A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Subjects with active rheumatoid arthritis as diagnosed by meeting ACR classification criteria for at least 6 months.

• Must be taking MTX consecutively for >/= 12 weeks and at a stable dose of methotrexate at 15-25 mg weekly for at least 4 weeks prior to screening

Exclusion Criteria:

• Receipt of commercial or experimental biologic therapies for the treatment of inflammatory disease

• Presence of serious infection

• Class IV rheumatoid arthritis

• Prior or current history of tuberculosis infection or exposure

• Any other DMARDs other than methotrexate within 6 weeks of screening

• Pregnant or nursing

• Receipt of live vaccines within 3 months

• Felty's syndrome