Anti-CD20 maintenance vs. de-escalation in relapsing-remitting MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 randomized non-inferiority study compares a maintenance strategy of anti-CD20 therapy with a de-escalation approach in adults with relapsing-remitting MS who have stable disease on anti-CD20 for at least 3 years. Eligible participants must have no relapses or new MRI lesions in the prior 3 years and meet imaging criteria per OFSEP. Interventions include platform disease-modifying therapies and anti-CD20 agents such as ocrelizumab, rituximab, or ofatumumab. The trial aims to determine if reducing treatment intensity maintains similar efficacy while potentially lowering risks and burden. Primary outcomes focus on relapse activity and MRI/clinical disease control, with secondary analyses on safety and patient-reported outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Neurology Department, Hospital Gui de Chauliac
  Montpellier, France Recruiting

Study contacts

• Study coordinator: Xavier AYRIGNAC, Medical Doctor
• Email: x-ayrignac@chu-montpellier.fr
• Phone: +33 4 67 33 74 13

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.