A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Spondylitis, Ankylosing

In brief

The purpose of this study is to evaluate the safety and efficacy of subcutaneous injections (under the skin) of golimumab for the treatment of active ankylosing spondylitis \[AS(arthritis of the spine)\]. Efficacy will be measured by reduction in the signs and symptoms of active AS, including effects on back pain and stiffness, physical function, range of motion in the spine, quality of life, and rate of spine damage or fusion on x-ray.

Key facts

Study ID

NCT00265083

Run by

Centocor, Inc.

People needed

356

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…

• Diagnosis of "Definite AS" (arthritis of the spine) as defined by the modified New York criteria, for at least 3 months prior to first dose of study drug
• Symptoms of active disease at screening and at baseline visits, as evidenced by both a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of >= 4, and a Total Back Pain score of >= 4 (each on a scale of 0 to 10cm)
• Inadequate response to 3 months of continuous therapy with maximal recommended doses of NSAIDs, or else unable to receive a full 3 months of maximal NSAID therapy because of intolerance, toxicity, or contraindications to non-steroidal anti-inflammatory drugs (NSAIDs)
• Stable doses of methotrexate, sulfasalazine, hydroxychloroquine, low-dose corticosteroids, and NSAIDs are permitted.

You may not qualify if…

• Patients cannot have complete ankylosis of the spine
• No prior treatment with biologic anti-TNF agents (infliximab, etanercept, adalimumab)

Where it is running

• Study site — Paradise Valley, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Ormond Beach, Florida, United States
• Study site — Portland, Oregon, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — Edmonds, Washington, United States
• Study site — Seattle, Washington, United States
• Study site — Brookfield, Wisconsin, United States
• Study site — La Crosse, Wisconsin, United States
• Study site — Brussels, Belgium
• Study site — Diepenbeek, Belgium
• Study site — Leuven, Belgium
• Study site — Edmonton, Alberta, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Victoria, British Columbia, Canada
• Study site — Winnipeg, Manitoba, Canada
• Study site — St. John's, Newfoundland and Labrador, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Sainte-Foy, Quebec, Canada
• Study site — Helsinki, Finland
• Study site — Rauma, Finland
• Study site — Nantes Cedex 01 N/A, France
• Study site — Bad Nauheim, Germany

Full record on ClinicalTrials.gov

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