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Note: This record shows only 24 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 27 January 2025
Main ID:  NCT05285904
Date of registration: 08/03/2022
Prospective Registration: Yes
Primary sponsor: Novartis Pharmaceuticals
Public title: Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study KOSMOS
Scientific title: Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study (KOSMOS)
Date of first enrolment: May 12, 2022
Target sample size: 149
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/ct2/show/NCT05285904
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Switzerland
Contacts
Contact type:
Name:     Novartis Pharmaceuticals
Address: 
Telephone:
Email:
Affiliation:  Novartis Pharmaceuticals
Contact type:
Name:     Novartis Pharmaceuticals
Address: 
Telephone: +41613241111
Email: novartis.email@novartis.com
Affiliation: 
Key inclusion & exclusion criteria
Inclusion Criteria:

1. Written informed consent must be obtained before participating in the study.

2. Diagnosis of RMS per McDonald Criteria (2017) occurred within 3 years prior to
initiation of Ofatumumab.

3. 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.

4. Ofatumumab treatment in line with the Swiss Kesimpta® label (i.e. adult patients
with active, relapsing forms of MS)

5. Patient is willing and able to complete patient diary during course of the study, as
well as to complete PRO questionnaires.

Exclusion Criteria:

1. 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.

2. Subjects who are not able to provide consent due to incapable judgement



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All
Health Condition(s) or Problem(s) studied
Multiple Sclerosis
Intervention(s)
Other: Ofatumumab
Primary Outcome(s)
Proportion of patients with no evidence of disease activity (NEDA-3) [Time Frame: Month 12]
Secondary Outcome(s)
Adherence to Ofatumumab [Time Frame: Month 12]
Interdependency of adherence and clinical outcome in terms of NEDA-3 [Time Frame: Month 12]
Proportion of participants with a cumulative treatment interruption of more than six months [Time Frame: Month 12]
Proportion of patients with clinical and MRI parameters [Time Frame: Baseline]
Proportion of patients demonstrating NEDA-3 [Time Frame: Month 12]
Proportion of Ofatumumab doses not completed [Time Frame: Month 12]
Proportion of patients permanently discontinuing Ofatumumab [Time Frame: Month 12]
Treatment effect of Ofatumumab on the impact of multiple sclerosis as measured by MSIS-29 [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]
Treatment satisfaction with Ofatumumab as measured by TSQM-9 [Time Frame: Month 12]
Secondary ID(s)
COMB157GCH01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
URL:
URL of the protocol:
Date Posted:
Date of completion:
Date of first publication:
Results summary:
Baseline characteristics:
Adverse events:
Outcome measures:
IPD sharing plan:
IPD sharing description:
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