Rheumatoid Arthritis Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | April 2005 |
Est. primary completion date | April 2005 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Local Institution | Leeds | Essex |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United Kingdom,
Buch MH, Boyle DL, Rosengren S, Saleem B, Reece RJ, Rhodes LA, Radjenovic A, English A, Tang H, Vratsanos G, O'Connor P, Firestein GS, Emery P. Mode of action of abatacept in rheumatoid arthritis patients having failed tumour necrosis factor blockade: a histological, gene expression and dynamic magnetic resonance imaging pilot study. Ann Rheum Dis. 2009 Jul;68(7):1220-7. doi: 10.1136/ard.2008.091876. Erratum in: Ann Rheum Dis. 2011 Aug;70(8):1519. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of each subject's synovial tissue markers | at baseline and after 4 months of treatment with abatacept | ||
Secondary | assess baseline & post treatment synovitis by dynamic gadolinium enhanced MRI; determine concentrations of abatacept in synovial fluid & serum | after 4 months of treatment | ||
Secondary | assess safety & tolerability of abatacept | administered for 4 months |
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