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Trial record 1 of 2 for:    NCT00247962
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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

Tracking Information
First Submitted Date  ICMJE October 31, 2005
First Posted Date  ICMJE November 2, 2005
Results First Submitted Date  ICMJE January 30, 2009
Results First Posted Date  ICMJE November 8, 2012
Last Update Posted Date November 8, 2012
Study Start Date  ICMJE December 2005
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2005)
To compare the efficacy of etanercept with sulphasalzine in the treatment of ankylosing spondylitis.
Change History Complete list of historical versions of study NCT00247962 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2012)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2005)
To compare the effect of etanercept with sulphasalazine on the quality of life. To evaluate the safety of etanercept.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis
Official Title  ICMJE A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ankylosing Spondylitis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: etanercept
  • Active Comparator: B
    Intervention: Drug: sulphasalazine (SSZ)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2012)
566
Original Enrollment  ICMJE
 (submitted: October 31, 2005)
525
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of ankylosing spondylitis
  • Active ankylosing spondylitis

Exclusion Criteria:

  • Complete ankylosis of spine
  • Previous treatment with etanercept
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   China,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   Ireland,   Italy,   Netherlands,   Poland,   Qatar,   Saudi Arabia,   Spain,   Sweden,   United Kingdom
Removed Location Countries Greece,   Portugal,   Switzerland
 
Administrative Information
NCT Number  ICMJE NCT00247962
Other Study ID Numbers  ICMJE 0881A3-402
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date October 2012

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