Czech Pharmaco-epidemiological Real World Data Study Focused on Effectiveness of Different Disease Modifying Drugs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17,478
- 试验地点
- 1
- 主要终点
- Effectiveness in relapses
研究概览
简要总结
Multiple sclerosis (MS) is a severe autoimmune disease that affects mainly young individuals. It is estimated that there are 17-20,000 affected persons in the Czech Republic.
Currently, MS remains an incurable but treatable disease. As of now, there are many drugs that are able to reduce the inflammatory part of the disease that prevails in its initial phases. The problem is the great variability of the severity of clinical course (from relatively benign to severe malignant courses) and different responses of particular patients to particular drugs. A personalized approach with long life monitoring and adjustment of treatment according to the activity of the disease is essential.
From this point of view registries represent one of the most important source of long term data that is used for evaluation of effectiveness and safety of different drugs in areal life setting.
The objective of this study is to compare effectiveness and safety profile in MS patients treated with a different Disease Modifying Drugs (DMDs) and Ocrelizumab using data from the real clinical practice from the Czech national multiple sclerosis patient registry (ReMuS).
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
- •Each participant must provide informed consent to registry ReMuS in accordance with local regulations
- •The patient is treated by any kind of DMDs
- •Confirmed diagnosis of multiple sclerosis
排除标准
- •Patient withdrawal of informed consent to registry ReMuS
结局指标
主要结局
Effectiveness in relapses
时间窗: 1 year from DMD initiation
Measurement of annualized relapse rate (ARR) in patients on different DMDs.
Effectiveness EDSS
时间窗: 1 year from DMD initiation
Description of disability measured by Expanded Disability Status Scale (EDSS) of values 0 to 10, where 0 represents no neurological disability due to multiple sclerosis (MS), and 10 represents death due to MS. The EDSS is commonly used among clinicians, and described by Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983; 33(11): 1444-1452.
次要结局
- Description of baseline characteristics of patients treated by different DMDs at the time of DMT initiation(Baseline)
- Description of termination of different DMDs treatment(Day of DMD termination, assessed up to 15 years)