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NCT03603457Active, not recruiting

OFSEP High Definition Cohort

Source: ClinicalTrials.gov · Last updated 14 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
2842 (actual)
First submitted
28 Jun 2018
Start date
10 Jul 2018
Primary completion date
31 Dec 2027
Lead sponsor
EDMUS Foundation
NCT number
NCT03603457

What you commit to

  • Study type: Observational
  • Participants enrolled: 2842
  • From 10 Jul 2018 to the primary completion date, 31 Dec 2027
  • 25 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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

Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU de Besançon
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BesançonFranceUnknown status
CHU de Bordeaux
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BordeauxFranceUnknown status
CHU de CAEN
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CaenFranceUnknown status
CHU de Clermont-Ferrand
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Clermont-FerrandFranceUnknown status
CHU de Créteil
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CréteilFranceUnknown status
CHU de DIJON
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DijonFranceUnknown status
CHU de Grenoble
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GrenobleFranceUnknown status
CHU de Lille
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LilleFranceUnknown status
CHU de Limoges
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LimogesFranceUnknown status
CHU de Lyon
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LyonFranceUnknown status
CHU de Montpellier
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MontpellierFranceUnknown status
CHU de Nancy
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NancyFranceUnknown status
CHU de Nantes
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NantesFranceUnknown status
CHU de Nice
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NiceFranceUnknown status
CHU de Nîmes
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NîmesFranceUnknown status
Fondation Rothschild
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ParisFranceUnknown status
CHU Pitie Salpetriere
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ParisFranceUnknown status
CHU Saint-Antoine
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ParisFranceUnknown status
CHI de Poissy-Saint-Germain-en-Laye
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PoissyFranceUnknown status
CHU de Poitiers
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PoitiersFranceUnknown status
CHU de Rennes
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RennesFranceUnknown status
CHU de Strasbourg
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StrasbourgFranceUnknown status
CHU de Toulouse
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ToulouseFranceUnknown status
CHU de Tours
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ToursFranceUnknown status
CHU de Fort de France
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Fort-de-FranceMartiniqueUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.