A 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 1,272
- 试验地点
- 98
- 主要终点
- Estimated Annualized Aggregate Relapse Rate (ARR)
研究概览
简要总结
This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
- •Patients with a relapsing-remitting disease course
- •Patients with EDSS score of 0-5.5
排除标准
- •Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
- •Pregnant or nursing women
- •Other protocol-defined inclusion/exclusion criteria applied to this study.
研究组 & 干预措施
Fingolimod 1.25 mg
干预措施: Fingolimod 1.25 mg (Drug)
Fingolimod 0.5 mg
干预措施: Fingolimod 0.5 mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Estimated Annualized Aggregate Relapse Rate (ARR)
时间窗: Baseline to end of study (Month 24)
The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group calculated as the total number of confirmed relapses divided by the total number of days on study, multiplied by 365.25.
次要结局
- Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)(Baseline to end of study (Month 24))
- Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline(Baseline to end of study (Month 24))