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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05950308
• Other study ID #: COMB157GUS23
• Status: Completed
• Start date: January 5, 2022
• Est. completion date: July 14, 2022

Study information

• Verified date: July 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 14, 2022
• Est. primary completion date: July 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Novartis	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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