Health TrialsbyHealthPanel

ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS

ConditionRelapsing Remitting Multiple Sclerosis (RRMS)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-99
SponsorNovartis Pharmaceuticals

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception

Trial design

Design model

Single group

Treatments tested in this trial

  • ETNATM-ProgMS

    Device

    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.

Treatment groups

224 Participants
are divided into 1 treatment group
Group A: ETNATM-ProgMSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1- Change Eye Movement Biomarkers (EMB)

Change in subtle eye movement anomalies referred to as Eye Movement Biomarkers (EMBs). EMB are derived from composite scores of various Eye Movement metrics. Results stratified by patients experiencing a clinically meaningful change (CMC) in at least one traditional MS outcome (CMCp) or no CMC in all traditional MS outcomes (CMCs/i) at 24 months (or at the time of ofatumumab discontinuation and treated with ofatumumab for at least 12 months)

Time frame
6 months from baseline

Secondary outcomes

1

1a. Change in EMB

Change in subtle eye movement anomalies referred to as Eye Movement Biomarkers (EMBs). EMB are derived from composite scores of various Eye Movement metrics

Time frame
3,12 and 24 months from Baseline
2

1b. Change in EMB trajectories

Trajectories of investigational EMBs over time

Time frame
3-, 6-, 12-, and 24-months
3

2a. Change in Annual Relapse Rate (ARR)

MS relapse is defined as the appearance of a new neurological abnormality or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must have been present for at least 24 hours and must have occurred in the absence of fever (\< 37.5°C) or of a known infection.

Time frame
12 and 24 months from baseline
4

2b. Change in patient disability measured by Expanded Disability Status Scale EDSS

The EDSS is an ordinal scale used for assessing neurologic impairment in MS based on a neurological examination. It consists of scores in each of seven functional systems (FSs) and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 \[normal\] to 10 (death due to MS). The FSs are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel \& Bladder, and Cerebral functions

Time frame
3,6,12,24 months from baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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