A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)
What it found
No result yet.
What was tested
Treatment tested
- Ublituximab
B-lymphocyte antigen CD20 binding agent
What it measured
Main measures
Incidence of infection (including UTI and other active acute, opportunistic and/or chronic infection)
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
Safety
Other measures (6)
Total number of new and/or enlarging T2 lesions on all available brain MRI scans
From Baseline to Month 24/End of Study
MRI lesionsFunctional Assessment (Expanded Disability Status Scale (EDSS))
From Baseline to Month 24/End of Study
Disability progressionMultiple Sclerosis Impact Scale (MSIS-29)
From Baseline to Month 24/End of Study
Quality of life (reported by participants)Absolute lymphocyte count (ALC)
From Baseline to Month 24/End of Study
Immune responseImmunoglobulin levels
From Baseline to Month 24/End of Study
Functional Assessment (Timed 25-Foot Walk Test (T25-FW))
From Baseline to Month 24/End of Study
Disability progressionWalking and mobility
Who could take part
Relapsing MS · 55 to 80
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
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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
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History
Started
Aug 2024
Main results due
Sept 2027
Finished
Sept 2027
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