Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
2842 participants
OBSERVATIONAL
2018-07-10
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Inability to answer questionnaires
* Pregnant women at the time of inclusion
15 Years
ALL
No
Sponsors
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EDMUS Foundation
OTHER
Responsible Party
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Locations
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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 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, , France
CHU de Fort-de-France
Fort-de-France, , Martinique
Countries
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References
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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.
Other Identifiers
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002
Identifier Type: -
Identifier Source: org_study_id
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