A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

An Open-label Multicenter Study to Assess Response to COVID-19 Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously

ClinicalTrials.gov Identifier: NCT04878211

Novartis Reference Number: COMB157GUS16

Last Update: Jan 20, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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 
Relapsing Multiple Sclerosis (RMS)
Phase 
Phase 4
Overall status 
Recruiting
Start date 
Jun 10, 2021
Completion date 
Aug 30, 2023
Gender 
All
Age(s)
18 Years - 55 Years (Adult)

Interventions

Drug
Ofatumumab
3 loading doses followed by monthly administrations
Biological
mRNA COVID-19 vaccine
Pfizer or Moderna mRNA Vaccine
Drug
interferon or glatiramer acetate
iDMT

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

Study Locations

United States
Novartis Investigative Site
Recruiting
Phoenix, 85032
Arizona
United States
Novartis Investigative Site
Recruiting
Sunrise, 33351
Florida
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63131
Missouri
United States
Novartis Investigative Site
Recruiting
Charlotte, 28204
North Carolina
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]