A Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Golimumab in Patients With Rheumatoid Arthritis (RA)

• Status: Completed
• Trial end date: 2009-02-27
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, pharmacokinetic and pharmacodynamic study of intravenous and subcutaneous administered golimumab in patients with rheumatoid arthritis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centocor, Inc.
• Treatments: Antibodies, Monoclonal; Golimumab

Criteria

Inclusion Criteria:

• Have a diagnosis of RA for at least 3 months prior to screening

• Have no history of latent or active tuberculosis (TB) and test negative for TB

Exclusion Criteria:

• Have inflammatory diseases other than RA

• Have been treated with disease-modifying anti-rheumatic drugs (DMARDs)/systemic immunosuppressives other than methotrexate (MTX), sulfasalazine, or hydroxychloroquine during the 4 weeks prior to the first administration of study agent

• Have received intramuscular (IM), IV, or intra-articular corticosteroids within 4 weeks of study agent administration

• Have a known hypersensitivity to human Ig proteins

• Have received infliximab, golimumab, adalimumab or abatacept within 3 months, or etanercept or anakinra within 1 month prior to the first administration of study agent

• Have received alefacept, efalizumab, natalizumab, rituximab, or any B-cell-depleting agent

• Have been treated with any other biologics or investigational drugs, within 5 half-lives of that drug prior to the first administration of study agent

• Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis, prior to screening

• Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening

• Have had a serious infection (eg, hepatitis, pneumonia, pyelonephritis, or sepsis)