Status:
COMPLETED
Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis
Lead Sponsor:
Abbott
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 resp...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT00085644
Start Date
January 1 2004
End Date
July 1 2009
Last Update
April 21 2011
Active Locations (22)
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1
Birmingham, Alabama, United States, 35924
2
Mobile, Alabama, United States, 36608
3
San Francisco, California, United States, 94143
4
Colorado Springs, Colorado, United States, 80910