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

NCT06854341 | Completed

• 1 other identifier: COMB157GCA04
• Study Type: observational
• Target: 5,448
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Patient Support Program; Ofatumumab; Persistence

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients who Discontinued Ofatumumab per Patient Characteristic

  Patient characteristics included age group, gender, type of insurance, and experience (naive or experienced) of disease-modifying therapy (DMT) before starting ofatumumab.

  Month 6, 12, 18, 24, 30, and 36

Secondary Outcomes (5)

• Number of Patients per Demographic Category

  Baseline

• Number of Patients per Clinical History Characteristic

  Baseline

• Cox Proportional Hazard Ratio for the Association Between Discontinuation of Ofatumumab and Patient Characteristics

  Up to 3 years

• Number of Patients by Reason for Discontinuation of Ofatumumab Treatment

  Up to 3 years

• Number of Patients by Reason for Leaving the Kesimpta Go Program

  Up to 3 years

Study Arms (1)

Ofatumumab Cohort

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, non-interventional cohort study.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

Related Publications (1)

• Selchen D, Grant R, Magnussen C, Murray J, Neish CS. A real-world study on persistence with ofatumumab in Canadian patients with multiple sclerosis. Mult Scler Relat Disord. 2026 Jan 6;107:106976. doi: 10.1016/j.msard.2026.106976. Online ahead of print.

  PMID: 41529661 DERIVED

Related Links

• Results for COMB157GCA04 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: February 9, 2024
• Primary Completion: August 27, 2024
• Study Completion: August 27, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

US (1)