A Study of the Safety and Efficacy of Golimumab in Patients With Active Psoriatic Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Arthritis, Psoriatic

In brief

The purpose of this study is to evaluate the safety and efficacy (improvement of signs and symptoms) of subcutaneous (under the skin) injections of golimumab for the treatment of active psoriatic arthritis (PsA). Efficacy will be measured by reduction in the signs and symptoms of active PsA, including effects on joint pain and swelling, changes on x-ray related to joint damage, psoriasis skin lesions, physical function, and quality of life.

Key facts

Study ID

NCT00265096

Run by

Centocor, Inc.

People needed

407

Starts

2005-12-01

Expected to finish

2012-01-01

Last updated by the study team

2013-07-19

Who can join

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

You may qualify if…

• Psoriatic arthritis (PsA) diagnosed > 6months prior
• Active PsA at the time of screening and at baseline visits, with >= 3 swollen joints and >= 3 tender joints
• Have at least 1 of the PsA subsets (DIP joint arthritis, polyarticular arthritis without rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis)
• Active plaque psoriasis with a lesion >= 2cm in diameter
• Active arthritis despite current disease modifying anti-rheumatic drug (DMARD) or nonsteroidal anti-inflammatory drug (NSAID) therapy
• Stable doses of methotrexate, low-dose corticosteroids, and NSAIDs are permitted.

You may not qualify if…

• No prior treatment with biologic anti-TNF agents (infliximab, etanercept, adalimumab)
• No treatment with alefacept or efalizumab within 3 months prior to the first study drug injection
• No DMARDs other than methotrexate, or immunosuppressive drugs within 4 weeks prior to the first study drug injection.

Where it is running

• Study site — La Jolla, California, United States
• Study site — Upland, California, United States
• Study site — Aventura, Florida, United States
• Study site — Coeur d'Alene, Idaho, United States
• Study site — Kansas City, Kansas, United States
• Study site — Wheaton, Maryland, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Omaha, Nebraska, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Mayfield, Ohio, United States
• Study site — Lake Oswego, Oregon, United States
• Study site — Portland, Oregon, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — West Reading, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — Edmonds, Washington, United States
• Study site — Seattle, Washington, United States
• Study site — Brussels, Belgium
• Study site — Ghent, Belgium
• Study site — Leuven, Belgium
• Study site — Liège, Belgium
• Study site — Merksem, Belgium
• Study site — Victoria, British Columbia, Canada
• Study site — Winnipeg, Manitoba, Canada
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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