A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study is to assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment. In addition, the safety of subcutaneous (SC) golimumab injections following transition from IV golimumab infusions will also be evaluated.

Key facts

Study ID

NCT00361335

Run by

Centocor, Inc.

People needed

643

Starts

2006-09-01

Expected to finish

2009-09-01

Last updated by the study team

2014-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have a diagnosis of active rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ARA (American Rheumatism Association) with at least 4 swollen and 4 tender joints for at least 3 months prior to screening - Have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg per week for at least 3 months prior to screening - Have been on a stable MTX dose of greater than or equal to 15 mg per week and less than or eual to 25 mg per week for at least 4 weeks prior to screening - If using non steroidal anti-inflammatory agents (such as naproxen) or other pain relievers for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent

You may not qualify if…

• Participants having known hypersensitivity (severe allergy) to human immunoglobulin proteins or other components of golimumab - Having known clinically serious adverse reaction to a biologic anti-TNF agent - Have had history of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to screening

Where it is running

• Study site — Aventura, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Omaha, Nebraska, United States
• Study site — Voorhees Township, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — Roslyn, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Norristown, Pennsylvania, United States
• Study site — West Reading, Pennsylvania, United States
• Study site — Willow Grove, Pennsylvania, United States
• Study site — Amarillo, Texas, United States
• Study site — Fort Worth, Texas, United States
• Study site — Lubbock, Texas, United States
• Study site — Spokane, Washington, United States
• Study site — Buenos Aires, Argentina
• Study site — Córdoba, Argentina
• Study site — Rosario, Argentina
• Study site — San Juan, Argentina
• Study site — San Miguel de Tucumán, Argentina
• Study site — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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