Exploratory Evaluation of Novel Investigational Eye Movement Biomarkers to Track Ofatumumab Treatment Response in Canadian Patients With Active Relapsing-Remitting Multiple Sclerosis (ELIOS)
The exploratory ELIOS study aims to assess the value of novel investigational Eye Movement Biomarkers (EMBs) in tracking disease-related changes among a real-world cohort of Canadian patients with active RRMS, within the context of disease-modifying treatment (i.e., ofatumumab). To that end, the study will use the patented investigational, Eye Tracking Neurological Assessment (ETNA-ProgMS) SaMD (v1.0.11 or later), which has not yet received Health Canada approval, to reliably and accurately track eye movements with precision.
⁃ Patients eligible for inclusion in the study must fulfill all of the following criteria:
• Adult patients who are prescribed ofatumumab as part of routine clinical care as per the PM but who have not yet received their first dose. The decision to prescribe ofatumumab must be made prior to and independent of study participation.
• Patients or their legally authorized representatives who sign the Institutional Review Boards/Independent Ethics Committee (IRB/IEC)-approved informed consent form.
• Patients who meet the EDSS score range of 0 up to 7 at the time of screening and enrollment for ofatumumab treatment.
• Patients with a diagnosis of active RRMS according to the 2017 Revised McDonald criteria2.
• Patients who can provide blood samples.
• Patients who can understand written and spoken Canadian English or French.
• Patients who have sufficient corrected visual acuity to allow for accurate reading of the on-screen visual task instructions, in the judgement of the Investigator. If a relapse temporarily affects a patient's corrected visual acuity, the Baseline Visit may be postponed until the patient can accurately read the on-screen visual task instructions, if deemed acceptable by the Investigator and the patient.
• Patients with a confirmed diagnosis of MS with no signs of progressive increase in physical disability independent of relapse activity within the past six months, as assessed by a physician.