Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis
NCT00420238
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- Active and severe ankylosing spondylitis
- Ankylosing spondylitis refractory to standard anti-rheumatic treatment
- Between 18 and 70 years of age
- 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
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Descriptive Information | ||||||||||||||||
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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 Summary | Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced 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 |
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Study Arms ICMJE |
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Publications * |
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* 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 | 82 | |||||||||||||||
Original Enrollment ICMJE | 80 | |||||||||||||||
Actual Study Completion Date ICMJE | May 2009 | |||||||||||||||
Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | |||||||||||||||
Eligibility Criteria ICMJE | Inclusion criteria
Exclusion criteria
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Sex/Gender ICMJE |
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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 Committee | Not Provided | |||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||
Responsible Party | Wyeth (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 |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||
Verification Date | June 2010 | |||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |