MS breakthrough? trial tests if older patients can ditch heavy drugs
NCT ID NCT07189325
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2031
An estimate. End dates often move.
- Lead sponsor
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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
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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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Genom att skicka in godkänner du våra Användarvillkor
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Neurology Department, Hospital Gui de Chauliac
RECRUITINGMontpellier, 34295, France
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