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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Comparison of each subject's synovial tissue markers [ Time Frame: at baseline and after 4 months of treatment with abatacept ]
- assess baseline & post treatment synovitis by dynamic gadolinium enhanced MRI; determine concentrations of abatacept in synovial fluid & serum [ Time Frame: after 4 months of treatment ]
- assess safety & tolerability of abatacept [ Time Frame: administered for 4 months ]
|Study Start Date:||December 2003|
|Study Completion Date:||April 2005|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
Parenteral, IV, 500 mg if < 60 kg; 750 mg if > 60 & < 100 kg; 1000 mg if > 100 kg, Monthly, 4 months.
Other Name: Orencia