Actively Recruiting

Phase 4
Age: 18Years - 99Years
All Genders
NCT06733922

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

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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