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Completed

NCT Number: NCT00247962

Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis

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

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Heidelberg West, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of ankylosing spondylitis
  • Active ankylosing spondylitis

Exclusion criteria

  • Complete ankylosis of spine
  • Previous treatment with etanercept

Treatment and study plan

etanercept

Drug

50 mg

sulphasalazine (SSZ)

Drug

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.

Primary outcomes

  1. Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)

    Time frame: 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 outcomes

  1. Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Nov 2, 2005
Registry last updated
Nov 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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