A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s)

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in subjects who have active rheumatoid arthritis and have been treated previously with at least 1 dose of a biologic anti-TNFa agent (etanercept, adalimumab or infliximab).

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

Details

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

Criteria

Inclusion Criteria:

• Patients have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ACR) for at least 3 months prior to screening

• Have active RA as defined by persistent disease activity with at least 4 swollen and 4 tender joints, at the time of screening and baseline

• Must have been previously treated with at least one dose of etanercept, adalimumab, or infliximab

• If currently using methotrexate, sulfasalazine and/or hydroxychloroquine must have tolerated these agents for at least 12 weeks and be on a stable dose for at least 4 weeks prior to the first administration of study agent

• If using NSAIDs or other analgesics must be on a stable dose for at least 2 weeks prior to the first administration of study agent

• If using oral corticosteroids must be on a stable dose equivalent to <= 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent

• Are considered eligible according to specified tuberculosis (TB) screening criteria.

Exclusion Criteria:

• Patients cannot have other inflammatory diseases other than RA that might interfere with the evaluation of the benefit of golimumab therapy

• No history of treatment with natalizumab, rituximab or cytotoxic agents

• No history of demyelinating diseases such as multiple sclerosis or optic neuritis or of concurrent congestive heart failure (CHF), lymphoproliferative disease, known malignancy or history of malignancy within the previous 5 years (with the exception of a nonmelanoma skin cancer that has been treated with no evidence of recurrence)

• No history of, or ongoing, chronic or recurrent infectious disease

• No serious infection within 2 months prior to first administration of study agent.