Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis

Phase 4

Completed

• Conditions: Ankylosing Spondylitis
• Interventions: Drug: sulphasalazine (SSZ); Drug: etanercept

• Registration Number: NCT00247962
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-10-31
• Study First Submitted QC: 2005-10-31
• Study First Posted: 2005-11-02
• Study Start: 2005-12
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Results First Submitted: 2009-01-30
• Status Verified: 2012-10
• Results First Submitted QC: 2012-10-09
• Last Update Submitted: 2012-10-09
• Results First Posted: 2012-11-08
• Last Update Posted: 2012-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 566

Inclusion Criteria

• Clinical diagnosis of ankylosing spondylitis
• Active ankylosing spondylitis

Exclusion Criteria

• Complete ankylosis of spine
• Previous treatment with etanercept

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	sulphasalazine (SSZ)	-
A	etanercept	-

Primary Outcome Measures

Name	Time	Method
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)	16 weeks	ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an improvement ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.

Secondary Outcome Measures

Name	Time	Method
Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline	Baseline and 16 Weeks	ASQoL is a questionnaire to assess disease specific quality of life. It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS). Each statement is answered by the patients as a "Yes" (scored as 1) or "No" (scored as 0). All item scores are summed to give a total score. Scores can range from 0 (good QoL) to 18 (poor QoL).