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Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

This study is currently recruiting participants.
Verified by Radboud University, May 2008

Sponsored by: Radboud University
Information provided by: Radboud University
ClinicalTrials.gov Identifier: NCT00441961
  Purpose

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


Condition Intervention
Fasciitis
Drug: methotrexate

ChemIDplus related topics:   Methotrexate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Efficacy is evaluated after 6 months. [ Time Frame: December 2008 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   6
Study Start Date:   October 2006
Estimated Study Completion Date:   June 2009
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: methotrexate
    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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441961

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    

Locations
Netherlands
Radboud University Nijmegen Medical Centre     Recruiting
      Nijmegen, Netherlands, 6500 HB
      Principal Investigator: M. Gerritsen, PhD            

Sponsors and Collaborators
Radboud University

Investigators
Principal Investigator:     M. Gerritsen, PhD     Radboud University    
  More Information

Responsible Party:   Radboud University ( Dr. M. Creemers )
Study ID Numbers:   mtx in eosinophilic fasciitis
First Received:   February 28, 2007
Last Updated:   May 28, 2008
ClinicalTrials.gov Identifier:   NCT00441961
Health Authority:   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Study placed in the following topic categories:
Folic Acid
Musculoskeletal Diseases
Eosinophilic fasciitis
Methotrexate
Fasciitis

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 05, 2008




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