Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04878211
Status:
TERMINATED
Last Update Posted:
2024-06-20
First Post:
2021-05-03
Brief Title:
A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
An Open-label Multicenter Study to Assess Response to COVID-19 Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial was terminated for business reasons There has been no change in the benefitrisk profile of ofatumumab
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluated if relapsing multiple sclerosis MS participants treated with ofatumumab 20 mg subcutaneous sc administered once monthly could develop an adequate immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or glatiramer acetate
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 with ofatumumab develop an immune response if receiving a COVID-19 mRNA vaccine two weeks prior to ofatumumab start 2 If receiving COVID-19 mRNA vaccine after introduction of ofatumumab treatment can participants develop an immune response Cohort 1 participants received an mRNA COVID-19 vaccine at least two weeks prior to ofatumumab start Cohort 2 participants received an mRNA COVID-19 vaccine at least four weeks after beginning ofatumumab Cohort 3 participants on an interferon or glatiramer acetate who received COVID-19 mRNA vaccine Cohort 4 participants fully vaccinated with an RNA COVID-19 vaccine at least four weeks after ofatumumab start Cohort 5 participants vaccinated with an RNA COVID-19 vaccine with or without a booster dose and on interferon or glatiramer acetate Cohort 6 participants fully vaccinated with an RNA COVID-19 vaccine who received a booster dose at least four weeks after ofatumumab start Participants obtained the COVID-19 mRNA vaccine from their HCP private insurance or appropriate federal state or local program
Participants in Cohort 1 received loading doses of ofatumumab and subsequent dosing was 20 mg sc administered monthly All other cohorts continued current dosing schedule of either ofatumumab glatiramer acetate or interferon Participation in trial was maximum of 421 days which was dependent on the Cohort
Participants in Cohort 1 received loading doses of ofatumumab and subsequent dosing was 20 mg sc administered monthly All other cohorts continued current dosing schedule of either ofatumumab glatiramer acetate or interferon Participation in trial was maximum of 421 days which was dependent on the Cohort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None