For patients with active multiple sclerosis, impact of annual versus semi-annual infusions of ocrelizumab after 2 years of initial treatment on the absence of radiological disease activity at 2 years: a multicentre randomised controlled non-inferiority trial

Phase 1

Recruiting

Conditions: Multiple sclerosis
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: CTIS2023-505420-62-00

Lead Sponsor: Hopital Fondation Adolphe De Rothschild

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 192

Inclusion Criteria

Patient 18 years or older, Coming for a 4th semester cycle of ocrelizumab (at least), Requires follow-up cerebral-medullary MRI as part of care, Who had relapsing remitting or secondarily progressive MS at the time of initiation of anti-CD20 (ocrelizumab or rituximab) therapy : relapse or radiological activity in the year priori to initiation of high-efficacy treatment, No relapse for at least 18 months, EDSS between 0 and 6 inclusive, Having received information about the study and having signed a consent to participate in the study, Knowledge of the French language, Affiliated or beneficiary to a social security scheme

Exclusion Criteria

Clinical forms of primary progressive multiple sclerosis (PP), Pregnant or breast-feeding woman, Patients already receiving routine spacing = 9 months of ocrelizumab doses, Contra-indication to continued treatment with ocrelizumab (hypersensitivity reaction, ongoing active infection, development of a malgnant disease since the previous inhection, development of a severe immune deficiency), Planning a pregnancy within 3 years, Contra-indication to MRI, Contra-indication to the injection of contrast products, Subjects with severe or uncontrolled symptoms of renal, hepatic, haematological, gastrointestinal, pulmonary, psychiatric or cardiac disease or any uncontrolled intercurrent disease, Patient under legal protection measure, Patients of childbearing potential who do not wish to use effective contraception during their participation and at least 12 months after the last dose (oral commitment of the patient recorded in the medical file by the investigator)