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

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

KAIROS was a prospective, multicenter, non-interventional study (NIS) in Germany. Prospective, primary data was 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 was collected including disease duration, EDSS, MRI parameters and relapses.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Ofatumumab

Detailed Description

The decision for ofatumumab as routine medical treatment must have been taken independently of and prior to the study start. During the observation phase of the study, data was collected according to standard of care as recommended by KKNMS (Competence Network Multiple Sclerosis in Germany).

The prospective observational period per patient was 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 was not dictated by the protocol. The follow-up documentation took place at a frequency defined as per investigator's discretion. The diagnostic or monitoring procedures were only those ordinarily applied to the therapeutic strategy and to routine clinical care, could be performed as telemedicine visits and took place as per investigator's discretion.

• Study Type: Observational
• Enrollment (Actual): 307

Contacts and Locations

Study Locations

• Germany
  • Alzey, Germany, 55232
    • Novartis Investigative Site
  • Bayreuth, Germany, 95445
    • Novartis Investigative Site
  • Berlin, Germany, 13347
    • Novartis Investigative Site
  • Berlin, Germany, 12099
    • Novartis Investigative Site
  • Berlin, Germany, 13357
    • Novartis Investigative Site
  • Bochum, Germany, 44787
    • Novartis Investigative Site
  • Bogen, Germany, 94327
    • Novartis Investigative Site
  • Bonn, Germany, 53111
    • Novartis Investigative Site
  • Böblingen, Germany, 71032
    • Novartis Investigative Site
  • Chemnitz, Germany, 09117
    • Novartis Investigative Site
  • Düsseldorf, Germany, 40211
    • Novartis Investigative Site
  • Düsseldorf, Germany, 40625
    • Novartis Investigative Site
  • Essen, Germany, 45257
    • Novartis Investigative Site
  • Gelsenkirchen, Germany, 45894
    • Novartis Investigative Site
  • Giessen, Germany, 35392
    • Novartis Investigative Site
  • Gladenbach, Germany, 35075
    • Novartis Investigative Site
  • Hagen, Germany, 58095
    • Novartis Investigative Site
  • Hamburg, Germany, 20249
    • Novartis Investigative Site
  • Hamburg, Germany, 22179
    • Novartis Investigative Site
  • Hanover, Germany, 30625
    • Novartis Investigative Site
  • Kaiserslautern, Germany, 67655
    • Novartis Investigative Site
  • Minden, Germany, 32423
    • Novartis Investigative Site
  • Osnabrück, Germany, 49074
    • Novartis Investigative Site
  • Pforzheim, Germany, 75172
    • Novartis Investigative Site
  • Quakenbrück, Germany, 49610
    • Novartis Investigative Site
  • Remscheid, Germany, 42853
    • Novartis Investigative Site
  • Rülzheim, Germany, 76761
    • Novartis Investigative Site
  • Siegen, Germany, 57076
    • Novartis Investigative Site
  • Sinsheim, Germany, 74889
    • Novartis Investigative Site
  • Stuttgart, Germany, 70174
    • Novartis Investigative Site
  • Stuttgart, Germany, 70182
    • Novartis Investigative Site
  • Unterhaching, Germany, 82008
    • Novartis Investigative Site
  • Baden-Wurttemberg
    • Mannheim, Baden-Wurttemberg, Germany, 66163
      • Novartis Investigative Site
  • Bavaria
    • Bamberg, Bavaria, Germany, 96052
      • Novartis Investigative Site
  • Hesse
    • Bad Homburg, Hesse, Germany, 61348
      • Novartis Investigative Site
    • Frankfurt am Main, Hesse, Germany, 60313
      • Novartis Investigative Site
    • Marburg, Hesse, Germany, 35043
      • Novartis Investigative Site
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 50935
      • Novartis Investigative Site
    • Essen, North Rhine-Westphalia, Germany, 45134
      • Novartis Investigative Site
  • Thuringia
    • Altenburg, Thuringia, Germany, 04600
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reasons for recent therapy switch to ofatumumab	Reasons for recent therapy switch to ofatumumab will be collected	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of patients by reasons for treatment interruptions	Reasons for treatment interruptions per patient will be collected	12 months
Number of treatment interruptions per patient	Number of treatment interruptions per patient will be collected	12 months
Duration of treatment interruptions per patient	Duration of treatment interruptions per patient will be collected	12 months
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
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
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
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
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
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
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
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
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
Number of participants with injection related AEs	injection site reaction AEs vs. injection systemic reaction AEs	12 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2022
• Primary Completion (Actual): May 28, 2025
• Study Completion (Actual): May 28, 2025

Study Registration Dates

• First Submitted: September 30, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: MS; Multiple sclerosis; ofatumumab; Kesimpta
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Antineoplastic Agents; ofatumumab
• Other Study ID Numbers: COMB157GDE03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO