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

Multiple Sclerosis Clinical Trial

— KAIROS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05566756
• Other study ID #: COMB157GDE03
• Status: Active, not recruiting
• Start date: October 28, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 307
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Altenburg
Germany	Novartis Investigative Site	Alzey
Germany	Novartis Investigative Site	Bad Homburg
Germany	Novartis Investigative Site	Bamberg	Bavaria
Germany	Novartis Investigative Site	Bayreuth
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Boblingen
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bogen
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Düsseldorf
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Essen	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Gelsenkirchen
Germany	Novartis Investigative Site	Giessen
Germany	Novartis Investigative Site	Gladenbach
Germany	Novartis Investigative Site	Hagen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Kaiserslautern
Germany	Novartis Investigative Site	Koln
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Minden
Germany	Novartis Investigative Site	Osnabrück
Germany	Novartis Investigative Site	Pforzheim
Germany	Novartis Investigative Site	Quakenbrueck
Germany	Novartis Investigative Site	Remscheid
Germany	Novartis Investigative Site	Ruelzheim
Germany	Novartis Investigative Site	Siegen
Germany	Novartis Investigative Site	Sinsheim
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Unterhaching

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reasons for recent therapy switch to ofatumumab	Reasons for recent therapy switch to ofatumumab will be collected	Baseline
Secondary	Proportion of missed ofatumumab doses	Proportion of missed ofatumumab doses within one year, defined as the difference between number of planned doses and number of administered doses	12 months
Secondary	Number of patients by reasons for treatment interruptions	Reasons for treatment interruptions per patient will be collected	12 months
Secondary	Number of treatment interruptions per patient	Number of treatment interruptions per patient will be collected	12 months
Secondary	Duration of treatment interruptions per patient	Duration of treatment interruptions per patient will be collected	12 months
Secondary	Proportion of patient subgroups with and without 100% adherence depending on different characteristics	Proportion of patient subgroups with and without 100% adherence depending on different characteristics, defined as patients with matching number of planned doses and number of administered doses within 1 year (e.g., previous experience with sub-cutaneous therapy)	12 months
Secondary	Proportion of patients permanently discontinuing ofatumumab during the study by reason for discontinuation	Proportion of patients permanently discontinuing ofatumumab during the study by reasons for discontinuation will be collected	12 months
Secondary	Proportion of patients permanently discontinuing ofatumumab during the study by planned next DMT	Proportion of patients permanently discontinuing ofatumumab during the study by planned next DMT	12 months
Secondary	Change on Multiple Sclerosis Impact Scale 29 (MSIS-29) as compared to baseline in general and depending on reasons for treatment switch	MSIS-29 is a 29-item, self administered questionnaire that includes two domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day-to-day life.; The questions in the scale ask the subjects for their views about the impact of MS on their day to-day life during the past 2 weeks.; Analysis will be done depending on the reasons for treatment switch.	Baseline, month 6, month 12
Secondary	Treatment Satisfaction Questionnaire for Medication (TSQM) 1.4 as compared to baseline in general and depending on reasons for treatment switch	The TSQM Version 1.4 comprises 14 items across four domains focusing on effectiveness (3 items), side effects (5 items), convenience (3 items), and global satisfaction (3 items) of the medication over the previous 2-3 weeks, or since the subject´s last use. With the exception of item 4 (presence of side effects; yes or no), all items have 5 or 7 responses, scored from 1 (least satisfied) to 5 or 7 (most satisfied). 7-item scales had a non-neutral midpoint, such that there were more positive response options than negative response options, to allow precise information to be obtained at the upper end of the score distribution. Item scores are summarized to give four domain scores, which are in turn transformed to a scale of 0; -100.	Baseline, month 6, month 12
Secondary	Fatigue Scale for Motor and Cognitive Functions (FSMC) compared to baseline in general and depending on reasons for treatment switch	FSMC is a 20 item scale developed as a measure of cognitive and motor fatigue for people with Multiple Sclerosis.; Each item is rated on a scale from 1-5 (1:"does not apply", 5: "applies completely").; Thus, a maximum of 100 points for the total scale can be achieved. A patient who has neither motor nor cognitive fatigue would thus achieve a score of 20 for the total scale.	Baseline, month 6, month 12
Secondary	Percentage of patients with no clinical evidence of disease activity (NEDA)	NEDA is defined by no confirmed MS relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening	Baseline, month 6, month 12
Secondary	Proportion of patients demonstrating the individual NEDA-3 components	The individual NEDA-3 components are: proportion of patients with no confirmed MS relapse; proportion of patients with no new or enlarging T2 lesions and no Gadolinium-positive T1 lesions; proportion of patients with no six-month confirmed disability worsening	Baseline, month 12
Secondary	The proportion of subjects discontinuing treatment due to insufficient effectiveness (lack of effectiveness) or tolerability/safety reasons	The proportion of subjects discontinuing treatment due to insufficient effectiveness or tolerability/safety reasons	12 months
Secondary	Number of participants with injection related AEs	injection site reaction AEs vs. injection systemic reaction AEs	12 months