At a glance
ClinicalIndex Comparison Record- ✓Rheumatoid Arthritis diagnosed > 1 year prior to enrollment
- ✓Methotrexate use for ≥ 3 months at a dose of ≥ 15 mg weekly
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Abatacept, Methotrexate, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 1,250 participants across 48 sites.
Detailed Summary
Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied. Long Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.
Study Details
Timeline
Interventions
Intravenous (IV) Solution, - Weight Titered (500 mg \< 60 kg); (750 mg 60-100 kg), )1 gram \> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 1 year
Tablets, Oral, \>= 15 mg, weekly, 1 year
IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 1 year