NCT06854341

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

A Canadian Retrospective Analysis of Persistence on Ofatumumab Using Patient Support Program Data

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,448 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Timeline

• Start date: 2024-02-09
• Primary completion: 2024-08-27
• Completion: 2024-08-27
• First posted: 2025-03-03
• Last updated: 2025-03-25

Locations

1 site across 1 country: United States