Actively Recruiting
ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS
Led by Novartis Pharmaceuticals · Updated on 2026-03-20
224
Participants Needed
14
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients prescribed ofatumumab as part of routine care who have not yet received their first dose
- Patients or their legal representatives who provide informed consent
- Patients with an Expanded Disability Status Scale (EDSS) score between 0 and 7 at screening and enrollment
- Diagnosis of active Relapsing-Remitting Multiple Sclerosis according to 2017 Revised McDonald criteria
- Ability to provide blood samples
- Ability to understand written and spoken Canadian English or French
- Sufficient corrected vision to accurately read on-screen visual instructions, with allowance for postponement if affected by relapse
- Confirmed MS diagnosis with no progressive increase in physical disability independent of relapse activity within past six months as assessed by a physician
You will not qualify if you...
- Patients with primary progressive MS, secondary progressive MS without disease activity, clinically isolated syndrome, or radiologically isolated syndrome
- Any condition interfering with study participation or compliance
- Pregnant or nursing (lactating) women
- Women of child-bearing potential not using effective contraception while on ofatumumab and for six months after
- Hypersensitivity to ofatumumab or any formulation ingredient, active hepatitis B, progressive multifocal leukoencephalopathy, severe infections, immunocompromised state, or active malignancies
- Active chronic immune diseases other than MS or immunodeficiency syndromes
- Use of other investigational drugs within 30 days or five elimination half-lives before baseline
- Contraindications or inability to undergo regular testing per standard care
- Treatment with cladribine or alemtuzumab within 12 months prior to baseline
- Prior exposure to anti-CD20 B-cell therapy or natalizumab
- Medical history or conditions that may affect movements or oculomotor control as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Novartis Investigative Site
Calgary, Alberta, Canada, T2N 4N1
Actively Recruiting
2
Novartis Investigative Site
Calgary, Alberta, Canada, T3M 1M4
Actively Recruiting
3
Novartis Investigative Site
Edmonton, Alberta, Canada, T6G 2C8
Actively Recruiting
4
Novartis Investigative Site
Burnaby, British Columbia, Canada, V5G 2X6
Actively Recruiting
5
Novartis Investigative Site
Vancouver, British Columbia, Canada, V6T 2A1
Actively Recruiting
6
Novartis Investigative Site
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Actively Recruiting
7
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3H 3A7
Actively Recruiting
8
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3R 1V9
Actively Recruiting
9
Novartis Investigative Site
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
10
Novartis Investigative Site
Montreal, Quebec, Canada, H1K 3V9
Actively Recruiting
11
Novartis Investigative Site
Montreal, Quebec, Canada, H3A 0G4
Actively Recruiting
12
Novartis Investigative Site
Montreal, Quebec, Canada, H4A 3T2
Actively Recruiting
13
Novartis Investigative Site
Québec, Quebec, Canada, G1W 4R4
Actively Recruiting
14
Novartis Investigative Site
Sherbrooke, Quebec, Canada, J1G 2E8
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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