Assessment of Immune Response in Multiple Sclerosis Patients With COVID-19/Vaccination Treated With Ofatumumab and Other Disease Modifying Therapies

Novartis

Status: Completed

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Industry

Identifiers

NCT05950308

COMB157GUS23

Details and patient eligibility

About

Vaccine responses in patients treated with anti-CD20 antibodies (ocrelizumab and ofatumumab) or S1P receptor modulators (fingolimod and siponimod) were evaluated before and after third SARS-CoV-2 vaccination as part of an ongoing longitudinal study. Total spike protein and spike receptor binding domain (RBD)-specific immunoglobulin G (IgG) responses were measured by Luminex bead-based assay. Spike-specific CD4+ and CD8+ T cell responses were measured by activation-induced marker expression.

Enrollment: 61 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

All Participants:

• Aged 18-75 years old MS Patients
• Diagnosed with MS based on 2017 McDonald criteria

Exclusion Criteria

All Participants:

• Participants with a known history of COVID-19 Healthy Adults
• Immunocompromised or on immunosuppressive therapy MS Patients
• None specified

Trial design

61 participants in 4 patient groups

HC

Description:

Healthy control

OFA

Description:

Received ofatumumab

OCR

Description:

Received ocrelizumab

S1P

Description:

Received sphingosine-1-phosphate receptor modulator