RecruitingPhase 4NCT06733922

ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS

Exploratory Evaluation of Novel Investigational Eye Movement Biomarkers to Track Ofatumumab Treatment Response in Canadian Patients With Active Relapsing-Remitting Multiple Sclerosis (ELIOS)


Sponsor

Novartis Pharmaceuticals

Enrollment

224 participants

Start Date

Nov 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking biological markers in the blood to understand how a drug called ofatumumab changes the course of relapsing-remitting multiple sclerosis (MS) — a type of MS where symptoms come and go. Researchers want to find measurable signs in the blood that show whether the treatment is working. **You may be eligible if...** - You are an adult with active relapsing-remitting MS (diagnosed using 2017 criteria) - Your doctor has already decided to prescribe ofatumumab for you as part of your regular care, but you haven't started it yet - Your MS disability score (EDSS) is between 0 and 7 - You can understand written and spoken English or French - You can provide blood samples **You may NOT be eligible if...** - You have primary or secondary progressive MS without relapses - You are pregnant or breastfeeding - You have another condition that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEETNATM-ProgMS

To that end, the study will use the patented investigational ETNATM-ProgMS SaMD (v1.0.11 or later), which has not yet received Health Canada approval, to reliably and accurately track eye movements with precision. Of note, investigational versions of this SaMD are used for the purpose of clinical research only and will not be commercialized.


Locations(14)

Novartis Investigative Site

Calgary, Alberta, Canada

Novartis Investigative Site

Calgary, Alberta, Canada

Novartis Investigative Site

Edmonton, Alberta, Canada

Novartis Investigative Site

Burnaby, British Columbia, Canada

Novartis Investigative Site

Vancouver, British Columbia, Canada

Novartis Investigative Site

St. John's, Newfoundland and Labrador, Canada

Novartis Investigative Site

Halifax, Nova Scotia, Canada

Novartis Investigative Site

Halifax, Nova Scotia, Canada

Novartis Investigative Site

Ottawa, Ontario, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Québec, Quebec, Canada

Novartis Investigative Site

Sherbrooke, Quebec, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06733922


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