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OpenTrials
Completed

NCT Number: NCT05950308

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of participants achieving humoral response (i.e. immune response) to an FDA-authorized COVID 19 vaccine in ofatumumab treated participants

    Time frame: 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

    Time frame: varied up to 6 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 18, 2023
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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