A Phase 2 interventional study of Abatacept and Placebo in Rheumatoid Arthritis, sponsored by Bristol-Myers Squibb. Completed at 38 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2011-04-25.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
The purpose of this study is to demonstrate that Abatacept combined with Methotrexate will demonstrate a dose response efficacy in Japanese subjects with active Rheumatoid Arthritis similar to the dose response efficacy previously observed in the International clinical trials.
3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.
This study's enrollment of 194 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
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Exclusion Criteria:
Drug: Abatacept
Drug: Abatacept
Drug: Placebo
Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks
Also known as: Orencia
Injectio, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks
Efficacy will be evaluated using the American College of Rheumatology response rate or ACR 20. This means the respective proportion of patients reaching an improvement of at least 20% of the ACR composite index from baseline.
Time frame: at 6 months
ACR 50 and ACR 70 will be assessed as respectively 50 and 70% improvement of the ACR composite index, quality of life by using SF36 questionnaire, Population Pharmacokinetics, Biomarkers, Immunogenicity
Time frame: at 6 months
Safety (Severity of adverse events, causal relationship to the study drug, outcome, action taken with respect to the investigational product, treatment required)
Time frame: at 6 months
This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb