Treatment with high dose Methotrexate in patients with eosinophilic fasciitis - High dose Methotrexate in eosinophilic fasciitis

Conditions: Eosinophilic fasciitis (EF) is a skin disorder involving the deep fascia, resulting in pain and swelling of extremities, cutaneous induration and joint contractures. Most patients require therapy. No controlled trials have been reported. we treated EF patients with intramuscular Methotrexate (MTX)
1 mg/kg weekly. In general, the results were not satisfactory and side-effects frequent. With high dose intravenous MTX
4 mg/kg every four weeks, we expect a better effect with less side effects.

Registration Number: EUCTR2006-003123-37-NL

Lead Sponsor: niversity Hospital Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients of 18 years or older with a by clinical judgement of an expert defined eosinophilic fasciitis and a skin-fascia-muscle biopsy compatible with eosinophilic fasciitis and: either the presence of a modified skin score according to Zachariae 10 of 8 or higher (0-18) or the presence of severe contractures due to EF lesions
Treatment-naïve or treatment-resistant patients.
Concurrent treatment with low dosage of prednisone (<15 mg/day), NSAID’s or analgesics is permitted.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The min objective of this study is to evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fasciitis. ;Secondary Objective: Secondary objectives are to study the effect of this treatment on joint mobility, peripheral blood eosinophilia, functional ability, and pulmonary function.;Primary end point(s): Score of involved skin with a modified skin score according to Zachariae and assessed with a durometer.

Secondary Outcome Measures