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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
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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ublituximab | Drug | Drug: ublituximab |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of infection (including UTI and other active acute, opportunistic and/or chronic infection) | Incidence of infection rate from Baseline to Month 24/End of Study | From Baseline to Month 24/End of Study |
| Incidence of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) | Incidence of TEAEs/SAEs from Baseline to Month 24/End of Study | From Baseline to Month 24/End of Study |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of new and/or enlarging T2 lesions on all available brain MRI scans | 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 | From Baseline to Month 24/End of Study |
| Functional Assessment (Expanded Disability Status Scale (EDSS)) |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible subjects meeting protocol-specified criteria will be recruited from the Neurology Center of New England P.C.'s internal patient database
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salvatore Napoli, MD | Contact | 781-551-5812 | ksciore@myneurodr.com | |
| Rachel ODonnell, BS | Contact | 781-551-5812 | 2 | ResearchNCNE@myneurodr.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology Center of New England P.C. | Recruiting | Foxborough | Massachusetts | 02035 | United States |
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Change from Baseline to Month 24/End of Study in EDSS |
| From Baseline to Month 24/End of Study |
| Multiple Sclerosis Impact Scale (MSIS-29) | Change from Baseline to Month 24/End of Study in Multiple Sclerosis Impact Scale (MSIS-29) | From Baseline to Month 24/End of Study |
| Absolute lymphocyte count (ALC) | Change from Baseline to Month 24/End of Study in ALC | From Baseline to Month 24/End of Study |
| Immunoglobulin levels | Change from Baseline to Month 24/End of Study in immunoglobulin levels | From Baseline to Month 24/End of Study |
| Functional Assessment (Timed 25-Foot Walk Test (T25-FW)) | Change from Baseline to Month 24/End of Study in T25-FW | From Baseline to Month 24/End of Study |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000619007 | ublituximab |
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