A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Rheumatoid Arthritis.
|ClinicalTrials.gov Identifier: NCT00036387|
Recruitment Status : Completed
First Posted : May 10, 2002
Last Update Posted : May 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Arthritis, Rheumatoid||Drug: Infliximab||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||347 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Actual Study Completion Date :||November 2003|
- The proportion of patients with serious infections occurring over the first 22 weeks of the trial
- The proportion of patients with infections & atypical/opportunistic infections. The duration of most frequently reported infections. Proportion of patients achieving ACR 20 criteria at 22 weeks. Effect of 1.5 mg/kg dose increment in reducing disease
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036387
|Study Director:||Centocor, Inc. Clinical Trial||Centocor, Inc.|