A Multi-center, Multi-regional Observational Study to Test the Responsiveness of the Validated MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Instrument to EDSS Status Changes in Any Form of Multiple Sclerosis (MS) in Patients With or Without Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 599
- 试验地点
- 3
- 主要终点
- MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Score
研究概览
简要总结
This is a multi-center, multi-regional observational,24 month study.
Health-related quality of life data from the MusiQoL instrument and SF-36 instrument will be collected at baseline, M6, M12, M18 and M24 in patients with MS. In addition, physical health outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.
详细描述
This is a multi-center, multi-regional observational,24 month study.
Health-related quality of life data from the MusiQoL instrument and SF-36 instrument will be collected at baseline, M6, M12, M18 and M24 in patients with MS. In addition, physical health outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.
研究设计
- 研究类型
- Observational
- 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
- •Patient has any form of MS (confirmed by McDonald and/or Poser criteria)
- •Patient is 18 years old or more (inclusive, at time of informed consent).
- •Patient has an EDSS score lower than 7.0 (inclusive, at time of informed consent)
- •Patient can be with or without treatment
- •Patient has read, understood, signed and dated informed consent form
- •Patient is able to fill in the questionnaire by him/herself
排除标准
- •CIS Patient (MS not confirmed by Mc Donald and /or Poser criteria)
- •Patient receives or is planned to receive during the course of this study any investigational drug or experimental procedure
- •Patient suffers from dementia in the opinion of the investigator
- •Patient suffers of major medical or psychiatric illness in the opinion of the investigator
结局指标
主要结局
MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Score
时间窗: Month 24
次要结局
未报告次要终点