A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)
- Conditions
- Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
- Registration Number
- NCT06681623
- Lead Sponsor
- Neurology Center of New England P.C.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of infection (including UTI and other active acute, opportunistic and/or chronic infection) From Baseline to Month 24/End of Study Incidence of infection rate from Baseline to Month 24/End of Study
Incidence of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) From Baseline to Month 24/End of Study Incidence of TEAEs/SAEs from Baseline to Month 24/End of Study
- Secondary Outcome Measures
Name Time Method Total number of new and/or enlarging T2 lesions on all available brain MRI scans From Baseline to Month 24/End of Study Change from Baseline to Month 24/End of Study in total number of new and/or enlarging T2 lesions on all available brain MRI scans
Functional Assessment (Expanded Disability Status Scale (EDSS)) From Baseline to Month 24/End of Study Change from Baseline to Month 24/End of Study in EDSS
Multiple Sclerosis Impact Scale (MSIS-29) From Baseline to Month 24/End of Study Change from Baseline to Month 24/End of Study in Multiple Sclerosis Impact Scale (MSIS-29)
Absolute lymphocyte count (ALC) From Baseline to Month 24/End of Study Change from Baseline to Month 24/End of Study in ALC
Immunoglobulin levels From Baseline to Month 24/End of Study Change from Baseline to Month 24/End of Study in immunoglobulin levels
Functional Assessment (Timed 25-Foot Walk Test (T25-FW)) From Baseline to Month 24/End of Study Change from Baseline to Month 24/End of Study in T25-FW
Trial Locations
- Locations (1)
Neurology Center of New England P.C.
🇺🇸Foxboro, Massachusetts, United States