Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2000-03-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Centocor, Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Immunoglobulins; Infliximab; Methotrexate

Criteria

Inclusion Criteria:

• Patients with active Rheumatoid Arthritis despite treatment with methotrexate

• Diagnosed with Rheumatoid Arthritis at least 6 months prior to screening

• Having active disease at the time of screening and pre-infusion as defined by having at least 6 or more swollen joints and 6 or more tender joints

• Using methotrexate for at least 3 months prior to study enrollment

Exclusion Criteria:

• Patients having any systemic inflammatory condition

• Having Lyme disease or a rheumatic disease other than Rheumatoid Arthritis

• Who have used Disease-Modifying Antirheumatic Drugs (DMARDs) other than methotrexate within 4 weeks prior to screening

• Who have used corticosteroids within 4 weeks prior to screening

• Having received previous administration of infliximab