A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
This is a three-cohort, multicenter, prospective study of up to 66 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. Participants will obtain the COVID-19 mRNA vaccine from their HCP (private insurance) or appropriate federal, state or local program.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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
|
Outcome Measures
Primary Outcome Measures
- Percentage of patients achieving a SARS-CoV-2 immune response [Vaccination up to 14 days]
An immune response is defined as achieving a positive SARS-CoV-2 qualitative IgG antibody assay 14 days after 2nd vaccination dose is received
Secondary Outcome Measures
- Percentage of patients with a sustained immune response to non-live mRNA COVID-19 vaccine in ofatumumab treated participants [From 14 to 45 days after vaccination]
A sustained immune response to non-mRNA COVID vaccine is defined as achieving a positive SARS-CoV-2 qualitative IgG antibody after more than 14 days up to approximately one year after 2nd vaccination dose is received.
- Percentage of patients achieving an immune conversion to non-live mRNA COVID-19 vaccine in ofatumumab treated participants [Vaccination up to 14 days]
Immune conversion to non-live mRNA COVID-19 vaccine is defined as either: Baseline absence of SARS-CoV-2 spike IgG with post-vaccination SARS-CoV-2 positive qualitative antibody assay 14 days after 2nd vaccination dose is received OR Baseline serum presence of SARS-CoV-2 quantitative IgG antibody with post-vaccination ≥ 4-fold increase in SARS-CoV-2 quantitative antibody titer as determined by dilution assay 14 days after 2nd vaccination dose is received
- Percentage of patients developing a neutralizing antibody [Vaccination up to 14 days]
Neutralizing antibody development is defined as positive SARS-CoV-2 neutralization antibody assay 14 days after 2nd vaccination dose is received.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Will be receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) at least two weeks prior to starting ofatumumab
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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:
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Already has received Pfizer, Moderna or Johnson & Johnson vaccine
-
Known diagnosis of COVID-19 prior to screening
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Has a contraindication to receiving an mRNA COVID-19 vaccine
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Has an immediate allergic reaction to past vaccine or injection
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Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Novartis Investigative Site | Phoenix | Arizona | United States | 85032 |
2 | Novartis Investigative Site | Sunrise | Florida | United States | 33351 |
3 | Novartis Investigative Site | Saint Louis | Missouri | United States | 63131 |
4 | Novartis Investigative Site | Charlotte | North Carolina | United States | 28204 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COMB157GUS16