NCT01941004撤回3 期
A 12 Month Study, With a 6-month, Double-blind, Randomized, Placebo-controlled, Multi-center Parallel- Groups, Treatment Phase Evaluating Efficacy and Safety of Fingolimod 0.5 mg and a 6-month, Open-label, Treatment Phase, in Chinese Patients With Relapsing-remitting Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- number of new/newly enlarged T2 MRI lesions over 6 months
研究概览
简要总结
To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have relapsing remitting multiple sclerosis
排除标准
- •Patients with:
- •History of chronic immune disease
- •Certain cancers
- •Uncontrolled diabetes
- •Certain eye disorders -Negative for varicella
- •zoster virus IgG antibodies
- •Certain hepatic conditions
- •Low white blood cell count
- •On certain immunosuppressive medications or heart medications
- •Certain heart conditions or certain lung conditions
- •Inability to undergo MRI scans -Diagnosis of Neuromyelitis optica.
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
double blinded Fingolimod 6 mos + open label fingolimod 6 mos
Experimental
Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily
干预措施: fingolimod (Drug)
Placebo 6 mos + open label fingolimod 6 mos
Placebo Comparator
Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily
干预措施: Placebo (6mos) + open label fingolimod (6 mos) (Drug)
结局指标
主要结局
number of new/newly enlarged T2 MRI lesions over 6 months
时间窗: 6 months
Cumulative number of new/newly enlarged T2 lesions over 6 months
次要结局
- annualized relapse rate (ARR)(6 months)
- number of Gd-enhancing T1 lesions(6 months)
- Safety and tolerability of fingolimod 0.5 mg compared to placebo(12 months)
研究者
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