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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05566756

Collaborator

(none)

300

Enrollment

Locations

25.1

Anticipated Duration (Months)

13.6

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: Ofatumumab

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 28, 2022

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Nov 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Ofatumumab Patients prescribed with ofatumumab	Other: Ofatumumab There is no treatment allocation. Patients administered Ofatumumab by prescription will be enrolled. Other Names: Kesimpta

Arm

Intervention/Treatment

Ofatumumab

Patients prescribed with ofatumumab

Other: Ofatumumab

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

Other Names:

Kesimpta

Outcome Measures

Primary Outcome Measures

Reasons for recent therapy switch to ofatumumab [Baseline]
Reasons for recent therapy switch to ofatumumab will be collected

Secondary Outcome Measures

Proportion of missed ofatumumab doses [12 months]
Proportion of missed ofatumumab doses within one year, defined as the difference between number of planned doses and number of administered doses
Number of patients by reasons for treatment interruptions [12 months]
Reasons for treatment interruptions per patient will be collected
Number of treatment interruptions per patient [12 months]
Number of treatment interruptions per patient will be collected
Duration of treatment interruptions per patient [12 months]
Duration of treatment interruptions per patient will be collected
Proportion of patient subgroups with and without 100% adherence depending on different characteristics [12 months]
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)
Proportion of patients permanently discontinuing ofatumumab during the study by reason for discontinuation [12 months]
Proportion of patients permanently discontinuing ofatumumab during the study by reasons for discontinuation will be collected
Proportion of patients permanently discontinuing ofatumumab during the study by planned next DMT [12 months]
Proportion of patients permanently discontinuing ofatumumab during the study by planned next DMT
Change on Multiple Sclerosis Impact Scale 29 (MSIS-29) as compared to baseline in general and depending on reasons for treatment switch [Baseline, month 6, month 12]
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.
Treatment Satisfaction Questionnaire for Medication (TSQM) 1.4 as compared to baseline in general and depending on reasons for treatment switch [Baseline, month 6, month 12]
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.
Fatigue Scale for Motor and Cognitive Functions (FSMC) compared to baseline in general and depending on reasons for treatment switch [Baseline, month 6, month 12]
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.
Percentage of patients with no clinical evidence of disease activity (NEDA) [Baseline, month 6, month 12]
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
Proportion of patients demonstrating the individual NEDA-3 components [Baseline, month 12]
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
The proportion of subjects discontinuing treatment due to insufficient effectiveness (lack of effectiveness) or tolerability/safety reasons [12 months]
The proportion of subjects discontinuing treatment due to insufficient effectiveness or tolerability/safety reasons
Number of participants with injection related AEs [12 months]
injection site reaction AEs vs. injection systemic reaction AEs

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Bamberg	Bavaria	Germany	96052
2	Novartis Investigative Site	Bad Homburg		Germany	61348
3	Novartis Investigative Site	Berlin		Germany	120999
4	Novartis Investigative Site	Boblingen		Germany	71032
5	Novartis Investigative Site	Bochum		Germany	44787
6	Novartis Investigative Site	Bogen		Germany	94327
7	Novartis Investigative Site	Bonn		Germany	53111
8	Novartis Investigative Site	Chemnitz		Germany	09117
9	Novartis Investigative Site	Düsseldorf		Germany	40211
10	Novartis Investigative Site	Düsseldorf		Germany	40625
11	Novartis Investigative Site	Essen		Germany	45257
12	Novartis Investigative Site	Gelsenkirchen		Germany	45894
13	Novartis Investigative Site	Hagen		Germany	58095
14	Novartis Investigative Site	Hamburg		Germany	20249
15	Novartis Investigative Site	Kaiserslautern		Germany	67655
16	Novartis Investigative Site	Mannheim		Germany	66163
17	Novartis Investigative Site	Pforzheim		Germany	75172
18	Novartis Investigative Site	Remscheid		Germany	42853
19	Novartis Investigative Site	Ruelzheim		Germany	76761
20	Novartis Investigative Site	Siegen		Germany	57076
21	Novartis Investigative Site	Sinsheim		Germany	74889
22	Novartis Investigative Site	Stuttgart		Germany	70182