Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247962
• Other study ID #: 0881A3-402
• Status: Completed
• Phase: Phase 4
• First received: October 31, 2005
• Last updated: October 9, 2012
• Start date: December 2005
• Est. completion date: February 2008

Study information

• Verified date: October 2012
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of ankylosing spondylitis

• Active ankylosing spondylitis

Exclusion Criteria:

• Complete ankylosis of spine

• Previous treatment with etanercept

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• etanercept
50 mg
• sulphasalazine (SSZ)
Sulphasalazine: The target dose for SSZ is 1.5 g (3 tablets) twice daily orally. Subject start the oral TA at 0.5 g daily for the first week and increase by 0.5 g every week until a daily dose of 3 g. Is achieved by the start of study week 5 of the study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Australia,  Austria,  China,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Hungary,  Ireland,  Italy,  Netherlands,  Poland,  Qatar,  Saudi Arabia,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)	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.	16 weeks	No
Secondary	Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline	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).	Baseline and 16 Weeks	Yes