A Study to Assess COVID-19 Vaccination Immune Response in Multiple Sclerosis Patients Treated With Ofatumumab

Novartis

Status: Completed

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Industry

Identifiers

NCT06460324

COMB157GUS27

Details and patient eligibility

About

This was a non-interventional, retrospective, observational cohort study involving the abstraction and review of pertinent data from medical records by participating physicians, who completed a customized electronic case report form hosted on the secure electronic data capture system.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• Aged at least 18 years of age upon receipt of first COVID-19 vaccination.

• Fully vaccinated with any FDA-authorized COVID-19 vaccination.

• Diagnosed with MS.

• Receiving ofatumumab at the time of either (or both) of the following:

  1. Initial COVID-19 vaccination.
  2. Booster vaccination.

• Had a documented measurement of humoral response at least 2 weeks after completion of either (or both) of the following:

  1. Full COVID-19 vaccination course.

  2. Booster vaccine (among patients receiving ofatumumab at the time of the booster).

     Exclusion criteria:

• Received treatment with monoclonal antibodies to treat or prevent COVID-19 at any time between the first COVID-19 vaccination to within 6 months of the last COVID-19 vaccination (booster-inclusive).

Trial design

38 participants in 1 patient group

COVID-19 Vaccination Cohort

Description:

Patients with multiple sclerosis (MS) who were receiving ofatumumab at the time of full COVID-19 vaccination and/or first booster vaccination.