NL-OMON30014尚未招募不适用
Treatment with high dose Methotrexate in patients with generalized eosinophilic fasciitis - High dose Methotrexate in eosinophilic fasciitis
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •eosinophilic fasciitis as defined by clinical judgement of an expert, histologically confirmed with a skin-fascia-muscle biopsy, and in addition:
- •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
排除标准
- •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
研究者
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Treatment with high dose Methotrexate in patients with eosinophilic fasciitis - High dose Methotrexate in eosinophilic fasciitisEosinophilic 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 MTX4 mg/kg every four weeks, we expect a better effect with less side effects.EUCTR2006-003123-37-NLniversity Hospital Sint Radboud
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