OFSEP High Definition Cohort

N/AActive Not RecruitingNCT03603457

EDMUS Foundation2,842 enrolled

Overview

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: 1. 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; 2. To study the effectiveness of treatments in real life; 3. 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.

Study Type

OBSERVATIONAL

Enrollment

2,842

Conditions

Multiple Sclerosis

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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

Locations (25)

CHU de Besançon

Besançon, France

CHU de Bordeaux

Bordeaux, France

CHU de Caen

Caen, France

CHU de Clermont-Ferrand

Clermont-Ferrand, France

CHU de Créteil

Créteil, France

CHU de Dijon

Dijon, France

CHU de Grenoble

Grenoble, France

CHU de Lille

Lille, France

CHU de Limoges

Limoges, France

CHU de Lyon

Lyon, France

...and 15 more locations

Outcomes

Primary Outcomes

Time to reach irreversible Expanded Disability Status Scale (EDSS) scores of 6

Time frame: Through study completion, an average of 2 years

Activity of disease

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)

Time frame: 1 year

Change in T2 lesion load evaluated by analysis of raw MRI

Time frame: 1 year

Change in quality of life evaluated by EQ-5D-5L scale

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.

Time frame: 1 year

Change in quality of life evaluated by SF-12 scale

The SF-12 questionnaire uses 12 questions to measure functional health and well-being from the patient's point of view.

Time frame: 1 year

Change in quality of life evaluated by MusiQoL scale

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 frame: 1 year