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

niversity Hospital Sint Radboud0 个研究点开始时间: 2006年6月19日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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.

发起方

niversity Hospital Sint Radboud