Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy
NCT ID: NCT00420303
Last Updated: 2010-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
24 participants
INTERVENTIONAL
2007-01-31
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
Etanercept
50 mg injection once weekly
B
Placebo
placebo
Interventions
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Etanercept
50 mg injection once weekly
Placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Prior exposure to any TNF-inhibitor, including etanercept
* Dose of NSAIDs changed within two weeks of study drug evaluation
18 Years
70 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Wyeth
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Arles, , France
Avignon, , France
Bordeaux, , France
Grenoble, , France
Montpellier, , France
Nice, , France
Orléans, , France
Paris (Bichat), , France
Paris (cochin), , France
Paris (Pitie Salpetriere), , France
Strasbourg, , France
Toulouse, , France
Berlin, , Germany
Herne, , Germany
Maastricht, , Netherlands
Countries
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References
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Dougados M, Combe B, Braun J, Landewe 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.
Other Identifiers
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0881A3-404
Identifier Type: -
Identifier Source: org_study_id
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