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

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Other: Ofatumumab

• Registration Number: NCT05285904
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-08
• Study First Posted: 2022-03-18
• Study Start: 2022-05-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 149

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ofatumumab	Ofatumumab	Population under routine medical care prescribed Ofatumumab in an early Relapsing Multiple Sclerosis

Primary Outcome Measures

Name	Time	Method
Proportion of patients with no evidence of disease activity (NEDA-3)	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients demonstrating NEDA-3	Month 12	Proportion of patients demonstrating NEDA-3 and its components in relation to the Ofatumumab arm of STHENOS.
Treatment satisfaction with Ofatumumab as measured by TSQM-9	Month 12	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.
Proportion of patients permanently discontinuing Ofatumumab	Month 12	Proportion of patients permanently discontinuing Ofatumumab during the study, and reasons for discontinuation.
Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3	Month 12	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
Proportion of patients with previous DMT medication	Baseline	Proportion of patients with previous Disease-modifying Therapy (DMT) medication will be collected
Proportion of participants with a cumulative treatment interruption of more than six months	Month 12	Proportion of participants with a cumulative treatment interruption of more than six months, calculated as 6 doses not completed.
Proportion of patients with clinical and MRI parameters	Baseline	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)
Proportion of Ofatumumab doses not completed	Month 12	Proportion of Ofatumumab doses not completed and reason for not completion within 14 days of expected date.
Adherence to Ofatumumab	Month 12	Proportion of participants with and without 100% adherence, defined as no dose administered outside of 14 days of expected date
Interdependency of adherence and clinical outcome in terms of NEDA-3	Month 12	Correlation between adherence and clinical outcome in terms of NEDA-3 activity to be measured
Treatment effect of Ofatumumab on the impact of multiple sclerosis as measured by MSIS-29	Month 12	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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇭 Zurich, Switzerland