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MS breakthrough? trial tests if older patients can ditch heavy drugs

NCT ID NCT07189325

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether people with relapsing-remitting multiple sclerosis (RRMS) who are over 40 and have been stable on strong anti-CD20 drugs for at least 3 years can safely switch to milder treatments. The goal is to see if this de-escalation approach prevents disease activity and disability worsening just as well as staying on the stronger therapy. The trial will involve 250 participants and aims to reduce treatment burden while maintaining control of the disease.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 250 people

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

Started

Jun 2026

Expected to finish

Jun 2031

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

40 years and older

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 : * Patients ≥40 years at inclusion * Patients with relapsing remitting multiple sclerosis at inclusion (according to 2017 McDonald criteria) treated with anti-CD20 for at least the last 3 years. For patients treated with IV ocrelizumab or rituximab at extended interval dosing, a maximum interval of 12 months between perfusions during the year before inclusion visit is required. * No evidence of disease activity for the last 3 years on anti-CD20 (No relapse AND no new/enlarged MRI lesion) * Brain MRI performed according to OFSEP protocol within a maximum of 6 months before randomization Non-inclusion criteria : * Secondary or primary progressive MS at inclusion * Previous experience of treatment failure in patients treated with natalizumab, fingolimod, rituximab, ocrelizumab, mitoxantrone, alemtuzumab or cladribine * Treatment with high dose corticosteroids during the 30 days preceding inclusion * Contraindication to MRI * Severely immunocompromised state * Current severe active infection * Known active malignancy * Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease * Severe hepatic impairment (Child-Pugh class C) * Significantly impaired bone marrow function or significant anaemia, leukopenia, neutropenia or thrombocytopenia * Severe renal impairment undergoing dialysis * Severe hypoproteinaemia, e.g. in nephrotic syndrome * Current severe depression and/or suicidal ideation * Suspected or confirmed progressive multifocal leukoencephalopathy (PML) * Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications * Participation in another therapeutic trial in the last 6 months * Protected population according to articles of the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship/curatorship) * All women of childbearing age not using effective contraception during the study * Subjects not covered by public health insurance * Failure to obtain written informed consent after a reflection period

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • Neurology Department, Hospital Gui de Chauliac

    RECRUITING

    Montpellier, 34295, France

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