This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

This study has been completed.
Information provided by:
Radboud University Identifier:
First received: February 28, 2007
Last updated: August 10, 2011
Last verified: July 2010
Evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fascia.

Condition Intervention
Fasciitis Drug: methotrexate

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Radboud University:

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

Enrollment: 6
Study Start Date: October 2006
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: methotrexate
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00441961

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

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
Study First Received: February 28, 2007
Last Updated: August 10, 2011

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 processed this record on August 18, 2017