Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study (KOSMOS)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Ofatumumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ofatumumab<br>Population under routine medical care prescribed Ofatumumab in an early Relapsing Multiple Sclerosis | Other: Ofatumumab<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients demonstrating NEDA-3 | Proportion of patients demonstrating NEDA-3 and its components in relation to the Ofatumumab arm of STHENOS. | 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 | Month 12 | 
| Proportion of patients with previous DMT medication | Proportion of patients with previous Disease-modifying Therapy (DMT) medication will be collected | 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) | Baseline | 
| Proportion of Ofatumumab doses not completed | Proportion of Ofatumumab doses not completed and reason for not completion within 14 days of expected date. | 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. | 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 | Month 12 | 
| Proportion of patients permanently discontinuing Ofatumumab | Proportion of patients permanently discontinuing Ofatumumab during the study, and reasons for discontinuation. | 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 | 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 | 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. | Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIS, Multiple sclerosis, MS, KOSMOS, Ofatumumab, Kesimpta