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

NCT ID: NCT05950308

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-05

Study Completion Date

2022-07-14

Brief Summary

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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

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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HC

Healthy control

No interventions assigned to this group

OFA

Received ofatumumab

No interventions assigned to this group

OCR

Received ocrelizumab

No interventions assigned to this group

S1P

Received sphingosine-1-phosphate receptor modulator

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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COMB157GUS23

Identifier Type: -

Identifier Source: org_study_id

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