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Sponsored by: |
Wyeth |
---|---|
Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00873730 |
The purpose of this study was to evaluate efficacy and safety of etanercept 100 mg (50 mg twice a week) compared with 50 mg once a week in adult subjects with ankylosing spondilitis (AS) and previous failure to usual practice therapies in Spain.
Condition | Intervention | Phase |
---|---|---|
Ankylosing Spondylitis |
Drug: etanercept/placebo Drug: etanercept 50 mg twice a week |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 12-Week Randomized, Double-Blind, Multicenter Pilot Study to Evaluate the Effect of Etanercept 100 mg and 50 mg Weekly in Subjects With Ankylosing Spondylitis |
Enrollment: | 126 |
Study Start Date: | December 2006 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Group 1 etanercept 50 mg twice a week for 12 weeks
|
Drug: etanercept/placebo |
2: Active Comparator
Group 2 etanercept 50 mg 1 day and placebo another day weekly for 12 weeks
|
Drug: etanercept 50 mg twice a week |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Abnormalities in hematology profiles defined by:
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 0881A3-406 |
Study First Received: | April 1, 2009 |
Last Updated: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00873730 History of Changes |
Health Authority: | Spain: Comité Ético de Investigación Clínica |
Effect of etanercept in subjects with ankylosing spondylitis |
Anti-Inflammatory Agents Spinal Diseases Immunologic Factors Joint Diseases Spondylarthropathy TNFR-Fc fusion protein Immunosuppressive Agents Bone Diseases Musculoskeletal Diseases Analgesics, Non-Narcotic |
Arthritis Spondylitis, Ankylosing Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Spondylarthritis Spondylitis Spondylarthropathies Ankylosis |
Anti-Inflammatory Agents Immunologic Factors Physiological Effects of Drugs TNFR-Fc fusion protein Infection Bone Diseases Musculoskeletal Diseases Sensory System Agents Arthritis Therapeutic Uses Spondylitis, Ankylosing Anti-Inflammatory Agents, Non-Steroidal Analgesics Spondylarthritis |
Spondylitis Ankylosis Spondylarthropathies Spinal Diseases Joint Diseases Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions Bone Diseases, Infectious Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |