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Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis

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NCT00420238

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Amiens, , 80094 France
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Active and severe ankylosing spondylitis

- Ankylosing spondylitis refractory to standard anti-rheumatic treatment

- Between 18 and 70 years of age

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

- Prior exposure to any TNF-inhibitor, including etanercept

- DMARDs (other than hydroxychloroquine, methotrexate and sulphasalazine) within 4 weeks
of study drug initiation

- Dose of NSAIDs changed within two weeks of study drug initiation

NCT00420238
Pfizer
Completed
Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis

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Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis
A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing Spondylitis
Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Ankylosing Spondylitis
  • Drug: Etanercept (Enbrel)
    50 mg injection once weekly
  • Other: Placebo
    placebo
  • Experimental: A
    Intervention: Drug: Etanercept (Enbrel)
  • Placebo Comparator: B
    Intervention: Other: Placebo


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
May 2009
February 2009   (Final data collection date for primary outcome measure)

Inclusion criteria

  • Active and severe ankylosing spondylitis
  • Ankylosing spondylitis refractory to standard anti-rheumatic treatment
  • Between 18 and 70 years of age

Exclusion criteria

  • Prior exposure to any TNF-inhibitor, including etanercept
  • DMARDs (other than hydroxychloroquine, methotrexate and sulphasalazine) within 4 weeks of study drug initiation
  • Dose of NSAIDs changed within two weeks of study drug initiation
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Hungary,   Netherlands
 
 
NCT00420238
0881A3-403
Not Provided
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
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 France, [email protected]
Principal Investigator: Trial Manager For Germany, [email protected]
Principal Investigator: Trial Manager For Netherlands, [email protected]
Principal Investigator: Trial Manager For Hungary: [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
June 2010

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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