Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

Fasciitis Clinical Trial

Official title:

Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441961
• Other study ID #: mtx in eosinophilic fasciitis
• Status: Completed
• Phase: N/A
• First received: February 28, 2007
• Last updated: August 10, 2011
• Start date: October 2006
• Est. completion date: June 2011

Study information

• Verified date: July 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eosinophilia
• Fasciitis

Intervention

Drug:
• methotrexate
methotrexate

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy is evaluated after 6 months.		December 2008	Yes