A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
Relapsing Multiple Sclerosis (RMS)
About this trial
This is an interventional treatment trial for Relapsing Multiple Sclerosis (RMS) focused on measuring Multiple Sclerosis, Relapsing Multiple Sclerosis, COVID, COVID-19, Vaccine, Coronavirus, adult, OMB157
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent must be obtained prior to participation in the study
- Diagnosis of relapsing MS by 2017 revised McDonald criteria
- Willing to comply with the study schedule
- Will be receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) at least two weeks prior to starting ofatumumab
- Eligible to receive and plan to be started on ofatumumab OR currently on prescribed ofatumumab for ≥ 4 weeks OR currently on commercially prescribed interferon or glatiramer acetate for ≥ 4 weeks
Exclusion Criteria:
- Already has received Pfizer, Moderna or Johnson & Johnson vaccine
- Known diagnosis of COVID-19 prior to screening
- Has a contraindication to receiving an mRNA COVID-19 vaccine
- Has an immediate allergic reaction to past vaccine or injection
- Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Ofatumumab - vaccine 2 weeks prior
Ofatumumab -vaccine 4 weeks after
Interferon or glatiramer acetate - vaccine 4 weeks after
RMS participants will receive non-live COVID-19 mRNA vaccine at least two weeks prior to start of ofatumumab (20 mg subcutaneous)
RMS participants will receive non-live COVID-19 mRNA vaccine at least four weeks after start of ofatumumab (20 mg subcutaneous)
RMS participants will receive non-live COVID-19 mRNA vaccine at least 4 weeks after start of prescribed interferon or glatiramer acetate