NCT00269867

Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 428 (actual)
• Sponsor: Centocor, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.
DRUG	Infliximab 3 mg/kg	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.
DRUG	Infliximab 10 mg/kg	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.

Timeline

• Start date: 1997-03-01
• Primary completion: 2000-03-01
• Completion: 2000-03-01
• First posted: 2005-12-26
• Last updated: 2014-11-04