Clinical trial NCT05576779: Characterization of Early Patients Initiating Ofatumumab for Treatment of Multiple Sclerosis.
Official title: Characterization of Early Patients Initiating Ofatumumab for Treatment of Multiple Sclerosis in the Real-World
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis,
ofatumumab,
disease-modifying therapy,
COVID-19
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-10-13
Enrollment: 2101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with prescription claims for ofatumumab or other DMTs of interest.

Brief summary: This was a retrospective cohort study utilizing secondary data from IQVIA's open source pharmacy claims database (i.e., IQVIA LRx) selecting patients with prescription claims for ofatumumab or other DMTs of interest.

Detailed description: The date of first ofatumumab prescription claim or other DMT of interest was defined as the index date. No post-index requirements were imposed.

Patients were linked to IQVIA's open source medical claims databases (Dx) to obtain patient clinical characteristics.

The initial data were extracted in October 2020. The data and results were refreshed in April 2021 and July 2021 to allow for assessment of changes in characteristics at 6 and 9 months post-launch.

Eligibility criteria: Inclusion Criteria:

* Patients with ≥ 1 prescription for ofatumumab in the LRx/Dx database were included. The date of the first observed prescription within the index window served as the index date.

  -. Patients with a diagnosis of COVID-19 or a COVID-19 vaccination any time during the study period.
* Patients with linkage to the Dx database.

Exclusion criteria

- No exclusion criteria were applied to patients in the study.

Primary outcomes:
measure: Proportion of patients initiating ofatumumab based on DMT use
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Secondary outcomes:
measure: Age
timeFrame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Gender
timeFrame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Number of patients: Geographic region
timeFrame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Number of patients: State level (Geographic region)
timeFrame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Number of patients: Insurance type
timeFrame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Number of patients: Payer
timeFrame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Follow-up time
timeFrame: Variable Post-index period, where index date was defined as date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
measure: Number of patients: Pre-index Charlson comorbidity index (CCI)
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Number of patients: Pre-index comorbidities
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Number of patients with a relapse in inpatient settings
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Number of patients with a relapse in outpatient settings
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Number of relapses in all patients
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Number of relapses in patients with at least 1 relapse
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Claims-Based Disability Score
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Number of pre-index Brain and Spinal MRI scans
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Number of patients: Hepatitis B virus screening
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Number of patients: Quantitative serum immunoglobulin screening
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Number of patients: Pre-index flu shot
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Number of patients: Post-index flu shot
timeFrame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
measure: Pre-index: Number of patients with COVID-19 diagnosis
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Post-index: Number of patients with COVID-19 diagnosis
timeFrame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
measure: Days between COVID-19 diagnosis and initiation of ofatumumab
timeFrame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
measure: Pre-index: Number of patients with COVID-19 vaccination
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Post-index: Number of patients with COVID-19 vaccination
timeFrame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
measure: Days between COVID-19 vaccination and initiation of ofatumumab
timeFrame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
measure: Proportion of patients with steroid use or antihistamine as pre-medication with ofatumumab first dose
timeFrame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
measure: Pre-index HCRU: Number of patients with an inpatient visit
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Pre-index HCRU: Number of patients with an ED visit
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Pre-index HCRU: Number of patients with an outpatient visit
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Pre-index HCRU: Number of patients with a pharmacy claim
timeFrame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
measure: Post-index HCRU: Number of patients with an inpatient visit
timeFrame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
measure: Post-index HCRU: Number of patients with an ED visit
timeFrame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
measure: Post-index HCRU: Number of patients with an outpatient visit
timeFrame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
measure: Post-index HCRU: Number of patients with a pharmacy claim
timeFrame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: