OFSEP High Definition Cohort

Multiple Sclerosis Clinical Trial

— OFSEP HD  

Official title:

OFSEP High Definition Cohort

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03603457
• Other study ID #: 002
• Status: Active, not recruiting
• Start date: July 10, 2018
• Est. completion date: December 2026

Study information

• Verified date: August 2023
• Source: EDMUS Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2900
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens
France	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	CHU de Marseille	Marseille
France	CHU de Montpellier	Montpellier
France	CHU de Nancy	Nancy
France	CHU de Nantes	Nantes
France	CHU de Nice	Nice
France	CHU de Nîmes	Nîmes
France	CHU Pitié-Salpétrière	Paris
France	CHU Saint-Antoine	Paris
France	Fondation Rothschild	Paris
France	CHI de Poissy-Saint-Germain-en-Laye	Poissy
France	CHU de Poitiers	Poitiers
France	CHU de Rennes	Rennes
France	CHU de Strasbourg	Strasbourg
France	CHU de Toulouse	Toulouse
France	CHU de Tours	Tours
Martinique	CHU de Fort-de-France	Fort-de-France

Sponsors (1)

Lead Sponsor	Collaborator
EDMUS Foundation

Countries where clinical trial is conducted

France,  Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to reach irreversible Expanded Disability Status Scale (EDSS) scores of 6		Through study completion, an average of 2 years
Primary	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)	1 year
Primary	Change in T2 lesion load evaluated by analysis of raw MRI		1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year