Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
Conditions
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.
Interventions
DRUGUblituximab
Drug: ublituximab
Sponsors
Neurology Center of New England P.C.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 (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 |
| Immunoglobulin levels | From Baseline to Month 24/End of Study | Change from Baseline to Month 24/End of Study in immunoglobulin levels |
| 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 |
Countries
United States
Contacts
Primary ContactSalvatore Napoli, MD
Backup ContactRachel ODonnell, BS
Outcome results
None listed