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Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis

Last updated on May 11, 2018

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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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
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, Senior)
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, [email protected]
Principal Investigator: Trial Manager For Italy, [email protected]
Principal Investigator: Trial Manager For Hungary, [email protected]
Principal Investigator: Trial Manager For Czech Republic, [email protected]
Principal Investigator: Trial Manager For Australia, [email protected]
Principal Investigator: Trial Manager For Germany, [email protected]
Principal Investigator: Trial Manager For Austria, [email protected]
Principal Investigator: Trial Manager For Spain, [email protected]
Principal Investigator: Trial Manager For Netherlands, [email protected]
Principal Investigator: Trial Manager For Denmark, [email protected]
Principal Investigator: Trial Manager For Finland, [email protected]
Principal Investigator: Trial Manager For Sweden, [email protected]
Principal Investigator: Trial Manager For UK/Great Britian, [email protected]
Principal Investigator: Trial Manager For Ireland, [email protected]
Principal Investigator: Trial Manager For France, [email protected]
Principal Investigator: Trial Manager For China, [email protected]
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

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