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

CompletedN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Multiple Sclerosis

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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).

Locations (1)

East Hanover, New Jersey, United States