogenous or lymphatic spread and without intra-abdominal source. Secondary peritonitis arises from the ABDOMINAL CAVITY itself through RUPTURE or ABSCESS of intra-abdominal organs.		01.9510
Remission, Spontaneous
A spontaneous diminution or abatement of a disease over time, without formal treatment.		01.9510
Cavernitis, Fibrous
[description not available]		01.9510
Penile Induration
A condition characterized by hardening of the PENIS due to the formation of fibrous plaques on the dorsolateral aspect of the PENIS, usually involving the membrane (tunica albuginea) surrounding the erectile tissue (corpus cavernosum penis). This may eventually cause a painful deformity of the shaft or constriction of the urethra, or both.		01.9510
Amyotrophy, Thenar, Of Carpal Origin
[description not available]		01.9810
Carpal Tunnel Syndrome
Entrapment of the MEDIAN NERVE in the carpal tunnel, which is formed by the flexor retinaculum and the CARPAL BONES. This syndrome may be associated with repetitive occupational trauma (CUMULATIVE TRAUMA DISORDERS); wrist injuries; AMYLOID NEUROPATHIES; rheumatoid arthritis (see ARTHRITIS, RHEUMATOID); ACROMEGALY; PREGNANCY; and other conditions. Symptoms include burning pain and paresthesias involving the ventral surface of the hand and fingers which may radiate proximally. Impairment of sensation in the distribution of the median nerve and thenar muscle atrophy may occur. (Joynt, Clinical Neurology, 1995, Ch51, p45)		01.9810
Baker Cyst
[description not available]		01.9810
Bone Cancer
[description not available]		01.9910
Intertrochanteric Fractures
[description not available]		01.9910
Kahler Disease
[description not available]		01.9910
Bone Neoplasms
Tumors or cancer located in bone tissue or specific BONES.		01.9910
Hip Fractures
Fractures of the FEMUR HEAD; the FEMUR NECK; (FEMORAL NECK FRACTURES); the trochanters; or the inter- or subtrochanteric region. Excludes fractures of the acetabulum and fractures of the femoral shaft below the subtrochanteric region (FEMORAL FRACTURES).		01.9910
Multiple Myeloma
A malignancy of mature PLASMA CELLS engaging in monoclonal immunoglobulin production. It is characterized by hyperglobulinemia, excess Bence-Jones proteins (free monoclonal IMMUNOGLOBULIN LIGHT CHAINS) in the urine, skeletal destruction, bone pain, and fractures. Other features include ANEMIA; HYPERCALCEMIA; and RENAL INSUFFICIENCY.		01.9910
Coracohumeral Impingement
[description not available]		03.3711
Shoulder Impingement Syndrome
Compression of the ROTATOR CUFF tendons and subacromial bursa between the HUMERAL HEAD and the ACROMION of the SCAPULA. This condition is associated with subacromial BURSITIS, as well as rotator cuff (largely supraspinatus) and bicipital tendon INFLAMMATION.		03.3711
Hallucination of Body Sensation
[description not available]		01.9910
Hallucinations
Subjectively experienced sensations in the absence of an appropriate stimulus, but which are regarded by the individual as real. They may be of organic origin or associated with MENTAL DISORDERS.		01.9910
Neuralgia, Sciatic
[description not available]		03.5930
Bone Diseases
Diseases of BONES.		0210
Sciatica
A condition characterized by pain radiating from the back into the buttock and posterior/lateral aspects of the leg. Sciatica may be a manifestation of SCIATIC NEUROPATHY; RADICULOPATHY (involving the SPINAL NERVE ROOTS; L4, L5, S1, or S2, often associated with INTERVERTEBRAL DISK DISPLACEMENT); or lesions of the CAUDA EQUINA.		03.5930
Leg Length Inequality
A condition in which one of a pair of legs fails to grow as long as the other, which could result from injury or surgery.		03.3811
Diffuse Tenosynovial Giant Cell Tumor
[description not available]		02.3920
Synovitis, Pigmented Villonodular
Diffuse outgrowth arising from the SYNOVIAL MEMBRANE; SYNOVIAL BURSA; or TENDON sheath around the joint cavity, with extension to surrounding soft tissue. It is characterized by pigmented HEMOSIDERIN-containing MACROPHAGES; FOAM CELLS; and multinucleated GIANT CELLS. It usually occurs in the hands and feet, and around large joints, such as in the ankle and knee joints.		02.3920
Back Ache
[description not available]		09.791010
Back Pain
Acute or chronic pain located in the posterior regions of the THORAX; LUMBOSACRAL REGION; or the adjacent regions.		09.791010
Spondylitis
Inflammation of the SPINE. This includes both arthritic and non-arthritic conditions.		03.7821
Foot Diseases
Anatomical and functional disorders affecting the foot.		03.3911
Fasciitis
Inflammation of the fascia. There are three major types: 1, Eosinophilic fasciitis, an inflammatory reaction with eosinophilia, producing hard thickened skin with an orange-peel configuration suggestive of scleroderma and considered by some a variant of scleroderma; 2, Necrotizing fasciitis (FASCIITIS, NECROTIZING), a serious fulminating infection (usually by a beta hemolytic streptococcus) causing extensive necrosis of superficial fascia; 3, Nodular/Pseudosarcomatous /Proliferative fasciitis, characterized by a rapid growth of fibroblasts with mononuclear inflammatory cells and proliferating capillaries in soft tissue, often the forearm; it is not malignant but is sometimes mistaken for fibrosarcoma.		03.3911
Spinal Diseases
Diseases involving the SPINE.		02.6730
Granulomas
[description not available]		01.9710
Aseptic Necrosis of Bone
[description not available]		02.3820
Granuloma
A relatively small nodular inflammatory lesion containing grouped mononuclear phagocytes, caused by infectious and noninfectious agents.		06.9710
Osteonecrosis
Death of a bone or part of a bone, either atraumatic or posttraumatic.		02.3820
Infantile Respiratory Distress Syndrome
[description not available]		01.9710
Respiratory Distress Syndrome, Newborn
A condition of the newborn marked by DYSPNEA with CYANOSIS, heralded by such prodromal signs as dilatation of the alae nasi, expiratory grunt, and retraction of the suprasternal notch or costal margins, mostly frequently occurring in premature infants, children of diabetic mothers, and infants delivered by cesarean section, and sometimes with no apparent predisposing cause.		01.9710
Necrosis
The death of cells in an organ or tissue due to disease, injury or failure of the blood supply.		01.9710
Cheilitis Granulomatosa
[description not available]		01.9710
Cheilitis
Inflammation of the lips. It is of various etiologies and degrees of pathology.		01.9710
Allergy, Drug
[description not available]		01.9710
Drug Hypersensitivity
Immunologically mediated adverse reactions to medicinal substances used legally or illegally.		01.9710
Cramp
[description not available]		01.9710
Besnier-Boeck Disease
[description not available]		01.9710
Muscle Cramp
A sustained and usually painful contraction of muscle fibers. This may occur as an isolated phenomenon or as a manifestation of an underlying disease process (e.g., UREMIA; HYPOTHYROIDISM; MOTOR NEURON DISEASE; etc.). (From Adams et al., Principles of Neurology, 6th ed, p1398)		01.9710
Sarcoidosis
An idiopathic systemic inflammatory granulomatous disorder comprised of epithelioid and multinucleated giant cells with little necrosis. It usually invades the lungs with fibrosis and may also involve lymph nodes, skin, liver, spleen, eyes, phalangeal bones, and parotid glands.		01.9710
Myofascial Trigger Point Pain
[description not available]		09.5999
Myofascial Pain Syndromes
Muscular pain in numerous body regions that can be reproduced by pressure on TRIGGER POINTS, localized hardenings in skeletal muscle tissue. Pain is referred to a location distant from the trigger points. A prime example is the TEMPOROMANDIBULAR JOINT DYSFUNCTION SYNDROME.		09.5999
Equine Diseases
[description not available]		01.9710
Angioma
A vascular anomaly due to proliferation of blood or lymphatic vessels that forms a tumor-like mass. Vessels in the angioma may or may not be dilated.		01.9710
Angioma, Cavernous
A tumor-like mass with large vascular space that is filled with blood or lymph.		01.9710
Facial Neoplasms
New abnormal growth of tissue in the FACE.		01.9710
Hemangioma
A vascular anomaly due to proliferation of BLOOD VESSELS that forms a tumor-like mass. The common types involve CAPILLARIES and VEINS. It can occur anywhere in the body but is most frequently noticed in the SKIN and SUBCUTANEOUS TISSUE. (from Stedman, 27th ed, 2000)		01.9710
Flushing
A transient reddening of the face that may be due to fever, certain drugs, exertion, or stress.		02.8810
Gasser Syndrome
[description not available]		01.9710
Chylopericardium
[description not available]		02.3720
Pleuropericarditis
Inflammation of both the PERICARDIUM and the PLEURA.		02.3720
Hemolytic-Uremic Syndrome
A syndrome that is associated with microvascular diseases of the KIDNEY, such as RENAL CORTICAL NECROSIS. It is characterized by hemolytic anemia (ANEMIA, HEMOLYTIC); THROMBOCYTOPENIA; and ACUTE RENAL FAILURE.		01.9710
Pericardial Effusion
Fluid accumulation within the PERICARDIUM. Serous effusions are associated with pericardial diseases. Hemopericardium is associated with trauma. Lipid-containing effusion (chylopericardium) results from leakage of THORACIC DUCT. Severe cases can lead to CARDIAC TAMPONADE.		02.3720
Pericarditis
Inflammation of the PERICARDIUM from various origins, such as infection, neoplasm, autoimmune process, injuries, or drug-induced. Pericarditis usually leads to PERICARDIAL EFFUSION, or CONSTRICTIVE PERICARDITIS.		07.3720
Uremia
A clinical syndrome associated with the retention of renal waste products or uremic toxins in the blood. It is usually the result of RENAL INSUFFICIENCY. Most uremic toxins are end products of protein or nitrogen CATABOLISM, such as UREA or CREATININE. Severe uremia can lead to multiple organ dysfunctions with a constellation of symptoms.		02.3720
Pachymeningitis
[description not available]		01.9610
Aseptic Meningitis
[description not available]		01.9610
Arachnoid Membrane Inflammation
[description not available]		01.9610
Meningitis
Inflammation of the coverings of the brain and/or spinal cord, which consist of the PIA MATER; ARACHNOID; and DURA MATER. Infections (viral, bacterial, and fungal) are the most common causes of this condition, but subarachnoid hemorrhage (HEMORRHAGES, SUBARACHNOID), chemical irritation (chemical MENINGITIS), granulomatous conditions, neoplastic conditions (CARCINOMATOUS MENINGITIS), and other inflammatory conditions may produce this syndrome. (From Joynt, Clinical Neurology, 1994, Ch24, p6)		01.9610
Meningitis, Aseptic
A syndrome characterized by headache, neck stiffness, low grade fever, and CSF lymphocytic pleocytosis in the absence of an acute bacterial pathogen. Viral meningitis is the most frequent cause although MYCOPLASMA INFECTIONS; RICKETTSIA INFECTIONS; diagnostic or therapeutic procedures; NEOPLASTIC PROCESSES; septic perimeningeal foci; and other conditions may result in this syndrome. (From Adams et al., Principles of Neurology, 6th ed, p745)		01.9610
Chronic Kidney Failure
[description not available]		01.9610
Kidney Failure, Chronic
The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.		01.9610
Elaeophoriasis
[description not available]		01.9610
Lung Diseases, Parasitic
Infections of the lungs with parasites, most commonly by parasitic worms (HELMINTHS).		01.9610
Filariasis
Infections with nematodes of the superfamily FILARIOIDEA. The presence of living worms in the body is mainly asymptomatic but the death of adult worms leads to granulomatous inflammation and permanent fibrosis. Organisms of the genus Elaeophora infect wild elk and domestic sheep causing ischemic necrosis of the brain, blindness, and dermatosis of the face.		01.9610
Cushing's Syndrome
[description not available]		01.9610
Cushing Syndrome
A condition caused by prolonged exposure to excess levels of cortisol (HYDROCORTISONE) or other GLUCOCORTICOIDS from endogenous or exogenous sources. It is characterized by upper body OBESITY; OSTEOPOROSIS; HYPERTENSION; DIABETES MELLITUS; HIRSUTISM; AMENORRHEA; and excess body fluid. Endogenous Cushing syndrome or spontaneous hypercortisolism is divided into two groups, those due to an excess of ADRENOCORTICOTROPIN and those that are ACTH-independent.		01.9610
Neuroma
A tumor made up of nerve cells and nerve fibers. (Dorland, 27th ed)		01.9610
Chondromalacia
Softening and degeneration of the CARTILAGE.		01.9610
Cartilage Diseases
Pathological processes involving the chondral tissue (CARTILAGE).		01.9610