Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis

Phase 3

Completed

• Conditions: Ankylosing Spondylitis

• Registration Number: NCT00421915
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The primary objective of the study was to compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) response criteria (ASAS 20%) at week 12.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Study Completion: 2002-08
• Status Verified: 2007-01
• Study First Submitted: 2007-01-08
• Study First Submitted QC: 2007-01-12
• Last Update Submitted: 2007-01-12
• Study First Posted: 2007-01-15
• Last Update Posted: 2007-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the
percentage of patients who achieved the assessment in Ankylosing Spondylitis (ASAS 20%) response criteria at week 12.

Secondary Outcome Measures

Name	Time	Method
To assess: 1) the safety of etanercept in this patient population; 2) the efficacy of etanercept
compared with that of placebo using the ASAS response criteria at 50% and 70% levels at week 12.