Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept; Antirheumatic Agents

Criteria

Inclusion Criteria:

• Completed double-blind portion of the IM101064 study.

• Rheumatoid arthritis (RA) for greater than 1 year from the time of initial diagnosis

• American College of Rheumatology (ACR) functional class I, II, III

• Subjects currently or previously received an anti-TNF therapy at an approved labeled dose for at least 3 months

Exclusion Criteria:

• Subjects with active vasculitis of a major organ system (except subcutaneous rheumatoid nodules)

• History of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection)