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Completed

NCT Number: NCT06854341

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

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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Percentage of Patients who Discontinued Ofatumumab per Patient Characteristic

    Time frame: 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 outcomes

  1. Number of Patients per Demographic Category

    Time frame: Baseline

    Demographic categories included age, age group, gender, index year, and type of insurance. Index year was the year patients started their medication.

  2. Number of Patients per Clinical History Characteristic

    Time frame: 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.

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

    Time frame: Up to 3 years

    Patient characteristics included age group, gender, type of insurance, and type of last DMT used before starting ofatumumab.

  4. Number of Patients by Reason for Discontinuation of Ofatumumab Treatment

    Time frame: 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.

  5. Number of Patients by Reason for Leaving the Kesimpta Go Program

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: CAPES

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 3, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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