Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with rheumatoid arthritis.

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

Details

• Lead Sponsor: Centocor, Inc.
• Collaborator: Schering-Plough
• Treatments: Antibodies, Monoclonal; Golimumab; Methotrexate

Criteria

Inclusion Criteria:

• Diagnosis of rheumatoid arthritis for at least 6 months

• Be on a stable dose of methotrexate for 4 weeks

• Have at least 4 swollen and 4 tender joints

Exclusion Criteria:

• Prior exposure to biologic anti-TNFalpha agents

• Inflammatory diseases other than rheumatoid arthritis

• Treatment with Disease Modifying Anti-rheumatic drug (DMARDs)/systemic immunosuppressives other than methotrexate during the 4 weeks prior to the first administration of study agent

• History of, or ongoing, chronic or recurrent infectious disease