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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Ofatumumab

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.

• Study Type: Observational
• Enrollment (Actual): 107

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4001
    • Novartis Investigative Site
  • Bern, Switzerland, 3010
    • Novartis Investigative Site
  • Lausanne, Switzerland, 1011
    • Novartis Investigative Site
  • Lucerne, Switzerland, 6000
    • Novartis Investigative Site
  • Lugano, Switzerland, 6900
    • Novartis Investigative Site
  • Zurich, Switzerland, 8091
    • Novartis Investigative Site
  • CHE
    • Zurich, CHE, Switzerland, 8001
      • Novartis Investigative Site
  • Canton of Aargau
    • Baden, Canton of Aargau, Switzerland, 5405
      • Novartis Investigative Site
  • Canton of Lucerne
    • Lucerne, Canton of Lucerne, Switzerland, 6004
      • Novartis Investigative Site
    • Lucerne, Canton of Lucerne, Switzerland, 6006
      • Novartis Investigative Site
  • Canton of St. Gallen
    • Sargans, Canton of St. Gallen, Switzerland, 7320
      • Novartis Investigative Site
  • Canton of Vaud
    • Gland, Canton of Vaud, Switzerland, 1196
      • Novartis Investigative Site
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8006
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include male and female patients (aged ≥ 18 years) with a documented diagnosis of RMS and treated for at least 3 months with Ofatumumab

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ofatumumab; Population under routine medical care prescribed Ofatumumab in an early Relapsing Multiple Sclerosis	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Actual): February 4, 2026
• Study Completion (Actual): February 4, 2026

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Ofatumumab; MS; Multiple sclerosis; Kesimpta; NIS; KOSMOS
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Antineoplastic Agents; ofatumumab
• Other Study ID Numbers: COMB157GCH01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO