Multiple SclerosisMS-HealthNCT07645703
MS and Health Cohort
An observational study of Multiple Sclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
This study aims to identify clinical, biological, imaging, and environmental factors that predict the progression and severity of Multiple Sclerosis (MS). We will establish a prospective, highly phenotyped cohort of patients diagnosed with MS according to the 2024 criteria, regardless of disease form or stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 11 Jun 2026to Jun 2034
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a monocentric cohort study conducted at the Fondation Rothschild Hospital, Paris, France (75019). The study will include adult patients with multiple sclerosis diagnosed according to the 2024 diagnostic criteria for multiple sclerosis who are followed at the institution.
Who may be able to join
- Age ≥ 18 years.
- Multiple sclerosis defined according to the 2024 criteria.
- Participant affiliated with or beneficiary of a social security system, Universal - -- Health Coverage (CMU), or any equivalent healthcare coverage scheme.
- Written informed consent.
Who cannot join
- Pregnant or breastfeeding women.
- Progressive disease with a life expectancy of less than one year.
- Inability to undergo MRI
- Person refusing to be informed of any clinically significant finding concerning their health discovered during participation in the study.
- Patient impairment making participation in the study or understanding of the - information provided difficult or impossible.
- Person under legal protection measures (guardianship, curatorship, or judicial protection).
- Person deprived of liberty by judicial or administrative decision.
About this study
Official title: Disability Progression in Multiple Sclerosis: Determinants, Pathophysiology, and Global Health Impact
This study aims to identify clinical, biological, imaging, and environmental factors that predict the progression and severity of Multiple Sclerosis (MS). We will establish a prospective, highly phenotyped cohort of patients diagnosed with MS according to the 2024 criteria, regardless of disease form or stage.
We hypothesize that combining neurological, vascular, metabolic, neuropsychological, environmental, and imaging data (from the central nervous system and the eye) will improve the identification of markers associated with MS progression. This integrative approach will help clarify the respective roles of inflammation, vascular dysfunction, myelin repair, and neurodegeneration in disability accumulation.
Read more
The study will also evaluate the impact of MS, disability, and treatments on patients' physical, mental, and social health, as defined by the World Health Organization (WHO). These results are expected to support personalized patient management and identify modifiable risk factors to reduce disability and inform future therapeutic strategies.
The primary objective is to identify factors that worsen neurological disability in MS patients, including disease-related, comorbidity, and environmental factors. The main outcome measure is time to confirmed disability accumulation (CDA), defined as an increase in the EDSS (Expanded Disability Status Scale) score confirmed after at least 3 months.
This single-center, 5-year prospective cohort study will be conducted at Hôpital Fondation Adolphe de Rothschild (Paris, France), with annual visits. A linkage with national health data (SNDS) will be established for both MS patients and a matched control group (5:1 ratio).
Additional research procedures include:
Ophthalmologic exams (OCT, angio-OCT, fundus photography, pupillometry) at baseline, year 1, 3, and 5.
Brain MRI with additional non-contrast research sequences (annual).
Clinical assessments including arterial stiffness and hearing tests.
Blood sampling (up to 40 mL) for biomarker analyses and long-term biobanking (25 years).
Lumbar puncture if clinically indicated at baseline (with extra samples for research).
Physical activity and circadian rhythm monitoring using a wrist accelerometer for 9 consecutive days.
Standardized questionnaires assessing quality of life, education, and social/professional impact.
Inclusion criteria:
Age ≥ 18 years
Diagnosis of MS according to 2024 criteria
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed disability accumulation (CDA)
The primary endpoint will be time to confirmed disability accumulation. Confirmed disability accumulation (CDA) will be defined as an increase in the Expanded Disability Status Scale (EDSS) score of ≥1.5 points if the previous EDSS score was 0; ≥1.0 point if the previous EDSS score ranged from 1.0 to 5.5; and ≥0.5 point if the previous EDSS score was greater than 5.5 (19). The increase must be confirmed after a minimum of 3 months. Each patient may experience one or several episodes of neurological disability worsening during follow-up.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start11 Jun 2026 (estimated)
- Primary completionJun 2034 (estimated)
- Study completionJun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645703
- Sponsor's protocol ID
- APX_2025_9
- Acronym
- MS-Health
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disability Progression in Multiple Sclerosis: Determinants, Pathophysiology, and Global Health Impact
- ClinicalTrials.gov ID
- NCT07645703
- Acronym / sponsor ID
- MS-Health / APX_2025_9
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 11 Jun 2026 (estimated)
- Primary completion
- Jun 2034 (estimated)
- Study completion
- Jun 2034 (estimated)
- First posted
- 12 Jun 2026 (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.
This study aims to identify clinical, biological, imaging, and environmental factors that predict the progression and severity of Multiple Sclerosis (MS). We will establish a prospective, highly phenotyped cohort of patients diagnosed with MS according to the 2024 criteria, regardless of disease form or stage.
We hypothesize that combining neurological, vascular, metabolic, neuropsychological, environmental, and imaging data (from the central nervous system and the eye) will improve the identification of markers associated with MS progression. This integrative approach will help clarify the respective roles of inflammation, vascular dysfunction, myelin repair, and neurodegeneration in disability accumulation.
The study will also evaluate the impact of MS, disability, and treatments on patients' physical, mental, and social health, as defined by the World Health Organization (WHO). These results are expected to support personalized patient management and identify modifiable risk factors to reduce disability and inform future therapeutic strategies.
The primary objective is to identify factors that worsen neurological disability in MS patients, including disease-related, comorbidity, and environmental factors. The main outcome measure is time to confirmed disability accumulation (CDA), defined as an increase in the EDSS (Expanded Disability Status Scale) score confirmed after at least 3 months.
This single-center, 5-year prospective cohort study will be conducted at Hôpital Fondation Adolphe de Rothschild (Paris, France), with annual visits. A linkage with national health data (SNDS) will be established for both MS patients and a matched control group (5:1 ratio).
Additional research procedures include:
Ophthalmologic exams (OCT, angio-OCT, fundus photography, pupillometry) at baseline, year 1, 3, and 5.
Brain MRI with additional non-contrast research sequences (annual).
Clinical assessments including arterial stiffness and hearing tests.
Blood sampling (up to 40 mL) for biomarker analyses and long-term biobanking (25 years).
Lumbar puncture if clinically indicated at baseline (with extra samples for research).
Physical activity and circadian rhythm monitoring using a wrist accelerometer for 9 consecutive days.
Standardized questionnaires assessing quality of life, education, and social/professional impact.
Inclusion criteria:
Age ≥ 18 years
Diagnosis of MS according to 2024 criteria
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a monocentric cohort study conducted at the Fondation Rothschild Hospital, Paris, France (75019). The study will include adult patients with multiple sclerosis diagnosed according to the 2024 diagnostic criteria for multiple sclerosis who are followed at the institution.
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Multiple sclerosis defined according to the 2024 criteria.
- Participant affiliated with or beneficiary of a social security system, Universal - -- Health Coverage (CMU), or any equivalent healthcare coverage scheme.
- Written informed consent.
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding women.
- Progressive disease with a life expectancy of less than one year.
- Inability to undergo MRI
- Person refusing to be informed of any clinically significant finding concerning their health discovered during participation in the study.
- Patient impairment making participation in the study or understanding of the - information provided difficult or impossible.
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
Confirmed disability accumulation (CDA)
Time frame: 5 years
The primary endpoint will be time to confirmed disability accumulation. Confirmed disability accumulation (CDA) will be defined as an increase in the Expanded Disability Status Scale (EDSS) score of ≥1.5 points if the previous EDSS score was 0; ≥1.0 point if the previous EDSS score ranged from 1.0 to 5.5; and ≥0.5 point if the previous EDSS score was greater than 5.5 (19). The increase must be confirmed after a minimum of 3 months. Each patient may experience one or several episodes of neurological disability worsening during follow-up.
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 12 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Confirmed disability accumulation (CDA) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026.