NCT01065727Unknown不适用
Study Impact, on Clinical Outcomes, Quality of Life and Costs of 2 Therapeutic Strategy (Monthly Natalizumab Versus Mitoxantrone Then Immunomodulator) at 3 Years of Follow-up for Aggressive Remitting Multiple Sclerosis
Rennes University Hospital4 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2010年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- cost effectiveness
研究概览
简要总结
Cost-effectiveness study of 2 disease-modifying therapies (natalizumab versus mitoxantrone followed by immunomodulator) in the management of aggressive remitting multiple sclerosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •Patients with remitting multiple sclerosis according to mac Donald criteria
- •aggressive remitting multiple sclerosis according to following criteria:
- •2 or less disabling relapse during the 12 months before inclusion
- •1 or more
- •EDSS between 2 and 5
- •aged less or equal to 40 years old for the women
- •effective contraception
排除标准
- •patients less than 18 years old
结局指标
主要结局
cost effectiveness
时间窗: 30 years
次要结局
- progressive neurological disability(3 years)
研究者
研究点 (4)
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