Clinical trial NCT05566756: Study Evaluating Kesimpta® Treatment Effects in Patients With Relapsing Multiple Sclerosis Transitioning From Other Therapies
Official title: A Non-interventional Study Evaluating Kesimpta® (Ofatumumab) Treatment Effects in Patients With Relapsing Multiple Sclerosis Transitioning From Other Therapies [KAIROS]
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
MS
Kesimpta
ofatumumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-10-04
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who previously received any approved DMT for RMS in Germany, and the decision to transition to ofatumumab therapy due to safety, tolerability, efficacy or other reasons was taken, will be eligible for enrollment

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.

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

Primary outcomes:
measure: Reasons for recent therapy switch to ofatumumab
timeFrame: Baseline
Secondary outcomes:
measure: Proportion of missed ofatumumab doses
timeFrame: 12 months
measure: Number of patients by reasons for treatment interruptions
timeFrame: 12 months
measure: Number of treatment interruptions per patient
timeFrame: 12 months
measure: Duration of treatment interruptions per patient
timeFrame: 12 months
measure: Proportion of patient subgroups with and without 100% adherence depending on different characteristics
timeFrame: 12 months
measure: Proportion of patients permanently discontinuing ofatumumab during the study by reason for discontinuation
timeFrame: 12 months
measure: Proportion of patients permanently discontinuing ofatumumab during the study by planned next DMT
timeFrame: 12 months
measure: Change on Multiple Sclerosis Impact Scale 29 (MSIS-29) as compared to baseline in general and depending on reasons for treatment switch
timeFrame: Baseline, month 6, month 12
measure: Treatment Satisfaction Questionnaire for Medication (TSQM) 1.4 as compared to baseline in general and depending on reasons for treatment switch
timeFrame: Baseline, month 6, month 12
measure: Fatigue Scale for Motor and Cognitive Functions (FSMC) compared to baseline in general and depending on reasons for treatment switch
timeFrame: Baseline, month 6, month 12
measure: Percentage of patients with no clinical evidence of disease activity (NEDA)
timeFrame: Baseline, month 6, month 12
measure: Proportion of patients demonstrating the individual NEDA-3 components
timeFrame: Baseline, month 12
measure: The proportion of subjects discontinuing treatment due to insufficient effectiveness (lack of effectiveness) or tolerability/safety reasons
timeFrame: 12 months
measure: Number of participants with injection related AEs
timeFrame: 12 months
Other outcomes:
Locations:
city: Bamberg
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Bad Homburg
country: Germany
facility: Novartis Investigative Site
state: Hesse
city: Essen
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Altenburg
country: Germany
facility: Novartis Investigative Site
city: Alzey
country: Germany
facility: Novartis Investigative Site
city: Bayreuth
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Boblingen
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Bogen
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Gelsenkirchen
country: Germany
facility: Novartis Investigative Site
city: Giessen
country: Germany
facility: Novartis Investigative Site
city: Gladenbach
country: Germany
facility: Novartis Investigative Site
city: Hagen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Kaiserslautern
country: Germany
facility: Novartis Investigative Site
city: Koln
country: Germany
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Minden
country: Germany
facility: Novartis Investigative Site
city: Osnabrueck
country: Germany
facility: Novartis Investigative Site
city: Pforzheim
country: Germany
facility: Novartis Investigative Site
city: Quakenbrueck
country: Germany
facility: Novartis Investigative Site
city: Remscheid
country: Germany
facility: Novartis Investigative Site
city: Ruelzheim
country: Germany
facility: Novartis Investigative Site
city: Siegen
country: Germany
facility: Novartis Investigative Site
city: Sinsheim
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Unterhaching
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: