跳至主要内容
临床试验/EUCTR2016-004819-12-IT
EUCTR2016-004819-12-IT进行中(未招募)1 期

Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients: a multicentre randomized clinical trial. - Full Responders

OSPEDALE SAN RAFFAELE0 个研究点目标入组 300 人开始时间: 2022年1月20日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
300

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

  • - patients with relapsing remitting multiple sclerosis
  • - males and females patients
  • - free from attacks and MRI active lesions in the last 4 years
  • - patients who require the discontinuation of DMT
  • - age between 18-55 years
  • - EDSS < 5.0
  • - women in childbearing age who use a contraceptive method
  • - patients negative to HIV blood examination
  • - patients negative to both HCV and HBV blood examination
  • 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 230
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 70

排除标准

  • - previous use of immunosuppressive treatments
  • - previous use of any experimental disease modifying treatments
  • - clinically relevant systemic diseases
  • - pregnancy
  • For IFNß-treated group:
  • - history of hypersensitivity to natural or recombinant interferon, human albumin, or any other component of the IFNß formulation
  • - history of depression and/or suicidal ideation
  • - active liver disease
  • For GA-treated group:
  • - history of hypersensitivity to GA or mannitol.

研究者

发起方
OSPEDALE SAN RAFFAELE

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