Status:
TERMINATED
Efficacy of COVID-19 Vaccination in Patients With Multiple Sclerosis Treated With Immune Modulating Medication
Lead Sponsor:
Providence Health & Services
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Brief Summary
The primary objective is to determine whether the use of immunomodulating medications have an impact on the ability to mount and sustain an immune response to SARS-CoV-2 spike protein following mRNA v...
Detailed Description
Analysis of cell-mediated and antibody-mediated immunity to the COVID-19, SARS-CoV-2 virus following treatment with mRNA vaccine, in patients with multiple sclerosis (MS) who are treated with immune m...
Eligibility Criteria
Inclusion
- Able to understand the purpose, benefits, and risks of the study; willing and able to adhere to the study requirements; able to provide informed consent in English
- Male or female, between the ages of 18 and 65 years inclusive at time of consent
- Meet one of the following:
- Plan to receive one of the FDA approved mRNA-based COVID SARS-CoV-2 vaccinations within 30 days of the screening visit
- Have received one of the FDA approved mRNA-based COVID SARS-CoV-2 vaccinations, their first vaccine injection having occurred 45±7 days prior to the screening visit
- Have received one of the FDA approved mRNA-based COVID SARS-CoV-2 vaccinations, their first vaccine injection having occurred 90±7 days prior to the screening visit
- Meet the criteria of one of the four groups at the time of consent:
- Group 1: Diagnosed with multiple sclerosis and currently being treated with a stable dose of ocrelizumab, for 6 months or longer Group 2: Diagnosed with multiple sclerosis and currently being treated with a stable dose of fingolimod, for 6 months or longer Group 3: Diagnosed with multiple sclerosis and currently being treated with a stable dose of natalizumab, for 6 months or longer Group 4: Diagnosed with multiple sclerosis and currently being treated with a stable dose of dimethyl fumarate or diroximel fumarate, for 6 months or longer
Exclusion
- 1\. Subjects who have a BMI of \>35.0 will be excluded
Key Trial Info
Start Date :
July 11 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 25 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04796584
Start Date
July 11 2022
End Date
October 25 2022
Last Update
April 3 2023
Active Locations (1)
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1
Providence Neurological Specialties West
Portland, Oregon, United States, 97225