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: Nov 24, 2022

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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

Study Locations

Germany
Novartis Investigative Site
Recruiting
Berlin, 120999
-
Germany
Novartis Investigative Site
Recruiting
Bochum, 44787
-
Germany
Novartis Investigative Site
Recruiting
Essen, 45257
-
Germany
Novartis Investigative Site
Recruiting
Hagen, 58095
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 20249
-
Germany
Novartis Investigative Site
Recruiting
Pforzheim, 75172
-
Germany
Novartis Investigative Site
Recruiting
Remscheid, 42853
-
Germany
Novartis Investigative Site
Recruiting
Siegen, 57076
-
Germany
Novartis Investigative Site
Recruiting
Sinsheim, 74889
-
Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]