OFSEP High Definition Cohort

NCT03603457 | Active Not Recruiting

• 1 other identifier: 002
• Study Type: observational
• Target: 2,842
• Locations: 2 countries
• Sites: 25

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

Conditions

Multiple Sclerosis

Keywords

Epidemiology; Prognostic factors; Stratified medicine; Quality of life; Economic assessment

Outcome Measures

Primary Outcomes (6)

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

  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)

  1 year

• Change in T2 lesion load evaluated by analysis of raw MRI

  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.

  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.

  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.

  1 year

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All MS patients from MS Clinical Reference Centre (CRC SEP).

You may qualify if:

• 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
• Inability to answer questionnaires

Sponsors & Collaborators

• EDMUS Foundation: lead

Study Sites (25)

CHU de Besançon

Besançon, France

Location

CHU de Bordeaux

Bordeaux, France

Location

CHU de Caen

Caen, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU de Créteil

Créteil, France

Location

CHU de Dijon

Dijon, France

Location

CHU de Grenoble

Grenoble, France

Location

CHU de Lille

Lille, France

Location

CHU de Limoges

Limoges, France

Location

CHU de Lyon

Lyon, France

Location

CHU de Montpellier

Montpellier, France

Location

CHU de Nancy

Nancy, France

Location

CHU de Nantes

Nantes, France

Location

CHU de Nice

Nice, France

Location

CHU de Nîmes

Nîmes, France

Location

CHU Pitié-Salpétrière

Paris, France

Location

CHU Saint-Antoine

Paris, France

Location

Fondation Rothschild

Paris, France

Location

CHI de Poissy-Saint-Germain-en-Laye

Poissy, France

Location

CHU de Poitiers

Poitiers, France

Location

CHU de Rennes

Rennes, France

Location

CHU de Strasbourg

Strasbourg, France

Location

CHU de Toulouse

Toulouse, France

Location

CHU de Tours

Tours, France

Location

CHU de Fort-de-France

Fort-de-France, Martinique

Location

Related Publications (1)

• Guillemin F, Casey R, Epstein J, Foucher Y, Laplaud D, Achit H, Rollot F, Leray E, Vukusic S; OFSEP-HD investigators. Prognostic factors of disability progression in multiple sclerosis in real life: the OFSEP-high definition (OFSEP-HD) prospective cohort in France. BMJ Open. 2025 Apr 7;15(4):e094688. doi: 10.1136/bmjopen-2024-094688.

  PMID: 40194873 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, serum

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 27, 2018
• Study Start: July 10, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

MA (1); FR (24)