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
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