Clinical trial NCT06681623: A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
Lead sponsor: Neurology Center of New England P.C.
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible subjects meeting protocol-specified criteria will be recruited from the Neurology Center of New England P.C.'s internal patient database

Brief 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

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.

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

Primary outcomes:
measure: Incidence of infection (including UTI and other active acute, opportunistic and/or chronic infection)
timeFrame: From Baseline to Month 24/End of Study
measure: Incidence of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs)
timeFrame: From Baseline to Month 24/End of Study
Secondary outcomes:
measure: Total number of new and/or enlarging T2 lesions on all available brain MRI scans
timeFrame: From Baseline to Month 24/End of Study
measure: Functional Assessment (Expanded Disability Status Scale (EDSS))
timeFrame: From Baseline to Month 24/End of Study
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: From Baseline to Month 24/End of Study
measure: Absolute lymphocyte count (ALC)
timeFrame: From Baseline to Month 24/End of Study
measure: Immunoglobulin levels
timeFrame: From Baseline to Month 24/End of Study
measure: Functional Assessment (Timed 25-Foot Walk Test (T25-FW))
timeFrame: From Baseline to Month 24/End of Study
Other outcomes:
Locations:
city: Foxboro
country: United States
facility: Neurology Center of New England P.C.
state: Massachusetts
Study officials:
References: