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A Single-Center, Prospective Cohort Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)
The purpose of this study is to evaluate the safety of ublituximab use in the older MS adult population, as measured by incidence of infection rate
This study is being done to see how safe and effective ublituximab is when given to older adult patients for their RMS. Since RMS patients over age 55 were excluded from previous clinical studies that studied the safety and efficacy of ublituximab, this study is designed to better understand how well this drug is tolerated in RMS patients between the ages of 55-80 years. Primary endpoints include: * Incidence of infection rate from Baseline to Month 24/EOS (including UTI and other active acute, opportunistic and/or chronic infection) * Incidence of TEAS/SAEs from Baseline to Month 24 with consideration to nature, severity, and occurrence rate of AEs Approximately 20 participants are expected to be enrolled. Participation in this study will last approximately 24 months and will include approximately 6 study visits to the study center.
Age
55 - 80 years
Sex
ALL
Healthy Volunteers
No
Neurology Center of New England P.C.
Foxborough, Massachusetts, United States
Start Date
August 13, 2024
Primary Completion Date
September 30, 2027
Completion Date
September 30, 2027
Last Updated
November 18, 2024
20
ESTIMATED participants
Ublituximab
DRUG
Lead Sponsor
Neurology Center of New England P.C.
Data Source & Attribution
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