OFSEP High Definition Cohort
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,842
- 试验地点
- 25
- 主要终点
- Activity of disease
研究概览
简要总结
For neurologists and patients, it appears that one major unmet need, beside of course a cure to multiple sclerosis (MS), is to better appreciate the causal factors of disease progression, and even to obtain reliable predictive tools that could apply on the individual level and at different key moments in the disease course.
The overarching objective of the OFSEP-HD cohort is to determine prognostic factors of the evolution of disability in MS in real life, looking at disease characteristics, care practices potentially modifying the evolution of the disease since MS clinical onset and along specific post-onset landmarks. This general framework leads to study 3 specific research objectives:
- To identify determinants (socio-demographic characteristics, clinical characteristics, health related quality of life (QoL), changes in classification, and biomarkers) for the progression of MS disease and its consequences;
- To study the effectiveness of treatments in real life;
- To merge both determinants and treatments for creating patient-centered prognostic tools for identifying specific subgroups of patients and helping making decision to start, maintain or adapt care management.
To achieve these objectives, the OFSEP (The French multiple sclerosis registry) infrastructure, managed under a quality insurance system, offers a unique opportunity for the first time in France to create a large cohort of MS cases, providing high-definition and sequential multimodal data.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of multiple sclerosis according to the most recent criteria at entry into the HD cohort
- •Followed in one MS Clinical Reference Centre (CRC SEP)
- •Newly diagnosed after the study start or
- •If MS onset occurred before study start, regular follow-up in a CRC SEP
- •Irreversible disability ≤ 7.0 (permanent use of a wheelchair) on EDSS at inclusion in the study
- •Non-inclusion Criteria:
- •Inability to answer questionnaires
- •Pregnant women at the time of inclusion
排除标准
- 未提供
结局指标
主要结局
Activity of disease
时间窗: 1 year
Activity is determined, according Lublin 2014, by clinical relapses and/or MRI activity (contrast-enhancing lesions ; new or unequivocally enlarging T2 lesions assessed at least annually)
Change in quality of life evaluated by EQ-5D-5L scale
时间窗: 1 year
The 5-level EQ-5D version (EQ-5D-5L) consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The five dimensions can be combined into a number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Change in quality of life evaluated by SF-12 scale
时间窗: 1 year
The SF-12 questionnaire uses 12 questions to measure functional health and well-being from the patient's point of view.
Change in quality of life evaluated by MusiQoL scale
时间窗: 1 year
The MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) is a multidimensional Health Related Quality of Life instrument that provides information based on the views and perceptions of the participants.
Time to reach irreversible Expanded Disability Status Scale (EDSS) scores of 6
时间窗: Through study completion, an average of 2 years
Change in T2 lesion load evaluated by analysis of raw MRI
时间窗: 1 year
次要结局
未报告次要终点