Status:
COMPLETED
Study of Adalimumab in Patients With Axial Spondyloarthritis
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Axial Spondyloarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate how well adalimumab works in the short and long term in patients with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or psoriatic arthri...
Detailed Description
This is a Phase 3, placebo-controlled, double-blind randomized study with an open-label phase designed to evaluate the efficacy and safety of adalimumab 40 mg administered every other week in adult pa...
Eligibility Criteria
Inclusion
- Adult patients with inadequate response to \>/= 1 non-steroidal anti-inflammatory drugs (NSAIDs)
- Chronic back pain with onset \< 45 years of age
- Magnetic resonance imaging (MRI) indicating active sacroiliitis or positive human leukocyte antigen-B27 (HLA-B27) blood test in addition to meeting spondyloarthritis clinical criteria
- Negative purified protein derivative (PPD) test and chest x-ray performed at Baseline visit must be negative
- Ability to administer subcutaneous injections
- General good health otherwise
Exclusion
- Prior anti-tumor necrosis factor (TNF) therapy
- Psoriasis or psoriatic arthritis
- Fulfillment of modified New York criteria for ankylosing spondylitis
- Recent infection requiring treatment
- Significant medical events or conditions that may put patients at risk for participation
- Females who are pregnant or breast-feeding or considering becoming pregnant during the study
- History of cancer, except successfully treated skin cancer
- Recent history of drug or alcohol abuse
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT00939003
Start Date
July 1 2009
End Date
August 1 2013
Last Update
September 9 2014
Active Locations (38)
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1
Site Reference ID/Investigator# 21250
Birmingham, Alabama, United States, 35205
2
Site Reference ID/Investigator# 21249
Colorado Springs, Colorado, United States, 80910
3
Site Reference ID/Investigator# 21245
Denver, Colorado, United States, 80230
4
Site Reference ID/Investigator# 21246
Wheaton, Maryland, United States, 20902