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

Neurology Center of New England P.C.

Status: Enrolling

Conditions: Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis

Treatments: Drug: Ublituximab

Study type: Observational

Funder types: Other

Identifiers

NCT06681623

Pro00078205

Details and patient eligibility

About

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

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Aged 55-80 years old
• Diagnosis of RMS according to the 2017 Revised McDonald criteria
• Anticipated to begin treatment with or newly treated with ublituximab (within 6 months prior to study entry) according to the local label

Exclusion criteria

• Active participation in an interventional clinical trial for MS
• Received initial dose of ublituximab more than 6 months prior to study entry
• History of life-threatening infusion reaction on any anti-CD20 therapy
• Evidence of clinically significant chronic or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment, or any history of recurrent infection within 6-12 months prior to initiation of ublituximab