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Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT00247962
Recruitment Status : Completed
First Posted : November 2, 2005
Results First Posted : November 8, 2012
Last Update Posted : November 8, 2012
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

October 31, 2005
November 2, 2005
January 30, 2009
November 8, 2012
November 8, 2012
December 2005
February 2008   (Final data collection date for primary outcome measure)
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.
To compare the efficacy of etanercept with sulphasalzine in the treatment of ankylosing spondylitis.
Complete list of historical versions of study NCT00247962 on ClinicalTrials.gov Archive Site
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).
To compare the effect of etanercept with sulphasalazine on the quality of life. To evaluate the safety of etanercept.
Not Provided
Not Provided
 
Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis
A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis
The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Ankylosing Spondylitis
  • Drug: etanercept
    50 mg
  • Drug: 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.
  • Experimental: A
    Intervention: Drug: etanercept
  • Active Comparator: B
    Intervention: Drug: sulphasalazine (SSZ)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
566
525
February 2008
February 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of ankylosing spondylitis
  • Active ankylosing spondylitis

Exclusion Criteria:

  • Complete ankylosis of spine
  • Previous treatment with etanercept
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   China,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   Ireland,   Italy,   Netherlands,   Poland,   Qatar,   Saudi Arabia,   Spain,   Sweden,   United Kingdom
Greece,   Portugal,   Switzerland
 
NCT00247962
0881A3-402
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Poland, WPWZMED@wyeth.com
Principal Investigator: Trial Manager For Italy, descresg@wyeth.com
Principal Investigator: Trial Manager For Hungary, WPBUMED@wyeth.com
Principal Investigator: Trial Manager For Czech Republic, WPPGCLI@wyeth.com
Principal Investigator: Trial Manager For Australia, medinfo@wyeth.com
Principal Investigator: Trial Manager For Germany, medinfoDEU@wyeth.com
Principal Investigator: Trial Manager For Austria, WPVIMED@wyeth.com
Principal Investigator: Trial Manager For Spain, infomed@wyeth.com
Principal Investigator: Trial Manager For Netherlands, trials-NL@wyeth.com
Principal Investigator: Trial Manager For Denmark, medinfonord@wyeth.com
Principal Investigator: Trial Manager For Finland, MedInfoNord@wyeth.com
Principal Investigator: Trial Manager For Sweden, MedInfoNord@wyeth.com
Principal Investigator: Trial Manager For UK/Great Britian, ukmedinfo@wyeth.com
Principal Investigator: Trial Manager For Ireland, ukmedinfo@wyeth.com
Principal Investigator: Trial Manager For France, infomedfrance@wyeth.com
Principal Investigator: Trial Manager For China, medinfo@wyeth.com
Wyeth is now a wholly owned subsidiary of Pfizer
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP