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| Name | Class |
|---|---|
| TG Therapeutics, Inc. | INDUSTRY |
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The purpose of the research study is to explore new retinal imaging biomarkers of immune cell activity in MS during use of ublituximab (Briumvi) treatment. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. This study will evaluate the efficacy of ublituximab to modulate MS pathology in a new manner. In order to assess this new biomarker, a specialized optical coherence tomography (OCT) scan will be performed at enrollment into the study and at 2 other timepoints throughout the study.
Subjects asked to take part in this study should have been diagnosed with relapsing multiple sclerosis (MS) and have recently been advised to start the medication ublituximab (Briumvi) or are currently on another medication for the treatment of their MS.
We plan to enroll 30 patients into this study. Fifteen (15) patients with Relapsing Remitting Multiple Sclerosis (RRMS) who are being initiated on B-cell depletion therapy by their treating physician at the University of Maryland Center for MS Treatment and Research will be offered enrollment into this study. Additionally, 15 age/sex matched patients with stable RRMS who are not undergoing any change in treatment and are not currently on B-cell depleting therapies will be enrolled as control subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ublituximab | Active Comparator | Subjects recently prescribed ublituximab will undergo a specialized OCT at Enrollment, Month 6 and Month 12 as well as other neurologic assessments typically used in MS clinical trials such as EDSS, MSFC and SDMT |
|
| Other Disease Modifying Therapy | Active Comparator | People on stable doses of non-B-cell depleting multiple sclerosis disease modifying therapies will undergo the specialized OCT scan at baseline, 6 months, and 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ublituximab | Drug | ublituximab |
| |
| Other disease modifying therapies |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the effect of ublituximab on macular hyperreflective foci (HRF) in MS. | A change in the number of HRF seen on baseline compared to months 6 and 12 in the ublituximab grop compared to the comparison group | From enrollment until the last OCT at Months 6 and 12 |
| Evaluation of the effect of ublituximab on inner limiting membrane (ILM) macrophage-like cells (MLC). | A change in the number of MLCs seen from baseline to months 6 and 12 in the ublituximab group compared to the comparison group. | From enrollment until the last OCT at Months 6 and 12 |
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Inclusion Criteria:
For Ublituximab Group:
For Comparison Group:
Exclusion Criteria:
For Ublituximab Group:
For Comparison Group:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kerry Naunton, RN | Contact | 410-328-1885 | knaunton@som.umaryland.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Harrison, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Baltimore | Recruiting | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000619007 | ublituximab |
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| Other |
Other disease modifying therapies for MS (not ublituximab) |
|
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |