Rheumatoid Arthritis Clinical Trial
Official title:
A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment
The purpose of this study is to evaluate the safety and effectiveness of infliximab (an anti-TNF chimeric monoclonal antibody [cA2]) in patients with active Rheumatoid Arthritis, despite methotrexate treatment.
This is a placebo-controlled, double-blinded, randomized clinical study to evaluate the
safety and effectiveness of infliximab in patients with active Rheumatoid Arthritis, despite
methotrexate treatment. Infliximab is an anti-TNF chimeric monoclonal antibody (cA2). The
primary measures of effectiveness include the change from baseline in American College of
Rheumatology (ACR20) response at week 30, and the change in the modified van der Heijde
Sharp Score. The ACR20 Responder Index a composite of clinical, laboratory, and functional
measures and the van der Heijde-Sharp (vdH-S) scoring method is a method of rating
structural damage in patients..
Patients will be treated with either infliximab or matching placebo.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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