Multiple Sclerosis
Conditions
Brief summary
This study is designed to determine whether symptom burden differs by time to infusion.
Interventions
DRUGOcrelizumab
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. * Initial dose: 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion. * Subsequent doses: single 600 mg intravenous infusion every 6 months. * Observe the patient for at least one hour after the completion of the infusion
Sponsors
Genentech, Inc.
NYU Langone Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 * Diagnosis of multiple sclerosis (revised 2017 criteria) * EDSS 0-7 * Plans to initiate treatment with ocrelizumab within 6 months or has been on an approved regimen of ocrelizumab for \>12 months as part of their clinical care * Individual must be able to provide consent, read/write/comprehend English Language
Exclusion criteria
* Clinical relapse within 3 months of first on-study infusion * Cognitive impairment limiting the ability to consent or fill out the electronic survey * Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding * Untreated psychiatric illness (such as major depressive disorder, Bipolar disorder, psychotic disorder, schizophrenia) * Active substance abuse disorder * Significant medical comorbidities (such as history of severe traumatic brain injury, stroke, systemic cancer or chronic infection) * Chemotherapy use within 6 months of first study infusion * Prior treatment with alemtuzumab within 12 months of first study infusion * Prior treatment with a B-cell depleting therapy other than ocrelizumab within 12 months of first on-study infusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life in Neurologic Disorders (NeuroQoL) Scores | Week 4, Week 22 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SymptoMScreen (SyMS) Scores | Week 4, Week 22 | 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. |
| Change in Work Productivity and Activity Impairment Questionnaire: MS (WPAI:MS) Scores | Week 4, Week 22 | 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. |
Countries
United States
Outcome results
None listed