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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centocor, Inc.
• Treatments: Infliximab; Methotrexate

Criteria

Inclusion Criteria:

• Patients must have a diagnosis of juvenile rheumatoid arthritis (JRA) with polyarticular JRA for at least 6 months, systemic JRA with a polyarticular course and no systemic symptoms (including fever, rash,hepatosplenomegaly, and serositis) for 1 year prior to study entry, or pauciarticular JRA with a polyarticular course for at least 6 months prior to study entry. The patient should have had at least 6 months of persistent synovitis before screening.

• The patient must have at least 5 joints with active arthritis (ie, presence of swelling, or if no swelling is present, limitation of motion accompanied by pain, tenderness, or both) at the time of enrollment, with at least 3 of these active joints having limitation of motion accompanied by pain, tenderness, or both

• The patient must be at least 4 years of age, but less than 18 years (ie, after the 4th but before the 18th birthday), with onset of disease before age 16.

Exclusion Criteria:

• Patient must not be pregnant, nursing, or planning a pregnancy within 6 months after the last study infusion

• Patient must not be incapacitated, largely or wholly bedridden, or confined to a wheelchair, or have little or no ability for age-appropriate self care

• Patient must not have a rheumatic disease other than JRA or any current systemic inflammatory condition (for example, Lyme disease,fibromyalgia, enthesitis-related arthritis, psoriatic arthritis, systemic lupus erythematosus, infectious or reactive arthritis, Reiter's syndrome, or parvovirus infection)