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

Multiple Sclerosis Clinical Trial

— KOSMOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05285904
• Other study ID #: COMB157GCH01
• Status: Recruiting
• Start date: May 12, 2022
• Est. completion date: January 31, 2026

Study information

• Verified date: March 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 149
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Ofatumumab
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.

Locations

Country	Name	City	State
Switzerland	Novartis Investigative Site	Baden	Aargau
Switzerland	Novartis Investigative Site	Basel
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Chur	GR
Switzerland	Novartis Investigative Site	Gland	Vaud
Switzerland	Novartis Investigative Site	Lausanne
Switzerland	Novartis Investigative Site	Liestal	BL
Switzerland	Novartis Investigative Site	Lugano
Switzerland	Novartis Investigative Site	Luzern
Switzerland	Novartis Investigative Site	Luzern
Switzerland	Novartis Investigative Site	Luzern	LU
Switzerland	Novartis Investigative Site	Sargans	Saint Gallen
Switzerland	Novartis Investigative Site	Sion
Switzerland	Novartis Investigative Site	Wil	SG
Switzerland	Novartis Investigative Site	Zuerich	CHE
Switzerland	Novartis Investigative Site	Zug	ZG
Switzerland	Novartis Investigative Site	Zurich	ZH
Switzerland	Novartis Investigative Site	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Proportion of patients with previous DMT medication	Proportion of patients with previous Disease-modifying Therapy (DMT) medication will be collected	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of patients permanently discontinuing Ofatumumab	Proportion of patients permanently discontinuing Ofatumumab during the study, and reasons for discontinuation.	Month 12
Secondary	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
Secondary	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
Secondary	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