NCT00441961已完成不适用
Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Efficacy is evaluated after 6 months.
研究概览
简要总结
Evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fascia.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
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
结局指标
主要结局
Efficacy is evaluated after 6 months.
时间窗: December 2008
次要结局
未报告次要终点
研究者
研究点 (2)
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