Clinical trial NCT06460324: A Study to Assess COVID-19 Vaccination Immune Response in Multiple Sclerosis Patients Treated With Ofatumumab
Official title: Assessment of COVID-19 Vaccination Immune Response in Multiple Sclerosis Patients Treated With Ofatumumab in the United States: A Multicenter Medical Record Review Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-06-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

Brief summary: 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 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).

Primary outcomes:
measure: Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Vaccination Status
timeFrame: From 2 weeks up to 6 months post-vaccine
measure: Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Prior Disease Modifying Therapy (DMT)
timeFrame: From 2 weeks up to 6 months post-vaccine
Secondary outcomes:
measure: Mean Age at Index Date by Vaccination Status
timeFrame: Index date
measure: Mean Age at Index Date by Prior Disease Modifying Therapy (DMT)
timeFrame: Index date
measure: Gender at Index Date by Vaccination Status
timeFrame: Index date
measure: Gender at Index Date by Prior DMT
timeFrame: Index date
measure: Race at Index Date by Vaccination Status
timeFrame: Index date
measure: Race at Index Date by Prior DMT
timeFrame: Index date
measure: Number of Patients per United States Region at Index Date by Vaccination Status
timeFrame: Index date
measure: Number of Patients per United States Region at Index Date by Prior DMT
timeFrame: Index date
measure: Time since MS Diagnosis at Index Date by Vaccination Status
timeFrame: Index date
measure: Time since MS Diagnosis at Index Date by Prior DMT
timeFrame: Index date
measure: Number of Patients with Relapsing-remitting Multiple Sclerosis (MS) at Index Date by Vaccination Status
timeFrame: Index date
measure: Number of Patients with Relapsing-remitting MS at Index Date by Prior DMT
timeFrame: Index date
measure: Number of Patients with Secondary Progressive MS at Index Date by Vaccination Status
timeFrame: Index date
measure: Number of Patients with Secondary Progressive MS at Index Date by Prior DMT
timeFrame: Index date
measure: Number of Patients with Primary Progressive MS at Index Date by Vaccination Status
timeFrame: Index date
measure: Number of Patients with Primary Progressive MS at Index Date by Prior DMT
timeFrame: Index date
measure: Mean Number of Comorbidities Within 12 Months Preceding Index Date by Vaccination Status
timeFrame: Within 12 months preceding index date
measure: Mean Number of Comorbidities Within 12 Months Preceding Index Date by Prior DMT
timeFrame: Within 12 months preceding index date
measure: Number of Patients by Most Common Comorbidities (greater than 15%) Within 12 Months Preceding Index Date by Vaccination Status
timeFrame: Within 12 months preceding index date
measure: Number of Patients by Most Common Comorbidities (greater than 15%) Within 12 Months Preceding Index Date by Prior DMT
timeFrame: Within 12 months preceding index date
measure: Number of Patients Treated with DMTs any Time Prior to Ofatumumab Initiation by Vaccination Status
timeFrame: Within 3 years of index date (defined as date of completion of full COVID-19 vaccination or date of booster vaccination)
measure: Number of Patients Treated with DMTs any Time Prior to Ofatumumab Initiation Categorized by Prior DMT
timeFrame: Within 3 years of index date (defined as date of completion of full COVID-19 vaccination or date of booster vaccination)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: