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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00779935 |
This is a Phase 4, multi-center, open-label, one-arm, pilot study in patients with active ankylosing spondylitis refractory to conventional treatment. Remicade will be given at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54. The number of patients showing ASAS-20 clinical response at Week 14 will be evaluated.
Condition | Intervention | Phase |
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Spondylitis, Ankylosing |
Biological: Remicade |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Baseline Serum Vascular Endothelial Growth Factor (VEGF) Concentration as Predictive Factor of Response to Infliximab (Remicade) Therapy in Patients With Active Ankylosing Spondylitis Despite Conventional Treatment: a Multicenter Pilot Study |
Enrollment: | 44 |
Study Start Date: | October 2004 |
Study Completion Date: | February 2007 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Remicade: Experimental
Remicade will be given at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
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Biological: Remicade
Remicade will be given at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Active disease defined by:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04041 |
Study First Received: | October 23, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00779935 |
Health Authority: | Hungary: National Institute of Pharmacy |
Spinal Diseases Infliximab Joint Diseases Spondylarthropathy Endothelial Growth Factors Bone Diseases Musculoskeletal Diseases |
Arthritis Spondylitis, Ankylosing Spondylarthritis Spondylitis Spondylarthropathies Ankylosis |
Anti-Inflammatory Agents Therapeutic Uses Gastrointestinal Agents Antirheumatic Agents |
Infection Dermatologic Agents Pharmacologic Actions Bone Diseases, Infectious |