NCT06854341Completed
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
Source: ClinicalTrials.gov · Last updated 25 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 5448 (actual)
- First submitted
- 25 Feb 2025
- Start date
- 9 Feb 2024
- Primary completion date
- 27 Aug 2024
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Multiple sclerosis
- NCT number
- NCT06854341
What you commit to
- Study type: Observational
- Participants enrolled: 5448
- From 9 Feb 2024 to the primary completion date, 27 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with 3+ treatment interruptions (patient was "on hold" - i.e., not currently receiving the treatment in the patient support program)
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Coordinator of this site? Confirm its status | East Hanover | United States | Unknown status |
Related publications
- A real-world study on persistence with ofatumumab in Canadian patients with multiple sclerosis.Mult Scler Relat Disord · 2026 · PMID 41529661
This page is information, not medical advice. Discuss any trial with your doctor.