NCT01621269撤回4 期
A 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Fingolimod in the Treatment of Relapsing-remitting Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Number of patients with active MRI lesions
研究概览
简要总结
Study to evaluate efficacy of fingolimod in patients with neutralizing antibodies over 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged 18-65 years
- •Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria
- •Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5
- •Interferon-beta (IFN-β) treatment for at least 18 months.
- •Positive IFN-NAb titer at screening or within 6 months prior to screening
- •Patients with disease activity despite treatment with IFN-ß measured by gadolinium-enhancing lesions on T1-weighted images on MRI using a triple-dose gadolinium protocol and/or new or newly enlarging T2 lesions (T2 lesions: compared to a reference MRI performed within the last 18 months)
排除标准
- •patients with previous or current disease of immune system
- •active infections
- •cardiovascular risk patients
- •Patients unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Fingolimod
Experimental
干预措施: Fingolimod (Drug)
结局指标
主要结局
Number of patients with active MRI lesions
时间窗: 12 months
number of patients with neutralizing antibodies against IFN-ß with reduction of number of combined unique active lesions on brain MRI (CUAL) defined as those lesions that are new or recurrent or enlarging on T2-weighted scans or those that are new and taking Gd-enhancement on T1-weighted scans, avoiding double counting
次要结局
- Number of patients with adverse events(12 months)
研究者
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