Status:
COMPLETED
Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab Treated With Ocrelizumab or Natalizumab
Lead Sponsor:
Dragonfly Research, LLC
Conditions:
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Eligibility:
All Genders
18-55 years
Brief Summary
The primary goal of this study is to provide additional data regarding B and T-cell mediated responses to COVID-19 vaccines in MS patients treated with OCR and to determine which clinical and paraclin...
Detailed Description
The purpose of this study is to see if patients on ocrelizumab (Ocrevus) produce a humoral and T-cell response to the coronavirus vaccine. Ocrelizumab depletes B-lymphocytes and has the potential to r...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age 18-55
- Diagnosis of multiple sclerosis (as per the revised 2017 criteria)
- EDSS score of 0-5.5 inclusive
- Has initiated ocrelizumab or natalizumab at least 6 months prior to study enrollment
- For women of childbearing potential: agreement to remain abstinent or to use a highly effective (99% efficacy or greater) contraceptive method
- Individual must be able to provide consent, read/write/comprehend English language or must be able to provide a consistent translator
- Exclusion Criteria
- Previous infection with COVID-19, confirmed by FDA approved testing
- Cognitive impairment limiting the ability to consent or complete study procedures
- Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding
- Any prior use of immunosuppressive or chemotherapy treatment (including, but not limited to, cladribine, alemtuzumab, mycophenolate mofetil, cyclophosphamide, methotrexate, azathioprine)
- Prior treatment with a B-cell depleting therapy other than ocrelizumab within 12 months of first on-study infusion excluding standard ocrelizumab pre-treatment therapy
- Use of systemic corticosteroid therapy within 12 weeks of screening (excluding corticosteroid treatment given concurrently with ocrelizumab)
- History of allergic reactions to vaccines
Exclusion
Key Trial Info
Start Date :
March 2 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04837651
Start Date
March 2 2021
End Date
July 1 2021
Last Update
August 2 2021
Active Locations (1)
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1
Dragonfly Research, LLC
Wellesley, Massachusetts, United States, 02481