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

Last updated on November 16, 2019

FOR MORE INFORMATION
Study Location
Amiens, , 80094 France
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
18-70 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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Descriptive Information
Brief Title  ICMJE Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis
Official Title  ICMJE A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing Spondylitis
Brief SummaryEvaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced 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 (Enbrel)
    50 mg injection once weekly
  • Other: Placebo
    placebo
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Etanercept (Enbrel)
  • Placebo Comparator: B
    Intervention: Other: Placebo
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 5, 2009)
82
Original Enrollment  ICMJE
 (submitted: January 8, 2007)
80
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion DateFebruary 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (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 France,   Germany,   Hungary,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00420238
Other Study ID Numbers  ICMJE 0881A3-403
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
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 France, [email protected]
Principal Investigator:Trial ManagerFor Germany, [email protected]
Principal Investigator:Trial ManagerFor Netherlands, [email protected]
Principal Investigator:Trial ManagerFor Hungary: [email protected]
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateJune 2010

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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