The objectives for the single-dose study are to evaluate the safety, tolerance, clinical response, immunogenicity and pharmacokinetics of a single dose of placebo, 5, 10 or 20 mg/kg of cA2 in patients with active rheumatoid arthritis (RA) who are receiving methotrexate. This is a Phase II multi-centered, placebo-controlled, double-blind, ,4-arm parallel trial to evaluate a new treatment for RA. RA is usually treated with non-steroidal anti-inflammatory drugs and slow-acting anti-rheumatic drugs. These drugs are felt to decrease arthritis by reducing inflammation and suppressing the immune system. A chimeric anti-TNF antibody has been developed to neutralize the inflammatory effects of TNF that is found in rheumatoid joints.

Project Start
Project End
Budget Start
Budget End
Support Year
35
Fiscal Year
1996
Total Cost
Indirect Cost
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