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Purpose

This study will evaluate if participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly can develop an adequate immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or glatiramer acetate.

Condition

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 - Cohort 1: Will be receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) at least two weeks prior to starting ofatumumab - Cohort 2: Will be receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) and on ofatumumab for at least 4 weeks - Cohort 3: Will be receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) and on interferon or glatiramer acetate for at least 4 weeks - Cohort 4: Fully vaccinated with a non-live COVID mRNA vaccine (Pfizer or Moderna vaccine) and on ofatumumab for at least 4 weeks - Cohort 5: Fully vaccinated with a non-live COVID mRNA vaccine (Pfizer or Moderna vaccine), with or without a booster, and on interferon or glatiramer acetate for at least 4 weeks - Cohort 6: Fully vaccinated with a non-live COVID mRNA vaccine, (Pfizer or Moderna vaccine), with a booster, and on ofatumumab for at least 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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ofatumumab - vaccine 2 weeks prior 		RMS participants will receive non-live COVID-19 mRNA vaccine at least two weeks prior to start of ofatumumab (20 mg subcutaneous)
  • Drug: Ofatumumab
    3 loading doses followed by monthly administrations
  • Biological: mRNA COVID-19 vaccine
    Pfizer or Moderna mRNA Vaccine
Experimental
Ofatumumab -vaccine 4 weeks after 		RMS participants will receive non-live COVID-19 mRNA vaccine at least four weeks after start of ofatumumab (20 mg subcutaneous)
  • Drug: Ofatumumab
    3 loading doses followed by monthly administrations
  • Biological: mRNA COVID-19 vaccine
    Pfizer or Moderna mRNA Vaccine
Active Comparator
Interferon or glatiramer acetate - vaccine 4 weeks after 		RMS participants will receive non-live COVID-19 mRNA vaccine at least 4 weeks after start of prescribed interferon or glatiramer acetate
  • Biological: mRNA COVID-19 vaccine
    Pfizer or Moderna mRNA Vaccine
  • Drug: interferon or glatiramer acetate
    iDMT
Experimental
Ofatumumab - fully vaccinated 		RMS participants fully vaccinated with a non-live COVID mRNA vaccine and on ofatumumab for at least 4 weeks (20 mg subcutaneous)
  • Drug: Ofatumumab
    3 loading doses followed by monthly administrations
  • Biological: mRNA COVID-19 vaccine
    Pfizer or Moderna mRNA Vaccine
Experimental
Interferon or glatiramer acetate - fully vaccinated, with or without booster 		RMS participants fully vaccinated with a non-live COVID mRNA vaccine, without or without a booster, and on interferon or glatiramer acetate for at least 4 weeks
  • Biological: mRNA COVID-19 vaccine
    Pfizer or Moderna mRNA Vaccine
  • Drug: interferon or glatiramer acetate
    iDMT
Experimental
Ofatumumab - fully vaccinated, with a booster 		RMS participants fully vaccinated with a non-live COVID mRNA vaccine with a booster and on ofatumumab for at least 4 weeks (20 mg subcutaneous)
  • Drug: Ofatumumab
    3 loading doses followed by monthly administrations
  • Biological: mRNA COVID-19 vaccine
    Pfizer or Moderna mRNA Vaccine

Recruiting Locations

More Details

NCT ID
NCT04878211
Status
Completed
Sponsor
Novartis Pharmaceuticals

Detailed Description

This is a six-cohort, multicenter, prospective study of up to 88 relapsing MS participants. The first cohort will be participants receiving an mRNA COVID-19 vaccine at least two weeks prior to ofatumumab start. The second cohort will be participants receiving an mRNA COVID-19 vaccine at least four weeks after beginning ofatumumab. The third cohort will be participants currently on an interferon or glatiramer acetate planning to receive COVID-19 mRNA vaccine. The fourth cohort will be participants fully vaccinated with an RNA COVID-19 vaccine at least four weeks after ofatumumab start. The fifth cohort will be participants fully vaccinated with an RNA COVID-19 vaccine, with or without a booster dose, and currently on interferon or glatiramer acetate. The sixth cohort will be participants fully vaccinated with an RNA COVID-19 vaccine and received a booster dose at least four weeks after ofatumumab start. Participants will obtain the COVID-19 mRNA vaccine from their HCP (private insurance) or appropriate federal, state or local program.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.