Study of Ozanimod as a New Treatment After Anti-CD20 Therapy in Adults with Relapsing Multiple Sclerosis

What this Trial Is About

Researchers are investigating the use of ozanimod as a de-escalation therapy in patients with relapsing forms of multiple sclerosis MS who have been clinically stable and previously treated with anti-CD20 therapies. This multicenter, open-label, prospective study aims to evaluate the safety and effectiveness of switching to ozanimod compared to continuing anti-CD20 treatment over a 36-month period. The study includes a comparison group of patients continuing anti-CD20 therapy to better understand outcomes in stable MS patients. Participants in the experimental group will begin ozanimod treatment 6 to 12 months after their last anti-CD20 infusion, including subcutaneous ocrelizumab, or 30 to 180 days after their last ofatumumab injection. Ozanimod will be provided by the study. The comparison group will continue their anti-CD20 treatment. The study follows patients for 36 months to monitor and compare the two approaches. Throughout the study, participants will undergo various assessments including brain MRI scans, laboratory tests, and monitoring for new T2 lesions and serious infections. Researchers will also track relapses, immunoglobulin levels, infection rates, disease activity status, brain volume changes, and adverse events. Participants must be able to comply with visit schedules, undergo brain MRI without anesthesia, and follow contraception guidelines if applicable. The study continues for 36 months, allowing detailed evaluation of long-term outcomes and safety.

Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod