At a glance
ClinicalIndex Comparison Record- ✓Active rheumatoid arthritis currently failing anti-TNF therapy
- ✓OR have failed anti-TNF therapy in the past
- ✓On background disease modifying anti-rheumatic drugs (DMARDs)
- ✕Pregnant or breast feeding
- ✕Current symptoms of serious medical disease
- ✕History of cancer in last 5 years (except non-melanoma skin cancer)
- ✕Chronic serious infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 in Subjects With Active Rheumatoid Arthritis on Background Disease Modifying Anti-Rheumatic Drugs (DMARDS) Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy
In Brief
A Phase 3 clinical trial evaluating Abatacept and Placebo for Rheumatoid Arthritis. Completed, enrolled 738 participants across 42 sites.
Detailed Summary
The purpose of this clinical research study is to determine whether abatacept treatment on a background of Disease Modifying Antirheumatic Drugs (DMARDs) will relieve the symptoms of rheumatoid arthritis (RA) in participants who are currently receiving anti-tumor necrosis factor (TNF) therapy for at least 3 months and are not responding or have taken anti-TNF therapy in the last 3 months and did not respond. The safety of treatment with abatacept will also be evaluated. This study also has a 4.5-year long-term extension beginning 6 months after the start of the study.
Study Details
Timeline
Interventions
Vials, intravenous (IV), \~10mg/kg abatacept, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.
Vials, IV, 0mg, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.
Vials, IV, \~10mg/kg abatacept, every 4 weeks, 5.5 years