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临床试验/EUCTR2006-004937-13-IT
EUCTR2006-004937-13-IT进行中(未招募)不适用

multicentee randomized controlled study of azathioprine versus iterferon beta in relapsing remitting multiple sclerosis - M.A.I.N. trial

niversita di Firenze0 个研究点开始时间: 2007年7月4日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • age 18-55 years; diagnosis of multiple sclerosis McDonald criteria 2001 with relapsin remitting course; at least 2 exacerbation in the preceding 2 years;Baseline EDSS score of 1 to 5,5; no clinical relapses within 30 days of study entry;effective method of contraception if women with childbearing potential; signed informed patient consent.
  • 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) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • immunomodulatory or immunosoppressive tratments in the preceding 6 mounths; steroid therapy in the last 30 days before study entry; concomitant diseases precluding interferon beta or azathioprine treatment; pregnancy or breastfeeding; inability to give the informed consent; pathological conditions interfering with multiple sclerosis evolution; allergy to paracetamol or known intolerance to azathioprine or interferon beta.

研究者

发起方
niversita di Firenze

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