Rheumatoid Arthritis Clinical Trial
Official title:
A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Verified date | May 2017 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the clinical efficacy including joint damage progression and safety of Abatacept plus Methotrexate (MTX) to placebo plus MTX.
Status | Completed |
Enrollment | 405 |
Est. completion date | December 26, 2016 |
Est. primary completion date | December 26, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - MTX inadequate responder - Biologic Naïve - Functional class I, II or III - =6 swollen and =6 tender joints - C-reactive protein (CRP) =2.0mg/dl or erythrocyte sedimentation rate (ESR) =28 mm/hr - Anti-cyclic citrullinated peptide (CCP) antibody positive - Have erosion Exclusion Criteria: - Any other rheumatic disease - Active angiitis on main organs excluding rheumatoid nodule |
Country | Name | City | State |
---|---|---|---|
Japan | Local Institution | Asahi | |
Japan | Local Institution | Fuchu | |
Japan | Local Institution | Fujieda-city | Shizuoka |
Japan | Local institution | Fukuoka | |
Japan | Local Institution | Fukuoka | |
Japan | Local institution | Funabashi | |
Japan | Local Institution | Hakodate | |
Japan | Local Institution | Hiroshima | |
Japan | Local Institution | Hitachi | |
Japan | Local institution | Hokkaido | |
Japan | Local Institution | Iizuka | |
Japan | Local Institution | Izumisano-city | Osaka |
Japan | Local Institution | Kagoshima | |
Japan | Local Institution | Kagoshima | |
Japan | Local Institution | Kakogawa-city | Hyogo |
Japan | Local Institution | Kamogawa-city | Chiba |
Japan | Local Institution | Kanazawa | |
Japan | Local Institution | Kasama | |
Japan | Local Institution | Kasamatsu-town | Gifu |
Japan | Local Institution | Kato | |
Japan | Local Institution | Kitakyushu | |
Japan | Local Institution | Kitakyushu | |
Japan | Local Institution | Kitakyushu | |
Japan | Local Institution | Kitamoto | |
Japan | Local institution | Kobe | |
Japan | Local institution | Kobe | |
Japan | Local Institution | Kochi | |
Japan | Local Institution | Koshi | |
Japan | Local institution | Kumamoto | |
Japan | Local Institution | Kurashiki-city | Okayama |
Japan | Local Institution | Matsumoto | |
Japan | Local Institution | Nagano | |
Japan | Local Institution | Nagaoka | |
Japan | Local Institution | Nagasaki | |
Japan | Local Institution | Nagoya | |
Japan | Local Institution | Nagoya | |
Japan | Local Institution | Narashino | |
Japan | Local Institution | Narita | |
Japan | Local Institution | Okayama | |
Japan | Local institution | Osaka | |
Japan | Local Institution | Osaki | |
Japan | Local institution | Oume | |
Japan | Local institution | Sapporo | |
Japan | Local Institution | Sapporo | |
Japan | Local Institution | Sapporo | |
Japan | Local Institution | Sapporo | |
Japan | Local Institution | Sasebo | |
Japan | Local Institution | Sayama | |
Japan | Local Institution | Sendai | |
Japan | Local Institution | Sendai | |
Japan | Local Institution | Sendai | |
Japan | Local Institution | Shimonoseki-city | Yamaguchi |
Japan | Local Institution | Shizuoka | |
Japan | Local Institution | Takaoka | |
Japan | Local Institution | Takasaki | |
Japan | Local institution | Tokyo | |
Japan | Local Institution | Tokyo | |
Japan | Local Institution | Tokyo | |
Japan | Local Institution | Tokyo | |
Japan | Local Institution | Tokyo | |
Japan | Local Institution | Tokyo | |
Japan | Local Institution | Tokyo | |
Japan | Local Institution | Tokyo | |
Japan | Local Institution | Tokyo | |
Japan | Local Institution | Tokyo | |
Japan | Local Institution | Tomakomai | |
Japan | Local Institution | Toyama | |
Japan | Local Institution | Toyama | |
Japan | Local Institution | Toyama-city | Toyama |
Japan | Local Institution | Utsunomiya | |
Japan | Local institution | Yokohama | |
Japan | Local institution | Yokohama | |
Japan | Local Institution | Yokohama-city | Kanagawa |
Japan | Local Institution | Yotsukaido |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | American College of Rheumatology (ACR) 20% response rate | 4 months (week 16) | ||
Primary | Change from baseline in Total Sharp Score (TSS) using the Modified van der Heijde Sharp (vdH-S) method to 6 months (Week 24) | Baseline (Day 1), 6 months (Week 24) | ||
Secondary | Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months (Week16) | Baseline (Day 1), 4 months (Week 16) | ||
Secondary | Non-progressors rate for the structural damage | The non-progressors rate is defined as the proportion of subjects meeting the change from baseline in the TSS at 6 months less than or equal to the smallest detectable difference (SDD) and/or the smallest detectable change (SDC) | Baseline (Day 1), 6 months (Week 24) | |
Secondary | ACR 50 response rates | 4 months (Week16) | ||
Secondary | ACR 70 response rates | 4 months (Week16) | ||
Secondary | Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities | 12 months (Week52) |
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