跳至主要内容
临床试验/NCT03375177
NCT03375177Unknown不适用

Multiple Sclerosis Registry in Argentina (RelevarEM)

Hospital Italiano de Buenos Aires1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2018年3月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
4,000
试验地点
1
主要终点
Demographic outcomes

研究概览

简要总结

The main reason for RelevarEM project is the creation of a registry based on a web platform to facilitate the collection of epidemiological data of multiple sclerosis patients from multiple sources in Argentina. The platform will provide the data in a global way that will show the frequency and distribution of the disease in our environment at low cost.

详细描述

Multiple sclerosis (MS) is a chronic degenerative disease of autoimmune etiology that affects young adults between 18 and 35 years of age, being the first cause of physical disability of non-traumatic origin in several countries of the world.

MS is characterized histopathologically by the presence of inflammatory plaques in the white matter associated with the presence of axonal damage. Clinically, four evolutionary courses can be distinguished from the disease: a form in which inflammatory outbreaks occur that affect the brain and that the patient refers to as relapses and remissions (RRMS). This form, in most cases and after years of evolution, enters a sustained progression of the disability known as secondary progressive phase (SPMS) being another clinical form of the disease. In a smaller percentage of patients, the disease may have a progressive course from the beginning with the presence of some interposed outbreaks, a form known as progressive with relapses (PRMS), and finally the fourth form of presentation of the disease may be manifest with progression of disability from the outset without originating outbreaks in the course of the same known as primary progressive form (PPMS).

South America is a low-middle risk area for MS with a reported prevalence of between 1.48 and 36 cases per 100,000 population. The cause of observed differences in disease frequency between Europe and North America relative to South America is unknown to date. It is suggested that genetic predisposition would mainly contribute to the geographical variation in the prevalence of MS; however, this factor alone can not explain the overall differences in risk between populations.

The frequency and distribution of this condition has been described in several parts of the world, but it is still necessary to identify it more precisely in the countries and regions of South America.

The main reason for RelevarEM project is the creation of a registry based on a web platform to facilitate the collection of epidemiological data of MS patients from multiple sources in Argentina. The platform will provide the data in a global way that will show the frequency and distribution of the disease in our environment at low cost.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who meet the diagnostic criteria for MS according to validated criteria

排除标准

  • Patients who do not meet the criteria of MS Patients who decide not to participate in the registry.

结局指标

主要结局

Demographic outcomes

时间窗: 2 years

age and sex of MS patients registered

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan Igancio Rojas

MD

Hospital Italiano de Buenos Aires

研究点 (1)

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Multiple Sclerosis Registry in Argentina (RelevarEM) | 临床试验