A Study to Assess COVID-19 Vaccination Immune Response in Multiple Sclerosis Patients Treated With Ofatumumab

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

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-20

Study Completion Date

2023-07-03

Brief Summary

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This was a non-interventional, retrospective, observational cohort study involving the abstraction and review of pertinent data from medical records by participating physicians, who completed a customized electronic case report form hosted on the secure electronic data capture system.

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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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COVID-19 Vaccination Cohort

Patients with multiple sclerosis (MS) who were receiving ofatumumab at the time of full COVID-19 vaccination and/or first booster vaccination.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Aged at least 18 years of age upon receipt of first COVID-19 vaccination.
* Fully vaccinated with any FDA-authorized COVID-19 vaccination.
* Diagnosed with MS.
* Receiving ofatumumab at the time of either (or both) of the following:

1. Initial COVID-19 vaccination.
2. Booster vaccination.
* Had a documented measurement of humoral response at least 2 weeks after completion of either (or both) of the following:

1. Full COVID-19 vaccination course.
2. Booster vaccine (among patients receiving ofatumumab at the time of the booster).

Exclusion Criteria

* Received treatment with monoclonal antibodies to treat or prevent COVID-19 at any time between the first COVID-19 vaccination to within 6 months of the last COVID-19 vaccination (booster-inclusive).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No