Study Evaluating Etanercept in Patients With Ankylosing Spondylitis

Phase 4

Completed

• Conditions: Ankylosing Spondylitis

• Registration Number: NCT00458185
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

This study will assess the efficacy of etanercept for the treatment of Ankylosing Spondylitis (AS).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study Completion: 2007-04
• Study First Submitted: 2007-04-05
• Study First Submitted QC: 2007-04-05
• Study First Posted: 2007-04-09
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-11
• Last Update Posted: 2008-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis, aged between 18 and 70 years of age.
• BASDAI greater than or equal to 40 (all scores on a scale of 0 to 100).
• Negative result of serum human chorionic gonadotropin (HCG) pregnancy test taken at screening in all women except those surgically sterile or at least 1 year postmenopausal.

Exclusion Criteria

• Complete ankylosis (fusion) of spine.
• Previous receipt of etanercept, antibody to TNFα, or other TNFα inhibitors.
• Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Patients treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the efficacy of etanercept (25 mg, twice weekly) based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) Response Criteria at 20% level at week 12.

Secondary Outcome Measures

Name	Time	Method
Efficacy at 50% and 70% levels week 12; frequency and time to partial remission; safety; patient and physician global assessment, nocturnal and total back pain, BASFI, BASDAI; spinal mobility; complete joint assessment; hip involvement; ESR, CRP.