Summary

Eligibility
for people ages 18-50 (full criteria)
Location
at UCLA
Dates
study started
study ends around
Principal Investigator
by Bijal Mehta (ucla)

Description

Summary

This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch to ofatumumab.

Official Title

A Randomized, Open Label, Multi-center, Active-comparator Study to Assess Efficacy, Safety & Tolerability of Ofatumumab 20mg sc Monthly Versus Continued Current Therapy in Relapsing-remitting Multiple Sclerosis After Elevation of Serum Neurofilament Light Levels (SOSTOS)

Details

This is a multicenter, prospective study of up to 150 relapsing-remitting MS participants/ The study is looking to see if patients who have not had a relapse in the past year would benefit from switching to ofatumumab.

After giving consent, participants will have a 1 week screening/qualification period. If they qualify to continue, they will start a a six month run-in period during which lab samples will be collected. Patients that are relapse-free during the run-in period will continue into next period of the study in which they will be randomized to either ofatumumab or continued therapy for the next 15 months. Every 3 out of 5 randomized participants will be selected to wear a digital study watch to collect physical activity, sleep, and vitals during this 15 month period. The study watch will be worn 24 hours a day, 7 days a week but can be removed during showers/bathing. At the end of the 15 month period, a study completion visit will be held.

The total study duration is 21 months plus 1 week for screening/qualification.

Keywords

Relapsing-Remitting Multiple Sclerosis, Ofatumumab, Multiple Sclerosis, adult, OMB157, RRMS, MS, secondary progressive MS, relapse, Sclerosis, Disease modifying treatment (DMT)

Eligibility

Locations

  • University of California at Los Angeles accepting new patients
    Torrance California 90509-2004 United States
  • Arizona Neuroscience Research LLC accepting new patients
    Phoenix Arizona 85032 United States

Lead Scientist at University of California Health

  • Bijal Mehta (ucla)
    HS Associate Clinical Professor, Neurology, Medicine. Authored (or co-authored) 9 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT05090371
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated