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

Last updated: January 14, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Neurologic Disorders

Memory Loss

Treatment

Ofatumumab

Clinical Study ID

NCT05566756
COMB157GDE03
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 studyparticipation and planned initiation of ofatumumab after respective wash-out periodof prior DMT (if applicable) or performed initiation of ofatumumab within the last 14 days

  5. Ofatumumab treatment in line with the German label

Exclusion

Exclusion Criteria:

  1. Use of investigational drugs during the study, OR within 3 months before ofatumumabinitiation, OR within 5 half-lives of investigational drug before ofatumumabinitiation, 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 simultaneousparticipation in another Novartis-sponsored non-interventional study with ofatumumab

Study Design

Total Participants: 307
Treatment Group(s): 1
Primary Treatment: Ofatumumab
Phase:
Study Start date:
October 28, 2022
Estimated Completion Date:
April 30, 2025

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Bamberg, Bavaria 96052
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Homburg, Hesse 61348
    Germany

    Site Not Available

  • Novartis Investigative Site

    Essen, Nordrhein-Westfalen 45134
    Germany

    Site Not Available

  • Novartis Investigative Site

    Altenburg, 04600
    Germany

    Site Not Available

  • Novartis Investigative Site

    Alzey, 55232
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bayreuth, 95445
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 13357
    Germany

    Site Not Available

  • Novartis Investigative Site

    Boblingen, 71032
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bochum, 44787
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bogen, 94327
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bonn, 53111
    Germany

    Site Not Available

  • Novartis Investigative Site

    Chemnitz, 09117
    Germany

    Site Not Available

  • Novartis Investigative Site

    Duesseldorf, 40625
    Germany

    Site Not Available

  • Novartis Investigative Site

    Düsseldorf, 40625
    Germany

    Site Not Available

  • Novartis Investigative Site

    Frankfurt, 60313
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gelsenkirchen, 45894
    Germany

    Site Not Available

  • Novartis Investigative Site

    Giessen, 35392
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gladenbach, 35075
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hagen, 58095
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg, 22179
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hannover, 30625
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kaiserslautern, 67655
    Germany

    Site Not Available

  • Novartis Investigative Site

    Koln, 50935
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mannheim, 66163
    Germany

    Site Not Available

  • Novartis Investigative Site

    Marburg, 35039
    Germany

    Site Not Available

  • Novartis Investigative Site

    Minden, 32423
    Germany

    Site Not Available

  • Novartis Investigative Site

    Osnabrueck, 49074
    Germany

    Site Not Available

  • Novartis Investigative Site

    Osnabrück, 49074
    Germany

    Site Not Available

  • Novartis Investigative Site

    Pforzheim, 75172
    Germany

    Site Not Available

  • Novartis Investigative Site

    Quakenbrueck, 49610
    Germany

    Site Not Available

  • Novartis Investigative Site

    Remscheid, 42853
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ruelzheim, 76761
    Germany

    Site Not Available

  • Novartis Investigative Site

    Siegen, 57076
    Germany

    Site Not Available

  • Novartis Investigative Site

    Sinsheim, 74889
    Germany

    Site Not Available

  • Novartis Investigative Site

    Stuttgart, 70182
    Germany

    Site Not Available

  • Novartis Investigative Site

    Unterhaching, 82008
    Germany

    Site Not Available

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