The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis...
Date First Received: October 31, 2005
Last Updated: July 25, 2008
Verified by: Wyeth, July 2008
Clinical Trial Phase: Phase 4 | Start Date: December 2005
Overall Status: Completed
Estimated Enrollment: 540
Brief Summary
Official Title: “A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Study Primary Completion Date: February 2008
Intervention(s) in this Clinical Trial
- Drug: etanercept
- 50mg
- 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.
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: A
- Active Comparator: B
Outcome Measures for this Clinical Trial
Primary Measures
- To compare the efficacy of etanercept with sulphasalazine in the treatment of ankylosing spondylitis.
- Time Frame: 22 weeks
Safety Issue?: No
- Time Frame: 22 weeks
Secondary Measures
- To compare the effect of etanercept with sulphasalazine on the quality of life. To evaluate the safety of etanercept.
- Time Frame: 22 Weeks
Safety Issue?: Yes
- Time Frame: 22 Weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Clinical diagnosis of ankylosing spondylitis
- Active ankylosing spondylitis
Exclusion Criteria:
- Complete ankylosis of spine
- Previous treatment with etanercept
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth
Additional Information
Information obtained from ClinicalTrials.gov on August 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00247962
Study ID Number: 0881A3-402
ClinicalTrials.gov Identifier: NCT00247962
Health Authority: European Union: European Medicines Agency
Clinical Trials Authorship and Review
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