Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Ankylosing Spondylitis

In brief

The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1 disease-modifying antirheumatic drug (DMARD).

Key facts

Study ID

NCT00085644

Run by

Abbott

People needed

315

Starts

2004-01-01

Expected to finish

2009-07-01

Last updated by the study team

2011-04-21

Who can join

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

You may qualify if…

• Subjects must be >= 18 years of age
• meet Modified NY Criteria definition of ankylosing spondylitis (AS)
• have diagnosis of active AS based on protocol specified criteria
• inadequate response or intolerance to >= 1 nonsteroidal antiinflammatory drug (NSAID)
• be able and willing to learn to self-administer subcutaneous (SC) injections

You may not qualify if…

• Active tuberculosis, listeriosis,or hepatitis B, or any history of hepatitis C
• History of demyelinating disease, multiple sclerosis, cancer, or lymphoproliferative disease
• Previous anti-tumor necrosis factor therapy
• Treatment with disease-modifying antirheumatic drugs (DMARDs - other than methotrexate, hydroxychloroquine, and sulfasalazine)
• Treatment with intra-articular corticosteroid joint injections within 4 weeks of study dosing
• Biologic or investigational therapy within 6 weeks of study dosing
• Treatment with intravenous (IV) antibiotics within 30 days of study dosing
• Treatment with oral antibiotics within 14 days of study dosing

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — San Francisco, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Boise, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Portland, Maine, United States
• Study site — Baltimore, Maryland, United States
• Study site — Wheaton, Maryland, United States
• Study site — Omaha, Nebraska, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Albany, New York, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — West Reading, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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