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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2030

Study Completion Date

September 30, 2030

Conditions
Relapsing-Remitting Multiple Sclerosis (RRMS)Anti-CD20 Therapy
Interventions
DRUG

Platform therapies (Dimethyl Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons)

"Patients randomized in the experimental group will be treated with platform therapies (Dimethyl Fumarate, Diroximel Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons) according to treatments' authorization from the day of randomization to M36 described below.~Patients will receive appropriate information and recommendation for the initiation of the chosen platform treatment as mention in the SmPC by treating neurologist or a member of the investigating team. If therapies are not tolerated, a therapeutic switch to other platform therapies will be possible. Any switch to a disease modifying therapy not listed as platform therapy will be considered as a major protocol deviation (see statistics).~Patients are allowed to switch from any platform DMT to another platform DMT."

DRUG

Anti-CD20 therapies (Ocrelizumab, Rituximab, Ofatumumab)

"Patients randomized in the control group will be treated every 6 months (or at previous extended interval dosing) for patients with anti-CD20 (Ocrelizumab, Rituximab) or every 4 weeks for patients with subcutaneous anti-CD20 (Ofatumumab) from the day of randomization to M36. If therapies are not tolerated, a therapeutic switch to other anti-CD20 therapy will be possible. Any switch to a disease modifying therapy not listed as anti-CD20 therapy will be considered as major protocol deviation (see statistics).~Patients are allowed to switch from any anti-CD20 to another anti-CD20."

Trial Locations (1)

34295

Neurology Department, Hospital Gui de Chauliac, Montpellier

All Listed Sponsors
lead

University Hospital, Montpellier

OTHER