A Long Term, Multicenter, Non-interventional, Observational Study Monitoring Long-term Safety and Effectiveness of Fingolimod 0.5 mg in Patients With Multiple Sclerosis Who Have Participated in the Fingolimod Clinical Development Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 64
- 试验地点
- 43
- 主要终点
- Long-term safety data in patients with relapsing forms of multiple sclerosis who have participated in clinical trials with fingolimod and who are now taking prescribed fingolimod under the conditions of routine medical practice
研究概览
简要总结
The purpose of this observational study is to collect long-term data on safety and effectiveness of fingolimod, particularly including clinical disease and patient outcome related parameters such as relapse and disability, in patients who have participated in prior trials within the fingolimod clinical development program. Furthermore, this study explores the incidence of selected safety related outcomes of fingolimod treatment during follow-up visits within the context of routine medical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 who are prescribed fingolimod as part of their routine medical care
- •Patients who have participated in a prior fingolimod clinical trials
排除标准
- •Restrictions regarding the use of fingolimod while pregnant or nursing in accordance with the local prescribing label
- •Any patient who has prematurely discontinued from the previous fingolimod trial
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Prescribed fingolimod 0.5 mg/day
干预措施: fingolimod (Drug)
结局指标
主要结局
Long-term safety data in patients with relapsing forms of multiple sclerosis who have participated in clinical trials with fingolimod and who are now taking prescribed fingolimod under the conditions of routine medical practice
时间窗: Throughout the entirety of the study up to a maximum of 8 years
次要结局
- Long-term effectiveness data, particularly including clinical disease and patient outcome related parameters such as relapse and disability(Throughout the entirety of the study up to a maximum of 8 years)