The Multiple Sclerosis Functional Composite (MSFC) in the Follow-up of MS Patients: Correlation With the Expanded Disability Status Scale (EDSS) Among Different Clinical Forms in Argentina
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- - Evaluation of correlations between changes over time
研究概览
简要总结
This observational study is being conducted to evaluate the usefulness of the MSFC and its relationship with EDSS scores in subjects with MS in Argentina.
详细描述
This observational, open-label study is being conducted to correlate change in EDSS score with the change in MSFC scores at the end of a 2-year follow-up period for subjects with MS in Argentina. Measurement of disability is an indispensable parameter in assessing the efficacy of experimental therapeutic agents in MS as well as in trying to determine possible individual evolution of the disease. Clinical scales are being used as primary or secondary outcome measures for recording disease progression in clinical trials. Kurtzke's EDSS is still used as a gold standard for measuring impairment and disability in MS. The MSFC is an examination-based quantitative scoring of neurological impairment. This study aims to establish a correlation between the usefulness of both scales.
OBJECTIVES
Primary Objective:
- To evaluate the change in MSFC score with change in EDSS scores at end of 2 year follow-up period for subjects with MS in Argentina
Secondary Objectives:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with definite diagnosis of MS, according to McDonald's criteria
- •All clinical types: relapsing-remitting MS (RRMS), primary progressive MS (PPMS) and secondary progressive MS (SPMS). Stable disease course without any relapse for at least the previous 3 months
- •Subjects treated or not with disease modifying drugs
- •Ages between 18 and 65 years and is capable of understanding and complying with protocol requirements
- •Subject has a stable residence with no planned move during the entire investigation period
排除标准
- •Life expectancy less than 5 years at admission
- •Diagnosis of clinically isolated syndrome (CIS)
- •Other clinical conditions that mimic MS
- •Psychiatric diseases
- •Alcohol or drug abuse
- •Pregnancy
- •The subject is unwilling or unable to comply with the protocol or scheduled appointments
- •Subject is unable to understand the language in which the approved informed consent is written
- •The subject is a study site employee, or an immediate family member (i.e., spouse, parent, child, sibling) of a study site employee, involved in conduct of this study
结局指标
主要结局
- Evaluation of correlations between changes over time
时间窗: Baseline and two years
- Evaluation of correlations between changes over time for MSFC composite score and arm, leg and cognitive MSFC scores versus EDSS score changes over the same periods
次要结局
- To evaluate the predictive validity of MSFC score of a subsequent EDSS change in a subgroup of MS patients(Baseline, 1 year, 2 years)