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Recruiting NCT06681623

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

— Observational Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ublituximab.
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis. Basic parameters: 55 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed 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.

Interventions

  • Drug Ublituximab
    Drug: ublituximab

Primary outcome measures

  • Incidence of infection (including UTI and other active acute, opportunistic and/or chronic infection) [Time frame: From Baseline to Month 24/End of Study]
  • Incidence of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) [Time frame: From Baseline to Month 24/End of Study]
Secondary outcome measures (6)
  • Total number of new and/or enlarging T2 lesions on all available brain MRI scans [Time frame: From Baseline to Month 24/End of Study]
  • Functional Assessment (Expanded Disability Status Scale (EDSS)) [Time frame: From Baseline to Month 24/End of Study]
  • Multiple Sclerosis Impact Scale (MSIS-29) [Time frame: From Baseline to Month 24/End of Study]
  • Absolute lymphocyte count (ALC) [Time frame: From Baseline to Month 24/End of Study]
  • Immunoglobulin levels [Time frame: From Baseline to Month 24/End of Study]
  • Functional Assessment (Timed 25-Foot Walk Test (T25-FW)) [Time frame: From Baseline to Month 24/End of Study]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Neurology Center of New England P.C. — Foxborough

Identifiers

NCT: NCT06681623 · Pro00078205

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗