Multiple SclerosisOFSEP HDNCT03603457
OFSEP High Definition Cohort
An observational study of Multiple Sclerosis, run by EDMUS Foundation at 25 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 2,842 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 10 Jul 2018to Dec 2027
- How long will I take part?
- 8 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All MS patients from MS Clinical Reference Centre (CRC SEP).
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
France24 sites
CHU de Besançon
Besançon
CHU de Bordeaux
Bordeaux
CHU de Caen
Caen
CHU de Clermont-Ferrand
Clermont-Ferrand
CHU de Créteil
Créteil
CHU de Dijon
Dijon
CHU de Grenoble
Grenoble
CHU de Lille
Lille
CHU de Limoges
Limoges
CHU de Lyon
Lyon
CHU de Montpellier
Montpellier
CHU de Nancy
Nancy
CHU de Nantes
Nantes
CHU de Nice
Nice
CHU de Nîmes
Nîmes
CHU Pitié-Salpétrière
Paris
CHU Saint-Antoine
Paris
Fondation Rothschild
Paris
CHI de Poissy-Saint-Germain-en-Laye
Poissy
CHU de Poitiers
Poitiers
CHU de Rennes
Rennes
CHU de Strasbourg
Strasbourg
CHU de Toulouse
Toulouse
CHU de Tours
Tours
About this study
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:
Read more
- 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;
- To study the effectiveness of treatments in real life;
- 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.
- Conditions
- Multiple Sclerosis
- Keywords
- Epidemiology, Prognostic factors, Stratified medicine, Quality of life, Economic assessment
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach irreversible Expanded Disability Status Scale (EDSS) scores of 6
Measured: 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)
Measured: 1 year
Change in T2 lesion load evaluated by analysis of raw MRI
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start10 Jul 2018
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,842 participants (actual)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- EDMUS Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603457
- Sponsor's protocol ID
- 002
- Acronym
- OFSEP HD
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2018
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 40194873
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OFSEP High Definition Cohort
- ClinicalTrials.gov ID
- NCT03603457
- Acronym / sponsor ID
- OFSEP HD / 002
- Conditions
- Multiple Sclerosis
- Keywords
- Epidemiology, Prognostic factors, Stratified medicine, Quality of life, Economic assessment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,842 participants (actual)
- Lead sponsor
- EDMUS FoundationUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- To study the effectiveness of treatments in real life;
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Years
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All MS patients from MS Clinical Reference Centre (CRC SEP).
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Derived from this study: PubMed 40194873Guillemin 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by EDMUS Foundation at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to reach irreversible Expanded Disability Status Scale (EDSS) scores of 6 (time frame: Through study completion, an average of 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03603457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.