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

NCT05566756

CompletedN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Multiple Sclerosis

Interventions: Ofatumumab

Countries: Germany

KAIROS was a prospective, multicenter, non-interventional study (NIS) in Germany. Prospective, primary data was 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 was collected including disease duration, EDSS, MRI parameters and relapses.

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (40)

Mannheim, Baden-Wurttemberg, Germany
Bamberg, Bavaria, Germany
Bad Homburg, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Marburg, Hesse, Germany
Cologne, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Altenburg, Thuringia, Germany
Alzey, Germany
Bayreuth, Germany
Berlin, Germany
Berlin, Germany
Berlin, Germany
Bochum, Germany
Bogen, Germany
Bonn, Germany
Böblingen, Germany
Chemnitz, Germany
Düsseldorf, Germany
Düsseldorf, Germany
Essen, Germany
Gelsenkirchen, Germany
Giessen, Germany
Gladenbach, Germany
Hagen, Germany
Hamburg, Germany
Hamburg, Germany
Hanover, Germany
Kaiserslautern, Germany
Minden, Germany
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