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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00478660 |
Due to the rigor of the clinical development program of adalimumab for the indication of AS, the population of subjects with active AS that could enroll in previous phase 3 studies was limited. Therefore, it is necessary to further evaluate the use of adalimumab in a setting that mimics day-to-day clinical practice to obtain further safety and efficacy data by allowing subjects meeting the characteristics noted below to enter this study:
Condition | Intervention | Phase |
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Ankylosing Spondylitis |
Drug: adalimumab (Humira) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis - An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Treatment with corticosteroids (prednisolone equivalents) under the following conditions:
Study Director: | Beverly Paperiello | Abbott |
Study ID Numbers: | M05-760 |
Study First Received: | May 23, 2007 |
Last Updated: | October 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00478660 History of Changes |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Anti-Inflammatory Agents Spinal Diseases Joint Diseases Spondylarthropathy Adalimumab Bone Diseases Musculoskeletal Diseases |
Arthritis Spondylitis, Ankylosing Antirheumatic Agents Spondylarthritis Spondylitis Spondylarthropathies Ankylosis |
Anti-Inflammatory Agents Spinal Diseases Joint Diseases Infection Adalimumab Bone Diseases Pharmacologic Actions Bone Diseases, Infectious Musculoskeletal Diseases |
Therapeutic Uses Arthritis Spondylitis, Ankylosing Antirheumatic Agents Spondylarthritis Spondylitis Spondylarthropathies Ankylosis |