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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This study is designed to determine whether symptom burden differs by time to infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Receiving Multiple Sclerosis care | Patients currently receiving ocrelizumab or initiating ocrelizumab per their MS treating physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab | Drug | Administer Ocrelizumab under the close supervision of an experienced healthcare professional with access to appropriate medical support to manage severe reactions such as serious infusion reactions.
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life in Neurologic Disorders (NeuroQoL) Scores | The NeuroQoL short form will be used for this study, which consists of 5 statements on how much difficulty one currently has during certain activities. Each statement is answered on a scale of 1 (cannot do) to 5 (none); the total range of score is 1-25. The higher the score, the less difficulty one has. | Week 4, Week 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SymptoMScreen (SyMS) Scores | SyMS consists of 12 questions. Participants are asked to choose a response that best describes how each MS symptom has affected everyday life activities. Each questions is answered on a scale of 0 (not affected at all) to 6 (total limitation/I'm unable to do most daily activities); the total range of score is 0-72. The higher the score, the higher the limitation from MS symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving Multiple Sclerosis care at the NYU Comprehensive MS Care Center or the Elliot Lewis MS Center will be recruited. A clinical list of patients currently receiving ocrelizumab, or potentially starting ocrelizumab will be screened for study inclusion/exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Ilya Kister, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elliot Lewis Center for Multiple Sclerosis Care | Wellesley | Massachusetts | 02481 | United States | ||
| NYU Langone Health Multiple Sclerosis Comprehensive Care Center (NYULH MSCCC) |
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| 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 |
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| ID | Term |
|---|---|
| C533411 | ocrelizumab |
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Study-specific biospecimens (peripheral venous blood) will be collected.
|
|
| Week 4, Week 22 |
| Change in Work Productivity and Activity Impairment Questionnaire: MS (WPAI:MS) Scores | There are 2 questions that are quantifiable - they pertain to how much MS has affected one's productivity while working or ability to do regular daily activities. The questions are answered on a scale of 0 (no effect) to 10 (complete prevention); the total range of score is 0-20. The higher the score, the higher the level of prevention. | Week 4, Week 22 |
| New York |
| New York |
| 10016 |
| United States |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |