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Completed

NCT Number: NCT05285904

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Zurich, CHE, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ofatumumab

Other

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.

Primary outcomes

  1. Proportion of patients with no evidence of disease activity (NEDA-3)

    Time frame: 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 outcomes

  1. Proportion of patients demonstrating NEDA-3

    Time frame: Month 12

    Proportion of patients demonstrating NEDA-3 and its components in relation to the Ofatumumab arm of STHENOS.

  2. Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3

    Time frame: 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

  3. Proportion of patients with previous DMT medication

    Time frame: Baseline

    Proportion of patients with previous Disease-modifying Therapy (DMT) medication will be collected

  4. Proportion of patients with clinical and MRI parameters

    Time frame: 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)

  5. Proportion of Ofatumumab doses not completed

    Time frame: Month 12

    Proportion of Ofatumumab doses not completed and reason for not completion within 14 days of expected date.

  6. Proportion of participants with a cumulative treatment interruption of more than six months

    Time frame: Month 12

    Proportion of participants with a cumulative treatment interruption of more than six months, calculated as 6 doses not completed.

  7. Adherence to Ofatumumab

    Time frame: Month 12

    Proportion of participants with and without 100% adherence, defined as no dose administered outside of 14 days of expected date

  8. Proportion of patients permanently discontinuing Ofatumumab

    Time frame: Month 12

    Proportion of patients permanently discontinuing Ofatumumab during the study, and reasons for discontinuation.

  9. Interdependency of adherence and clinical outcome in terms of NEDA-3

    Time frame: Month 12

    Correlation between adherence and clinical outcome in terms of NEDA-3 activity to be measured

  10. Treatment effect of Ofatumumab on the impact of multiple sclerosis as measured by MSIS-29

    Time frame: 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

  11. Treatment satisfaction with Ofatumumab as measured by TSQM-9

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: KOSMOS

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2022
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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