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

Completed

• Conditions: Multiple Sclerosis, Relapsing-Remitting

• Registration Number: NCT06854341
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-09
• Primary Completion: 2024-08-27
• Study Completion: 2024-08-27
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-25
• Status Verified: 2025-03
• Study First Posted: 2025-03-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5448

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Patients who Discontinued Ofatumumab per Patient Characteristic	Month 6, 12, 18, 24, 30, and 36	Patient characteristics included age group, gender, type of insurance, and experience (naive or experienced) of disease-modifying therapy (DMT) before starting ofatumumab.

Secondary Outcome Measures

Name	Time	Method
Number of Patients per Demographic Category	Baseline	Demographic categories included age, age group, gender, index year, and type of insurance. Index year was the year patients started their medication.
Number of Patients per Clinical History Characteristic	Baseline	Clinical history characteristics included experience of disease-modifying therapy (DMT) before starting ofatumumab (naive or experienced) and the type of last DMT used before starting ofatumumab.
Cox Proportional Hazard Ratio for the Association Between Discontinuation of Ofatumumab and Patient Characteristics	Up to 3 years	Patient characteristics included age group, gender, type of insurance, and type of last DMT used before starting ofatumumab.
Number of Patients by Reason for Discontinuation of Ofatumumab Treatment	Up to 3 years	Reasons for discontinuation included lack of efficacy, non-adherence, side effects, switched medications, trying to conceive/pregnancy, patient request, physician request, treatment interruption gap \>90 days.
Number of Patients by Reason for Leaving the Kesimpta Go Program	Up to 3 years	Reasons for leaving the Kesimpta Go program included could not contact participant, deceased, doesn't meet eligibility, patient moved, refused coverage, reimbursement issues, no reason given.

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States