Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy
NCT00420303
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- Spondylarthropathy
- Heel enthesitis refractory to standard treatment
- Between 18 and 70 years of age
- The patient global assessment of the disease activity (measured by a 100 mm VAS) must be >40 in the last 48 hours
- Use of > 1 local steroid injection within 2 weeks of screening
- Prior exposure to any TNF-inhibitor, including etanercept
- Dose of NSAIDs changed within two weeks of study drug evaluation
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Descriptive Information | |||||||||||||
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Brief Title ICMJE | Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy | ||||||||||||
Official Title ICMJE | A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients With Refractory Heel Enthesitis in Spondylarthropathy | ||||||||||||
Brief Summary | To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis. | ||||||||||||
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 | Spondylarthropathies, Enthesitis | ||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Dougados M, Combe B, Braun J, Landewé R, Sibilia J, Cantagrel A, Feydy A, van der Heijde D, Leblanc V, Logeart I. A randomised, multicentre, double-blind, placebo-controlled trial of etanercept in adults with refractory heel enthesitis in spondyloarthritis: the HEEL trial. Ann Rheum Dis. 2010 Aug;69(8):1430-5. doi: 10.1136/ard.2009.121533. Epub 2010 May 28. | ||||||||||||
* 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 | 24 | ||||||||||||
Original Enrollment ICMJE | 20 | ||||||||||||
Actual Study Completion Date ICMJE | September 2008 | ||||||||||||
Actual Primary Completion Date | September 2008 (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, Netherlands | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT00420303 | ||||||||||||
Other Study ID Numbers ICMJE | 0881A3-404 | ||||||||||||
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 | July 2010 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |