prednisolone and Disease Exacerbation studies

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.

Research Excerpts

Excerpt	Relevance	Reference
"To determine whether 2 doses of dexamethasone is as effective as 5 days of prednisolone/prednisone therapy in improving symptoms and quality of life of children with asthma exacerbations admitted to the emergency department (ED)."	9.24	Randomized Trial of Dexamethasone Versus Prednisone for Children with Acute Asthma Exacerbations. ( Arana-Arri, E; Benito, J; Lopez, R; Mintegi, S; Mojica, E; Muñoz, N; Paniagua, N; Tames, M, 2017)
"To compare the efficacy of tacrolimus (TAC) and mycophenolate mofetil (MMF) for the initial therapy of lupus nephritis (LN)."	9.22	Tacrolimus versus mycophenolate mofetil for induction therapy of lupus nephritis: a randomised controlled trial and long-term follow-up. ( Mok, CC; Ng, WL; Siu, YP; To, CH; Tong, KH; Yim, CW; Ying, KY, 2016)
"To analyse if predictors of radiographic progression differ between patients treated with or without prednisolone in early rheumatoid arthritis (RA)."	9.19	Rheumatoid factor and anti-CCP do not predict progressive joint damage in patients with early rheumatoid arthritis treated with prednisolone: a randomised study. ( Boonen, A; Engvall, IL; Hafström, I; Rönnelid, J; Svensson, B; van der Heijde, D, 2014)
"We conducted a prospective, multicenter trial to evaluate the efficacy and safety of a 12-month course of cyclosporine in children with steroid-resistant nephrotic syndrome (SRNS)."	9.14	Cyclosporine and steroid therapy in children with steroid-resistant nephrotic syndrome. ( Hamasaki, Y; Hattori, S; Honda, M; Iijima, K; Ishikura, K; Kaneko, T; Matsuyama, T; Nakanishi, K; Sasaki, S; Yata, N; Yoshikawa, N, 2009)
"To assess the efficacy of low-dose prednisolone on joint damage and disease activity in patients with early rheumatoid arthritis (RA)."	9.11	Low-dose prednisolone in addition to the initial disease-modifying antirheumatic drug in patients with early active rheumatoid arthritis reduces joint destruction and increases the remission rate: a two-year randomized trial. ( Albertsson, K; Boonen, A; Hafström, I; Keller, C; Svensson, B; van der Heijde, D, 2005)
"To assess the effect of 5 mg/day prednisolone on disease progression in patients with early rheumatoid arthritis (RA) receiving standardized disease-modifying antirheumatic drug (DMARD) therapy."	9.11	Very low-dose prednisolone in early rheumatoid arthritis retards radiographic progression over two years: a multicenter, double-blind, placebo-controlled trial. ( Rau, R; Steinfeld, P; Wassenberg, S; Zeidler, H, 2005)
"Assessment of the cost-effectiveness and cost-utility of early intervention in rheumatoid arthritis (RA) patients, with combined step-down prednisolone, methotrexate and sulphasalazine, compared to sulphasalazine alone."	9.08	Cost-effectiveness and cost-utility of combination therapy in early rheumatoid arthritis: randomized comparison of combined step-down prednisolone, methotrexate and sulphasalazine with sulphasalazine alone. COBRA Trial Group. Combinatietherapie Bij Reumat ( Bibo, JC; Boers, M; Engel, GL; van der Linden, S; Verhoeven, AC, 1998)
"An 11-year-old girl with a calpain-3 gene (CAPN-3) mutation and eosinophilic myositis on muscle biopsy had high serum CK levels and eosinophil counts which showed spontaneous fluctuations."	7.75	Eosinophilic myositis in calpainopathy: could immunosuppression of the eosinophilic myositis alter the early natural course of the dystrophic disease? ( Dincer, P; Gundesli, H; Oflazer, PS; Sabuncu, T; Zorludemir, S, 2009)
"A total of 11 patients with clinically stable lupus nephritis treated with oral MZR pulse therapy combined with low-dose prednisolone were enrolled in the cross-sectional study."	7.73	Implication of the peak serum level of mizoribine for control of the serum anti-dsDNA antibody titer in patients with lupus nephritis. ( Ito, E; Kudo, M; Nakahata, T; Suzuki, K; Tanaka, H; Tsugawa, K, 2005)
"Because of its potential nephrotoxicity, the long-term use of cyclosporine (CsA) as treatment for nephrotic syndrome (NS) is controversial."	7.73	Long-term effects of cyclosporine in children with idiopathic nephrotic syndrome: a single-centre experience. ( El-Basuony, F; El-Husseini, A; Hassan, N; Hassan, R; Mahmoud, I; Sabry, A; Sayed-Ahmad, N; Sheashaa, H; Sobh, M; Taha, N, 2005)
"Although pulse methylprednisolone therapy (PMT) has been used successfully in the management of children with steroid-resistant nephrotic syndrome (SRNS), the relationship between initial presenting findings and renal histological characteristics to the subsequent clinical response to PMT is unknown."	7.71	Clinicopathologic correlates predict the outcome in children with steroid-resistant idiopathic nephrotic syndrome treated with pulse methylprednisolone therapy. ( Kim, MK; Kirpekar, R; Sibley, RK; Tune, BM; Yorgin, PD, 2002)
"Infantile spasms is a severe infantile seizure disorder that is difficult to treat and has a high morbidity."	6.71	The United Kingdom Infantile Spasms Study (UKISS) comparing hormone treatment with vigabatrin on developmental and epilepsy outcomes to age 14 months: a multicentre randomised trial. ( Edwards, SW; Hancock, E; Johnson, AL; Kennedy, CR; Lux, AL; Newton, RW; O'Callaghan, FJ; Osborne, JP; Verity, CM, 2005)
"This post hoc analysis used data from a placebo-controlled, phase 3 trial (RAJ4) of peficitinib in patients with rheumatoid arthritis and inadequate response to methotrexate."	5.69	Post hoc analysis of clinical characteristics of patients with radiographic progression in a Japanese phase 3 trial of peficitinib and methotrexate treatment (RAJ4). ( Fukuda, M; Izutsu, H; Kaneko, Y; Kato, D; Rokuda, M; Takeuchi, T; Tanaka, Y; van der Heijde, D, 2023)
"CsA stabilized disease progression on HRCT in the early treatment group (p = 0."	5.43	Survival benefit associated with early cyclosporine treatment for dermatomyositis-associated interstitial lung disease. ( Go, DJ; Kang, EH; Kwon, HM; Lee, EB; Lee, YJ; Park, JK; Song, YW, 2016)
"Current treatment of rheumatoid arthritis includes systemic administration of glucocorticoids."	5.42	[(18)]F FDG PET/CT imaging to monitor the therapeutic effect of liposome-encapsulated prednisolone in experimental rheumatoid arthritis. ( Boerman, OC; Gerrits, D; Laverman, P; Metselaar, JM; Storm, G; van der Geest, T; van Lent, PL, 2015)
"Treatment with lenalidomide, as the final therapeutic option, resolved the intractable melena and improved both the intestinal lesions and myeloma."	5.39	Therapeutic effects of lenalidomide on hemorrhagic intestinal myeloma-associated AL amyloidosis. ( Aoki, K; Arima, H; Imai, H; Ishikawa, T; Kato, A; Matsushita, A; Mori, M; Nagano, S; Ono, Y; Tabata, S; Takahashi, T; Takiuchi, Y; Yanagita, S, 2013)
"Prednisolone was started again, after which his serum bilirubin level became normal and the thickening of the bile duct was resolved."	5.38	Newly developed autoimmune cholangitis without relapse of autoimmune pancreatitis after discontinuing prednisolone. ( Chang, JH; Han, SW; Im, YS; Kim, CW; Kim, JH; Kim, TH; Lee, MJ; Maeng, IH; Nam, SM; Park, JY, 2012)
"To assess the incidence and severity of disease modifying antirheumatic drug (DMARD)-induced adverse effects (AE) in patients with rheumatoid arthritis (RA) taking/not taking glucocorticoids (GC)."	5.35	Low-dose prednisolone in rheumatoid arthritis: adverse effects of various disease modifying antirheumatic drugs. ( Arnold, S; Baerwald, CG; Häntzschel, H; Malysheva, OA; Pierer, M; Wagner, U; Wahle, M, 2008)
"The patient was diagnosed with acute tubulointerstitial nephritis caused by cefdinir."	5.31	Successful steroid therapy for cefdinir-induced acute tubulointerstitial nephritis with progressive renal failure. ( Fujiwara, T; Hiramori, K; Kawamura, M; Kimura, Y; Maesawa, C; Owada, M, 2001)
" The dosage of steroids was tapered in 3 out of 4 CyA-responsive cases without re-exacerbation."	5.31	Usefulness of cyclosporine A on rapidly progressive interstitial pneumonia in dermatomyositis. ( Inase, N; Miyake, S; Miyasaka, N; Miyazaki, Y; Ohtani, Y; Sawada, M; Takano, S; Yoshizawa, Y, 2002)
"Pentosidine is an advanced glycation endproduct formed by glycosylation and oxidation."	5.30	Pentosidine in synovial fluid in osteoarthritis and rheumatoid arthritis: relationship with disease activity in rheumatoid arthritis. ( Chen, JR; Inoue, T; Kushida, K; Miyamoto, S; Suzuki, M; Takahashi, M, 1998)
"To determine whether 2 doses of dexamethasone is as effective as 5 days of prednisolone/prednisone therapy in improving symptoms and quality of life of children with asthma exacerbations admitted to the emergency department (ED)."	5.24	Randomized Trial of Dexamethasone Versus Prednisone for Children with Acute Asthma Exacerbations. ( Arana-Arri, E; Benito, J; Lopez, R; Mintegi, S; Mojica, E; Muñoz, N; Paniagua, N; Tames, M, 2017)
"To compare the efficacy of tacrolimus (TAC) and mycophenolate mofetil (MMF) for the initial therapy of lupus nephritis (LN)."	5.22	Tacrolimus versus mycophenolate mofetil for induction therapy of lupus nephritis: a randomised controlled trial and long-term follow-up. ( Mok, CC; Ng, WL; Siu, YP; To, CH; Tong, KH; Yim, CW; Ying, KY, 2016)
"Chemoimmunotherapy containing rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) is the standard treatment for diffuse large B-cell lymphoma (DLBCL)."	5.22	Cardiotoxicity with rituximab, cyclophosphamide, non-pegylated liposomal doxorubicin, vincristine and prednisolone compared to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone in frontline treatment of patients with diffuse large B- ( Andel, J; Burgstaller, S; Fridrik, MA; Greil, R; Jaeger, U; Keil, F; Krieger, O; Lang, A; Oberaigner, W; Petzer, A; Sihorsch, K; Willenbacher, W, 2016)
"In the PREDICT study, a randomised controlled trial comparing dexamethasone with prednisolone in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), almost a quarter of patients deteriorated soon after starting treatment."	5.19	Deterioration after corticosteroids in CIDP may be associated with pure focal demyelination pattern. ( Eftimov, F; Liesdek, MH; van Schaik, IN; Verhamme, C, 2014)
"To analyse if predictors of radiographic progression differ between patients treated with or without prednisolone in early rheumatoid arthritis (RA)."	5.19	Rheumatoid factor and anti-CCP do not predict progressive joint damage in patients with early rheumatoid arthritis treated with prednisolone: a randomised study. ( Boonen, A; Engvall, IL; Hafström, I; Rönnelid, J; Svensson, B; van der Heijde, D, 2014)
"Early treatment of patients with rheumatoid arthritis (RA) with combination treatment starting with methotrexate, sulfasalazine, hydroxychloroquine and prednisolone (FIN-RACo strategy) is superior to monotherapy."	5.17	Infliximab for 6 months added on combination therapy in early rheumatoid arthritis: 2-year results from an investigator-initiated, randomised, double-blind, placebo-controlled study (the NEO-RACo Study). ( Blåfield, H; Hannonen, PJ; Ilva, K; Julkunen, HA; Kaipiainen-Seppänen, O; Karjalainen, A; Kauppi, MJ; Kautiainen, H; Korpela, M; Laasonen, L; Leirisalo-Repo, M; Luosujärvi, R; Luukkainen, R; Moilanen, E; Möttönen, T; Paimela, L; Puolakka, K; Uutela, T, 2013)
"We conducted a prospective, multicenter trial to evaluate the efficacy and safety of a 12-month course of cyclosporine in children with steroid-resistant nephrotic syndrome (SRNS)."	5.14	Cyclosporine and steroid therapy in children with steroid-resistant nephrotic syndrome. ( Hamasaki, Y; Hattori, S; Honda, M; Iijima, K; Ishikura, K; Kaneko, T; Matsuyama, T; Nakanishi, K; Sasaki, S; Yata, N; Yoshikawa, N, 2009)
" At the beginning of the study, lung function values (FEV1, FVC, functional residual capacity, and diffusion capacity of the lung for carbon monoxide [Dlco]) and serum levels of C-reactive protein, fibrinogen, lipopolysaccharide binding protein, tumor necrosis factor (TNF)-alpha, and its soluble receptors (soluble TNF receptors 55 and 75) as markers of systemic inflammation were determined."	5.13	Increased systemic inflammation is a risk factor for COPD exacerbations. ( Groenewegen, KH; Hop, WC; Postma, DS; Schlösser, NJ; Wielders, PL; Wouters, EF, 2008)
"Sixteen patients, with nephrotic syndrome due to IMN and well-preserved renal function, were treated with prednisolone (starting dose: 0."	5.11	The remission of nephrotic syndrome with cyclosporin treatment does not attenuate the progression of idiopathic membranous nephropathy. ( Goumenos, DS; Kalliakmani, P; Sotsiou, F; Tsakas, S; Vlachojannis, JG, 2004)
"To assess the efficacy of low-dose prednisolone on joint damage and disease activity in patients with early rheumatoid arthritis (RA)."	5.11	Low-dose prednisolone in addition to the initial disease-modifying antirheumatic drug in patients with early active rheumatoid arthritis reduces joint destruction and increases the remission rate: a two-year randomized trial. ( Albertsson, K; Boonen, A; Hafström, I; Keller, C; Svensson, B; van der Heijde, D, 2005)
"To assess the effect of 5 mg/day prednisolone on disease progression in patients with early rheumatoid arthritis (RA) receiving standardized disease-modifying antirheumatic drug (DMARD) therapy."	5.11	Very low-dose prednisolone in early rheumatoid arthritis retards radiographic progression over two years: a multicenter, double-blind, placebo-controlled trial. ( Rau, R; Steinfeld, P; Wassenberg, S; Zeidler, H, 2005)
"In patients with early, active rheumatoid arthritis, prednisolone (7."	5.08	The effect of glucocorticoids on joint destruction in rheumatoid arthritis. The Arthritis and Rheumatism Council Low-Dose Glucocorticoid Study Group. ( Kirwan, JR, 1995)
"Prednisolone reduced the progression of joint destruction over 2 yr in early, active rheumatoid arthritis."	5.08	Joint destruction after glucocorticoids are withdrawn in early rheumatoid arthritis. Arthritis and Rheumatism Council Low Dose Glucocorticoid Study Group. ( Hickling, P; Jacoby, RK; Kirwan, JR, 1998)
"Assessment of the cost-effectiveness and cost-utility of early intervention in rheumatoid arthritis (RA) patients, with combined step-down prednisolone, methotrexate and sulphasalazine, compared to sulphasalazine alone."	5.08	Cost-effectiveness and cost-utility of combination therapy in early rheumatoid arthritis: randomized comparison of combined step-down prednisolone, methotrexate and sulphasalazine with sulphasalazine alone. COBRA Trial Group. Combinatietherapie Bij Reumat ( Bibo, JC; Boers, M; Engel, GL; van der Linden, S; Verhoeven, AC, 1998)
"5 mg/day prednisone) in the treatment of rheumatoid arthritis is still controversial."	4.90	Glucocorticoid treatment in rheumatoid arthritis. ( Rau, R, 2014)
" The SLE Disease Activity Index score and prednisolone dose were significantly reduced after switching, with few disease exacerbations over 12 months."	4.31	Safety and efficacy of switching immunosuppressive drugs for maintenance treatment in patients with systemic lupus erythematosus: A retrospective cohort study. ( Akahoshi, M; Akashi, K; Arinobu, Y; Ayano, M; Horiuchi, T; Kimoto, Y; Mitoma, H; Niiro, H; Ono, N, 2023)
" History of lupus nephritis and a higher average dose of prednisolone used since diagnosis were associated with cIMT progression in patients."	3.96	Similar progression of carotid intima-media thickness in 7-year surveillance of patients with mild SLE and controls, but this progression is still promoted by dyslipidaemia, lower HDL levels, hypertension, history of lupus nephritis and a higher prednisol ( Ajeganova, S; Frostegård, J; Gustafsson, T; Hafström, I; Lindberg, L, 2020)
"We herein report the case of a 59-year-old man with anti-leucine-rich glioma-inactivated 1 (LGI1) antibody encephalitis who presented with slowly progressive cognitive impairment mimicking dementia for over 3 years and then developed seizures."	3.91	A Patient with Limbic Encephalitis Associated with Anti-leucine-rich Glioma-inactivated 1 (LGI1) Antibody Presenting with Slowly Progressive Cognitive Impairment and Fluctuating Striatal Lesions. ( Kishida, D; Miyazaki, D; Sato, M; Sekijima, Y, 2019)
"A 62 year-old man, who was taking prednisolone for nephrotic syndrome, was diagnosed with herpes zoster of the trigeminal nerve and treated with oral valacyclovir."	3.88	[A case of bilateral cervical internal carotid artery dissection following herpes zoster of the trigeminal nerve]. ( Abe, Y; Ito, A; Iwasa, M; Mima, Y; Otsubo, R; Ueda, N, 2018)
"Children with IgA nephropathy showing diffuse (>80%) mesangial proliferation are at high risk for end-stage renal failure (ESRF)."	3.85	Long-term results of a randomized controlled trial in childhood IgA nephropathy. ( Hataya, H; Honda, M; Iijima, K; Ishikura, K; Ito, S; Kamei, K; Nakanishi, K; Saito, M; Sako, M; Yoshikawa, N, 2011)
" These are the use of selected ion flow tube mass spectrometry for the detection of biomarkers associated with pulmonary pathogens, the measurement of lung clearance index in preschool children, structured light plethysmography in children and the use of oral prednisolone for asthma exacerbations in children."	3.83	Research is the Future, the Future is……. ( Gilchrist, FJ, 2016)
" Ten and 15 days respectively after initiation of prednisolone treatment both patients experienced exacerbation of sensory symptoms and emerging of muscle weakness."	3.81	Pure sensory chronic inflammatory polyneuropathy: rapid deterioration after steroid treatment. ( Chroni, E; Gavanozi, E; Papathanasopoulos, P; Polychronopoulos, P; Veltsista, D; Vlachou, T, 2015)
"We herein investigated the clinical features of three patients with anti-muscle-specific tyrosine kinase (MuSK) antibody-positive myasthenia gravis (MG), which was initially difficult to distinguish from amyotrophic lateral sclerosis (ALS)."	3.81	Anti-MuSK Antibody-positive Myasthenia Gravis Mimicking Amyotrophic Lateral Sclerosis. ( Fujita, Y; Furuta, N; Ikeda, M; Ikeda, Y; Ishizawa, K; Makioka, K; Motomura, M; Nagamine, S; Okamoto, K; Shibata, M; Tsukagoshi, S; Yoshimura, S, 2015)
"Three cost effectiveness models for the treatment of multiple myeloma, were compared that had been developed to inform resource allocation in the UK for the chemotherapy regimens bortezomib, melphalan and prednisolone (BMP); and melphalan, prednisolone and thalidomide (MPT) versus melphalan and prednisolone (MP)."	3.80	Comparative cost-effectiveness models for the treatment of multiple myeloma. ( Bryant, J; Clegg, A; Cooper, K; Picot, J, 2014)
"The expressions of TLR1, TLR2, TLR3, TLR4, TLR6, and TLR9 and levels of pro-inflammatory cytokines (TNF-alpha, IL-1beta, IL-6, IL-8, and IFN-gamma) on the peripheral blood mononuclear cells (PBMCs) of 36 stable asthmatics on treatment (the on-treatment group), 15 asthmatics (the treatment-naïve group) before and after a 7-day course of oral prednisolone (30 mg/day), and on the PBMCs of 15 healthy controls were measured after in vitro stimulation using TLR-specific ligands."	3.76	Toll-like receptor expression on peripheral blood mononuclear cells in asthmatics; implications for asthma management. ( Cho, SH; Chun, E; Kim, YY; Lee, SH; Lee, SY; Min, KU; Park, HW; Shim, EJ, 2010)
"An 11-year-old girl with a calpain-3 gene (CAPN-3) mutation and eosinophilic myositis on muscle biopsy had high serum CK levels and eosinophil counts which showed spontaneous fluctuations."	3.75	Eosinophilic myositis in calpainopathy: could immunosuppression of the eosinophilic myositis alter the early natural course of the dystrophic disease? ( Dincer, P; Gundesli, H; Oflazer, PS; Sabuncu, T; Zorludemir, S, 2009)
"One hundred twenty-eight patients with pemphigus vulgaris, treated with prednisolone 2 mg/kg/day plus azathioprine 2 to 2."	3.74	Outcome of pemphigus vulgaris. ( Abedini, R; Chams-Davatchi, C; Daneshpazhooh, M; Farahani, F; Kavusi, S; Lajevardi, V, 2008)
"A total of 11 patients with clinically stable lupus nephritis treated with oral MZR pulse therapy combined with low-dose prednisolone were enrolled in the cross-sectional study."	3.73	Implication of the peak serum level of mizoribine for control of the serum anti-dsDNA antibody titer in patients with lupus nephritis. ( Ito, E; Kudo, M; Nakahata, T; Suzuki, K; Tanaka, H; Tsugawa, K, 2005)
"Seventy-seven patients (92%) were treated with prednisolone during the follow-up period, and 11 patients (13%) developed decompensated liver cirrhosis."	3.73	Persistent normalization of serum alanine aminotransferase levels improves the prognosis of type 1 autoimmune hepatitis. ( Ikeda, H; Iwasaki, Y; Kobashi, H; Makino, Y; Miyake, Y; Okamaoto, R; Sakaguchi, K; Sakai, N; Shiratori, Y; Takagi, S; Takaguchi, K; Terada, R, 2005)
"Because of its potential nephrotoxicity, the long-term use of cyclosporine (CsA) as treatment for nephrotic syndrome (NS) is controversial."	3.73	Long-term effects of cyclosporine in children with idiopathic nephrotic syndrome: a single-centre experience. ( El-Basuony, F; El-Husseini, A; Hassan, N; Hassan, R; Mahmoud, I; Sabry, A; Sayed-Ahmad, N; Sheashaa, H; Sobh, M; Taha, N, 2005)
"Hypercholesterolemia was observed in 46% to 80% and hypertriglyceridemia in 43% to 78% of sirolimus-treated patients during the first 6 posttransplantation months."	3.72	Dyslipidemia in renal transplant recipients treated with a sirolimus and cyclosporine-based immunosuppressive regimen: incidence, risk factors, progression, and prognosis. ( Chueh, SC; Kahan, BD, 2003)
"Although pulse methylprednisolone therapy (PMT) has been used successfully in the management of children with steroid-resistant nephrotic syndrome (SRNS), the relationship between initial presenting findings and renal histological characteristics to the subsequent clinical response to PMT is unknown."	3.71	Clinicopathologic correlates predict the outcome in children with steroid-resistant idiopathic nephrotic syndrome treated with pulse methylprednisolone therapy. ( Kim, MK; Kirpekar, R; Sibley, RK; Tune, BM; Yorgin, PD, 2002)
"Severe alcoholic hepatitis (SAH) is often a progressive disease with high mortality and limited steroid responsiveness."	2.90	Efficacy of Granulocyte Colony-stimulating Factor in the Management of Steroid-Nonresponsive Severe Alcoholic Hepatitis: A Double-Blind Randomized Controlled Trial. ( Pande, A; Sarin, SK; Sharma, MK; Shasthry, SM; Shasthry, V, 2019)
"In patients with mild-to-severe COPD receiving treatment for an exacerbation in an outpatient setting, the antibiotic doxycycline added to the oral corticosteroid prednisolone did not prolong time to next exacerbation compared with prednisolone alone."	2.84	Doxycycline for outpatient-treated acute exacerbations of COPD: a randomised double-blind placebo-controlled trial. ( Baars, JJ; Bresser, P; Brinkman, P; Dagelet, JWF; Daniels, JMA; Groeneveld-Tjiong, DRGL; Jonkers, RE; Krouwels, FH; Pool, K; Prins, JM; Rudolphus, A; Sterk, PJ; Ter Riet, G; van den Berg, BTJ; van den Berg, JWK; van Kan, C; van Velzen, P, 2017)
"Treatment with prednisolone was associated with a 3."	2.82	Effects of Prednisolone on Disease Progression in Antiretroviral-Untreated HIV Infection: A 2-Year Randomized, Double-Blind Placebo-Controlled Clinical Trial. ( Dölken, L; Gschmack, E; Hain, J; Hofmann, D; Horn, A; Kabyemera, R; Kalluvya, S; Kasang, C; Klinker, H; Kongola, G; Koutsilieri, E; Magambo, K; Majinge, C; Massawe, I; Mlewa, M; Müller, A; Preiser, W; Rethwilm, A; Scheller, C; Stich, A; Ulmer, A; Weissbrich, B, 2016)
"Acute exacerbations of COPD (AE-COPD) often result in administration of antibiotics although more than half of exacerbations are associated with detection of respiratory viruses and potentially pathogenic bacteria can only be detected in 20-30% of cases."	2.80	Randomized double blind placebo-controlled study to demonstrate that antibiotics are not needed in moderate acute exacerbations of COPD--the ABACOPD study. ( Koch, A; Rohde, GG; Welte, T, 2015)
"Of the 86 deaths not attributable to disease progression, 18 (<1%) were caused by a drug-related adverse event, as assessed by the investigator."	2.79	Abiraterone acetate for patients with metastatic castration-resistant prostate cancer progressing after chemotherapy: final analysis of a multicentre, open-label, early-access protocol trial. ( Castellano, D; Daugaard, G; De Porre, P; Galli, L; Garrido, JM; Géczi, L; George, DJ; Goon, B; Hotte, SJ; Lee, E; Londhe, A; Mainwaring, PN; McGowan, T; Molina, A; Naini, V; Saad, F; Souza, C; Sternberg, CN; Tay, MH; Todd, MB, 2014)
"Exacerbations of chronic obstructive pulmonary disease (COPD) and responses to treatment are heterogeneous."	2.77	Blood eosinophils to direct corticosteroid treatment of exacerbations of chronic obstructive pulmonary disease: a randomized placebo-controlled trial. ( Bafadhel, M; Barer, MR; Brightling, CE; Johnston, SL; Lomas, DA; McKenna, S; Mistry, V; Pancholi, M; Pavord, ID; Terry, S; Venge, P, 2012)
"Indication of tonsillectomy in IgA nephropathy is controversial."	2.77	Tonsillectomy has beneficial effects on remission and progression of IgA nephropathy independent of steroid therapy. ( Endo, G; Hamada, M; Hayashi, T; Imanishi, M; Kishida, M; Kitabayashi, C; Konishi, M; Konishi, Y; Maeda, I; Morikawa, T; Okada, N; Okumura, M; Sato, KK; Shibata, MO, 2012)
"Early treatment of rheumatoid arthritis (RA) has been shown to retard the development of joint damage for a period of up to 5 years."	2.75	Early combination disease-modifying antirheumatic drug therapy and tight disease control improve long-term radiologic outcome in patients with early rheumatoid arthritis: the 11-year results of the Finnish Rheumatoid Arthritis Combination Therapy trial. ( Blåfield, H; Hannonen, P; Järvenpää, S; Karjalainen, A; Kautiainen, H; Korpela, M; Laasonen, L; Leirisalo-Repo, M; Möttönen, T; Puolakka, K; Rantalaiho, V, 2010)
"Chronic obstructive pulmonary disease (COPD) is a chronic disease with a high prevalence and rapidly increasing incidence rates."	2.74	(Cost)-effectiveness of self-treatment of exacerbations on the severity of exacerbations in patients with COPD: the COPE II study. ( Effing, T; Kerstjens, H; van der Palen, J; van der Valk, P; Zielhuis, G, 2009)
"Scoliosis is a frequent complication (68-90%) of Duchenne muscular dystrophy (DMD)."	2.73	Predictive factors for the development of scoliosis in Duchenne muscular dystrophy. ( Edge, G; Eliahoo, J; Kinali, M; Knight, RK; Lehovsky, J; Main, M; Manzur, AY; Mercuri, E; Messina, S; Muntoni, F, 2007)
"For advanced progressive primary IgA nephropathy (IgAN) no established therapy exists."	2.71	Cyclophosphamide pulse therapy in advanced progressive IgA nephropathy. ( Czock, D; Jehle, PM; Karges, W; Keller, F; Klotz, CH; Mertz, A; Muche, R; Rasche, FM, 2003)
"Infantile spasms is a severe infantile seizure disorder that is difficult to treat and has a high morbidity."	2.71	The United Kingdom Infantile Spasms Study (UKISS) comparing hormone treatment with vigabatrin on developmental and epilepsy outcomes to age 14 months: a multicentre randomised trial. ( Edwards, SW; Hancock, E; Johnson, AL; Kennedy, CR; Lux, AL; Newton, RW; O'Callaghan, FJ; Osborne, JP; Verity, CM, 2005)
" In this context, we speculated that single-dose daily administration of low-dose CsA may be associated with a higher peak blood level without associated trough blood level elevation, and thereby yield better results and allow safer use of the drug than the conventional twice daily administration dosing used for the treatment of childhood idiopathic nephrotic syndrome (INS)."	2.71	C1-C2 point monitoring of low-dose cyclosporin a given as a single daily dose in children with steroid-dependent relapsing nephrotic syndrome. ( Ito, E; Kudo, M; Nakahata, T; Suzuki, K; Tanaka, H; Tsugawa, K; Waga, S, 2005)
"In prednisolone-treated patients there was no correlation between clinical synovitis and change in Larsen score (r=0."	2.70	The relationship between soft tissue swelling, joint space narrowing and erosive damage in hand X-rays of patients with rheumatoid arthritis. ( Byron, M; Kirwan, J; Watt, I, 2001)
"Prednisolone was given in 10 patients (study group) in a dose of 0."	2.70	Prednisolone in Duchenne muscular dystrophy. ( Bhoumick, NB; Hannan, MA; Haque, A; Mondol, BA; Rahman, MM, 2001)
"Proteinuria has significantly reduced in 10 patients, and only four patients still have nephrotic-range proteinuria."	2.69	Treatment of renal failure in idiopathic membranous nephropathy with azathioprine and prednisolone. ( Brown, JH; Doherty, CC; Douglas, AF; Hill, CM; McNamee, PT; Murphy, BG; Nelson, WE, 1998)
"There was no association of infections or febrile episodes with the use of corticosteroids or the CD4 count at the end of treatment and a poor correlation with the increase in CD4 counts during remission."	2.69	Long-term follow-up of patients with chronic lymphocytic leukemia (CLL) receiving fludarabine regimens as initial therapy. ( Beran, M; Estey, E; Freireich, EJ; Kantarjian, H; Keating, MJ; Koller, C; Lerner, S; O'Brien, S; Robertson, LE, 1998)
"Renal failure was in progression since Pcreat was 2."	2.68	Effects of steroids on the progression of renal failure in chronic interstitial renal fibrosis: a pilot study in Chinese herbs nephropathy. ( Abramowicz, D; Depierreux, M; Tielemans, C; Vanherweghem, JL, 1996)
"The early stage of progressive IgA nephropathy was defined as having moderate proteinuria between 1 and 2 g/day, creatinine clearance values of 70 ml/min or more, and a histological severity score of 7 or more."	2.68	Steroid therapy during the early stage of progressive IgA nephropathy. A 10-year follow-up study. ( Hiki, Y; Horii, A; Kobayashi, Y; Kokubo, T; Tateno, S, 1996)
"Deflazacort-treated patients experienced significantly lower functional decline over 48 weeks."	2.66	Deflazacort vs prednisone treatment for Duchenne muscular dystrophy: A meta-analysis of disease progression rates in recent multicenter clinical trials. ( Cox, DA; Darras, BT; Elfring, G; Landry, J; McDonald, CM; McDonnell, E; Peltz, SW; Sajeev, G; Shieh, PB; Signorovitch, J; Souza, M; Yao, Z, 2020)
"Autoimmune hepatitis is a rare and chronic liver disease that is characterised by increased serum transaminases and immunoglobulin G, inflammatory liver histology and presence of circulating autoantibodies."	2.61	Clinical management of autoimmune hepatitis. ( Gevers, TJ; Pape, S; Schramm, C, 2019)
"Time to the next COPD exacerbation did not differ in one large study that was powered to detect non-inferiority and compared five days versus 14 days of systemic corticosteroid treatment (n = 311; hazard ratio 0."	2.58	Different durations of corticosteroid therapy for exacerbations of chronic obstructive pulmonary disease. ( Tan, DJ; Walters, JA; White, CJ; Wood-Baker, R, 2018)
"The clinical course suggests that the pneumonitis was induced by hydroxycarbamide."	2.58	A 66-year-old man with hydroxycarbamide induced pneumonitis. ( Derichs, C; Klooster, P; Vlasveld, LT, 2018)
"A 45-year-old man with hemophagocytic syndrome was started on prednisolone, with a maximum dose of 40 mg/day."	2.52	MRI-detected bone marrow changes within 3 weeks after initiation of high-dose corticosteroid therapy: a possible change preceding the subsequent appearance of low-intensity band in femoral head osteonecrosis. ( Hatanaka, H; Iwamoto, Y; Karasuyama, K; Kubo, Y; Motomura, G; Sonoda, K; Tsukamoto, N; Utsunomiya, T; Yamamoto, T, 2015)
"Pancreatic disorders, such as chronic or acute pancreatitis, and carcinoma may be infrequently accompanied or preceded by panniculitis or polyarthritis."	2.50	Polyarthritis and pancreatic panniculitis associated with pancreatic carcinoma: review of the literature. ( Arbeláez-Cortés, A; Correa-Londoño, LA; González-Naranjo, LA; Restrepo-Escobar, M; Vanegas-García, AL, 2014)
"Time to the next COPD exacerbation did not differ in one large study that was powered to detect non-inferiority and compared five days versus 14 days of systemic corticosteroid treatment (n = 311; hazard ratio 0."	2.50	Different durations of corticosteroid therapy for exacerbations of chronic obstructive pulmonary disease. ( Tan, DJ; Walters, JA; White, CJ; Wood-Baker, R, 2014)
"Without prompt immunosuppressive treatment, autoimmune hepatitis is a devastating, albeit rare, liver disease."	2.47	Pharmacological management of autoimmune hepatitis. ( Mieli-Vergani, G; Vergani, D, 2011)
"Chronic pancreatitis is a progressive fibroinflammatory disease that exists in large-duct (often with intraductal calculi) or small-duct form."	2.47	Chronic pancreatitis. ( Braganza, JM; Lee, SH; McCloy, RF; McMahon, MJ, 2011)
"Abiraterone acetate has recently demonstrated a significant improvement in survival when compared to placebo in patients with docetaxel-treated mCRPC."	2.47	Role of second-line systemic treatment post-docetaxel in metastatic castrate resistant prostate cancer- current strategies and future directions. ( Alhasso, A; Ansari, A; Ansari, J; Glaholm, J; Hussain, SA; Mahmood, R, 2011)
"No study specified COPD diagnostic criteria and only one specified exacerbation criteria."	2.47	Different durations of corticosteroid therapy for exacerbations of chronic obstructive pulmonary disease. ( Morley, C; Soltani, A; Walters, JA; Wang, W; Wood-Baker, R, 2011)
"Short term high dose corticosteroid treatment improves symptoms and short term disability after an acute exacerbation of multiple sclerosis (MS) but it is unknown whether its long-term use can reduce the accumulation of disability."	2.44	Corticosteroids for the long-term treatment in multiple sclerosis. ( Beretta, S; Brusaferri, F; Ciccone, A; Galea, I; Protti, A; Spreafico, C, 2008)
"Oral prednisolone treatment initiated at 20 mg daily, combined with oral cyclophosphamide at 50 mg daily markedly improved not only the clinical symptoms, but also the mass shadows in the left upper lobe."	2.42	[A case of the limited from of Wegener's granulomatosis without c-ANCA]. ( Bandoh, S; Fujita, J; Horiike, A; Ishida, T; Ishii, T; Kubo, A; Tojo, Y; Yokomise, H, 2003)
"This report describes two patients with pancreatic cholera caused by vasoactive intestinal polypeptide (VIP)-producing tumors, which originated in the pancreas and showed metastases in both hepatic lobes at time of diagnosis."	2.40	Long-term survival after diagnosis of hepatic metastatic VIPoma: report of two cases with disparate courses and review of therapeutic options. ( Backes, B; Busch, N; Lammert, F; Matern, S; Nguyen, HN; Rieband, H; Wildberger, J; Winograd, R, 1999)
"The role of corticosteroids in treating rheumatoid arthritis is controversial, but recourse to the available evidence of efficacy should guide patient management decisions."	2.39	Low dose corticosteroids in early rheumatoid arthritis. Can these drugs slow disease progression? ( Kirwan, JR; Lim, KK, 1996)
"From a total of 1,174 IgAN patients in a multicenter retrospective cohort analysis in Japan, 195 patients were treated by tonsillectomy combined with corticosteroid."	1.62	Impact of the number of steroid pulses in tonsillectomy combined with steroid pulse therapy: a nationwide retrospective study in Japan. ( Hirano, K; Kataoka, H; Kawamura, T; Koike, K; Maruyama, S; Matsuo, S; Matsuzaki, K; Moriyama, T; Nitta, K; Suzuki, Y; Yasuda, T; Yasuda, Y; Yokoo, T, 2021)
"Differentiating Crohn's disease (CD) from intestinal tuberculosis (TB) is a challenge."	1.62	Case of Crohn's Disease Initially Misdiagnosed as Intestinal Tuberculosis Due to Active Pulmonary Tuberculosis. ( Choi, S; Kim, D; Lee, T; Lim, W; Oh, H; Park, H; Park, S; Song, C; Yun, J, 2021)
"The novel coronavirus disease 2019 (COVID-19) is a respiratory infection that has received much attention due to its rapid expansion."	1.62	COVID-19 progression in kidney transplant recipients: a single-center case series. ( Keykhaei, M; Mansouri, ES; Rahimzadeh, H; Razeghi, E; Zivari, E, 2021)
"Lower extremity deep vein thrombosis (LEDVT) is a serious complication of Behçet's syndrome."	1.56	Clinical course of acute deep vein thrombosis of the legs in Behçet's syndrome. ( Cetinkaya, F; Hamuryudan, V; Hatemi, G; Melikoglu, M; Ozguler, Y; Seyahi, E; Tascilar, K; Ugurlu, S; Yazici, H, 2020)
" The patient groups later developing hypothyroidism did not differ in age, BMI, pre-treatment TSH levels or initial dosage of prednisolone treatment."	1.56	Long-term Outcome of Subacute Thyroiditis. ( Diederich, S; Görges, J; Janssen, OE; Keck, C; Müller-Wieland, D; Ulrich, J, 2020)
"Crescent formation in immunoglobulin A nephropathy (IgAN) has been demonstrated to be a risk factor for worse outcomes."	1.56	Efficacy of corticosteroids in immunoglobulin A nephropathy with less than 25% crescents. ( Chen, J; Li, C; Lin, L; Liu, S; Peng, Z; Xu, H; Zhu, X, 2020)
"Tubulointerstitial nephritis was treated with 30 mg prednisolone, the dose of which was tapered to and maintained at 5 mg."	1.56	Successful Treatment of Non-small-cell Lung Cancer with Atezolizumab Following Tubulointerstitial Nephritis Due to Pembrolizumab. ( Fujioka, Y; Mitani, R; Oda, N; Oshiro, Y; Takata, I; Taki, T; Takigawa, N; Tokura, T, 2020)
"They also presented with pulmonary fibrosis findings, including traction bronchiectasis and marked lung volume reduction."	1.56	Coronavirus disease 2019-associated rapidly progressive organizing pneumonia with fibrotic feature: Two case reports. ( Akiyama, Y; Fukunaga, K; Hasegawa, N; Ishii, M; Kabata, H; Kaneko, Y; Kondo, Y; Lee, H; Okamori, S, 2020)
"The prednisolone dose was increased, and oral methotrexate was added."	1.56	Eosinophilic Fasciitis - Clinical Features and Therapeutic Management. ( Bergler-Czop, B; Bilewicz-Stebel, M; Matuszewska, A; Stebel, R; Weryńska-Kalemba, M, 2020)
" The lower dosage of oral prednisolone was a significant risk factor compared with higher dosage when used."	1.51	Oral steroid decreases the progression of joint destruction of large joints in the lower extremities in rheumatoid arthritis. ( Azukizawa, M; Doi, K; Hashimoto, M; Ito, H; Matsuda, S; Mimori, T; Murakami, K; Murata, K; Nishitani, K; Okahata, A; Saito, M; Tanaka, M; Tomizawa, T, 2019)
"Uveitis was the initial presenting complaint of sarcoidosis in 78."	1.51	Sarcoidosis-related Uveitis: Clinical Presentation, Disease Course, and Rates of Systemic Disease Progression After Uveitis Diagnosis. ( Brennan, J; Hall, AJ; Hodgson, L; Lim, LL; Ma, SP; Rogers, SL; Stawell, RJ, 2019)
"Excessive weight gain is a potential risk."	1.51	Twice-weekly glucocorticosteroids in infants and young boys with Duchenne muscular dystrophy. ( Alfano, LN; Anand, P; Connolly, AM; Cradock, MM; Finkel, RS; Flanigan, KM; Florence, JM; Golumbek, PT; Iannaccone, ST; Johnson, LB; Kuntz, NL; Lowes, LP; McDonald, CM; Mendell, JR; Nelson, LL; Nicorici, A; Siener, CA; Zaidman, CM, 2019)
"Acute exacerbation of pre-existing interstitial lung disease (ILD) associated with systemic anticancer therapy is recognized as a life-threatening adverse event of lung cancer treatment."	1.51	Organizing Pneumonia after Nivolumab Treatment in a Patient with Pathologically Proven Idiopathic Pulmonary Fibrosis. ( Atsumi, K; Gemma, A; Kashiwada, T; Kato, T; Kubota, K; Minegishi, Y; Saito, Y; Seike, M; Terasaki, Y, 2019)
"In response to treatment, interstitial pneumonia (IP) improved in three patients, stable in seven patients, and deteriorated in one patient."	1.48	Efficacy and safety of combination therapy with prednisolone and oral tacrolimus for progressive interstitial pneumonia with systemic sclerosis: A retrospective study. ( Arawaka, S; Fujiki, Y; Hata, K; Konma, J; Kotani, T; Makino, S; Nagai, K; Shoda, T; Suzuka, T; Takeuchi, T; Yoshida, S, 2018)
"Four high-risk patients reached ESRD."	1.48	Outcome of Idiopathic Membranous Nephropathy: A Retrospective Study. ( Benchetrit, S; Kotliroff, A; Rozenberg, I; Zahavi, T, 2018)
"She was diagnosed with interstitial lung disease (ILD) with anti-MDA5 Ab-positive DM."	1.48	Successful treatment of plasma exchange for rapidly progressive interstitial lung disease with anti-MDA5 antibody-positive dermatomyositis: A case report. ( Endo, Y; Fujita, Y; Fukui, S; Hara, K; Ichinose, K; Igawa, T; Ishida, M; Iwamoto, N; Kawakami, A; Kawashiri, SY; Koga, T; Kuwana, M; Nakamura, H; Nishino, A; Origuchi, T; Shimizu, T; Sumiyoshi, R; Suzuki, T; Takatani, A; Tamai, M; Tsuji, S; Umeda, M, 2018)
"Despite advances in understanding and treatment of autoimmune hepatitis, important unmet clinical needs remain in both adult and paediatric patient populations."	1.48	Unmet needs and new models for future trials in autoimmune hepatitis. ( Jones, D; Manns, MP; Terracciano, L; Torbenson, M; Vierling, JM, 2018)
"To examine the disease flare rate in lupus nephritis (LN), focusing on renal flares, and the factors associated with relapse risk in recent years."	1.46	Longterm Data on Disease Flares in Patients with Proliferative Lupus Nephritis in Recent Years. ( Chan, GCW; Chan, TM; Kwan, LPY; Ma, MKM; Mok, MMY; Tang, C; Yap, DYH, 2017)
"He was provided with diagnosis of central nervous system vasculitis (CNSV)."	1.46	Case report of a 28-year-old male with the rapid progression of steroid-resistant central nervous system vasculitis diagnosed by a brain biopsy. ( Hattori, H; Sato, H; Suzuki, N; Takahashi, K; Takahashi, S; Takao, M, 2017)
"The development of subepidermal blisters has been described in all clinical forms of circumscribed scleroderma."	1.46	[Generalized circumscribed scleroderma with blisters]. ( Meyer, V; Sachse, MM; Wagner, G, 2017)
"Fibrodysplasia Ossificans Progressiva is a rare debilitating disorder of the musculoskeletal system affecting one in two million individuals."	1.43	Fibrodysplasia ossificans progressiva: a case report. ( Baidoo, RO; Dayie, MS, 2016)
"CsA stabilized disease progression on HRCT in the early treatment group (p = 0."	1.43	Survival benefit associated with early cyclosporine treatment for dermatomyositis-associated interstitial lung disease. ( Go, DJ; Kang, EH; Kwon, HM; Lee, EB; Lee, YJ; Park, JK; Song, YW, 2016)
"Cardiac sarcoidosis is an infiltrative, granulomatous inflammatory disease of the myocardium."	1.42	What type of different clinical manifestations can cardiac sarcoidosis present? ( Argüder, E; Baştuğ, S; Hasanoğlu, HC; Karabekir, E; Karalezli, A; Maraş, Y; Öğüt, T; Şentürk, A, 2015)
"Current treatment of rheumatoid arthritis includes systemic administration of glucocorticoids."	1.42	[(18)]F FDG PET/CT imaging to monitor the therapeutic effect of liposome-encapsulated prednisolone in experimental rheumatoid arthritis. ( Boerman, OC; Gerrits, D; Laverman, P; Metselaar, JM; Storm, G; van der Geest, T; van Lent, PL, 2015)
"Lymphoma is one of the most common types of cancer in dogs, characterized by the proliferation of lymphoid cells."	1.42	Oxidative stress in dogs with multicentric lymphoma: Effect of chemotherapy on oxidative and antioxidant biomarkers. ( Anai, LA; Bollick, YS; Bottari, NB; Da Silva, AS; França, RT; Jark, PC; Lopes, ST; Moresco, RN; Munhoz, TD; Semolin, LM; Stefani, LM; Tinucci-Costa, M; Tonin, AA; Torbitz, VD, 2015)
"Extraintestinal manifestations in Crohn's disease (CD) are frequent and well recognized."	1.42	Histologically confirmed case of cerebral vasculitis associated with Crohn's disease--a case report. ( Asaoka, K; Gekka, M; Kato, Y; Nishihara, H; Nomura, M; Sugiyama, T, 2015)
"Cabazitaxel/prednisone has been shown to prolong survival versus mitoxantrone/prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or after docetaxel."	1.40	Safety of cabazitaxel in senior adults with metastatic castration-resistant prostate cancer: results of the European compassionate-use programme. ( Bracarda, S; Climent, MA; Fossa, S; Heidenreich, A; Hitier, S; Mason, M; Ozen, H; Papandreou, C; Sengelov, L; Van Oort, I, 2014)
"Primary MALT lymphoma in the larynx is extremely rare."	1.40	[Mucosa-associated lymphoid tissue lymphoma of the larynx]. ( Hagihara, M; Hua, J; Inoue, M; Iwaki, Y; Ota, Y; Takiguchi, Y, 2014)
"We encountered an adolescent with Cogan syndrome complicated by aortitis and anti-neutrophil cytoplasmic antibody (ANCA)-associated glomerulonephritis."	1.40	Childhood Cogan syndrome with aortitis and anti-neutrophil cytoplasmic antibody-associated glomerulonephritis. ( Enya, T; Izu, A; Miyazawa, T; Nishi, H; Okada, M; Sugimoto, K; Takemura, T, 2014)
"Waldenström's macroglobulinemia (WM) is an indolent chronic lymphoproliferative disorder within the spectrum of lymphoplasmacytic lymphoma (LPL), characterized by a proliferation of plasmacytoid lymphocytes and the production of monoclonal IgM."	1.40	Optic nerve involvement of Waldenström's macroglobulinemia: with autopsy findings. ( Hashida, R; Hatano, M; Hori, M; Nishida, H; Obara, K, 2014)
"Prednisolone therapy was tapered over several months."	1.39	[Woman with type 1 diabetes mellitus and rapidly progressive edema]. ( Dietrich, JW; Ehren, M, 2013)
"Treatment with lenalidomide, as the final therapeutic option, resolved the intractable melena and improved both the intestinal lesions and myeloma."	1.39	Therapeutic effects of lenalidomide on hemorrhagic intestinal myeloma-associated AL amyloidosis. ( Aoki, K; Arima, H; Imai, H; Ishikawa, T; Kato, A; Matsushita, A; Mori, M; Nagano, S; Ono, Y; Tabata, S; Takahashi, T; Takiuchi, Y; Yanagita, S, 2013)
"Adjuvant arthritis was induced by single intra-dermal injection of 0."	1.39	Anti-arthritic and anti-inflammatory activity of combined pioglitazone and prednisolone on adjuvant-induced arthritis. ( Banerjee, BD; Mediratta, PK; Negi, H; Sharma, KK; Suke, SG, 2013)
"She also had developed anasarca two years prior to presentation."	1.39	Systemic lupus erythematosus and granulomatous lymphadenopathy. ( Dhakal, AK; Shah, SC; Shakya, A; Shakya, H; Shiva, RK; Shrestha, D, 2013)
"Neuromyelitis optica is a rare, severe idiopathic disease that predominantly involves optic nerves and spinal cord."	1.39	Unusual manifestations of pediatric neuromyelitis optica. ( Kiresi, D; Yavuz, H, 2013)
"We report a rare case of diffuse systemic sclerosis (SSc) evolving into diffuse SSc/systemic lupus erythematosus (SLE) overlap syndrome."	1.38	Juvenile diffuse systemic sclerosis/systemic lupus erythematosus overlap syndrome--a case report. ( Fu, LS; Lin, HK; Wang, JD, 2012)
"The final diagnosis was classical polyarteritis nodosa (PAN)."	1.38	Interstitial pneumonia and nodular regenerative hyperplasia of the liver as initial manifestations of polyarteritis nodosa. ( Asai, N; Hasegawa, Y; Hashimoto, I; Imaizumi, K; Matsuno, T; Tanaka, I; Yokoi, T, 2012)
"Prednisolone was started again, after which his serum bilirubin level became normal and the thickening of the bile duct was resolved."	1.38	Newly developed autoimmune cholangitis without relapse of autoimmune pancreatitis after discontinuing prednisolone. ( Chang, JH; Han, SW; Im, YS; Kim, CW; Kim, JH; Kim, TH; Lee, MJ; Maeng, IH; Nam, SM; Park, JY, 2012)
"He was being treated for alcoholic liver cirrhosis, but as bloody urine was noticed macroscopically, his renal function rapidly decreased."	1.37	[Two cases of rapidly progressive nephritic syndrome complicated with alcoholic liver cirrhosis]. ( Aoki, M; Arakawa, Y; Arima, R; Fujita, E; Fukuda, K; Fukui, M; Hirama, A; Iino, Y; Kaneko, T; Mii, A; Shimizu, A; Utsumi, K, 2011)
"Autoimmune hepatitis is a rare disease."	1.37	[Autoimmune hepatitis: two case reports with different clinical courses - case 3/2011]. ( Adam, P; Klein, R; Lauer, U; Minkley, L, 2011)
"Coexistence of primary biliary cirrhosis (PBC) and autoimmune hepatitis (AIH) is referred to as PBC-AIH overlap."	1.36	Overlap of primary biliary cirrhosis and autoimmune hepatitis: Characteristics, therapy, and long term outcomes. ( Abe, K; Honma, F; Kanno, Y; Monoe, K; Ohira, H; Saito, H; Sakamoto, N; Takahashi, A; Yokokawa, H; Yokokawa, J, 2010)
"As renal insufficiency was progressing, hemodialysis was started soon after admission and oral prednisolone was also started at the dose of 0."	1.36	[Case of IgG4-related tubulointerstitial nephritis showing the progression of renal dysfunction after a cure for autoimmune pancreatitis]. ( Gejyo, F; Hama, H; Homma, N; Imai, N; Nishi, S; Saida, Y; Ueno, M, 2010)
"Sweet's syndrome was diagnosed."	1.35	Case of Sweet's syndrome with extensive necrosis and ulcers accompanied by myelodysplastic syndrome. ( Futagami, A; Kato, T; Kawana, S; Kikuchi, S; Takezaki, S, 2008)
"Three patients with FSGS developed chronic renal failure 8 to 15 yr after the diagnosis."	1.35	Clinicopathologic correlation and outcome of C1q nephropathy. ( Fukuma, Y; Hatae, K; Hisano, S; Iwasaki, H; Kaku, Y; Niimi, K; Saitoh, T; Segawa, Y; Takeshita, M, 2008)
"We describe a case of pediatric Wegener granulomatosis initially treated with cyclophosphamide and oral corticosteroids resulting in remission for 5 years."	1.35	Rituximab for severe refractory pediatric Wegener granulomatosis. ( Lehman, TJ; Patel, AM, 2008)
"The mechanism of neuropathology in MPS IIIB is unclear."	1.35	Innate and adaptive immune activation in the brain of MPS IIIB mouse model. ( Auer, H; Best, V; Charrier, A; DiRosario, J; Divers, E; Etter, J; Fu, H; Jukkola, P; McCarty, DM; Newsom, DL; Wang, C, 2009)
"Eosinophilia has been reported previously in patients with Calpainopathy and Becker Muscular Dystrophy and might be an early, but transient feature of a wider range of muscular dystrophies."	1.35	Eosinophilic myositis as presenting symptom in gamma-sarcoglycanopathy. ( Baumeister, SK; Dekomien, G; Lochmüller, H; Milić-Rasić, V; Todorovic, S; Walter, MC, 2009)
"The patient was diagnosed with breast carcinoma 4 months after initial presentation and underwent resective surgery, radiotherapy, and hormonotherapy."	1.35	Steroid-responsive paraneoplastic demyelinating neuropathy and myelopathy associated with breast carcinoma. ( Abbott, RJ; Qaddoura, B; Rajabally, YA, 2008)
"To report a case of tubulointerstitial nephritis and uveitis syndrome (TINU) with novel posterior segment features of bilateral vitritis and retinal pigment epithelial detachments."	1.35	TINU-associated retinal pigment epithelium detachments: a possible novel posterior segment feature. ( Laverde-Konig, T; Raina, J; Sheth, HG, 2009)
"To assess the incidence and severity of disease modifying antirheumatic drug (DMARD)-induced adverse effects (AE) in patients with rheumatoid arthritis (RA) taking/not taking glucocorticoids (GC)."	1.35	Low-dose prednisolone in rheumatoid arthritis: adverse effects of various disease modifying antirheumatic drugs. ( Arnold, S; Baerwald, CG; Häntzschel, H; Malysheva, OA; Pierer, M; Wagner, U; Wahle, M, 2008)
"Although ocular sarcoidosis is often accompanied by secondary glaucoma or optic nerve atrophy, the progression of neurosarcoidosis can lead to visual field defects."	1.34	[Case of neurosarcoidosis with rapid visual field defect progression]. ( Asukata, Y; Hasumi, Y; Hayashi, K; Ishihara, M; Mizuki, N; Nakamura, S; Nishida, T, 2007)
"In Caucasian type 1 autoimmune hepatitis patients with a main susceptibility of human leukocyte antigen DR3 and DR4, elderly patients have a higher frequency of concurrent autoimmune disease and cirrhosis at presentation."	1.34	Clinical features of Japanese elderly patients with type 1 autoimmune hepatitis. ( Iwasaki, Y; Kobashi, H; Miyake, Y; Sakaguchi, K; Shiratori, Y; Takaki, A, 2007)
"However, a definitive diagnosis of Wegener's granulomatosis was based on positive anti-neutrophil cytoplasmic antibodies directed against proteinase 3 and otorhinolaryngological manifestations."	1.34	A case of Wegener's granulomatosis associated with progressive dysphagia owing to esophageal involvement. ( Imanishi, M; Kawasaki, Y; Konishi, Y; Morikawa, T; Sato, T; Ueda, M; Yamagami, K; Yamaguchi, T; Yoshioka, K, 2007)
"The histology was consistent with ulcerative colitis."	1.33	Development of ulcerative colitis after heart transplantation during immunosuppressive therapy. ( Böhm, M; Ecker, KW; Giese, T; Jüngling, B; Kindermann, I; Moser, C; Püschel, W; Schäfers, HJ; Stallmach, A; Zeuzem, S, 2005)
"We enrolled 35 patients with MPGN type 1 who had a normal creatinine clearance at the time of their first renal biopsy and divided them into 2 groups based on clinical status at the time of their most recent examination: 12 patients with normal urine test results and 12 patients with minor urinary abnormalities at the latest observation (group 1) and 7 patients with persistent nephropathy and 4 patients with renal insufficiency (group 2)."	1.33	Myeloid-related protein 8 expression on macrophages is a useful prognostic marker for renal dysfunction in children with MPGN type 1. ( Hosoya, M; Isome, M; Kawasaki, Y; Suzuki, H; Takahashi, A; Tanji, M, 2005)
"We assessed the changes in liver fibrosis before and after treatment among these patients."	1.33	Impact of immunosuppressive treatment on liver fibrosis in autoimmune hepatitis. ( Alimohamadi, SM; Hagh-Azali, S; Malekzadeh, R; Mohamadnejad, M; Nasseri-Moghaddam, S; Rakhshani, N; Sedaghat, M; Tavangar, SM, 2005)
"During the past 10 years, acute disseminated encephalomyelitis has been reported a few times after organ transplantation."	1.33	Acute disseminated encephalomyelitis after liver transplantation. ( Gilani, A; Lindzen, E; Mann, D; Markovic-Plese, S, 2005)
"Unlike typical hairy cell leukemia (HCL) where the complete response (CR) rate to 2-chlorodeoxyadenosine and 2'-deoxycoformycin can approach about 90%, in HCL-v CR is rare and partial response (PR) occurs in approximately 50% with these agents."	1.33	Complete remission of hairy cell leukemia variant (HCL-v) complicated by red cell aplasia post treatment with rituximab. ( Januszewicz, H; Quach, H; Westerman, D, 2005)
"A 75-year-old man with type 1 diabetes and history of insulin therapy for previous 3 years using only human recombinant ones was suffering from unstable glycemic control."	1.33	A case of slowly progressive type 1 diabetes with unstable glycemic control caused by unusual insulin antibody and successfully treated with steroid therapy. ( Araki, E; Chirioka, T; Matsuyoshi, A; Miyamura, N; Sakakida, M; Sakamoto, F; Shimoda, S; Taketa, K; Tsuruzoe, K, 2006)
"A 61-year-old man with primary macroglobulinemia (PMG) had been followed without any treatment as he had no apparent manifestations."	1.33	[Successful treatment with CHOP therapy for progressive of primary macroglobulinemia without further increase of serum IgM]. ( Bessho, M; Ito, Y; Jinnai, I; Kawai, N; Maeda, T; Matsuda, A; Misumi, M; Nakamura, Y; Sato, Y; Shimada, T; Sugahara, Y; Takahashi, N; Wakao, D; Wakimoto, N; Yagasaki, F; Yoshida, K, 2005)
"Takayasu's arteritis is a systemic disease, presenting as chronic inflammation of the main arteries."	1.33	[Fulminant course of a Takayasu's arteritis and rare mesenteric arterial maninfestion]. ( Bösenberg, H; Holl-Ulrich, K; Schittko, G; Schwarz-Eywill, M; Simon, S, 2006)
"Two patients progressed to end-stage renal failure despite treatment with steroids."	1.32	Seven cases of granulomatous interstitial nephritis in the absence of extrarenal sarcoid. ( Banerjee, D; Cairns, HS; Hopster, D; Robson, MG, 2003)
"She was diagnosed as having tubulointerstitial nephritis and uveitis syndrome (TINU)."	1.32	[Repeat renal biopsy in tubulointerstitial nephritis and uveitis syndrome: report of a case]. ( Nakahata, T; Suzuki, K; Tanaka, H; Waga, S, 2003)
"Idiopathic (primary) tubulointerstitial nephritis (TIN) of childhood is relatively rare."	1.32	Repeat renal biopsy in children with severe idiopathic tubulointerstitial nephritis. ( Ito, E; Suzuki, K; Tanaka, H; Waga, S, 2004)
"A 30 year-old woman with Wegener's granulomatosis with typical lesions of nose, mouth, skin, lung and positive c-ANCA titre was admitted to our hospital because of ineffective treatment with corticosteroids and cyclophosphamide."	1.32	[Wegener's granulomatosis overlapped with Takayasu arteritis complicated by thrombosis of the internal jugular vein]. ( Demkow, U; Dobkowski, P; Drygalska-Pozorońska, A; Kurzyna, M; Langfort, R; Opoka, L; Orłowski, T; Roszkowski-Sliz, K; Wiatr, E, 2003)
"Pemphigus is an antidesmoglein (Dsg) autoimmune disease that is divided into two major subtypes: pemphigus foliaceus (PF) and pemphigus vulgaris (PV)."	1.31	Monitoring disease activity in pemphigus with enzyme-linked immunosorbent assay using recombinant desmogleins 1 and 3. ( Amagai, M; Cheng, SW; Kinoshita-Kuroda, K; Kobayashi, M; Nishikawa, T; Tanikawa, A, 2002)
"The question whether progressive sensorineural hearing loss during childhood is the fateful course of a main illness has been discussed controversially over 60 years."	1.31	Progressive hearing loss in hearing impaired children: immediate results of antiphlogistic--rheologic infusion therapy. ( Michel, O; Schöndorf, HJ; Stennert, E; Streppel, M; von Wedel, H; Walger, M; Wittekindt, C, 2001)
"Ursodeoxycholic acid (UDCA) treatment for primary sclerosing cholangitis (PSC) has been considered a rational therapy, though its effectiveness in the clinical course is still open to discussion."	1.31	Paradoxical progression of biliary strictures against recovery of biochemical parameters under ursodeoxycholic acid treatment in a case of primary sclerosing cholangitis with ulcerative colitis. ( Kikuchi, S; Kisara, N; Komatsu, K; Maruhama, Y; Shimosegawa, T; Toyota, T; Uchi, M; Ueno, Y, 2000)
"When prednisolone was again tapered down, increased nuchal rigidity, abducent nerve palsy and papilloedema appeared again with a marked increase in the number of CSF cells of 1309/mm3 on the 91th day."	1.31	[Repeated deterioration of tuberculous meningitis due to a reduction in the corticosteroid dosage during chemotherapy]. ( Itoh, H; Miyoshi, Y; Murai, H; Noda, S, 2000)
"The patient was diagnosed with acute tubulointerstitial nephritis caused by cefdinir."	1.31	Successful steroid therapy for cefdinir-induced acute tubulointerstitial nephritis with progressive renal failure. ( Fujiwara, T; Hiramori, K; Kawamura, M; Kimura, Y; Maesawa, C; Owada, M, 2001)
"We report here a case of acute monocytic leukemia (M5b subtype according to the French-American-British [FAB] classification) with chromosomal translocation t(11;20)(p15;q11."	1.31	Involvement of the NUP98 gene in a chromosomal translocation t(11;20)(p15;q11.2) in a patient with acute monocytic leukemia (FAB-M5b). ( Abe, T; Arai, Y; Gotoh, S; Ishikawa, T; Kakazu, N; Matsushita, A; Nagai, K; Ohki, M; Ohno, T; Shinzato, I; Takahashi, T; Tsuchiya, T, 2001)
"Treatment of interstitial lung disease (ILD) in rheumatoid arthritis (RA) has been controversial."	1.31	Successful treatment of progressive rheumatoid interstitial lung disease with cyclosporine: a case report. ( Chang, HK; Park, W; Ryu, DS, 2002)
" The dosage of steroids was tapered in 3 out of 4 CyA-responsive cases without re-exacerbation."	1.31	Usefulness of cyclosporine A on rapidly progressive interstitial pneumonia in dermatomyositis. ( Inase, N; Miyake, S; Miyasaka, N; Miyazaki, Y; Ohtani, Y; Sawada, M; Takano, S; Yoshizawa, Y, 2002)
"We describe a B cell chronic lymphocytic leukemia/lymphoma (B-CLL) patient with an adrenocortical adenoma."	1.30	Functional adrenocortical adenoma in a case with B cell chronic lymphoproliferative disorder. ( Adachi, M; Adachi, Y; Fukushima, H; Hinoda, Y; Imai, K; Takahashi, T, 1997)
"Oral prednisolone treatment was started and the retinopathy was improved, but was complicated by acute interstitial pneumonia."	1.30	[A case of dermatomyositis with severe retinopathy in a patient who died of acute interstitial pneumonia]. ( Enoki, T; Murakami, A; Nakabayasi, I; Nakagami, T; Okisaka, S; Yoshizawa, N, 1997)
"In the weeks after admission, gait ataxia progressively worsened, and then she developed alternating skew deviation on lateral gaze, suggesting that the CNS was involved."	1.30	[Inflammatory sensory ataxic neuropathy presenting with alternating skew deviation on lateral gaze: a case report]. ( Hamano, H; Hirabayashi, H; Nitta, M; Ohnuki, Y; Shinohara, Y, 1997)
"However, the erythema has been seldom documented in detail."	1.30	Lipodystrophia centrifugalis abdominalis infantilis. ( Ishizawa, T; Kondo, S; Mitsuhashi, Y; Takeda, H, 1998)
"Pentosidine is an advanced glycation endproduct formed by glycosylation and oxidation."	1.30	Pentosidine in synovial fluid in osteoarthritis and rheumatoid arthritis: relationship with disease activity in rheumatoid arthritis. ( Chen, JR; Inoue, T; Kushida, K; Miyamoto, S; Suzuki, M; Takahashi, M, 1998)
"One hundred and fifty-six patients with multiple myeloma were treated over a period of 12 years at St."	1.29	Myeloma during a decade: clinical experience in a single centre. ( Carter, M; Clark, PI; Ganjoo, RK; Gregory, W; Johnson, PW; Lim, JM; Love, SB; Mahmoud, MM; Malpas, JS; Williams, AH, 1995)
"We report a patient with acute myelomonocytic leukemia (AMMoL) who showed two independent point mutations of the N-ras gene at codons 12 and 13."	1.29	Double mutations of the N-ras gene in a patient with acute myelomonocytic leukemia. ( Hirakawa, K; Horiike, S; Kaneko, H; Kashima, K; Misawa, S; Nakai, H; Nakao, M; Taniwaki, M; Ueda, Y, 1995)
"Scleredema is a rare disease, affecting the skin connective tissue with increased amounts of collagen and glycosaminoglycans."	1.29	Increased collagen propeptides in the skin of a scleredema patient but no change in re-epithelialisation rate. ( Haapasaari, KM; Kallioinen, M; Oikarinen, A; Palatsi, R; Risteli, J; Tasanen, K, 1996)
"12 patients with rapidly progressive systemic lupus erythematosus (SLE) combined with renal failure were treated for 6 months according to the following scheme: 3 consecutive procedures of plasmapheresis (60 ml/kg x 3), 3 consecutive pulse doses of cyclophosphamide (400 mg/m2 x 3), 3 prednisolone infusions (2 mg/kg x 3), oral cyclophosphamide (100-250 mg/day) and prednisolone (0."	1.29	[Synchronizing therapy with plasmapheresis and cyclophosphamide in rapidly progressing systemic lupus erythematosis with kidney involvement]. ( Demin, AA; Demina, LM; Mamin, IV; Sentiakova, TN; Smirnov, VV, 1996)

Research

Studies (470)

Authors

Clinical Trials (26)

Trial Overview

Trial Outcomes

Change From Baseline in CRP at Week 12

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	52 (11.06)	18.2507
2000's	173 (36.81)	29.6817
2010's	216 (45.96)	24.3611
2020's	29 (6.17)	2.80

Authors	Studies
Tanaka, Y	2
Takeuchi, T	2
Kato, D	1
Kaneko, Y	2
Fukuda, M	1
Izutsu, H	1
Rokuda, M	1
van der Heijde, D	7
Ayano, M	1
Kimoto, Y	1
Mitoma, H	1
Akahoshi, M	1
Ono, N	1
Arinobu, Y	1
Akashi, K	1
Horiuchi, T	1
Niiro, H	1
Ozguler, Y	1
Hatemi, G	1
Cetinkaya, F	1
Tascilar, K	1
Hamuryudan, V	1
Ugurlu, S	1
Seyahi, E	1
Yazici, H	1
Melikoglu, M	1
Görges, J	1
Ulrich, J	1
Keck, C	1
Müller-Wieland, D	1
Diederich, S	1
Janssen, OE	1
McDonald, CM	2
Sajeev, G	1
Yao, Z	1
McDonnell, E	1
Elfring, G	1
Souza, M	1
Peltz, SW	1
Darras, BT	1
Shieh, PB	1
Cox, DA	1
Landry, J	1
Signorovitch, J	1
Chen, J	1
Xu, H	1
Peng, Z	1
Lin, L	1
Li, C	1
Zhu, X	1
Liu, S	1
Colard, S	1
Van Bol, L	1
Bidgoli, S	1
Lim, J	1
Ten Dam, L	1
Baars, PA	1
Van der Kooi, AJ	1
Pape, S	1
Schramm, C	2
Gevers, TJ	1
Doi, K	1
Ito, H	1
Tomizawa, T	1
Murata, K	1
Hashimoto, M	1
Tanaka, M	2
Murakami, K	2
Nishitani, K	1
Azukizawa, M	1
Okahata, A	1
Saito, M	2
Mimori, T	2
Matsuda, S	1
Lanario, JW	1
Hyland, ME	1
Wei, Y	1
Jones, RC	1
Masoli, M	1
Ajeganova, S	1
Gustafsson, T	1
Lindberg, L	1
Hafström, I	4
Frostegård, J	1
Taki, T	1
Oda, N	1
Fujioka, Y	1
Mitani, R	1
Tokura, T	1
Takata, I	1
Oshiro, Y	1
Takigawa, N	1
Trucco, F	1
Domingos, JP	1
Tay, CG	1
Ridout, D	1
Maresh, K	1
Munot, P	1
Sarkozy, A	1
Robb, S	1
Quinlivan, R	1
Riley, M	1
Burch, M	1
Fenton, M	1
Wallis, C	1
Chan, E	1
Abel, F	1
Manzur, AY	2
Muntoni, F	2
Funayama, Y	1
Watanabe, G	1
Tsukita, K	1
Suzuki, H	2
Uenohara, H	1
Suzuki, Y	4
Othonos, N	1
Marjot, T	1
Woods, C	1
Hazlehurst, JM	1
Nikolaou, N	1
Pofi, R	1
White, S	1
Bonaventura, I	1
Webster, C	1
Duffy, J	1
Cornfield, T	1
Moolla, A	1
Isidori, AM	1
Hodson, L	1
Tomlinson, JW	1
Schünemann, C	1
Göhring, G	1
Behrens, YL	1
Kreipe, HH	1
Ganser, A	1
Thol, F	1
Okamori, S	1
Lee, H	1
Kondo, Y	2
Akiyama, Y	1
Kabata, H	1
Ishii, M	2
Hasegawa, N	1
Fukunaga, K	1
Moriyama, T	2
Kataoka, H	1
Nitta, K	2
Hirano, K	3
Matsuzaki, K	1
Yasuda, T	1
Yasuda, Y	1
Koike, K	1
Maruyama, S	1
Yokoo, T	1
Matsuo, S	1
Kawamura, T	1
Sasaki, N	1
Ishii, A	2
Kurabayashi, T	1
Sugiyama, M	1
Izumi, Y	2
Nakagome, Y	1
Sasaki, S	2
Nogi, S	1
Nishikawa, A	1
Hosono, Y	1
Yamada, C	1
Sato, S	1
Yoshizumi, K	1
Kimura, T	2
Ukon, S	1
Watanabe, S	2
Kasama, S	1
Takeda, M	2
Crabb, SJ	1
Griffiths, G	1
Marwood, E	1
Dunkley, D	1
Downs, N	1
Martin, K	1
Light, M	1
Northey, J	1
Wilding, S	1
Whitehead, A	1
Shaw, E	1
Birtle, AJ	1
Bahl, A	1
Elliott, T	1
Westbury, C	1
Sundar, S	1
Robinson, A	1
Jagdev, S	1
Kumar, S	2
Rooney, C	1
Salinas-Souza, C	1
Stephens, C	1
Khoo, V	1
Jones, RJ	2
Skribek, M	1
Rounis, K	1
Afshar, S	1
Grundberg, O	1
Friesland, S	1
Tsakonas, G	1
Ekman, S	1
De Petris, L	1
Bilewicz-Stebel, M	1
Bergler-Czop, B	1
Stebel, R	1
Weryńska-Kalemba, M	1
Matuszewska, A	1
Park, S	2
Lee, T	1
Lim, W	1
Park, H	1
Yun, J	1
Kim, D	1
Choi, S	2
Oh, H	1
Song, C	1
Nogueira, RF	1
Oliveira, N	1
Sousa, V	1
Alves, R	1
Takashi, N	1
Nakamura, A	2
Kataoka, K	1
Usui, Y	1
Ito, Y	2
Kaneko, H	3
Takeuchi, Y	1
Murahashi, S	1
Hara, Y	1
Nakajima, M	1
Ueda, M	2
Rahimzadeh, H	1
Keykhaei, M	1
Razeghi, E	1
Zivari, E	1
Mansouri, ES	1
Crossingham, I	1
Turner, S	1
Ramakrishnan, S	1
Fries, A	1
Gowell, M	1
Yasmin, F	1
Richardson, R	1
Webb, P	1
O'Boyle, E	1
Hinks, TS	1
Ogura, S	1
Miyabe, Y	1
Karasawa, K	1
Wolff, JM	1
van Velzen, P	1
Ter Riet, G	1
Bresser, P	1
Baars, JJ	1
van den Berg, BTJ	1
van den Berg, JWK	1
Brinkman, P	1
Dagelet, JWF	1
Daniels, JMA	1
Groeneveld-Tjiong, DRGL	1
Jonkers, RE	1
van Kan, C	1
Krouwels, FH	1
Pool, K	1
Rudolphus, A	1
Sterk, PJ	1
Prins, JM	1
Kitamura, N	1
Nakanishi, T	2
Yoshida, Y	2
Higashi, T	1
Tsukada, J	2
Coler-Reilly, ALG	1
Sato, T	2
Matsuzaki, T	1
Nakagawa, M	1
Niino, M	1
Nagai, M	1
Nakamura, T	2
Takenouchi, N	1
Araya, N	1
Yagishita, N	1
Inoue, E	2
Yamano, Y	1
Baidoo, RO	1
Dayie, MS	1
Yap, DYH	2
Tang, C	1
Ma, MKM	2
Mok, MMY	2
Chan, GCW	2
Kwan, LPY	2
Chan, TM	2
Corral Magaña, O	1
Escalas Taberner, J	1
Bauzá Alonso, A	1
Martin-Santiago, A	1
Chou, JW	1
Lin, YL	1
Cheng, KS	1
Wu, PY	1
Reanne Ju, T	1
Wangkaew, S	1
Lertthanaphok, S	1
Puntana, S	1
Noppakun, K	1
Borlak, J	1
van Bömmel, F	1
Berg, T	1
Takahashi, K	2
Sato, H	1
Hattori, H	2
Takao, M	1
Takahashi, S	2
Suzuki, N	3
Konijn, NPC	1
van Tuyl, LHD	2
Boers, M	8
den Uyl, D	1
Ter Wee, MM	1
van der Wijden, LKM	1
Bultink, IEM	1
Kerstens, PJSM	1
Voskuyl, AE	2
van Schaardenburg, D	1
Nurmohamed, MT	1
Lems, WF	2
Rulach, RJ	1
McKay, S	1
Neilson, S	1
White, L	1
Wallace, J	1
Carruthers, R	1
Lamb, C	1
Cascales, A	1
Marashi, H	1
Glen, H	1
Venugopal, B	1
Sadoyze, A	1
Sidek, N	1
Russell, JM	1
Alhasso, A	2
Dodds, D	1
Laskey, J	1
MacLeod, N	1
Piga, M	1
Floris, A	1
Cappellazzo, G	1
Chessa, E	1
Congia, M	1
Mathieu, A	1
Cauli, A	1
Biró, K	1
Budai, B	1
Szőnyi, M	1
Küronya, Z	1
Gyergyay, F	1
Nagyiványi, K	1
Géczi, L	2
Paniagua, N	1
Lopez, R	1
Muñoz, N	1
Tames, M	1
Mojica, E	1
Arana-Arri, E	1
Mintegi, S	1
Benito, J	1
Elkhayat, HA	1
El-Rashidy, OF	1
Elagouza, IA	1
Zaitoun, R	1
Abbas, YAA	1
Sugiyama, Y	1
Yoshimi, R	1
Tamura, M	2
Takeno, M	1
Kunishita, Y	1
Kishimoto, D	1
Yoshioka, Y	1
Kobayashi, K	3
Takase-Minegishi, K	1
Watanabe, T	1
Hamada, N	1
Nagai, H	1
Tsuchida, N	1
Soejima, Y	1
Nakano, H	2
Kamiyama, R	1
Uehara, T	2
Kirino, Y	1
Sekiguchi, A	1
Ihata, A	1
Ohno, S	1
Nagaoka, S	1
Nakajima, H	1
Koya, J	1
Ebisawa, K	1
Abe, H	1
Shinozaki-Ushiku, A	1
Nakamura, F	1
Kurokawa, M	1
Konma, J	1
Kotani, T	1
Shoda, T	1
Suzuka, T	1
Fujiki, Y	1
Nagai, K	2
Hata, K	1
Yoshida, S	2
Makino, S	1
Arawaka, S	1
Wong, YYM	1
Hacohen, Y	1
Armangue, T	1
Wassmer, E	1
Verhelst, H	1
Hemingway, C	1
van Pelt, ED	1
Catsman-Berrevoets, CE	1
Hintzen, RQ	1
Deiva, K	1
Lim, MJ	1
Rostásy, K	1
Neuteboom, RF	1
Yamamoto, M	5
Shibata, Y	1
Oka, N	1
Inoue, M	2
Tachibana, N	1
Hamano, T	1
Rozenberg, I	1
Kotliroff, A	1
Zahavi, T	1
Benchetrit, S	1
Walters, JA	3
Tan, DJ	2
White, CJ	2
Wood-Baker, R	3
Murtagh, P	1
Treacy, M	1
Stephenson, K	1
Dooley, I	1
Sabaté-Llobera, A	1
Llinares, E	1
Vallansot, R	1
Landeyro, J	1
Gámez-Cenzano, C	1
Endo, Y	1
Koga, T	2
Suzuki, T	1
Hara, K	1
Ishida, M	2
Fujita, Y	2
Tsuji, S	1
Takatani, A	1
Shimizu, T	1
Sumiyoshi, R	1
Igawa, T	1
Umeda, M	1
Fukui, S	1
Nishino, A	1
Kawashiri, SY	1
Iwamoto, N	1
Ichinose, K	1
Tamai, M	2
Nakamura, H	1
Origuchi, T	1
Kuwana, M	2
Kawakami, A	2
Jones, D	1
Manns, MP	1
Terracciano, L	1
Torbenson, M	1
Vierling, JM	1
Iwasa, M	1
Mima, Y	1
Ito, A	2
Abe, Y	2
Ueda, N	1
Otsubo, R	1
So, H	1
Wong, VTL	1
Lao, VWN	1
Pang, HT	1
Yip, RML	1
Vale, CL	1
Fisher, DJ	1
White, IR	1
Carpenter, JR	1
Burdett, S	1
Clarke, NW	1
Fizazi, K	1
Gravis, G	1
James, ND	1
Mason, MD	1
Parmar, MKB	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to MTX[NCT02305849]	Phase 3	519 participants (Actual)	Interventional	2014-07-25	Completed
An Open Label Phase I/Randomised, Double Blind Phase II Study in Metastatic Castration Resistant Prostate Cancer of AZD5363 In Combination With Docetaxel and Prednisolone Chemotherapy (ProCAID)[NCT02121639]	Phase 1/Phase 2	160 participants (Actual)	Interventional	2014-01-29	Completed
Ideal Steroids for Asthma Treatment in the PICU (iSTAT PICU): A Prospective, Comparative, Single-arm Study Assessing Dexamethasone Versus Methylprednisolone in Severe Status Asthmaticus Admitted to the Pediatric Intensive Care Unit[NCT03900624]	Phase 4	92 participants (Actual)	Interventional	2019-04-21	Completed
Phase I/II Randomized, Double-blind, Placebo-controlled Cross-over Study of Prednisone on Airway Inflammatory Response to Inhaled Wood Smoke.[NCT03861390]	Phase 1/Phase 2	14 participants (Anticipated)	Interventional	2019-03-22	Recruiting
Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis. - A Double Blind Randomized Control Trial.[NCT01820208]		28 participants (Actual)	Interventional	2014-03-01	Completed
Phase 2 Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular Dystrophy[NCT02167217]	Phase 2	25 participants (Actual)	Interventional	2014-04-17	Completed
Use of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid Arthritis[NCT00908089]	Phase 4	100 participants (Actual)	Interventional	2003-03-31	Active, not recruiting
Trial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA)[NCT00443430]	Phase 4	85 participants (Actual)	Interventional	2007-05-31	Completed
An Open Label Study of Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy[NCT01217697]		0 participants	Expanded Access		Approved for marketing
To Compare the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis[NCT00371319]	Phase 4	150 participants (Actual)	Interventional	2005-09-30	Completed
Randomized Double Blind Placebo-controlled Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD - The ABACOPD Study[NCT01892488]	Phase 4	295 participants (Actual)	Interventional	2013-06-07	Completed
Phase II Study of Mogamulizumab With DA-EPOCH in Patients With Aggressive T Cell Lymphoma[NCT05996185]	Phase 2	36 participants (Anticipated)	Interventional	2024-01-31	Not yet recruiting
Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma (Untreated Primary Disease)[NCT01173887]	Phase 2	44 participants (Actual)	Interventional	2010-07-31	Completed
Telehealth Follow-up in Patients With Rheumatoid Arthritis. A Noninferiority Randomized Control Trial[NCT04536844]		220 participants (Actual)	Interventional	2020-06-15	Active, not recruiting
Randomized Controlled Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis[NCT00974766]	Phase 2/Phase 3	92 participants (Actual)	Interventional	2009-04-30	Completed
A Phase II Clinical Trial to Assess Risk and Benefit of Oral Low Dose Prednisolone for HIV Infected People Prior to the Commencement of Antiretroviral Treatment[NCT01299948]	Phase 2	326 participants (Actual)	Interventional	2007-06-30	Completed
Towards Personalized Medicine for Refractory/Relapsed Follicular Lymphoma Patients: the Cantera/Lupiae Registry[NCT04587388]		500 participants (Anticipated)	Observational [Patient Registry]	2019-05-22	Recruiting
Efficacy and Safety of Oral Corticosteroids for the Treatment of Acute Exacerbations of COPD in General Practice[NCT02330952]	Phase 4	189 participants (Actual)	Interventional	2015-02-10	Completed
Mesenchymal Stem Cell Therapy for Liver Cirrhosis: A Phase I/II Study[NCT03626090]	Phase 1/Phase 2	20 participants (Anticipated)	Interventional	2018-08-18	Recruiting
Decreasing Parental Stress and Costs While Improving Overall Satisfaction of Caregivers of Infants With Infantile Spasms on ACTH Therapy Utilizing Innovative Telemedicine Technology: A Randomized Study[NCT04086992]		40 participants (Anticipated)	Interventional	2019-10-10	Recruiting
Comparison of the Efficacy and Safety of Two Different Starting Dosages of Prednisolone in Early Active Rheumatoid Arthritis: a Randomized, Placebo Controlled Trial[NCT02000336]	Phase 3	395 participants (Actual)	Interventional	2014-01-31	Completed
Phase II/III Study of Oral Prednisolone Test in Patients With Rheumatoid Arthritis[NCT01395251]	Phase 2/Phase 3	130 participants (Actual)	Interventional	2012-02-29	Completed
A UKLG Randomised Trial of Initial Chemotherapy for Advanced Stage Hodgkins Disease[NCT00003421]	Phase 3	800 participants (Anticipated)	Interventional	1998-06-30	Completed
Antibiotic Stewardship Through CRP-guided Antibiotic Treatment for Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)[NCT05286918]		1,184 participants (Anticipated)	Interventional	2022-09-01	Not yet recruiting
Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients: A Randomized Double-Blind Controlled Study[NCT00506896]	Phase 2	60 participants (Actual)	Interventional	2004-07-31	Completed
Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients Aged From 18 to 59 Years With Diffuse Large B-cell Lymphoma and a Age-adjusted IPI of 1.[NCT00140595]	Phase 3	380 participants (Anticipated)	Interventional	2003-12-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Higher CRP indicates greater disease activity. (NCT02305849)
Timeframe: Baseline and week 12/ET

Change From Baseline in DAS28-ESR at Week 12

Intervention	mg/dL (Mean)
Placebo	-0.001
Peficitinib 100 mg	-1.499
Peficitinib 150 mg	-1.421

DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. (NCT02305849)
Timeframe: Baseline and week 12/ET

Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12

Intervention	units on a scale (Mean)
Placebo	-0.51
Peficitinib 100 mg	-1.66
Peficitinib 150 mg	-2.12

DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. (NCT02305849)
Timeframe: Baseline and week 12/ET

Change From Baseline in ESR at Week 12

Intervention	units on a scale (Mean)
Placebo	-0.51
Peficitinib 100 mg	-1.70
Peficitinib 150 mg	-2.09

Higher ESR indicates greater disease activity. (NCT02305849)
Timeframe: Baseline and week 12/ET

Change From Baseline in HAQ-DI at Week 12

Intervention	mm/h (Mean)
Placebo	-2.42
Peficitinib 100 mg	-18.90
Peficitinib 150 mg	-22.17

Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. (NCT02305849)
Timeframe: Baseline and week 12/ET

Change From Baseline in mTSS at Week 28

Intervention	units on a scale (Mean)
Placebo	0.01
Peficitinib 100 mg	-0.22
Peficitinib 150 mg	-0.37

mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 28 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. (NCT02305849)
Timeframe: Baseline and week 28/ET

Change From Baseline in mTSS at Week 52

Intervention	units on a scale (Mean)
Placebo	3.37
Peficitinib 100 mg	1.62
Peficitinib 150 mg	1.03

mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 52 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. (NCT02305849)
Timeframe: Baseline and week 52/ET

Change From Baseline in Percent Overall Work Impairment at Week 12

Intervention	units on a scale (Mean)
Placebo	6.27
Peficitinib 100 mg	2.12
Peficitinib 150 mg	1.54

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent overall work impairment due to problem was calculated as Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline and week 12/ET

Change From Baseline in PGA at Week 12

Intervention	percent overall work impairment (Mean)
Placebo	-2.75
Peficitinib 100 mg	-11.58
Peficitinib 150 mg	-16.91

The investigator assessed the participants' disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment. (NCT02305849)
Timeframe: Baseline and week 12/ET

Change From Baseline in SDAI Score at Week 12

Intervention	units on a scale (Mean)
Placebo	-11.88
Peficitinib 100 mg	-28.83
Peficitinib 150 mg	-35.96

SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description: SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. (NCT02305849)
Timeframe: Baseline and week 12/ET

Change From Baseline in SF-36v2 Mental Component Summary Score at Week 12

Intervention	units on a scale (Mean)
Placebo	-4.90
Peficitinib 100 mg	-15.66
Peficitinib 150 mg	-19.57

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02305849)
Timeframe: Baseline and week 12/ET

Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12

Intervention	units on a scale (Mean)
Placebo	1.07
Peficitinib 100 mg	3.28
Peficitinib 150 mg	2.50

Change From Baseline in SGA at Week 12

Intervention	units on a scale (Mean)
Placebo	-0.09
Peficitinib 100 mg	2.30
Peficitinib 150 mg	3.90

The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment. (NCT02305849)
Timeframe: Baseline and week 12/ET

Change From Baseline in SGAP at Week 12

Intervention	units on a scale (Mean)
Placebo	-7.11
Peficitinib 100 mg	-21.09
Peficitinib 150 mg	-26.57

The participant assessed his/her own pain severity on a visual analog scale (VAS) of 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicated greater activity pain. (NCT02305849)
Timeframe: Baseline and week 12/ET

Change From Baseline in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12

Intervention	units on a scale (Mean)
Placebo	-6.64
Peficitinib 100 mg	-21.09
Peficitinib 150 mg	-26.87

Change From Baseline in SJC (66 Joints) at Week 12

Intervention	units on a scale (Mean)
Placebo	0.57
Peficitinib 100 mg	6.60
Peficitinib 150 mg	9.02

The participants were examined for the swollen joints and the location was confirmed by the investigator who assessed the following 66 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher SJC indicated greater disease activity. (NCT02305849)
Timeframe: Baseline and week 12/ET

Change From Baseline in TJC (68 Joints) at Week 12

Intervention	swollen joint count (Mean)
Placebo	-2.2
Peficitinib 100 mg	-5.9
Peficitinib 150 mg	-7.6

The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity. (NCT02305849)
Timeframe: Baseline and week 12/ET

Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12

Intervention	tender joint count (Mean)
Placebo	-2.1
Peficitinib 100 mg	-6.9
Peficitinib 150 mg	-9.1

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent work time missed due to problem was calculated as Q2/(Q2+Q4). Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline and week 12/ET

Change From Baseline in WPAI Percent Activity Impairment at Week 12

Intervention	percent work time missed (Mean)
Placebo	-0.82
Peficitinib 100 mg	0.36
Peficitinib 150 mg	-1.46

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline and week 12/ET

Change From Baseline in WPAI Percent Impairment While Working at Week 12

Intervention	percent activity impairment (Mean)
Placebo	-2.50
Peficitinib 100 mg	-13.98
Peficitinib 150 mg	-19.35

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculated as Q5/10. Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline and week 12/ET

Number of Participants Who Withdrew Due to Lack of Efficacy

Intervention	percent work impairment (Mean)
Placebo	-2.42
Peficitinib 100 mg	-11.71
Peficitinib 150 mg	-15.96

Participants who discontinued due to lack of efficacy have been reported. (NCT02305849)
Timeframe: Up to week 52

Percentage of Participants Achieving ACR / EULAR Remission at Week 12

Intervention	Participants (Count of Participants)
Peficitinib 100 mg	10
Peficitinib 150 mg	6
Placebo / Peficitinib 100 mg	3
Placebo / Peficitinib 150 mg	9

ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤1, CRP ≤1 mg/dL, and participant's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm). (NCT02305849)
Timeframe: Week 12/ET

Percentage of Participants Achieving DAS28-CRP Score < 2.6 at Week 12

Intervention	percentage of participants (Number)
Placebo	0.6
Peficitinib 100 mg	5.8
Peficitinib 150 mg	9.9

DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission. (NCT02305849)
Timeframe: Week 12/ET

Percentage of Participants Achieving DAS28-CRP Score <= 3.2 at Week 12

Intervention	percentage of participants (Number)
Placebo	7.7
Peficitinib 100 mg	31.4
Peficitinib 150 mg	35.1

DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity. (NCT02305849)
Timeframe: Week 12/ET

Percentage of Participants Achieving DAS28-ESR Score < 2.6 at Week 12

Intervention	percentage of participants (Number)
Placebo	12.4
Peficitinib 100 mg	47.1
Peficitinib 150 mg	57.9

DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission. (NCT02305849)
Timeframe: Week 12/ET

Percentage of Participants Achieving DAS28-ESR Score <= 3.2 at Week 12

Intervention	percentage of participants (Number)
Placebo	2.4
Peficitinib 100 mg	12.8
Peficitinib 150 mg	19.3

DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity. (NCT02305849)
Timeframe: Week 12/ET

Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission <=3.3 at Week 12

Intervention	percentage of participants (Number)
Placebo	4.7
Peficitinib 100 mg	25.0
Peficitinib 150 mg	36.3

SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3. (NCT02305849)
Timeframe: Week 12/ET

Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR at Week 12

Intervention	percentage of participants (Number)
Placebo	0.6
Peficitinib 100 mg	7.0
Peficitinib 150 mg	14.0

The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure. (NCT02305849)
Timeframe: Week 12/ET

Percentage of Participants With a EULAR Good Response Using DAS28-ESR at Week 12

Intervention	percentage of participants (Number)
Placebo	32.0
Peficitinib 100 mg	74.4
Peficitinib 150 mg	78.9

The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in the outcome measure. (NCT02305849)
Timeframe: Week 12/ET

Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12

Intervention	percentage of participants (Number)
Placebo	4.1
Peficitinib 100 mg	23.8
Peficitinib 150 mg	34.5

The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in this outcome measure. (NCT02305849)
Timeframe: Week 12/ET

Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12

Intervention	percentage of participants (Number)
Placebo	10.1
Peficitinib 100 mg	43.0
Peficitinib 150 mg	55.6

Percentage of Participants With an ACR50-CRP Response at Week 12

Intervention	percentage of participants (Number)
Placebo	35.5
Peficitinib 100 mg	77.9
Peficitinib 150 mg	84.8

ACR50 response: ≥50% improvement in tender and swollen joint counts and 50% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT02305849)
Timeframe: Baseline and week 12/ET

Percentage of Participants With an ACR70-CRP Response at Week 12

Intervention	percentage of participants (Number)
Placebo	7.6
Peficitinib 100 mg	29.9
Peficitinib 150 mg	46.0

ACR70 response: ≥ 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT02305849)
Timeframe: Baseline and week 12/ET

Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12

Intervention	percentage of participants (Number)
Placebo	2.4
Peficitinib 100 mg	12.1
Peficitinib 150 mg	23.6

ACR20 response: greater than and equal to (≥) 20 percent (%) improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. (NCT02305849)
Timeframe: Baseline and week 12/Early termination (ET)

Change From Baseline in CRP Through Week 52

Intervention	percentage of participants (Number)
Placebo	21.8
Peficitinib 100 mg	58.6
Peficitinib 150 mg	64.4

Higher CRP indicates greater disease activity. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Change From Baseline in DAS28-CRP Through Week 52

Intervention	mg/dL (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-1.055	-1.207	-1.532	-1.666	-1.660	-1.774	-1.803	-1.844	-1.832	-1.833	-1.815	-1.771	-1.841	-1.545
Peficitinib 150 mg	-1.411	-1.569	-1.458	-1.513	-1.660	-1.721	-1.721	-1.640	-1.696	-1.716	-1.725	-1.751	-1.912	-1.629

Change From Baseline in DAS28-ESR Score Through Week 52

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-1.11	-1.48	-1.72	-2.01	-2.21	-2.40	-2.42	-2.50	-2.55	-2.66	-2.65	-2.62	-2.67	-2.43
Peficitinib 150 mg	-1.39	-1.87	-2.15	-2.40	-2.53	-2.71	-2.70	-2.77	-2.83	-2.86	-2.88	-2.92	-2.96	-2.76
Placebo / Peficitinib 100 mg at Week 12	-0.28	-0.21	0.24	-1.11	-1.69	-2.01	-2.24	-2.49	-2.49	-2.66	-2.68	-2.86	-2.80	-2.61
Placebo / Peficitinib 100 mg at Week 28	-0.82	-0.94	-1.34	-1.37	-1.38	-1.41	-1.53	-2.18	-2.22	-2.62	-2.63	-2.66	-2.70	-2.72
Placebo / Peficitinib 150 mg at Week 12	-0.30	-0.10	0.27	-1.37	-1.76	-2.26	-2.51	-2.72	-2.70	-2.72	-2.72	-2.90	-2.74	-2.52
Placebo / Peficitinib 150 mg at Week 28	-0.74	-0.90	-1.20	-1.31	-1.48	-1.64	-1.71	-2.47	-2.57	-2.73	-2.87	-2.96	-2.89	-2.87

Change From Baseline in Erosion Score at Week 28 and Week 52

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-1.07	-1.47	-1.68	-1.98	-2.23	-2.43	-2.47	-2.56	-2.59	-2.70	-2.71	-2.64	-2.70	-2.47
Peficitinib 150 mg	-1.37	-1.88	-2.18	-2.46	-2.60	-2.78	-2.79	-2.87	-2.91	-2.96	-3.00	-3.01	-3.07	-2.86
Placebo / Peficitinib 100 mg at Week 12	-0.26	-0.24	0.24	-1.01	-1.61	-1.94	-2.11	-2.39	-2.45	-2.60	-2.63	-2.80	-2.77	-2.60
Placebo / Peficitinib 100 mg at Week 28	-0.87	-1.00	-1.40	-1.47	-1.45	-1.47	-1.63	-2.27	-2.38	-2.71	-2.74	-2.72	-2.79	-2.80
Placebo / Peficitinib 150 mg at Week 12	-0.26	-0.12	0.25	-1.38	-1.78	-2.24	-2.48	-2.68	-2.71	-2.78	-2.76	-2.88	-2.78	-2.56
Placebo / Peficitinib 150 mg at Week 28	-0.67	-0.85	-1.10	-1.21	-1.37	-1.56	-1.62	-2.37	-2.54	-2.68	-2.78	-2.93	-2.85	-2.82

The joint erosion score was a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint in the hand is scored from 0-5 and each joint in the foot is scored from 0-10. The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet. By summing these score, the range of total erosion score is 0-280. Higher erosion score indicates greater disease activity. (NCT02305849)
Timeframe: Baseline and weeks 28/ET and 52/ET

Change From Baseline in ESR Through Week 52

Intervention	units on a scale (Mean)
	Week 28/ET	Week 52/ET
Peficitinib 100 mg	0.63	0.82
Peficitinib 150 mg	0.18	0.32
Placebo	1.35	2.52

Higher ESR indicates greater disease activity. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Change From Baseline in HAQ-DI Through Week 52

Intervention	mm/h (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-11.09	-14.96	-19.14	-21.42	-23.22	-25.35	-26.03	-26.92	-25.95	-25.86	-27.13	-25.63	-26.86	-24.00
Peficitinib 150 mg	-16.59	-21.10	-22.92	-24.29	-26.20	-27.36	-27.88	-27.21	-27.25	-27.74	-27.99	-27.83	-29.12	-26.11

Change From Baseline in JSN Score at Week 28 and Week 52

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-0.08	-0.18	-0.23	-0.30	-0.33	-0.36	-0.36	-0.37	-0.39	-0.42	-0.45	-0.44	-0.43	-0.36
Peficitinib 150 mg	-0.21	-0.32	-0.38	-0.41	-0.47	-0.48	-0.51	-0.53	-0.53	-0.56	-0.54	-0.56	-0.56	-0.51

JSN was defined as narrowing in joint space width over the course of the study. The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. Higher scores indicate greater disease activity. (NCT02305849)
Timeframe: Baseline and weeks 28/ET and 52/ET

Change From Baseline in PGA Through Week 52

Intervention	units on a scale (Mean)
	Week 28/ET	Week 52/ET
Peficitinib 100 mg	0.99	1.30
Peficitinib 150 mg	0.82	1.19
Placebo	1.90	3.55

The investigator assessed the participants disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Change From Baseline in SDAI Score Through Week 52

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-18.36	-25.79	-29.07	-33.60	-36.18	-37.13	-38.72	-40.04	-39.35	-41.04	-41.47	-41.55	-41.49	-38.41
Peficitinib 150 mg	-22.94	-31.54	-36.55	-38.86	-41.44	-43.67	-42.43	-43.96	-44.37	-44.32	-46.00	-45.84	-45.46	-43.33

Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-11.02	-14.60	-15.94	-18.75	-20.24	-21.62	-21.89	-22.61	-22.89	-23.55	-23.55	-23.23	-23.67	-21.48
Peficitinib 150 mg	-13.79	-18.36	-20.08	-22.21	-23.03	-24.68	-24.57	-25.38	-25.55	-26.14	-26.44	-26.50	-26.63	-24.72

Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 28	Week 52	EOT
Peficitinib 100 mg	1.45	2.72	3.44	3.06	2.62	2.21
Peficitinib 150 mg	1.33	2.44	2.67	3.12	1.85	1.67

Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 28	Week 52	EOT
Peficitinib 100 mg	3.84	4.92	6.68	9.89	11.27	9.92
Peficitinib 150 mg	5.77	7.91	9.32	12.44	12.45	11.51

Change From Baseline in SGA Through Week 52

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 28	Week 52	EOT
Peficitinib 100 mg	1.41	2.50	2.32	4.06	4.30	3.49
Peficitinib 150 mg	1.70	3.30	3.92	4.81	7.17	5.88

Change From Baseline in SGAP Through Week 52

Change From Baseline in SJC (66 Joints) Through Week 52

Change From Baseline in TJC (68 Joints) Through Week 52

Change From Baseline in WPAI Percent Activity Impairment Through Week 52

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

Change From Baseline in WPAI Percent Impairment While Working Through Week 52

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculates as Q5/10. Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52

Change From Baseline in WPAI Percent Work Time Missed Through Week 52

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent work time missed due to problem was calculated as Q2/(Q2+Q4). Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

Number of Participants With TEAEs From Week 12 to Week 28

TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on NCI-CTCAE, AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE (NCT02305849)
Timeframe: Week 12 to week 28

Number of Participants With TEAEs From Week 28 to Week 52

TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE. (NCT02305849)
Timeframe: Week 28 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks

TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by System Organ Class (SOC) and Preferred Term (PT). Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE. (NCT02305849)
Timeframe: Week 0 to week 12

Percentage of Participants Achieving ACR / EULAR Remission Through Week 52

Percentage of Participants Achieving Change From Baseline in mTSS <= 0.5 at Week 28 and Week 52

mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. (NCT02305849)
Timeframe: Baseline and week 28/ET and 52/ET

Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52

DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52

DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52

DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52

DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52

Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52

Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52

The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in this outcome measure. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52

The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in this outcome measure. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52

Percentage of Participants With an ACR20-CRP Response Through Week 52

ACR20 response:≥ 20% improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. EOT was defined as end of treatment i.e, either early termination or week 52. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Percentage of Participants With an ACR50-CRP Response Through Week 52

Percentage of Participants With an ACR70-CRP Response Through Week 52

Duration of Continuous Nebulized Albuterol

Duration (in days) of continuous nebulized albuterol. (NCT03900624)
Timeframe: From enrollment through hospital discharge, up to 1 week

Length of Stay

Hospital length of stay measured in days. (NCT03900624)
Timeframe: From enrollment through hospital discharge, up to 1 week

Number of Participants Receiving an Adjunctive Asthma Therapy

"Number of participants receiving an adjunctive therapy:~use of non-invasive ventilation (NIV)~terbutaline~inhaled helium~inhaled anesthetic gas~mechanical ventilation~extracorporeal life support" (NCT03900624)
Timeframe: From enrollment through hospital discharge, up to 1 week

Corticosteroid-related Adverse Events

Rates of known corticosteroid-related adverse events including clinically-relevant gastrointestinal bleeding, gastritis, ventilator associated pneumonia, necrotizing enterocolitis, hypertension, hyperglycemia, altered mentation (including hallucinations and delirium), and adrenal insufficiency observed prior to hospital discharge. (NCT03900624)
Timeframe: From enrollment through hospital discharge, up to 1 week

Bayley III Gross Motor Scaled Score (Change From Baseline to 12 Month)

Bayley III Gross Motor Scaled Score measures motor development. This is normed for typically developing children and follow a bell shaped curve. The scale has mean of 10 +/-3 for children at all ages and is bell shaped. Therefore the two standard deviation range is 16 to 4 with higher values indicated better performance. Lower values have been shown to be common in boys with DMD and it this study the baseline average score was 4.2. (NCT02167217)
Timeframe: One year

Clinical Remission on Medication

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

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-13.80	-19.11	-21.59	-25.20	-26.94	-29.00	-30.04	-31.92	-32.38	-32.80	-33.49	-33.69	-33.18	-29.34
Peficitinib 150 mg	-17.59	-24.97	-27.40	-30.14	-31.20	-32.79	-34.25	-33.46	-34.01	-34.24	-35.31	-35.33	-36.16	-34.05

Intervention	Participants (Count of Participants)
	TEAEs	Drug-related TEAEs	TEAEs leading to death	Serious TEAEs	Drug-related serious TEAEs	≥ Grade 3 TEAEs	TEAEs leading to permanent discontinuation	Drug-Related TEAE leading to permanent dicont.
Peficitinib 100 mg	95	63	0	5	3	7	4	3
Peficitinib 150 mg	104	72	0	3	1	6	1	1
Placebo	50	27	0	2	2	5	4	3
Placebo / Peficitinib 100 mg at Week 12	21	16	0	0	0	1	0	0
Placebo / Peficitinib 150 mg at Week 12	25	11	0	0	0	1	0	0

Intervention	days (Median)
Methylprednisolone Arm - Standard Care	1
Dexamethasone Arm - Interventional Arm	0.8

Intervention	Participants (Count of Participants)
	Hyperglycemia	Hypertension	Adrenal insufficiency	Altered mentation	Clinically-relevant gastrointestinal bleeding	Gastritis	Necrotizing enterocolitis	Ventilator associated pneumonia
Dexamethasone Arm	2	1	0	0	0	0	0	0
Methylprednisolone Arm	7	1	2	2	0	0	0	0

Intervention	participants (Number)
Methotrexate Arm	10
Methotrexate-Prednisolone-Etanercept Arm	17

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Clinical management of autoimmune hepatitis. United European gastroenterology journal, 2019, Volume: 7, Issue:9 Topics: Alanine Transaminase; Aspartate Aminotransferases; Autoantibodies; Azathioprine; Disease Progression	2019
Combination fixed-dose beta agonist and steroid inhaler as required for adults or children with mild asthma. The Cochrane database of systematic reviews, 2021, 05-04, Volume: 5 Topics: Adolescent; Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Adult; Anti-Asthmatic Agen	2021
[Not Available]. Oncology research and treatment, 2017, Volume: 40 Suppl 2 Topics: Abiraterone Acetate; Adenocarcinoma; Androgen Antagonists; Antineoplastic Combined Chemotherapy Prot	2017
Dermatomyositis Induced by Hepatitis B Virus-related Hepatocellular Carcinoma: A Case Report and Review of the Literature. Internal medicine (Tokyo, Japan), 2017, Volume: 56, Issue:14 Topics: Anti-Inflammatory Agents; Carcinoma, Hepatocellular; Dermatomyositis; Disease Progression; Hepatitis	2017
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MRI-detected bone marrow changes within 3 weeks after initiation of high-dose corticosteroid therapy: a possible change preceding the subsequent appearance of low-intensity band in femoral head osteonecrosis. Rheumatology international, 2015, Volume: 35, Issue:11 Topics: Arthroplasty, Replacement, Hip; Bone Marrow; Disease Progression; Early Diagnosis; Femur Head; Femur	2015
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Epstein-Barr-virus-related mucocutaneous ulceration that mimics oral squamous cell carcinoma: the importance of recognising this new condition. The British journal of oral & maxillofacial surgery, 2017, Volume: 55, Issue:4 Topics: Aged, 80 and over; Antirheumatic Agents; Biopsy; Carcinoma, Squamous Cell; Diagnosis, Differential;	2017
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The role of an all-oral chemotherapy containing lomustine (CCNU) in advanced,fs progressive Hodgkin lymphoma: a patient-friendly palliative option which can result in long-term disease control. Annals of oncology : official journal of the European Society for Medical Oncology, 2010, Volume: 21, Issue:2 Topics: Administration, Oral; Antineoplastic Combined Chemotherapy Protocols; Chlorambucil; Disease Progress	2010
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The evolution of clinicopathologic features in eruptive lichen planus: a case report and review of literature. Dermatology online journal, 2013, Jan-15, Volume: 19, Issue:1 Topics: Adult; Disease Progression; Female; Humans; Lichen Planus; Prednisolone	2013
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Corticosteroids for the long-term treatment in multiple sclerosis. The Cochrane database of systematic reviews, 2008, Jan-23, Issue:1 Topics: Adrenal Cortex Hormones; Disease Progression; Humans; Long-Term Care; Methylprednisolone; Multiple S	2008
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[Cardiac sarcoidosis with myopathy and advanced A-V nodal block in a woman with a previous diagnosis of sarcoidosis]. Nihon Kyobu Shikkan Gakkai zasshi, 1995, Volume: 33, Issue:10 Topics: Anti-Inflammatory Agents; Cardiomyopathies; Disease Progression; Female; Heart Block; Humans; Middle	1995
Low dose corticosteroids in early rheumatoid arthritis. Can these drugs slow disease progression? Drugs & aging, 1996, Volume: 8, Issue:3 Topics: Arthritis, Rheumatoid; Clinical Trials as Topic; Disease Progression; Glucocorticoids; Humans; Multi	1996
Recurrent aortic valve prosthesis dehiscence secondary to aortoarteritis: three case reports and literature review. International journal of cardiology, 1996, Oct-11, Volume: 56, Issue:2 Topics: Adult; Anti-Inflammatory Agents; Aortic Valve; Aortic Valve Insufficiency; Aortitis; Arteritis; Dise	1996
[Conversion of chronic necrotizing pulmonary aspergillosis to invasive pulmonary aspergillosis, and successful treatment with fluconazole]. Nihon Kyobu Shikkan Gakkai zasshi, 1997, Volume: 35, Issue:4 Topics: Aged; Aged, 80 and over; Anti-Inflammatory Agents; Antifungal Agents; Arthritis, Rheumatoid; Aspergi	1997
Long-term survival after diagnosis of hepatic metastatic VIPoma: report of two cases with disparate courses and review of therapeutic options. Digestive diseases and sciences, 1999, Volume: 44, Issue:6 Topics: Antineoplastic Agents, Hormonal; Chemoembolization, Therapeutic; Combined Modality Therapy; Disease	1999
[A case of Chinese herbs nephropathy in which the progression of renal dysfunction was slowed by steroid therapy]. Nihon Jinzo Gakkai shi, 2000, Volume: 42, Issue:2 Topics: Adult; Anti-Inflammatory Agents; Disease Progression; Drugs, Chinese Herbal; Female; Humans; Kidney;	2000
A systematic overview of chemotherapy effects in B-cell chronic lymphocytic leukaemia. Acta oncologica (Stockholm, Sweden), 2001, Volume: 40, Issue:2-3 Topics: Adolescent; Adult; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Antineoplastic Combined	2001
Combination chemotherapy and rituximab. Anti-cancer drugs, 2001, Volume: 12 Suppl 2 Topics: Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Agents; Antineoplasti	2001
[Use of glucocorticoids in rheumatoid arthritis. Inhibition of disease progression versus risk of steroid osteoporosis]. Zeitschrift fur Rheumatologie, 2001, Volume: 60, Issue:6 Topics: Arthritis, Rheumatoid; Clinical Trials as Topic; Disease Progression; Dose-Response Relationship, Dr	2001
Therapy-related myelodysplastic syndrome in a case of cutaneous adult T-cell lymphoma. International journal of hematology, 2002, Volume: 75, Issue:1 Topics: Acute Disease; Aged; Anemia, Refractory, with Excess of Blasts; Antineoplastic Combined Chemotherapy	2002
Unrelated cord blood transplantation for an infant with chemotherapy-resistant progressive Langerhans cell histiocytosis. Journal of pediatric hematology/oncology, 2001, Volume: 23, Issue:9 Topics: Combined Modality Therapy; Cyclophosphamide; Cytarabine; Disease Progression; Doxorubicin; Drug Resi	2001
Is escalated BEACOPP a standard therapy for advanced Hodgkin's disease? The hematology journal : the official journal of the European Haematology Association, 2000, Volume: 1, Issue:4 Topics: Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Chlorambucil; Clinical Trials, Phase III	2000
Testicular lymphoma: a literature review and report of a case with a zoster-like cutaneous recurrence. Clinical lymphoma, 2002, Volume: 2, Issue:4 Topics: Antineoplastic Combined Chemotherapy Protocols; Biopsy, Needle; Combined Modality Therapy; Cyclophos	2002
Anaplastic large cell lymphoma in childhood: analysis of 72 patients treated on The United Kingdom Children's Cancer Study Group chemotherapy regimens. British journal of haematology, 2002, Volume: 117, Issue:4 Topics: Adolescent; Antineoplastic Combined Chemotherapy Protocols; Child; Child, Preschool; Cyclophosphamid	2002