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Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy

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NCT00420303

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Arles, , 13200 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.
Enthesitis Spondylarthropathies
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

- 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

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

- 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

NCT00420303
Pfizer
Completed
Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy

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Similar Trials

Enthesitis Spondylarthropathies
Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy
NCT00420303
All Genders
18+
Years
Multiple Sites
Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy
A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients With Refractory Heel Enthesitis in Spondylarthropathy
To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Spondylarthropathies, Enthesitis
  • Drug: Etanercept
    50 mg injection once weekly
  • Other: Placebo
    placebo
  • Experimental: A
    Intervention: Drug: Etanercept
  • Placebo Comparator: B
    Intervention: Other: Placebo
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.
 
Completed
24
September 2008
September 2008   (Final data collection date for primary outcome measure)

Inclusion criteria

  • 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

Exclusion criteria

  • 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
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,   Netherlands
 
 
NCT00420303
0881A3-404
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]
Wyeth is now a wholly owned subsidiary of Pfizer
July 2010

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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1-800-718-1021

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