ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS (NCT06733922) | Clinical Trial Compass
RecruitingPhase 4
ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS
Canada224 participantsStarted 2024-11-27
Plain-language summary
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.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion 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.
Exclusion criteria
✕. Patients with primary progressive MS, secondary progressive MS without disease activity, clinically isolated syndrome, or radiologically isolated syndrome.
✕. Any disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.
✕. Pregnant or nursing (lactating) women.
✕. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception while taking ofatumumab and for six months after stopping medication. Effective contraception methods include:
✕. Patients with hypersensitivity to ofatumumab or to any ingredient in the formulation, active hepatitis B virus, progressive multifocal leukoencephalopathy (PML), severe active infections, in a severely immunocompromised state or with known active malignancies.
✕. Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency).
✕. Patients who are using other investigational drugs within 30 days prior to or at the Baseline Visit, or within a period corresponding to five elimination half-lives, whichever is longer, or who are using other investigational drugs for which the expected pharmacodynamic effect has not returned to baseline.
✕. Contraindication or inability to undergo regular testing (e.g., MRI, blood tests) as per standard of care.