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Sponsors and Collaborators: |
Centocor, Inc. Centocor BV |
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Information provided by: | Centocor, Inc. |
ClinicalTrials.gov Identifier: | NCT00207701 |
A study of the safety and efficacy of Infliximab (Remicade) versus placebo in subjects with Ankylosing Spondylitis
Condition | Intervention | Phase |
---|---|---|
Ankylosing Spondylitis |
Drug: infliximab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind Trial of the Efficacy of REMICADE (Infliximab) Compared With Placebo in Subjects With Ankylosing Spondylitis Receiving Standard Anti-Inflammatory Drug Therapy |
Estimated Enrollment: | 275 |
Study Start Date: | September 2002 |
Study Completion Date: | February 2005 |
This is a clinical research study that will determine if there is a reduction in the signs and symptoms (such as back pain and stiffness) of patients with ankylosing spondylitis with infliximab therapy. This study will also study the safety of infliximab in patients with ankylosing spondylitis. The effect of infliximab on physical function, damage to joints and thequality of life in patients with ankylosing spondylitis will also be studied.
Subjects received infusions of either placebo at weeks 0, 2, 6, 12, 18 and 5 mg/kg infliximab at weeks 24, 26, 30 and every 6 weeks through week 96, or 5 mg/kg infiximab at weeks 1, 2, 6, 12, 18 and every 6 weeks through week 96
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR004792 |
Study First Received: | September 13, 2005 |
Last Updated: | June 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00207701 |
Health Authority: | United States: Food and Drug Administration |
infusion Ankylosing Spondylitis |
Spinal Diseases Musculoskeletal Diseases Infliximab Spondylarthropathy Arthritis Joint Diseases |
Spondylitis, Ankylosing Spondylarthritis Bone Diseases Spondylitis Ankylosis Spondylarthropathies |
Anti-Inflammatory Agents Therapeutic Uses Gastrointestinal Agents Antirheumatic Agents |
Infection Dermatologic Agents Pharmacologic Actions Bone Diseases, Infectious |