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AI-Powered tool aims to sharpen MS treatment choices

NCT ID NCT07647952

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a computer program called PRIMUS that helps neurologists choose treatments for people with relapsing-remitting multiple sclerosis (MS). The tool uses data from past patients to predict how the disease might progress under different therapies. Doctors in some clinics will use the tool during consultations, while others will not. The goal is to see if the tool leads to more use of highly effective treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Clinical decision support system (CDSS) software
What this could lead to
If successful, this tool could help doctors and patients make more informed, personalized treatment decisions for multiple sclerosis, potentially improving outcomes.
What could go wrong
The study is relatively small and focuses on decision-making rather than direct health outcomes. The tool may not change treatment choices or improve patient health in the long run.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 448 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men and women aged \>18 and ≤50 years. * Patients with relapsing-remitting multiple sclerosis (RRMS) according to the McDonald 2024 criteria. * Patients for whom a change in therapeutic management is being considered due to: * intolerance to treatment or personal preference in the absence of inflammatory activity, whether patients are: * on a moderately effective disease-modifying therapy \[Interferon beta; Glatiramer acetate; Teriflunomide; Dimethyl fumarate; Diroximel fumarate\] for at least 12 months without interruption * on anti-S1P therapy \[Fingolimod; Ponesimod\] for at least 12 months without interruption or * recent inflammatory activity (relapse or at least one T1 Gd+ lesion or one new T2 lesion) reported or observed at inclusion, whether patients are: * treatment-naïve * on a moderately effective disease-modifying therapy for at least 6 months or on anti-S1P therapy for at least 6 months * untreated for at least one year * Patients with MRI follow-up including at least one 3D brain FLAIR sequence and a T1 Gd+ sequence in the case of a re-baseline brain MRI within the past 6 months. * Patients whose MRI scans are available for download on the day of consultation. * Patients affiliated with or beneficiaries of a social security system. * Patients able to provide written informed consent. For women of childbearing potential, use of an effective method of contraception throughout the study in accordance with the recommendations of the Clinical Trials Coordination Group Exclusion Criteria: * Patients with a progressive form of multiple sclerosis (primary or secondary). * Patients with current or past history of other autoimmune diseases. * Patients with uncontrolled disease, other than active MS. * Patients exposed to Mitoxantrone, Alemtuzumab, or Cladribine within the 3 years prior to inclusion. * Patients exposed to Ocrelizumab or Rituximab within the 18 months prior to inclusion. * Patients exposed to Ofatumumab within the 12 months prior to inclusion. * Patients receiving high-efficacy disease-modifying therapy \[Natalizumab; Ofatumumab; Alemtuzumab; Cladribine; Mitoxantrone; Ocrelizumab\], or Rituximab, with the exception of S1P receptor modulators. * Patients receiving Mycophenolate mofetil, azathioprine, cyclophosphamide (Endoxan), or having undergone stem cell transplantation. * Patients participating in another clinical trial, whether therapeutic or not, that could interfere with the objectives of the study. * Patients who have participated in a therapeutic trial within the 24 months prior to inclusion. * Pregnant or breastfeeding women, or those planning pregnancy during the study. * Patients under legal protection (guardianship, curatorship, or other protective measures).

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsing-remitting multiple sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Angers Hospital

    Angers, 49933, France

  • Antibes Hospital

    Antibes, 06606, France

  • Bordeaux Hospital

    Bordeaux, 33076, France

  • CHD Vendee

    La Roche-sur-Yon, 85925, France

  • CHIC Poissy

    Poissy, 78303, France

  • CHR Metz-Thionville / Mercy Hospital

    Metz, 57530, France

  • CHU Brest

    Brest, 29609, France

  • CHU Colmar

    Colmar, France

  • Caen Hospital

    Caen, 14000, France

  • Clermont-Ferrand Hospital

    Clermont-Ferrand, France

  • Dijon Hospital

    Dijon, 21079, France

  • Grenoble Alpes Hospital

    Grenoble, 38700, France

  • Groupement Hospitalier Brocéliande Atlantique Vannes

    Vannes, 56017, France

  • Groupement Hospitalier Rance Emeraude Saint Malo

    St-Malo, France

  • Hopital Fondation ROTSCHILD

    Paris, 75019, France

  • Hospices civils de Lyon

    Lyon, 69500, France

  • Hôpital Emile Durkheim Epinal

    Épinal, 88000, France

  • Hôpital Henri Mondor

    Créteil, 94000, France

  • Lille Hospital

    Lille, 59037, France

  • Marseille Hospital / La Timone

    Marseille, 13385, France

  • Montpellier Hospital

    Montpellier, 34295, France

  • Nancy Hospital

    Nancy, 54035, France

  • Nice Hospital

    Nice, 06000, France

  • Nimes Hospital

    Nîmes, 30029, France

  • Poitiers Hospital

    Poitiers, 86021, France

  • Rennes Hospital

    Rennes, 35000, France

  • Rouen Hospital

    Rouen, 76000, France

  • Saint-Brieuc Hospital

    Saint-Brieuc, 22027, France

  • Strasbourg Hospital

    Strasbourg, 67200, France

  • Toulouse Hospital

    Toulouse, 31059, France

  • tours Hospital

    Tours, 37044, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.