A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate Versus Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Phase 1
- Conditions
- -M069M069
- Registration Number
- PER-079-02
- Lead Sponsor
- BRISTOL MYERS SQUIBB COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Rheumatoid Arthritis (RA) for greater than 1 year from the time of initial diagnosis of RA.
Participants must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg.
Exclusion Criteria
Women who are pregnant or nursing.
Women who have obtained a positive result in the pregnancy test performed during the enrollment or before the administration of the study drug.
Women of childbearing age who are unwilling or unable to use a
method of birth control that is acceptable throughout the study and during a
period of up to 10 weeks after the last infusion of the study medication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method