At a glance
ClinicalIndex Comparison Record- ✓Rheumatoid arthritis diagnosed ≤2 years ago
- ✓Methotrexate naive or minimal prior exposure (≤10 mg/week for ≤3 weeks, no dose within 3 months)
- ✓C-Reactive Protein (CRP) ≥4.5 mg/L
- ✓Rheumatoid factor or anti-CCP antibody positive
- ✕Unwilling to use birth control
- ✕Diagnosis of other rheumatic disease
- ✕History of cancer within 5 years
- ✕Active tuberculosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate
In Brief
A Phase 3 clinical trial evaluating Abatacept, placebo, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 1,052 participants across 89 sites in 18 countries.
Detailed Summary
This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.
Study Details
Timeline
Interventions
abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months
placebo IV, monthly, methotrexate weekly for 12 months followed by abatacept 10 mg/kg IV monthly, methotrexate weekly for 12 months
Oral, titrated to at least 15 mg per week not to exceed 20 mg per week administered every 28 days from Month 12 to Month 24