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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
428
Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.
Infliximab (anti-TNF chimeric monoclonal antibody \[cA2\]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.
Infliximab (anti-TNF chimeric monoclonal antibody \[cA2\]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.
Change from baseline in ACR20 response at week 30; Change in modified van der Heijde-Sharp Score
Time frame: Baseline and Week 30
safety
Time frame: up to Week 54
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