NCT00036374

A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid Arthritis

A Randomized, Double-Blind Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate for the Treatment of Patients With Polyarticular Juvenile Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Centocor, Inc. · Industry
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Juvenile Rheumatoid Arthritis (JRA).

Detailed description

The purpose of this study is to determine if infliximab in combination with methotrexate is safe and effective in the treatment of patients with juvenile rheumatoid arthritis. The second purpose of this study is to see how children's bodies react to the combination of study drug and methotrexate. Patients will receive either infliximab at 3 mg/kg for 44 weeks or, placebo for 14 weeks followed by infliximab at 6 mg/kg for 30 weeks. Patients who complete the original study are eligible for additional treatment with 3 to 6 mg/kg of infliximab every 8 weeks for up to three years. 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 either infliximab at 3 mg/kg for 44 weeks or, placebo for 14 weeks followed by infliximab at 6 mg/kg for 30 weeks. Patients who complete the original study are eligible for additional treatment with 3 to 6 mg/kg of infliximab every 8 weeks for up to three years

Conditions

• Rheumatoid Arthritis, Juvenile

Interventions

Type	Name	Description
DRUG	Infliximab

Timeline

• Start date: 2001-10-01
• Completion: 2006-12-01
• First posted: 2002-05-10
• Last updated: 2011-05-17