Multiple SclerosisKAIROSNCT05566756
Study Evaluating Kesimpta® Treatment Effects in Patients With Relapsing Multiple Sclerosis Transitioning From Other Therapies
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 40 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ofatumumab
- How many people
- 307 participants
- Where
- 40 sitesGermany
- Study dates
- 28 Oct 2022to 28 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Germany40 sites
Novartis Investigative Site
Altenburg, Thuringia, 04600
Novartis Investigative Site
Alzey, 55232
Novartis Investigative Site
Bad Homburg, Hesse, 61348
Novartis Investigative Site
Bamberg, Bavaria, 96052
Novartis Investigative Site
Bayreuth, 95445
Novartis Investigative Site
Berlin, 12099
Novartis Investigative Site
Berlin, 13347
Novartis Investigative Site
Berlin, 13357
Novartis Investigative Site
Böblingen, 71032
Novartis Investigative Site
Bochum, 44787
Novartis Investigative Site
Bogen, 94327
Novartis Investigative Site
Bonn, 53111
Novartis Investigative Site
Chemnitz, 09117
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50935
Novartis Investigative Site
Düsseldorf, 40211
Novartis Investigative Site
Düsseldorf, 40625
Novartis Investigative Site
Essen, North Rhine-Westphalia, 45134
Novartis Investigative Site
Essen, 45257
Novartis Investigative Site
Frankfurt am Main, Hesse, 60313
Novartis Investigative Site
Gelsenkirchen, 45894
Novartis Investigative Site
Giessen, 35392
Novartis Investigative Site
Gladenbach, 35075
Novartis Investigative Site
Hagen, 58095
Novartis Investigative Site
Hamburg, 20249
Novartis Investigative Site
Hamburg, 22179
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Kaiserslautern, 67655
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, 66163
Novartis Investigative Site
Marburg, Hesse, 35043
Novartis Investigative Site
Minden, 32423
Novartis Investigative Site
Osnabrück, 49074
Novartis Investigative Site
Pforzheim, 75172
Novartis Investigative Site
Quakenbrück, 49610
Novartis Investigative Site
Remscheid, 42853
Novartis Investigative Site
Rülzheim, 76761
Novartis Investigative Site
Siegen, 57076
Novartis Investigative Site
Sinsheim, 74889
Novartis Investigative Site
Stuttgart, 70174
Novartis Investigative Site
Stuttgart, 70182
Novartis Investigative Site
Unterhaching, 82008
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Ofatumumab
- Keywords
- Multiple sclerosis, MS, Kesimpta, ofatumumab
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfatumumabOther
Also called Kesimpta
There is no treatment allocation. Patients administered Ofatumumab by prescription will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Ofatumumab | Patients prescribed with ofatumumab Receives: Other: Ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reasons for recent therapy switch to ofatumumab
Reasons for recent therapy switch to ofatumumab will be collected
Measured: Baseline
Secondary outcomes (14)
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
Measured: 12 months
Number of patients by reasons for treatment interruptions
Reasons for treatment interruptions per patient will be collected
Measured: 12 months
Number of treatment interruptions per patient
Number of treatment interruptions per patient will be collected
Measured: 12 months
Duration of treatment interruptions per patient
Duration of treatment interruptions per patient will be collected
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Number of participants with injection related AEs
injection site reaction AEs vs. injection systemic reaction AEs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start28 Oct 2022
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566756
- Sponsor's protocol ID
- COMB157GDE03
- Acronym
- KAIROS
- Status last verified
- Aug 2025
- First submitted
- 30 Sep 2022
- Last updated
- 29 May 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study Evaluating Kesimpta® (Ofatumumab) Treatment Effects in Patients With Relapsing Multiple Sclerosis Transitioning From Other Therapies [KAIROS]
- ClinicalTrials.gov ID
- NCT05566756
- Acronym / sponsor ID
- KAIROS / COMB157GDE03
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, MS, Kesimpta, ofatumumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab | – | Other: OfatumumabPatients prescribed with ofatumumab |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OfatumumabAlso: KesimptaThere is no treatment allocation. Patients administered Ofatumumab by prescription will be enrolled. | Other | Ofatumumab |
Primary outcome
Reasons for recent therapy switch to ofatumumab
Time frame: Baseline
Reasons for recent therapy switch to ofatumumab will be collected
14 secondary outcomes
Proportion of missed ofatumumab doses
Time frame: 12 months
Number of patients by reasons for treatment interruptions
Time frame: 12 months
Number of treatment interruptions per patient
Time frame: 12 months
Duration of treatment interruptions per patient
Time frame: 12 months
Proportion of patient subgroups with and without 100% adherence depending on different characteristics
Time frame: 12 months
Proportion of patients permanently discontinuing ofatumumab during the study by reason for discontinuation
Time frame: 12 months
Proportion of patients permanently discontinuing ofatumumab during the study by planned next DMT
Time frame: 12 months
Change on Multiple Sclerosis Impact Scale 29 (MSIS-29) as compared to baseline in general and depending on reasons for treatment switch
Time frame: 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
Time frame: 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
Time frame: Baseline, month 6, month 12
Percentage of patients with no clinical evidence of disease activity (NEDA)
Time frame: Baseline, month 6, month 12
Proportion of patients demonstrating the individual NEDA-3 components
Time frame: Baseline, month 12
The proportion of subjects discontinuing treatment due to insufficient effectiveness (lack of effectiveness) or tolerability/safety reasons
Time frame: 12 months
Number of participants with injection related AEs
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 40 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reasons for recent therapy switch to ofatumumab (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.