Status:
TERMINATED
A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Relapsing Multiple Sclerosis (RMS)
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
This study evaluated if relapsing multiple sclerosis (MS) participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly could develop an adequate immune response to the COVI...
Detailed Description
This was a six-cohort, multicenter, prospective study planned for up to 88 relapsing multiple sclerosis (MS) participants. The study was intended to address two questions: 1) Can participants treated ...
Eligibility Criteria
Inclusion
- Signed informed consent must be obtained prior to participation in the study
- Diagnosis of relapsing MS by 2017 revised McDonald criteria
- Were willing to comply with the study schedule
- Cohort 1: Were receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) at least two weeks prior to starting ofatumumab
- Cohort 2: Were receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) and on ofatumumab for at least 4 weeks
- Cohort 3: Were 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
- Received the J\&J vaccine.
- Had a contraindication to receiving an mRNA COVID-19 vaccine
- Had an immediate allergic reaction to past vaccine or injection
- Experienced a major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit
Key Trial Info
Start Date :
June 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04878211
Start Date
June 10 2021
End Date
April 14 2023
Last Update
May 16 2025
Active Locations (7)
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1
Center For Neurology and Spine
Phoenix, Arizona, United States, 85032
2
Infinity Clinical Research LLC .
Hollywood, Florida, United States, 33024
3
Dragonfly Research LLC
Wellesley, Massachusetts, United States, 02481
4
Minnesota Center Multiple Sclerosis
Plymouth, Minnesota, United States, 55446