NCT05566756

Brief Summary

KAIROS is a prospective, multicenter, non-interventional study (NIS) in Germany. Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of one year (max. 1.5 years) of treatment. Additionally, medical history of participants will be collected including disease duration, EDSS, MRI parameters and relapses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

40 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

September 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

October 28, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2025

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

2.6 years

First QC Date

September 30, 2022

Last Update Submit

August 26, 2025

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisMSKesimptaofatumumab

Outcome Measures

Primary Outcomes (1)

  • Reasons for recent therapy switch to ofatumumab

    Reasons for recent therapy switch to ofatumumab will be collected

    Baseline

Secondary Outcomes (14)

  • Proportion of missed ofatumumab doses

    12 months

  • Number of patients by reasons for treatment interruptions

    12 months

  • Number of treatment interruptions per patient

    12 months

  • Duration of treatment interruptions per patient

    12 months

  • Proportion of patient subgroups with and without 100% adherence depending on different characteristics

    12 months

  • +9 more secondary outcomes

Study Arms (1)

Ofatumumab

Patients prescribed with ofatumumab

Other: Ofatumumab

Interventions

OfatumumabOTHER

There is no treatment allocation. Patients administered Ofatumumab by prescription will be enrolled.

Also known as: Kesimpta
Ofatumumab

Eligibility Criteria

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

Patients who previously received any approved DMT for RMS in Germany, and the decision to transition to ofatumumab therapy due to safety, tolerability, efficacy or other reasons was taken, will be eligible for enrollment

You may qualify if:

  • Written informed consent must be obtained before participating in the study
  • Diagnosis of RMS per McDonald Criteria (2017) (Thompson, Banwell et al. 2018)
  • Prior treatment with EU approved DMT for MS other than ofatumumab
  • Decision for treatment initiation of ofatumumab (Kesimpta®) prior to study participation and planned initiation of ofatumumab after respective wash-out period of prior DMT (if applicable) or performed initiation of ofatumumab within the last 14 days
  • Ofatumumab treatment in line with the German label

You may not qualify if:

  • Use of investigational drugs during 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
  • Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with ofatumumab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (40)

Novartis Investigative Site

Mannheim, Baden-Wurttemberg, 66163, Germany

Location

Novartis Investigative Site

Bamberg, Bavaria, 96052, Germany

Location

Novartis Investigative Site

Bad Homburg, Hesse, 61348, Germany

Location

Novartis Investigative Site

Frankfurt am Main, Hesse, 60313, Germany

Location

Novartis Investigative Site

Marburg, Hesse, 35043, Germany

Location

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50935, Germany

Location

Novartis Investigative Site

Essen, North Rhine-Westphalia, 45134, Germany

Location

Novartis Investigative Site

Altenburg, Thuringia, 04600, Germany

Location

Novartis Investigative Site

Alzey, 55232, Germany

Location

Novartis Investigative Site

Bayreuth, 95445, Germany

Location

Novartis Investigative Site

Berlin, 12099, Germany

Location

Novartis Investigative Site

Berlin, 13347, Germany

Location

Novartis Investigative Site

Berlin, 13357, Germany

Location

Novartis Investigative Site

Bochum, 44787, Germany

Location

Novartis Investigative Site

Bogen, 94327, Germany

Location

Novartis Investigative Site

Bonn, 53111, Germany

Location

Novartis Investigative Site

Böblingen, 71032, Germany

Location

Novartis Investigative Site

Chemnitz, 09117, Germany

Location

Novartis Investigative Site

Düsseldorf, 40211, Germany

Location

Novartis Investigative Site

Düsseldorf, 40625, Germany

Location

Novartis Investigative Site

Essen, 45257, Germany

Location

Novartis Investigative Site

Gelsenkirchen, 45894, Germany

Location

Novartis Investigative Site

Giessen, 35392, Germany

Location

Novartis Investigative Site

Gladenbach, 35075, Germany

Location

Novartis Investigative Site

Hagen, 58095, Germany

Location

Novartis Investigative Site

Hamburg, 20249, Germany

Location

Novartis Investigative Site

Hamburg, 22179, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Kaiserslautern, 67655, Germany

Location

Novartis Investigative Site

Minden, 32423, Germany

Location

Novartis Investigative Site

Osnabrück, 49074, Germany

Location

Novartis Investigative Site

Pforzheim, 75172, Germany

Location

Novartis Investigative Site

Quakenbrück, 49610, Germany

Location

Novartis Investigative Site

Remscheid, 42853, Germany

Location

Novartis Investigative Site

Rülzheim, 76761, Germany

Location

Novartis Investigative Site

Siegen, 57076, Germany

Location

Novartis Investigative Site

Sinsheim, 74889, Germany

Location

Novartis Investigative Site

Stuttgart, 70174, Germany

Location

Novartis Investigative Site

Stuttgart, 70182, Germany

Location

Novartis Investigative Site

Unterhaching, 82008, Germany

Location

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

September 30, 2022

First Posted

October 4, 2022

Study Start

October 28, 2022

Primary Completion

May 28, 2025

Study Completion

May 28, 2025

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(40)