A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of infliximab (Remicade) in patients with early rheumatoid arthritis.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of rheumatoid arthritis for at least 3 months and less than or equal to 3 years before screening

• Active disease at the time of screening and pre-infusion of the drug

Exclusion Criteria:

• Pregnant, nursing, or planning a pregnancy within 18 months of enrollment

• Incapacitated, largely or wholly bedridden, or confined to a wheelchair, or had little or no ability for self care

• Rheumatic disease other than rheumatoid arthritis or any current systemic inflammatory condition