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Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

This study is currently recruiting participants.
Study NCT00441961.   Last updated on May 28, 2008.   Information provided by Radboud University

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Descriptive Information Fields
Brief Title  Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
Official Title  Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
Brief Summary

Evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fascia.

Detailed Description

Eosinophilic fasciitis (EF)is a fibrosing skin disorder extensively involving the deep fascia. The aim of this pilot study is to evaluate the effect of high dose MTX on skin induration in patients with EF. In addition, we study the effect of this treatment on joint mobility, peripheral blood eosinophilia, functional ability, and pulmonary function. By administering high dose MTX intravenously every four weeks with a Leukovorin rescue, we hope to induce a more pronounced and sustained effect on the involved skin with less (long-lasting) side effects.

Study Phase
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure  Efficacy is evaluated after 6 months. [ Time Frame: December 2008 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure 
Condition  Fasciitis
Intervention  Drug: methotrexate
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  6
Start Date  October 2006
Completion Date June 2009
Eligibility Criteria 

Inclusion Criteria:

  • Eosinophilic fasciitis as defined by clinical judgement of an expert,
  • Histologically confirmed with a skin-fascia-muscle biopsy, and in additon:

    • Either the presence of a modified skin score according to Zachariae of 8 or higher (0-18), regarded as a generalised eosinophilic fasciitis or the presence of severe contractures due to eosinophilic fasciitis lesions.

Exclusion Criteria:

  • Age < 18 yrs
  • Contraindications to MTX: AST/ALT level > 2 times upper limit of normal, WBC count < 3.5 x 109/l or platelet count < 150 x 109/l, serum creatinine > 130 micromol/l or clearance < 50 ml/min, confirmed by two repeated tests within one month.
  • Chronic liver disease, insulin dependant diabetes mellitus, alcohol abuse
  • Restrictive pulmonary disease (total lung capacity or vital capacity < 40% of predicted) or interstitial lung disease (KCO < 60% of predicted)
  • Pregnancy or child bearing potential without adequate contraception
  • The presence of any serious co-morbidity or malignancy
  • Use of other anti-folate drugs than MTX
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: M. Gerritsen, PhD     0031-24-3619383     m.gerritsen@reuma.umcn.nl    
Contact: M. Creemers, PhD     0031-24-3617714     m.creemers@reuma.umcn.nl    
Location Countries  Netherlands
Administrative Information Fields
NCT ID  NCT00441961
Organization ID mtx in eosinophilic fasciitis
Secondary IDs ††
Study Sponsor  Radboud University
Collaborators ††
Investigators 
Principal Investigator:     M. Gerritsen, PhD     Radboud University    
Information Provided By Radboud University
Verification Date May 2008
First Received Date  February 28, 2007
Last Updated Date May 28, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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