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

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT05950308
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-05
• Primary Completion: 2022-07-14
• Study Completion: 2022-07-14
• Status Verified: 2023-07
• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-14
• Last Update Submitted: 2023-07-14
• Study First Posted: 2023-07-18
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants achieving T-cell response (i.e. immune response) to an FDA-authorized COVID 19 vaccine in ofatumumab treated participants	varied up to 6 months
Percentage of participants achieving humoral response (i.e. immune response) to an FDA-authorized COVID 19 vaccine in ofatumumab treated participants	varied up to 6 months

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States