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Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Heidelberg West, Victoria, 3081 Australia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankylosing Spondylitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Clinical diagnosis of ankylosing spondylitis

- Active ankylosing spondylitis

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Complete ankylosis of spine

- Previous treatment with etanercept

NCT00247962
Pfizer
Completed
Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis

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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 SummaryThe purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.
Detailed DescriptionNot 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 DateFebruary 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 CountriesGreece,   Portugal,   Switzerland
 
Administrative Information
NCT Number  ICMJE NCT00247962
Other Study ID Numbers  ICMJE 0881A3-402
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth 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 MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Poland, [email protected]
Principal Investigator:Trial ManagerFor Italy, [email protected]
Principal Investigator:Trial ManagerFor Hungary, [email protected]
Principal Investigator:Trial ManagerFor Czech Republic, [email protected]
Principal Investigator:Trial ManagerFor Australia, [email protected]
Principal Investigator:Trial ManagerFor Germany, [email protected]
Principal Investigator:Trial ManagerFor Austria, [email protected]
Principal Investigator:Trial ManagerFor Spain, [email protected]
Principal Investigator:Trial ManagerFor Netherlands, [email protected]
Principal Investigator:Trial ManagerFor Denmark, [email protected]
Principal Investigator:Trial ManagerFor Finland, [email protected]
Principal Investigator:Trial ManagerFor Sweden, [email protected]
Principal Investigator:Trial ManagerFor UK/Great Britian, [email protected]
Principal Investigator:Trial ManagerFor Ireland, [email protected]
Principal Investigator:Trial ManagerFor France, [email protected]
Principal Investigator:Trial ManagerFor China, [email protected]
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateOctober 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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