OFSEP High Definition Cohort

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Besançon, Besançon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Time frame: 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 T2 lesion load evaluated by analysis of raw MRI

Time frame: 1 year
Change in quality of life evaluated by EQ-5D-5L scale

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

EDMUS Foundation

Other

Registry information

Acronym: OFSEP HD

Important dates

Study start: 2018
Primary completion: 2027
Study completion: 2027
First posted: Jul 27, 2018
Registry last updated: Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting