Relapsing Multiple SclerosisKRONOSNCT05776888
Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years
An observational study of Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals.
Trial summary
This non-interventional study aims to observe the effect of early versus late Ofatumumab treatment in RMS patients in a real-world setting in Austria over an observational period of 24 months. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Ofatumumab
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population will include male and female patients (aged ≥ 18 years) with a documented diagnosis of RMS and treated for at least 3 months with Ofatumumab
Who may be able to join
- Patients with relapsing multiple sclerosis (RMS) with disease activity defined by clinical assessment or MRI analysis.
- Written informed consent must be obtained before participating in the study.
- Patient is willing and able to complete the assessments, as outlined in this study.
- Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab.
- Patients in both cohorts must have been on treatment with Ofatumumab for at least 3 months, but not longer than 12 months prior to inclusion in the study.
- Cohort 1: Patients that, before initiation of Ofatumumab, were either treatment naive or have started their treatment for RMS with another disease modifying therapy (BRACE, teriflunomide or fumarates). Non-naive patients in this cohort must have started the use of Ofatumumab within 3 years after first DMT initiation.
- Cohort 2: Patients must have been on either BRACE or Teriflunomide or fumarates for at least three years or longer before the switch to Ofatumumab has been initiated. Thus, this cohort includes patients that use Ofatumumab as second or later line DMT.
Who cannot join
- Patients who have been on Ofatumumab less than 3 months or more than 12 months before inclusion.
- Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
- Use of any high efficacy therapy (including Fingolimod, Siponimod, Ponesimod, Ozanimod, Rituximab, Ocrelizumab, Natalizumab, Alemtuzumab, Mitoxantron or Cladribine) in either cohort prior to the initiation of Ofatumumab.
- Previous use of any DMTs other than BRACE, Teriflunomide or fumarates prior to the initiation of Ofatumumab.
About this study
Official title: Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years- A Non-interventional Observational Study
This non-interventional study aims to observe the effect of early versus late Ofatumumab treatment in RMS patients in a real-world setting in Austria over an observational period of 24 months.
Read the detailed description
This multi-center, observational study will describe the effects of Ofatumumab in 2 cohorts in a routine medical care setting. Cohort one will comprise patients who have started Ofatumumab early during their disease (treatment naive patients or those that started Ofatumumab within 3 years of first therapy initiation). Cohort two will include patients who have been on other DMTs (one or several) for a minimum of 3 years prior to switching to Ofatumumab. Patients in both cohorts will be observed for two years.
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Ofatumumab
- Keywords
- relapsing multiple sclerosis, RMS, Ofatumumab, NIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfatumumabOther
There is no treatment allocation. For both cohorts, only patients that have received Ofatumumab treatment for at least 3 months prior to inclusion in the study will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Early Treatment Cohort (Cohort 1) | Patients that, before initiation of Ofatumumab, were either treatment naive or have started their treatment for RMS with another disease modifying therapy (BRACE, teriflunomide or fumarates). Non-naive patients in this cohort must have started the use of Ofatumumab within 3 years after first DMT initiation. Receives: Other: Ofatumumab | |
| Later Treatment Cohort (Cohort 2) | Patients that have been on BRACE and/or Teriflunomide and/or fumarates for at least three years or longer before the switch to Ofatumumab has been initiated. Receives: Other: Ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients demonstrating NEDA-3
Proportion and comparison of patients in both cohorts achieving NEDA-3 in the second year after treatment initiation, which refers to a comparison between month 12 and 24 after Ofatumumab treatment was initiated. NEDA-3 is defined by no confirmed MS relapse, no new or enlarging T2 lesions, no new Gadolinium-positive T1 lesions (in case Gadolinium was utilized), and no six-month confirmed disability worsening.
Measured: from month 12 up to month 24
Secondary outcomes (2)
Proportion of patients displaying NEDA-3, as well as individual NEDA components
Proportion of patients displaying NEDA-3, as well as individual NEDA components (i) experiencing no confirmed clinical relapses, (ii) lack of diseases progression measured by expanded disability status scale (EDSS) and (iii) absence of new disease activity (new or enhancing T2 or Gadolinium-positive T1 lesions (in case Gadolinium was utilized)), respectively, in the first treatment year (Baseline to month 12), the second treatment year (month 12 to month 24) as well as over the whole study period (Baseline to month 24).
Measured: Baseline, month 12, month 24
Proportion of patients permanently discontinuing Ofatumumab during the study
Proportion of patients permanently discontinuing Ofatumumab during the study, and reasons for discontinuation will be provided
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start10 Jul 2023
- Primary completion16 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing 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
- 106 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
- NCT05776888
- Sponsor's protocol ID
- COMB157GAT02
- Acronym
- KRONOS
- Status last verified
- Oct 2026
- First submitted
- 27 Feb 2023
- Last updated
- 28 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years- A Non-interventional Observational Study
- ClinicalTrials.gov ID
- NCT05776888
- Acronym / sponsor ID
- KRONOS / COMB157GAT02
- Conditions
- Relapsing Multiple Sclerosis
- Keywords
- relapsing multiple sclerosis, RMS, Ofatumumab, NIS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 16 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Mar 2023 (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.
This non-interventional study aims to observe the effect of early versus late Ofatumumab treatment in RMS patients in a real-world setting in Austria over an observational period of 24 months.
Detailed description
This multi-center, observational study will describe the effects of Ofatumumab in 2 cohorts in a routine medical care setting. Cohort one will comprise patients who have started Ofatumumab early during their disease (treatment naive patients or those that started Ofatumumab within 3 years of first therapy initiation). Cohort two will include patients who have been on other DMTs (one or several) for a minimum of 3 years prior to switching to Ofatumumab. Patients in both cohorts will be observed for two years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Treatment Cohort (Cohort 1) | – | Other: OfatumumabPatients that, before initiation of Ofatumumab, were either treatment naive or have started their treatment for RMS with another disease modifying therapy (BRACE, teriflunomide or fumarates). Non-naive patients in this cohort must have started the use of Ofatumumab within 3 years after first DMT initiation. |
| Later Treatment Cohort (Cohort 2) | – | Other: OfatumumabPatients that have been on BRACE and/or Teriflunomide and/or fumarates for at least three years or longer before the switch to Ofatumumab has been initiated. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include male and female patients (aged ≥ 18 years) with a documented diagnosis of RMS and treated for at least 3 months with Ofatumumab
Key inclusion criteria (7 listed)
- Patients with relapsing multiple sclerosis (RMS) with disease activity defined by clinical assessment or MRI analysis.
- Written informed consent must be obtained before participating in the study.
- Patient is willing and able to complete the assessments, as outlined in this study.
- Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab.
- Patients in both cohorts must have been on treatment with Ofatumumab for at least 3 months, but not longer than 12 months prior to inclusion in the study.
Key exclusion criteria (4 listed)
- Patients who have been on Ofatumumab less than 3 months or more than 12 months before inclusion.
- Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
- Use of any high efficacy therapy (including Fingolimod, Siponimod, Ponesimod, Ozanimod, Rituximab, Ocrelizumab, Natalizumab, Alemtuzumab, Mitoxantron or Cladribine) in either cohort prior to the initiation of Ofatumumab.
- Previous use of any DMTs other than BRACE, Teriflunomide or fumarates prior to the initiation of 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 |
|---|---|---|
| OfatumumabThere is no treatment allocation. For both cohorts, only patients that have received Ofatumumab treatment for at least 3 months prior to inclusion in the study will be enrolled. | Other | Early Treatment Cohort (Cohort 1), Later Treatment Cohort (Cohort 2) |
Primary outcome
Proportion of patients demonstrating NEDA-3
Time frame: from month 12 up to month 24
Proportion and comparison of patients in both cohorts achieving NEDA-3 in the second year after treatment initiation, which refers to a comparison between month 12 and 24 after Ofatumumab treatment was initiated. NEDA-3 is defined by no confirmed MS relapse, no new or enlarging T2 lesions, no new Gadolinium-positive T1 lesions (in case Gadolinium was utilized), and no six-month confirmed disability worsening.
2 secondary outcomes
Proportion of patients displaying NEDA-3, as well as individual NEDA components
Time frame: Baseline, month 12, month 24
Proportion of patients permanently discontinuing Ofatumumab during the study
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 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
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals.
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 7 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of patients demonstrating NEDA-3 (time frame: from month 12 up to month 24). 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 28 Oct 2026.