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

Recruiting · NCT06681623 · Observational (researchers observe without assigning treatment) · Lead sponsor: Neurology Center of New England P.C.

Interventions studied

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

Age range

55 Years to 80 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

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

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

1 location listed across 1 US state.