NCT03603457|Active Not Recruiting
OFSEP High Definition Cohort
OFSEP HD
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OFSEP HD
Sponsor study identifier
observational
2,842
2 countries
25
Study Start
July 10, 2018
Actual (reported)Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 28, 2018
Actual (reported)July 10, 2018
Actual (reported)July 27, 2018
Actual (reported)December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
All MS patients from MS Clinical Reference Centre (CRC SEP).
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
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.
blood, serum
2,842 participants (actual enrollment reported by the registry).
First Submitted
June 28, 2018
First Posted
July 27, 2018
Study Start
July 10, 2018
Actual (reported)Wearable Biosensor to Track and Quantify Limb Dysfunction in Multiple Sclerosis Patients
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
Contact the study team to confirm eligibility.
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
Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 14, 2026
Record last verified: 2026-07
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Source: ClinicalTrials.gov.
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