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

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patients must have a diagnosis of Rheumatoid Arthritis at least 3 months before screening

• If the patient is of childbearing potential, must have been using adequate birth control measures

• Patients must be receiving MTX for =3 months before randomization and at a stable dose(=25 mg/week) for =4 weeks before randomization

Exclusion Criteria:

• Patients must not be pregnant, nursing, or planning a pregnancy within 18 months of enrollment

• Patients must not have rheumatic disease other than Rheumatoid Arthritis or had any systemic inflammatory condition

• Patients must not be confined to a wheelchair

• Patients must not be treated with any approved or investigational biologic agent except for approved vaccines for immunizations