Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis
NCT ID: NCT00085644
Last Updated: 2011-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
315 participants
INTERVENTIONAL
2004-01-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Adalimumab
adalimumab (D2E7)
Adalimumab 40 mg every other week, subcutaneous
Placebo
placebo
Placebo every other week, subcutaneous
Interventions
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adalimumab (D2E7)
Adalimumab 40 mg every other week, subcutaneous
placebo
Placebo every other week, subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Laura Redden, MD, PhD
Role: STUDY_DIRECTOR
Abbott
Locations
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Birmingham, Alabama, United States
Mobile, Alabama, United States
San Francisco, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Portland, Maine, United States
Baltimore, Maryland, United States
Wheaton, Maryland, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
Albany, New York, United States
Oklahoma City, Oklahoma, United States
Duncansville, Pennsylvania, United States
West Reading, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Countries
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References
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van der Heijde D, Breban M, Halter D, DiVittorio G, Bratt J, Cantini F, Kary S, Pangan AL, Kupper H, Rathmann SS, Sieper J, Mease PJ. Maintenance of improvement in spinal mobility, physical function and quality of life in patients with ankylosing spondylitis after 5 years in a clinical trial of adalimumab. Rheumatology (Oxford). 2015 Jul;54(7):1210-9. doi: 10.1093/rheumatology/keu438. Epub 2014 Dec 25.
Kimel M, Revicki D, Rao S, Fryback D, Feeny D, Harnam N, Thompson C, Cifaldi M. Norms-based assessment of patient-reported outcomes associated with adalimumab monotherapy in patients with ankylosing spondylitis. Clin Exp Rheumatol. 2011 Jul-Aug;29(4):624-32. Epub 2011 Aug 31.
Revicki DA, Rentz AM, Luo MP, Wong RL. Psychometric characteristics of the short form 36 health survey and functional assessment of chronic illness Therapy-Fatigue subscale for patients with ankylosing spondylitis. Health Qual Life Outcomes. 2011 May 22;9:36. doi: 10.1186/1477-7525-9-36.
Reilly MC, Gooch KL, Wong RL, Kupper H, van der Heijde D. Validity, reliability and responsiveness of the Work Productivity and Activity Impairment Questionnaire in ankylosing spondylitis. Rheumatology (Oxford). 2010 Apr;49(4):812-9. doi: 10.1093/rheumatology/kep457. Epub 2010 Jan 25.
van der Heijde D, Salonen D, Weissman BN, Landewe R, Maksymowych WP, Kupper H, Ballal S, Gibson E, Wong R; Canadian (M03-606) study group; ATLAS study group. Assessment of radiographic progression in the spines of patients with ankylosing spondylitis treated with adalimumab for up to 2 years. Arthritis Res Ther. 2009;11(4):R127. doi: 10.1186/ar2794. Epub 2009 Aug 24.
van der Heijde DM, Revicki DA, Gooch KL, Wong RL, Kupper H, Harnam N, Thompson C, Sieper J; ATLAS Study Group. Physical function, disease activity, and health-related quality-of-life outcomes after 3 years of adalimumab treatment in patients with ankylosing spondylitis. Arthritis Res Ther. 2009;11(4):R124. doi: 10.1186/ar2790. Epub 2009 Aug 17.
van der Heijde D, Schiff MH, Sieper J, Kivitz AJ, Wong RL, Kupper H, Dijkmans BA, Mease PJ, Davis JC Jr; ATLAS Study Group. Adalimumab effectiveness for the treatment of ankylosing spondylitis is maintained for up to 2 years: long-term results from the ATLAS trial. Ann Rheum Dis. 2009 Jun;68(6):922-9. doi: 10.1136/ard.2007.087270. Epub 2008 Aug 13.
Dougados M, Luo MP, Maksymowych WP, Chmiel JJ, Chen N, Wong RL, Davis JC Jr, van der Heijde D; ATLAS STUDY GROUP. Evaluation of the patient acceptable symptom state as an outcome measure in patients with ankylosing spondylitis: data from a randomized controlled trial. Arthritis Rheum. 2008 Apr 15;59(4):553-60. doi: 10.1002/art.23527.
van der Heijde D, Pangan AL, Schiff MH, Braun J, Borofsky M, Torre J, Davis JC Jr, Wong RL, Kupper H, Collantes E; ATLAS Study Group. Adalimumab effectively reduces the signs and symptoms of active ankylosing spondylitis in patients with total spinal ankylosis. Ann Rheum Dis. 2008 Sep;67(9):1218-21. doi: 10.1136/ard.2007.082529. Epub 2007 Dec 4.
Other Identifiers
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M03-607
Identifier Type: -
Identifier Source: org_study_id
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