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

NCT06681623

RecruitingN/A

Sponsor: Neurology Center of New England P.C.

Conditions: Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis

Interventions: Ublituximab

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 55 Years to 80 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (1)

Foxborough, Massachusetts, United States