Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

This study is currently recruiting participants.

Verified by Radboud University, March 2009

First Received: February 28, 2007 Last Updated: March 5, 2009 History of Changes

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

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

Resource links provided by NLM:

Drug Information available for: Methotrexate

U.S. FDA Resources

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 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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. CW Creemers, PhD	0031-24-3617714	m.creemers@reuma.umcn.nl
Contact: E. MGJ de Jong, PhD	0031-24-3613644	e.dejong@derma.umcn.nl

Locations

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

Sponsors and Collaborators

Radboud University

Investigators

Principal Investigator:

M. CW Creemers, PhD

Radboud University

More Information

No publications provided

Responsible Party:	Radboud University ( Dr. M. Creemers )
Study ID Numbers:	mtx in eosinophilic fasciitis
Study First Received:	February 28, 2007
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00441961 History of Changes
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:

Antimetabolites
Immunologic Factors
Folate
Folic Acid Antagonists
Folinic Acid
Immunosuppressive Agents
Vitamin B9

Folic Acid
Eosinophilic Fasciitis
Musculoskeletal Diseases
Methotrexate
Fasciitis
Antirheumatic Agents

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
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal

Immunosuppressive Agents
Pharmacologic Actions
Musculoskeletal Diseases
Therapeutic Uses
Abortifacient Agents
Methotrexate
Fasciitis
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 06, 2009