Multiple Sclerosis, Relapsing-RemittingCAPESNCT06854341
A Canadian Study of Persistence on Ofatumumab Using Patient Support Program Data
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Novartis Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- How many people
- 5,448 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2024to 27 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, non-interventional cohort study.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Canadian Retrospective Analysis 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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Patient Support Program, Ofatumumab, Persistence
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ofatumumab Cohort | Adult patients with relapsing remitting multiple sclerosis (RRMS) who started treatment with ofatumumab, and were enrolled in the Kesimpta Go Program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 6, 12, 18, 24, 30, and 36
Secondary outcomes (5)
Number of Patients per Demographic Category
Demographic categories included age, age group, gender, index year, and type of insurance. Index year was the year patients started their medication.
Measured: Baseline
Number of Patients per Clinical History Characteristic
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.
Measured: Baseline
Cox Proportional Hazard Ratio for the Association Between Discontinuation of Ofatumumab and Patient Characteristics
Patient characteristics included age group, gender, type of insurance, and type of last DMT used before starting ofatumumab.
Measured: Up to 3 years
Number of Patients by Reason for Discontinuation of Ofatumumab Treatment
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.
Measured: Up to 3 years
Number of Patients by Reason for Leaving the Kesimpta Go Program
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.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start9 Feb 2024
- Primary completion27 Aug 2024
- Study completion27 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854341
- Sponsor's protocol ID
- COMB157GCA04
- Acronym
- CAPES
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
Publications
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 Mar;107:106976. doi: 10.1016/j.msard.2026.106976. Epub 2026 Jan 6.
PubMed 41529661
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Canadian Retrospective Analysis of Persistence on Ofatumumab Using Patient Support Program Data
- ClinicalTrials.gov ID
- NCT06854341
- Acronym / sponsor ID
- CAPES / COMB157GCA04
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Patient Support Program, Ofatumumab, Persistence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,448 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab Cohort | – | –Adult patients with relapsing remitting multiple sclerosis (RRMS) who started treatment with ofatumumab, and were enrolled in the Kesimpta Go Program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, non-interventional cohort study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Number of Patients per Demographic Category
Time frame: Baseline
Number of Patients per Clinical History Characteristic
Time frame: Baseline
Cox Proportional Hazard Ratio for the Association Between Discontinuation of Ofatumumab and Patient Characteristics
Time frame: Up to 3 years
Number of Patients by Reason for Discontinuation of Ofatumumab Treatment
Time frame: Up to 3 years
Number of Patients by Reason for Leaving the Kesimpta Go Program
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Derived from this study: PubMed 41529661Selchen 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 Mar;107:106976. doi: 10.1016/j.msard.2026.106976. Epub 2026 Jan 6.
- Results for COMB157GCA04 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients who Discontinued Ofatumumab per Patient Characteristic (time frame: Month 6, 12, 18, 24, 30, and 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06854341, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.