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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT05950308
Collaborator
(none)
61
Enrollment
1
Location
6.2
Actual Duration (Months)
9.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    61 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Assessment of Immune Response in Multiple Sclerosis Patients With COVID-19/Vaccination Treated With Ofatumumab and Other Disease Modifying Therapies
    Actual Study Start Date :
    Jan 5, 2022
    Actual Primary Completion Date :
    Jul 14, 2022
    Actual Study Completion Date :
    Jul 14, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    HC

    Healthy control
    OFA

    Received ofatumumab
    OCR

    Received ocrelizumab
    S1P

    Received sphingosine-1-phosphate receptor modulator

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis East Hanover New Jersey United States 07936

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05950308
    Other Study ID Numbers:
    • COMB157GUS23
    First Posted:
    Jul 18, 2023
    Last Update Posted:
    Jul 18, 2023
    Last Verified:
    Jul 1, 2023
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis
    Disease

    Study Results

    No Results Posted as of Jul 18, 2023