Study of Eye Movement Biomarkers to Track Ofatumumab Treatment in Adults with Active Relapsing-Remitting Multiple Sclerosis in Canada

What this Trial Is About

Researchers are evaluating novel investigational Eye Movement Biomarkers EMBs to track disease-related changes in Canadian patients with active Relapsing-Remitting Multiple Sclerosis RRMS who are receiving treatment with ofatumumab. This exploratory Phase 4 study aims to assess how well these EMBs can monitor disease progression within a real-world group of patients using a specialized eye tracking software device that has not yet been approved by Health Canada. The study uses an investigational software device called ETNA-ProgMS version 1.0.11 or later to accurately track eye movements. Patients prescribed ofatumumab as part of their routine care will have their eye movements assessed at the start of treatment and again at 3, 6, 12, and 24 months after beginning ofatumumab. This device is used solely for research and is not commercially available. The study focuses on patients with active RRMS starting this specific medication. Participants will attend scheduled visits over a two-year period where eye movement data will be collected alongside clinical assessments such as relapse rates, disability status using EDSS, Timed 25-foot walk, and 9-hole peg tests, and cognitive performance tests. Blood samples will also be taken to measure biomarkers like Neurofilament light Chain. Patient-reported outcomes related to physical, psychological, mobility, and cognitive impacts will be collected. Safety monitoring for adverse events will occur throughout the 24 months of follow-up.

ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS