A Canadian Study of Persistence on Ofatumumab Using Patient Support Program Data (CAPES)

Novartis

Status: Completed

Conditions: Multiple Sclerosis, Relapsing-Remitting

Study type: Observational

Funder types: Industry

Identifiers

NCT06854341

COMB157GCA04

Details and patient eligibility

About

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.

Enrollment: 5,448 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

5,448 participants in 1 patient group

Ofatumumab Cohort

Description:

Adult patients with relapsing remitting multiple sclerosis (RRMS) who started treatment with ofatumumab, and were enrolled in the Kesimpta Go Program.