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

A Non-interventional Study Evaluating Kesimpta® (Ofatumumab) Treatment Effects in Patients With Relapsing Multiple Sclerosis Transitioning From Other Therapies [KAIROS]

ClinicalTrials.gov Identifier: NCT05566756

Novartis Reference Number: COMB157GDE03

Last Update: Jan 26, 2023

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Condition

Multiple Sclerosis

Phase

Not Given

Overall status

Recruiting

Start date

Oct 28, 2022

Completion date

Nov 30, 2024

Gender

All

Age(s)

18 Years - 99 Years (Adult, Older Adult)

Interventions

Other

Ofatumumab

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

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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