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)
Conditions
Interventions
Trade Name: Emthexate
Product Name: Emthexate
Pharmaceutical Form: Intravenous infusion
Sponsors
University Hospital Sint Radboud
Eligibility
Sex/Gender
All
Inclusion criteria
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 (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Age 2 times upper limit of normal, WBC count 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed