NCT05285904

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 12, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2026

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

March 8, 2022

Last Update Submit

April 9, 2026

Conditions

Multiple Sclerosis

Keywords

NISMultiple sclerosisMSKOSMOSOfatumumabKesimpta

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Proportion of patients demonstrating NEDA-3

    Month 12

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

    Month 12

  • Proportion of patients with previous DMT medication

    Baseline

  • Proportion of patients with clinical and MRI parameters

    Baseline

  • Proportion of Ofatumumab doses not completed

    Month 12

  • +6 more secondary outcomes

Study Arms (1)

Ofatumumab

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

Other: Ofatumumab

Interventions

OfatumumabOTHER

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.

Ofatumumab

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • Subjects who are not able to provide consent due to incapable judgement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Novartis Investigative Site

Baden, Canton of Aargau, 5405, Switzerland

Location

Novartis Investigative Site

Lucerne, Canton of Lucerne, 6004, Switzerland

Location

Novartis Investigative Site

Lucerne, Canton of Lucerne, 6006, Switzerland

Location

Novartis Investigative Site

Sargans, Canton of St. Gallen, 7320, Switzerland

Location

Novartis Investigative Site

Gland, Canton of Vaud, 1196, Switzerland

Location

Novartis Investigative Site

Zurich, Canton of Zurich, 8006, Switzerland

Location

Novartis Investigative Site

Zurich, CHE, 8001, Switzerland

Location

Novartis Investigative Site

Basel, 4001, Switzerland

Location

Novartis Investigative Site

Bern, 3010, Switzerland

Location

Novartis Investigative Site

Lausanne, 1011, Switzerland

Location

Novartis Investigative Site

Lucerne, 6000, Switzerland

Location

Novartis Investigative Site

Lugano, 6900, Switzerland

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 18, 2022

Study Start

May 12, 2022

Primary Completion

February 4, 2026

Study Completion

February 4, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(13)