Study of Ublituximab Safety and Effectiveness in Older Adults Aged 55 to 80 with Relapsing Multiple Sclerosis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of ublituximab in older adults with relapsing forms of multiple sclerosis RMS, focusing on patients aged 55 to 80 years. This study addresses the gap in previous research where RMS patients over 55 were excluded, aiming to better understand how well this drug is tolerated in this population. It is a single-center, prospective cohort study sponsored by Neurology Center of New England P.C. Participants will receive ublituximab treatment, with the study lasting approximately 24 months and including about six visits to the study center. The study will monitor participants from baseline through month 24 or the end of the study, assessing the incidence of infections such as urinary tract infections and other active or chronic infections, as well as treatment-emergent and serious adverse events. During the study, participants will undergo various assessments including brain MRI scans to detect new or enlarging lesions, functional tests like the Expanded Disability Status Scale and Timed 25-Foot Walk Test, and blood tests measuring lymphocyte counts and immunoglobulin levels. Researchers will closely monitor safety and side effects throughout the 24-month period to gain insight into the drugs tolerance in older adults with RMS.

A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)