A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate
- Registration Number
- NCT00345748
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 194
Inclusion Criteria
- patients with active Rheumatoid Arthritis while on methotrexate having 12 tender and 10 swollen joints at randomization
Exclusion Criteria
- no current infection or other evolutive or uncontrolled disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abatacept 2 mg/kg Abatacept - Abatacept 10 mg/kg Abatacept - Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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. at 6 months
- Secondary Outcome Measures
Name Time Method 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 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) at 6 months
Trial Locations
- Locations (1)
Local Institution
🇯🇵Tochigi, Japan