A Retrospective Study On The Management of Multiple Sclerosis (MS) Over The Last 10 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Distribution of locations (medical centre, regional hospital, general practitioners) where subjects were treated for the first episode of attack prior to multiple sclerosis diagnosis
研究概览
简要总结
This is an observational, non comparative, non-randomised, open-label, retrospective, single centre study planned to collect the data of subjects diagnosed with multiple sclerosis (MS) as per Poser or McDonald criteria between 1997 and 2007 in Taiwan. The clinical features and annual relapse rate in the first five years after the onset of disease have been compared between conventional and optico-spinal MS in the earlier studies. This study aims to understand the clinical care pathway of MS subjects and facilitate the subject's diagnosis before converting to MS.
详细描述
Multiple Sclerosis is a chronic, inflammatory disease of the central nervous system (CNS) and is characterised by areas of demyelination, or plaques in the CNS. The disease is twice as prevalent in women as compared to men and causes considerable disability over time and continues for the lifetime of the subject. Subjects with MS are thought to have a genetic predisposition for the disease, though environmental factors such as geographic location and possibly viral infection also play an important role in the process of development of the disease.
OBJECTIVES
Primary objective:
- To understand the clinical care pathways of MS subjects at the site over the last 10 years in order to raise the medical attention of MS diagnosis
Secondary objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with MS as per Poser or McDonald criteria between 1997 and 2007
- •EDSS before treatment was available if subject has started the disease modifying drug treatment.
排除标准
- 未提供
结局指标
主要结局
Distribution of locations (medical centre, regional hospital, general practitioners) where subjects were treated for the first episode of attack prior to multiple sclerosis diagnosis
时间窗: Data collected for last 10 years between 1997 and 2007
次要结局
- Duration from first attack to confirmation of MS(Data collected for last 10 years between 1997 and 2007)
- Distribution of MS diagnosis criteria and treatment regimens(Data collected for last 10 years between 1997 and 2007)
- Annual relapse rate before and after MS treatment(Data collected for last 10 years between 1997 and 2007)
- Changes in Expanded Disability Status Scale (EDSS) before and after treatment(Data collected for last 10 years between 1997 and 2007)
- Changes in VEP before and after treatment(Data collected for last 10 years between 1997 and 2007)
- Association between baseline demographics/disease characteristics and MS(Data collected for last 10 years between 1997 and 2007)