An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Study to assess changes in synovial tissue before and after treatment with Abatacept in subjects with RA who remained on their background disease modifying anti-arthritis medications but who have failed previous therapy with anti-TNF (tumor necrosing factor)blocking agents.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept

Criteria

Inclusion Criteria:

• RA for at least 1 year

• Clear clinical signs of active RA in 1 knee joint

• Meet ARA (1987) criteria for diagnosis of RA and ACR (1991) criteria for RA functional classes I, II, or III

• Inadequate clinical response to a minimum of 3 months of therapy with anti-TNF-blocking agents

• Taking background DMARDs for a minimum of 3 months and at stable doses for at least 28 days

Exclusion Criteria:

• Serious bacterial infection in last 3 months

• History of TB

• History of cancer within 5 years

• Evidence of latent or active bacterial or viral infection

• Intra-articular corticosteroids within 3 months

• Exposure to live vaccines

• Exposure to CTLA4Ig or BMS-188667

• Treatment with immunoadsorption column(s), mycophenolate mofetil, leflunomide, anakinra, cyclosporine, etanercept, adalimumab, infliximab, azathioprine, oral or parenteral gold, D-penacillamine, calcineurin inhibitors, cyclophosphamide or other alkylating agents