Clinical trial NCT06854341: A Canadian Study of Persistence on Ofatumumab Using Patient Support Program Data
Official title: A Canadian Retrospective Analysis of Persistence on Ofatumumab Using Patient Support Program Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Patient Support Program
Ofatumumab
Persistence
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-03-03
Enrollment: 5448
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, non-interventional cohort study.

Brief summary: This was an observational, non-interventional, real world study involving secondary use of de-identified aggregate data from patients prescribed ofatumumab, collected by the Kesimpta Go Program in Canada. This study utilized a cohort design. The study period included all available data captured by the Kesimpta Go Program from program inception (April 2, 2021) to the time of data transfer (May 1, 2024). Patients were indexed into the study on the date they started their medication, from April 2, 2021 to May 1, 2024. The baseline period represented the period prior to ofatumumab treatment initiation. Baseline variables were collected from the enrollment form, which include demographic and clinical history, such as whether the patient had prior treatment with disease-modifying therapy (DMT). Patients were followed until the first of the following censoring events: ofatumumab discontinuation; end of the study period; or leaving the Kesimpta Go Program.


Eligibility criteria: Inclusion criteria:

Patients were included if they met all of the following criteria:

* Patients enrolled in the Kesimpta Go Program
* Patients with documented informed consent from enrollment in the Kesimpta Go Program
* Patients who started treatment with ofatumumab

Exclusion criteria:

Patients were excluded if they met any of the criteria below:

* Patients with no demographic information
* Patients who could not be linked across the data sources required for analysis (Kesimpta Go Program Enrollment Form, Pharmacy Claims Forms, Kesimpta Go Program Database)
* Patients with 3+ treatment interruptions (patient was "on hold" - i.e., not currently receiving the treatment in the patient support program)

Primary outcomes:
measure: Percentage of Patients who Discontinued Ofatumumab per Patient Characteristic
timeFrame: Month 6, 12, 18, 24, 30, and 36
Secondary outcomes:
measure: Number of Patients per Demographic Category
timeFrame: Baseline
measure: Number of Patients per Clinical History Characteristic
timeFrame: Baseline
measure: Cox Proportional Hazard Ratio for the Association Between Discontinuation of Ofatumumab and Patient Characteristics
timeFrame: Up to 3 years
measure: Number of Patients by Reason for Discontinuation of Ofatumumab Treatment
timeFrame: Up to 3 years
measure: Number of Patients by Reason for Leaving the Kesimpta Go Program
timeFrame: Up to 3 years
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: