Arthritis, Rheumatoid Clinical Trial
Official title:
A Randomized, Double-blind Trial of the Safety of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis on Standard Disease-modifying Anti-Rheumatic Drug Background Therapy.
The purpose of this study is to evaluate the safety and effectiveness of Infliximab (Remicade) in patients with Rheumatoid Arthritis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce the pain of rheumatoid arthritis.
This is a randomized (patients are assigned different treatments based on chance),
double-blind (neither the patient nor the physician knows whether drug or placebo is being
taken, or at what dosage) trial of the safety of anti-tumor necrosis factor (TNF) chimeric
monoclonal antibody (Infliximab) in combination with methotrexate (MTX) compared to
methotrexate alone in patients with rheumatoid arthritis on standard disease-modifying
anti-rheumatic drug background therapy. The purpose of the study is to better understand the
safety and occurrence of infections in patients treated with either placebo or 3 mg/kg and
10 mg/kg of infliximab in combination with methotrexate (MTX).
Patients will receive infusions of either placebo or 3 to 10mg/kg Infliximab at weeks 0, 2,
6, and 14 then every 8 weeks through week 46.
Safety evaluations will be performed at specified intervals throughout the study and will
consist of laboratory tests, vital signs (such as blood pressure), physical examinations and
the occurrence and severity of adverse events as well as other study specific procedures.
Patients will receive 3 to10mg/kg Infliximab (Remicade) or placebo via infusion at weeks 0,
2, 6, and 14 then every 8 weeks through week 46.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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