Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2011-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Fasciitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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methotrexate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No