Status:
COMPLETED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 fail...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00162201
Start Date
October 1 2003
End Date
April 1 2005
Last Update
January 12 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution
Leeds, Essex, United Kingdom