Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00441961
First received: February 28, 2007
Last updated: August 10, 2011
Last verified: July 2010

February 28, 2007
August 10, 2011
October 2006
December 2010   (final data collection date for primary outcome measure)
Efficacy is evaluated after 6 months. [ Time Frame: December 2008 ] [ Designated as safety issue: Yes ]
Efficacy is evaluated after 6 months.
Complete list of historical versions of study NCT00441961 on ClinicalTrials.gov Archive Site
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Not Provided
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Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Fasciitis
Drug: methotrexate
methotrexate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
June 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00441961
mtx in eosinophilic fasciitis
No
H. Knaapen, MD, Radboud University
Radboud University
Not Provided
Principal Investigator: H. Knaapen, MD Radboud University
Radboud University
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP