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| Sponsored by: |
Wyeth |
|---|---|
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00247962 |
Purpose
The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Ankylosing Spondylitis |
Drug: etanercept Drug: sulphasalazine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis |
| Estimated Enrollment: | 540 |
| Study Start Date: | December 2005 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| A: Experimental |
Drug: etanercept
50mg
|
| B: Active Comparator |
Drug: sulphasalazine
Sulphasalazine: The target dose for SSZ is 1.5g (3 tablets) twice daily orally. Subject start the oral TA at 0.5g daily for the first week and increase by 0.5g every week until a daily dose of 3g. Is achieved by the start of study week 5 of the study.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 83 Study Locations| Study Director: | Medical Monitor | Wyeth |
| Principal Investigator: | Trial Manager | For Poland, WPWZMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Italy, descresg@wyeth.com |
| Principal Investigator: | Trial Manager | For Hungary, WPBUMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Czech Republic, WPPGCLI@wyeth.com |
| Principal Investigator: | Trial Manager | For Australia, medinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Germany, medinfoDEU@wyeth.com |
| Principal Investigator: | Trial Manager | For Austria, WPVIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Spain, infomed@wyeth.com |
| Principal Investigator: | Trial Manager | For Netherlands, trials-NL@wyeth.com |
| Principal Investigator: | Trial Manager | For Denmark, medinfonord@wyeth.com |
| Principal Investigator: | Trial Manager | For Finland, MedInfoNord@wyeth.com |
| Principal Investigator: | Trial Manager | For Sweden, MedInfoNord@wyeth.com |
| Principal Investigator: | Trial Manager | For UK/Great Britian, ukmedinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Ireland, ukmedinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For France, infomedfrance@wyeth.com |
| Principal Investigator: | Trial Manager | For China, medinfo@wyeth.com |
More Information
| Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
| Study ID Numbers: | 0881A3-402 |
| Study First Received: | October 31, 2005 |
| Last Updated: | July 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00247962 |
| Health Authority: | European Union: European Medicines Agency |
|
Ankylosing Spondylitis (AS) |
|
Spinal Diseases Joint Diseases Spondylarthropathy Sulfasalazine TNFR-Fc fusion protein Bone Diseases Musculoskeletal Diseases |
Arthritis Spondylitis, Ankylosing Spondylarthritis Spondylitis Spondylarthropathies Ankylosis |
|
Anti-Inflammatory Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Gastrointestinal Agents Infection Immunosuppressive Agents Pharmacologic Actions Bone Diseases, Infectious |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |
