Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00441961
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : August 11, 2011
Information provided by:
Radboud University

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

Condition or disease Intervention/treatment Phase
Fasciitis Drug: methotrexate Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
Study Start Date : October 2006
Actual Primary Completion Date : December 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: methotrexate

Primary Outcome Measures :
  1. Efficacy is evaluated after 6 months. [ Time Frame: December 2008 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00441961

Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Principal Investigator: H. Knaapen, MD Radboud University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: H. Knaapen, MD, Radboud University Identifier: NCT00441961     History of Changes
Other Study ID Numbers: mtx in eosinophilic fasciitis
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: August 11, 2011
Last Verified: July 2010

Keywords provided by Radboud University:
Eosinophilic fasciitis, Shulman's syndrome, methotrexate

Additional relevant MeSH terms:
Musculoskeletal Diseases
Leukocyte Disorders
Hematologic Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors