This is a single arm, pilot multicenter prospective study in up to 22 participants with relapsing multiple sclerosis. Patients screened for the study can either be scheduled for vaccine, have received a single vaccine with a scheduled second dose, or already completed full course (two dose) vaccination. Fully vaccinated participants must be able to complete immune assay No.1 ≥ 14 days after the second dose of vaccine
Study Type
OBSERVATIONAL
Enrollment
25
Prospective observational cohort study. There is no treatment allocation. Patients administered Ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.
Prospective observational cohort study. There is no treatment allocation. Participants will obtain the COVID-19 FDA approved Emergency Use mRNA vaccine through their HCP (private insurance) or appropriate federal, state or local program.
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Owosso, Michigan, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
Plainview, New York, United States
Proportion of participants achieving immune response - immune assay No. 1
Achieving immune response as defined by a positive SARS-CoV-2 qualitative IgG antibody assay. (yes/no)
Time frame: 14 days after full course vaccination (two doses)
Proportion of participants achieving immune response - immune assay No. 2
Achieving immune response as defined by a positive SARS-CoV-2 qualitative IgG antibody assay 90 days after assay No. 1 (yes/no)
Time frame: 90 days post assay 1
Adverse events/serious adverse events
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
Time frame: 120 days after full course vaccination
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Novartis Investigative Site
Guaynabo, Puerto Rico