Status:
COMPLETED
Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-80 years
Brief Summary
This study is designed to determine whether symptom burden differs by time to infusion.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 26 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04855617
Start Date
October 26 2020
End Date
October 1 2022
Last Update
June 15 2023
Active Locations (2)
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1
Elliot Lewis Center for Multiple Sclerosis Care
Wellesley, Massachusetts, United States, 02481
2
NYU Langone Health Multiple Sclerosis Comprehensive Care Center (NYULH MSCCC)
New York, New York, United States, 10016