Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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27 January 2025 |
Main ID: |
NCT05285904 |
Date of registration:
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08/03/2022 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study
KOSMOS |
Scientific title:
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Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study (KOSMOS) |
Date of first enrolment:
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May 12, 2022 |
Target sample size:
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149 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/ct2/show/NCT05285904 |
Study type:
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Observational |
Study design:
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Phase:
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Countries of recruitment
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Switzerland
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Contacts
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Contact type:
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Name:
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Novartis Pharmaceuticals |
Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Contact type:
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Name:
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Novartis Pharmaceuticals |
Address:
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Telephone:
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+41613241111 |
Email:
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novartis.email@novartis.com |
Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Other: Ofatumumab
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Primary Outcome(s)
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Proportion of patients with no evidence of disease activity (NEDA-3)
[Time Frame: Month 12]
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Secondary Outcome(s)
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Adherence to Ofatumumab
[Time Frame: Month 12]
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Interdependency of adherence and clinical outcome in terms of NEDA-3
[Time Frame: Month 12]
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Proportion of participants with a cumulative treatment interruption of more than six months
[Time Frame: Month 12]
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Proportion of patients with clinical and MRI parameters
[Time Frame: Baseline]
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Proportion of patients demonstrating NEDA-3
[Time Frame: Month 12]
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Proportion of Ofatumumab doses not completed
[Time Frame: Month 12]
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Proportion of patients permanently discontinuing Ofatumumab
[Time Frame: Month 12]
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Treatment effect of Ofatumumab on the impact of multiple sclerosis as measured by MSIS-29
[Time Frame: Month 12]
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Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3
[Time Frame: Month 12]
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Proportion of patients with previous DMT medication
[Time Frame: Baseline]
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Treatment satisfaction with Ofatumumab as measured by TSQM-9
[Time Frame: Month 12]
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Secondary ID(s)
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COMB157GCH01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available: |
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URL: |
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URL of the protocol: |
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Date Posted: |
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Date of completion: |
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Date of first publication: |
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Results summary: |
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Baseline characteristics: |
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Outcome measures: |
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IPD sharing plan: |
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IPD sharing description: |
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