Comparing Annual and Biannual Ocrelizumab Infusions in Adults with Active Multiple Sclerosis After 2 Years of Treatment to Assess Disease Activity

What this Trial Is About

Multiple sclerosis MS is a long-lasting autoimmune disease affecting the central nervous system and is a leading cause of severe disability in young people, impacting many individuals in France. Researchers are studying the effects of ocrelizumab, an anti-CD20 monoclonal antibody, which has shown strong results in reducing disease activity in earlier trials. This study aims to compare the safety and effectiveness of giving ocrelizumab infusions once a year versus the usual every six months in adults with active MS who have already been treated for two years. Participants will receive ocrelizumab infusions either every 12 months or every 6 months. These two schedules will be compared to see if the less frequent dosing is not worse than the standard regimen in controlling the disease. The study is randomized and controlled, involving adults who have already had at least four cycles of semi-annual ocrelizumab. The goal is to see if extending the time between infusions can reduce infection risks and treatment costs without increasing disease activity. During the study, participants will have regular MRI scans to monitor for signs of MS activity, and disease symptoms will be tracked. Researchers will measure the absence of new radiological disease activity after two years as the main outcome. The study includes follow-up visits and assessments to ensure safety and effectiveness, with participants usual care continuing alongside the trial. The total study duration and detailed monitoring will help understand the impact of spacing out ocrelizumab infusions over time.

Impact of Annual Versus Biannual Infusions of Ocrelizumab in Patients With Active MS,After 2 Years of Initial Treatment, on Freedom From Radiological Disease Activity at Two Years: a Multicenter Randomized Controlled Non-inferiority Trial