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

NCT00420303

Last updated date
Study Location
Arles, , 13200, France
Contact
1-800-718-1021

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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

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Enthesitis SpondylarthropathiesStudy Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy NCT00420303
  1. Arles,
  2. Avignon,
  3. Bordeaux,
  4. Grenoble,
  5. Montpellier,
  6. Nice,
  7. Orleans,
  8. Paris (Bichat),
  9. Paris (COCHIN),
  10. Paris (Pitie Salpetriere),
  11. Strasbourg,
  12. Toulouse,
  13. Berlin,
  14. Herne,
  15. Maastricht,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Drug: Etanercept
    50 mg injection once weekly
  • Other: Placebo
    placebo
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Etanercept
  • Placebo Comparator: B
    Intervention: Other: Placebo
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
 (submitted: October 5, 2009)
24
Original Enrollment  ICMJE
 (submitted: January 8, 2007)
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

  • 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
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,   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
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]
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