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

Completed · Phase 1

Conditions studied: Rheumatoid Arthritis

In brief

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

Key facts

Study ID

NCT01362153

Run by

Centocor, Inc.

People needed

49

Starts

2007-12-26

Expected to finish

2009-02-27

Last updated by the study team

2017-10-02

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Glendale, Arizona, United States
• Study site — Aventura, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Lexington, Kentucky, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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