Clareo Health | A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis
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
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
