Study Evaluating Kesimpta® Treatment Effects in Patients With Relapsing Multiple Sclerosis Transitioning From Other Therapies

NCT ID: NCT05566756

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 307 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-28
• Study Completion Date: 2025-05-28

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.

Detailed Description

The decision for ofatumumab as routine medical treatment must be taken independently of and prior to the study start. During the observation phase of the study, data will be collected according to standard of care as recommended by KKNMS (Competence Network Multiple Sclerosis in Germany).

The prospective observational period per patient will be up to approx. one year from the time of consent (1 year ± 2 months visit window + potentially 6 months follow-up to confirm disability worsening in patients who showed increase in EDSS within 6 months prior to EOS). The observational period will not be dictated by the protocol. The follow-up documentation will take place at a frequency defined as per investigator's discretion. The diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy and to routine clinical care, can be performed as telemedicine visits and will take place as per investigator's discretion.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ofatumumab

Patients prescribed with ofatumumab

Ofatumumab

Intervention Type: OTHER

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

Interventions

Ofatumumab

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

Intervention Type: OTHER

Other Intervention Names

Kesimpta

Eligibility Criteria

Inclusion Criteria

1. Written informed consent must be obtained before participating in the study

2. Diagnosis of RMS per McDonald Criteria (2017) (Thompson, Banwell et al. 2018)

3. Prior treatment with EU approved DMT for MS other than ofatumumab

4. 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

5. Ofatumumab treatment in line with the German label

Exclusion Criteria

1. 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

2. Subjects who are not able to provide consent due to incapable judgement

3. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with ofatumumab

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Mannheim, Baden-Wurttemberg, Germany

Novartis Investigative Site

Bamberg, Bavaria, Germany

Novartis Investigative Site

Bad Homburg, Hesse, Germany

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Novartis Investigative Site

Marburg, Hesse, Germany

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Essen, North Rhine-Westphalia, Germany

Novartis Investigative Site

Altenburg, Thuringia, Germany

Novartis Investigative Site

Alzey, , Germany

Novartis Investigative Site

Bayreuth, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Bochum, , Germany

Novartis Investigative Site

Bogen, , Germany

Novartis Investigative Site

Bonn, , Germany

Novartis Investigative Site

Böblingen, , Germany

Novartis Investigative Site

Chemnitz, , Germany

Novartis Investigative Site

Düsseldorf, , Germany

Novartis Investigative Site

Düsseldorf, , Germany

Novartis Investigative Site

Essen, , Germany

Novartis Investigative Site

Gelsenkirchen, , Germany

Novartis Investigative Site

Giessen, , Germany

Novartis Investigative Site

Gladenbach, , Germany

Novartis Investigative Site

Hagen, , Germany

Novartis Investigative Site

Hamburg, , Germany

Novartis Investigative Site

Hamburg, , Germany

Novartis Investigative Site

Hanover, , Germany

Novartis Investigative Site

Kaiserslautern, , Germany

Novartis Investigative Site

Minden, , Germany

Novartis Investigative Site

Osnabrück, , Germany

Novartis Investigative Site

Pforzheim, , Germany

Novartis Investigative Site

Quakenbrück, , Germany

Novartis Investigative Site

Remscheid, , Germany

Novartis Investigative Site

Rülzheim, , Germany

Novartis Investigative Site

Siegen, , Germany

Novartis Investigative Site

Sinsheim, , Germany

Novartis Investigative Site

Stuttgart, , Germany

Novartis Investigative Site

Stuttgart, , Germany

Novartis Investigative Site

Unterhaching, , Germany

Countries

Germany

Other Identifiers

COMB157GDE03

Identifier Type: -

Identifier Source: org_study_id