A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

PHASE4CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

January 14, 2021

Primary Completion Date

July 6, 2023

Study Completion Date

July 6, 2023

Conditions
Relapsing Multiple Sclerosis
Interventions
BIOLOGICAL

Quadrivalent influenza vaccine

2020-2021, 2021-2022, or 2022-2023 inactivated quadrivalent influenza vaccine. Participants received the vaccine within 9 calendar days after the Screening Visit, before the Week 0 Visit occurred.

DRUG

Ofatumumab

"Auto-injector containing 20 mg ofatumumab (20 mg/0.4mL) for subcutaneous (s.c.) administration.~* Participants in Cohort 1 received loading doses of 20 mg ofatumumab s.c. at Weeks 2, 3, and 4 in the Investigational Period. In the open-label Extension Period, they administered the first dose of ofatumumab at Week 6 and continued monthly dosing until the final dose at Week 26. Novartis supplied participants in Cohort 1 with ofatumumab treatment.~* Participants in Cohort 2 continued on their commercially prescribed ofatumumab treatment during the Investigational Period. In the open-label Extension Period, they continued to administer ofatumumab monthly until the final dose at Week 28. Cohort 2 participants in the extension could have either remained on their prescribed ofatumumab or switched to study supplied ofatumumab."

DRUG

iDMT

Participants in Cohort 3 continued on their commercially prescribed injectable disease modifying therapy (iDMT) during the Investigational Period.

Trial Locations (3)

33024

Infinity Clinical Research LLC, Hollywood

63131

The MS Center for Innovation in Care, St Louis

85018

Hope Research Institute Center Neurology and Spine, Phoenix

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY