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

Last updated: November 15, 2024
Sponsor: Neurology Center of New England P.C.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Loss

Neurologic Disorders

Multiple Sclerosis

Treatment

Ublituximab

Clinical Study ID

NCT06681623
Pro00078205
  • Ages 55-80
  • All Genders

Study Summary

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 Criteria

Inclusion

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 6months prior to study entry) according to the local label

Exclusion

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, orfungal infectious disease requiring long term systemic treatment, or any history ofrecurrent infection within 6-12 months prior to initiation of ublituximab

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Ublituximab
Phase:
Study Start date:
August 13, 2024
Estimated Completion Date:
September 30, 2027

Study 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.

Connect with a study center

  • Neurology Center of New England P.C.

    Foxboro, Massachusetts 02035
    United States

    Active - Recruiting

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