Multiple SclerosisKOSMOSNCT05285904
Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 13 sites in Switzerland.
Trial summary
This is a multi-center, observational study carried out in Switzerland that aims to describe the effects of Ofatumumab in a setting of routine medical care. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ofatumumab
- How many people
- 107 participants
- Where
- 13 sitesSwitzerland
- Study dates
- 12 May 2022to 4 Feb 2026
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include male and female patients (aged ≥ 18 years) with a documented diagnosis of RMS and treated for at least 3 months with Ofatumumab
Who may be able to join
- Written informed consent must be obtained before participating in the study.
- Diagnosis of RMS per McDonald Criteria (2017) occurred within 3 years prior to initiation of Ofatumumab.
- Adult patients who have been on treatment with Ofatumumab for at least 3 months, but not longer than 12 months prior to inclusion in the study.
- Ofatumumab treatment in line with the Swiss Kesimpta® label (i.e. adult patients with active, relapsing forms of MS)
- Patient is willing and able to complete patient diary during course of the study, as well as to complete PRO questionnaires.
Who cannot join
- Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 3 months before Ofatumumab initiation, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
- Subjects who are not able to provide consent due to incapable judgement
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Switzerland13 sites
Novartis Investigative Site
Baden, Canton of Aargau, 5405
Novartis Investigative Site
Basel, 4001
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Gland, Canton of Vaud, 1196
Novartis Investigative Site
Lausanne, 1011
Novartis Investigative Site
Lucerne, Canton of Lucerne, 6004
Novartis Investigative Site
Lucerne, Canton of Lucerne, 6006
Novartis Investigative Site
Lucerne, 6000
Novartis Investigative Site
Lugano, 6900
Novartis Investigative Site
Sargans, Canton of St. Gallen, 7320
Novartis Investigative Site
Zurich, Canton of Zurich, 8006
Novartis Investigative Site
Zurich, CHE, 8001
Novartis Investigative Site
Zurich, 8091
About this study
Official title: Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study (KOSMOS)
This is a multi-center, observational study carried out in Switzerland that aims to describe the effects of Ofatumumab in a setting of routine medical care.
Read the detailed description
This non-interventional study will observe the effect of Ofatumumab treatment compared to the standard of care (SoC) arm of a closely monitored phase-IIIb study (STHENOS-COMB157G3301) in MS patients in a real-world setting in Switzerland over an observational period of 12 month.
- Conditions
- Multiple Sclerosis
- Being tested
- Ofatumumab
- Keywords
- NIS, Multiple sclerosis, MS, KOSMOS, Ofatumumab, Kesimpta
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfatumumabOther
Prospective observational cohort study. There is no treatment allocation. Patients administered Ofatumumab, that have started before inclusion of the patient into the study will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Ofatumumab | Population under routine medical care prescribed Ofatumumab in an early Relapsing Multiple Sclerosis Receives: Other: Ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with no evidence of disease activity (NEDA-3)
No evidence of disease activity (NEDA-3), as defined by no confirmed MS relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening, as compared to the SoC arm of STHENOS.
Measured: Month 12
Secondary outcomes (11)
Proportion of patients demonstrating NEDA-3
Proportion of patients demonstrating NEDA-3 and its components in relation to the Ofatumumab arm of STHENOS.
Measured: Month 12
Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3
Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3:
- No confirmed MS relapse
- No new or enlarging T2 lesions
- No Gadolinium-positive T1 lesions
- No six-month confirmed disability worsening
Measured: Month 12
Proportion of patients with previous DMT medication
Proportion of patients with previous Disease-modifying Therapy (DMT) medication will be collected
Measured: Baseline
Proportion of patients with clinical and MRI parameters
Proportion of patients with Magnet Resonance Imaging (MRI) and clinical parameters will be collected.
Clinical parameters includes number of T2-hyperintense lesions, T1-contrast-enhancing lesions; number of MS relapse; Extended disability status scale (EDSS)
Measured: Baseline
Proportion of Ofatumumab doses not completed
Proportion of Ofatumumab doses not completed and reason for not completion within 14 days of expected date.
Measured: Month 12
Proportion of participants with a cumulative treatment interruption of more than six months
Proportion of participants with a cumulative treatment interruption of more than six months, calculated as 6 doses not completed.
Measured: Month 12
Adherence to Ofatumumab
Proportion of participants with and without 100% adherence, defined as no dose administered outside of 14 days of expected date
Measured: Month 12
Proportion of patients permanently discontinuing Ofatumumab
Proportion of patients permanently discontinuing Ofatumumab during the study, and reasons for discontinuation.
Measured: Month 12
Interdependency of adherence and clinical outcome in terms of NEDA-3
Correlation between adherence and clinical outcome in terms of NEDA-3 activity to be measured
Measured: Month 12
Treatment effect of Ofatumumab on the impact of multiple sclerosis as measured by MSIS-29
The Multiple Sclerosis Impact Scale (MSIS-29) Questionnaire is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options. Higher scores reflect greater impact on day to day life
Measured: Month 12
Treatment satisfaction with Ofatumumab as measured by TSQM-9
The TSQM-9 is a patient questionnaire assessing treatment satisfaction with Ofatumumab.
It consists of 3 subscales: effectiveness, convenience and global satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0-100 scale. Higher summary scores indicate better satisfaction with treatment.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start12 May 2022
- Primary completion4 Feb 2026
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Prospective
- Enrolment
- 107 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
- NCT05285904
- Sponsor's protocol ID
- COMB157GCH01
- Acronym
- KOSMOS
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2022
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study (KOSMOS)
- ClinicalTrials.gov ID
- NCT05285904
- Acronym / sponsor ID
- KOSMOS / COMB157GCH01
- Conditions
- Multiple Sclerosis
- Keywords
- NIS, Multiple sclerosis, MS, KOSMOS, Ofatumumab, Kesimpta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 May 2022 (actual)
- Primary completion
- 4 Feb 2026 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 18 Mar 2022 (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 is a multi-center, observational study carried out in Switzerland that aims to describe the effects of Ofatumumab in a setting of routine medical care.
Detailed description
This non-interventional study will observe the effect of Ofatumumab treatment compared to the standard of care (SoC) arm of a closely monitored phase-IIIb study (STHENOS-COMB157G3301) in MS patients in a real-world setting in Switzerland over an observational period of 12 month.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab | – | Other: OfatumumabPopulation under routine medical care prescribed Ofatumumab in an early Relapsing Multiple Sclerosis |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include male and female patients (aged ≥ 18 years) with a documented diagnosis of RMS and treated for at least 3 months with Ofatumumab
Key inclusion criteria (5 listed)
- Written informed consent must be obtained before participating in the study.
- Diagnosis of RMS per McDonald Criteria (2017) occurred within 3 years prior to initiation of Ofatumumab.
- Adult patients who have been on treatment with Ofatumumab for at least 3 months, but not longer than 12 months prior to inclusion in the study.
- Ofatumumab treatment in line with the Swiss Kesimpta® label (i.e. adult patients with active, relapsing forms of MS)
- Patient is willing and able to complete patient diary during course of the study, as well as to complete PRO questionnaires.
Key exclusion criteria (2 listed)
- Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 3 months before Ofatumumab initiation, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
- Subjects who are not able to provide consent due to incapable judgement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OfatumumabProspective observational cohort study. There is no treatment allocation. Patients administered Ofatumumab, that have started before inclusion of the patient into the study will be enrolled. | Other | Ofatumumab |
Primary outcome
Proportion of patients with no evidence of disease activity (NEDA-3)
Time frame: Month 12
No evidence of disease activity (NEDA-3), as defined by no confirmed MS relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening, as compared to the SoC arm of STHENOS.
11 secondary outcomes
Proportion of patients demonstrating NEDA-3
Time frame: Month 12
Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3
Time frame: Month 12
Proportion of patients with previous DMT medication
Time frame: Baseline
Proportion of patients with clinical and MRI parameters
Time frame: Baseline
Proportion of Ofatumumab doses not completed
Time frame: Month 12
Proportion of participants with a cumulative treatment interruption of more than six months
Time frame: Month 12
Adherence to Ofatumumab
Time frame: Month 12
Proportion of patients permanently discontinuing Ofatumumab
Time frame: Month 12
Interdependency of adherence and clinical outcome in terms of NEDA-3
Time frame: Month 12
Treatment effect of Ofatumumab on the impact of multiple sclerosis as measured by MSIS-29
Time frame: Month 12
Treatment satisfaction with Ofatumumab as measured by TSQM-9
Time frame: Month 12
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 14 Apr 2026.
- Individual participant dataSharing planned: No
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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
13 sites 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, run by Novartis Pharmaceuticals at 13 sites in Switzerland.
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 5 inclusion and 2 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 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Switzerland. 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?
Proportion of patients with no evidence of disease activity (NEDA-3) (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2026.