Fingolimod Real World Experience: the French Grand-Est Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CHU de Reims
- 入组人数
- 1,014
- 主要终点
- the course of the disease by magnetic resonance imaging (MRI)
研究概览
简要总结
Objectives: This study describes efficacy and safety of Fingolimod in patients treated for at least 6 months in the east of France from January 2011 to December 2014.
Background: The Grand-Est is a geographical region in France with a high prevalence of multiple sclerosis (more than 10000 patients registered in the European Database for Multiple Sclerosis (EDMUS) database). In this region and since January 2011, more than 1014 patients have been treated for at least 6 months with Fingolimod, the first oral therapy for patient with very active relapsing-remitting MS.
Methods: Features of patients followed up in the Grand-Est region and treated with fingolimod in the 6 university hospitals, general hospitals and private neurologists were reviewed in a retrospective study after identification of the clinical files reported in the EDMUS database.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 MS treated with Gilenya because of the disease
排除标准
- •contraindications of Gilenya treatment or receiving Gilenya after the 31st of March 2014
结局指标
主要结局
the course of the disease by magnetic resonance imaging (MRI)
时间窗: assessed between January 2012 and September 2014, up to a total of 32 months
次要结局
未报告次要终点