Status:
NOT_YET_RECRUITING
A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Relapsing-Remitting Multiple Sclerosis (RRMS)
Anti-CD20 Therapy
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
Multiple sclerosis (MS), the main central nervous system autoimmune disorder, is the first cause of non-traumatic disability in young adults and has thus significant individual consequences with eleva...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT07189325
Start Date
September 1 2025
End Date
September 1 2030
Last Update
September 23 2025
Active Locations (1)
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1
Neurology Department, Hospital Gui de Chauliac
Montpellier, France, 34295