Relapsing Multiple Sclerosis (RMS)CHRONOSNCT06486779
Kesimpta (Ofatumumab) in Greek Multiple Sclerosis Patients - an Observational Study
An observational study of Relapsing Multiple Sclerosis (RMS), run by Novartis Pharmaceuticals at 15 sites in Greece.
Trial summary
This study is a single-country, non-interventional, multicenter, observational study, mainly based on primary data collection to assess the effect of ofatumumab on clinical parameters of Multiple Sclerosis (MS) in a routine medical care setting, as compared to the standard of care (SoC) arm of a closely monitored… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Multiple Sclerosis (RMS)
- What is being tested?
- Ofatumumab
- How many people
- 160 participants
- Where
- 15 sitesGreece
- Study dates
- 10 Dec 2024to 30 Dec 2028
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients with RMS who have initiated treatment with ofatumumab early in their disease course. Patients will have been administered ofatumumab (Kesimpta®) three to six months prior to informed consent (IC) and will continue to be treated according to the local product's prescribing information and routine medical practice in terms of visit frequency and type of assessments performed, after enrolment.
Who may be able to join
- Written IC must be obtained before participating in the study.
- Patients with diagnosis of RMS per McDonald Criteria (2017) and <5 years since first MS symptom prior to initiation of ofatumumab.
- Patients who have been on treatment with ofatumumab for at least 3 months, but not longer than 6 months prior to inclusion in the study.
- Ofatumumab treatment in line with the European Product Information of Kesimpta (i.e., adult patients with relapsing forms of MS with active disease defined by clinical or imaging features).
- Patients with at least one available brain MRI scan performed at least 3 months after ofatumumab initiation OR for whom the physician (as per her/his routine practice and independently of his/her decision to include the patient in the current study) plans to perform such scanning within 31 days after patient's inclusion in the study.
- Notes: This MRI scan can be either brain gadolinium enhanced (Gd+) or not. In case it is not gadolinium enhanced, the most recent MRI prior to ofatumumab treatment should be brain gadolinium enhanced, for relevant comparison and identification of new lesions. This MRI scan will serve as the index reference assessment for the evaluation of NEDA-3 radiological component and shall not have been performed within 30 days after the termination of steroid therapy.
- Patients willing and able to complete the assessments, including PRO questionnaires, as per physicians' clinical practice and as outlined in this study.
Who cannot join
- Use of investigational drugs during the study, OR between ofatumumab initiation and inclusion into 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.
- Currently pregnant (or intention to become pregnant within the study period), breastfeeding or lactating women.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
15 sites in 1 country
Greece15 sites, 14 recruiting
- Recruiting
Novartis Investigative Site
Alexandroupoli, 681 00
- Recruiting
Novartis Investigative Site
Athens, Attica, 15562
- Recruiting
Novartis Investigative Site
Athens, GR, 115 26
- Recruiting
Novartis Investigative Site
Athens, 115 21
- Recruiting
Novartis Investigative Site
Athens, 115 25
- Recruiting
Novartis Investigative Site
Athens, 115 27
- Withdrawn
Novartis Investigative Site
Athens, 115 28
- Recruiting
Novartis Investigative Site
Athens, 145 61
- Recruiting
Novartis Investigative Site
Chaïdári, 124 62
- Recruiting
Novartis Investigative Site
Crete Heraklion, 714 09
- Recruiting
Novartis Investigative Site
Ioannina, 455 00
- Recruiting
Novartis Investigative Site
Larissa, 411 10
- Recruiting
Novartis Investigative Site
Pátrai, 265 04
- Recruiting
Novartis Investigative Site
Thessaloniki, 53246
- Recruiting
Novartis Investigative Site
Thessaloniki, 54636
About this study
Official title: A Non-interventional multiCenter Observational Study to Evaluate tHe Effectiveness and Patient-Reported Outcomes of Ofatumumab (Kesimpta®) in patieNts With Relapsing Multiple sclerOsis Treated in Routine Care Settings in Greece (CHRONOS)
This study is a single-country, non-interventional, multicenter, observational study, mainly based on primary data collection to assess the effect of ofatumumab on clinical parameters of Multiple Sclerosis (MS) in a routine medical care setting, as compared to the standard of care (SoC) arm of a closely monitored phase-IIIb study (STHENOS, which includes glatiramer acetate, interferons, teriflunomide, or dimethyl fumarate)
Read the detailed description
Primary data from MS adult patients who initiate ofatumumab early in their disease course will be collected over a period of two years, and will be compared to the ofatumumab and Standard of Care (SoC) arms of the STHENOS trial, a closely monitored phase-IIIb trial. Eligible patients are those with Relapsing Multiple Sclerosis (RMS) diagnosis, with 1st MS symptom within 5 years prior to ofatumumab's initiation and on treatment with ofatumumab for at least 3 months, but not longer than 6 months prior to inclusion in the study. The overall study duration is expected to be 48 months, including a recruitment period and a per-patient observation period of 24 months each. Follow-up visit frequency will be determined by the treating physician, however study-related data will be collected at study enrollment and at 6-, 12-, 18-, and 24-month data collection timepoints post with an allowable time window of ±1 month for all data collection timepoints. NEDA-3 status, MS Relapse, EDSS, MRI, PROs questionnaires, MSIS-29, SDMT, Adherence and persistence, AEs will be assessed during the study.
- Conditions
- Relapsing Multiple Sclerosis (RMS)
- Being tested
- Ofatumumab
- Keywords
- Relapsing Multiple Sclerosis (RMS), RMS, NIS, Greece, Ofatumumab, Kesimpta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfatumumabOther
This is an observational study. There is no treatment allocation. The decision to initiate ofatumumab will be based solely on clinical judgement.
| Study group | Role | What they receive |
|---|---|---|
| CHRONOS cohort | Patients prescribed with ofatumumab in a real world setting Receives: Other: Ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with no evidence of disease activity (NEDA-3) compared to SoC arm of STHENOS
Achievement of NEDA-3 status (no evidence of disease activity based on three components):
- No confirmed multiple sclerosis clinical relapse B) No new MRI brain activity (no new or enlarging T2 lesions, no gadolinium positive (Gd+) T1 lesions) C) No six-month confirmed disability worsening (6m-CDW).
Measured: 12 months post-enrollment for Chronos cohort and 15 months post-baseline for SoC arm of Sthenos
Secondary outcomes (8)
Proportion of patients achieving NEDA-3 status compared to Ofatumumab arm of STHENOS
Achievement of NEDA-3 status (no evidence of disease activity based on three components):
- No confirmed multiple sclerosis clinical relapse B) No new MRI brain activity (no new or enlarging T2 lesions, no gadolinium positive (Gd+) T1 lesions) C) No six-month confirmed disability worsening (6m-CDW).
Measured: 12 months post-enrollment for Chronos cohort and 15 months post-baseline for ofatumumab arm of Sthenos
Proportion of patients achieving each individual component of NEDA-3 compared to Ofatumumab arm of STHENOS
Achievement of NEDA-3 status and individual NEDA-3 components:
- Proportion of patients with no confirmed multiple sclerosis clinical relapse B) Proportion of patients with no new or enlarging T2 lesions, no gadolinium positive (Gd+) T1 lesions C) Proportion of patients with no six-month confirmed disability worsening (6m-CDW).
Measured: 12 months post-enrollment for Chronos cohort and 15 months post-baseline for ofatumumab arm of Sthenos
Proportion of patients achieving NEDA-3 status (no comparator)
Achievement of NEDA-3 status (no evidence of disease activity based on three components):
- No confirmed multiple sclerosis clinical relapse B) No new MRI brain activity (no new or enlarging T2 lesions, no gadolinium positive (Gd+) T1 lesions) C) No six-month confirmed disability worsening (6m-CDW).
Measured: 18 months post-enrollment
Proportion of patients achieving each individual component of NEDA-3 (no comparator)
Achievement of NEDA-3 status and individual NEDA-3 components:
- Proportion of patients with no confirmed multiple sclerosis clinical relapse B) Proportion of patients with no new or enlarging T2 lesions, no gadolinium positive (Gd+) T1 lesions C) Proportion of patients with no six-month confirmed disability worsening (6m-CDW).
Measured: 18 months post-enrollment
Proportion of patients free of 6m-RAW and 6m-PIRA - no comparator
- Proportion of patients free of 6-month confirmed relapse-associated worsening (6m-RAW)
- Proportion of patients free of 6-month confirmed progression independent of relapse activity (6m-PIRA)
- Proportion of patients free of both 6m-RAW and 6m-PIRA
Measured: 12 and 18 months post-enrollment
Change in MSIS-29 impact score from enrollment.
- Change in MSIS-29 physical impact score from enrollment.
- Change in MSIS-29 psychological impact score from enrollment.
The MSIS-29 is a brief self-reported measurement of the impact of multiple sclerosis on patients' quality of life (measuring 20 items for physical \& 9 items for mental/psychological health), where high scores indicate worse health.
Measured: Enrollment, 12, 18 and 24 months post-enrollment
Persistence and treatment discontinuation
Proportion of patients remaining on treatment with ofatumumab and proportion of patients permanently discontinuing ofatumumab during the study.
Measured: 24 months post-enrollment
Time from the start of ofatumumab to all-cause treatment discontinuation
Time from the start of ofatumumab to all-cause treatment discontinuation
Measured: 24 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start10 Dec 2024
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple Sclerosis (RMS)Studies 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
- 160 participants (estimated)
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
- NCT06486779
- Sponsor's protocol ID
- COMB157GGR01
- Acronym
- CHRONOS
- Status last verified
- Jun 2026
- First submitted
- 27 Jun 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional multiCenter Observational Study to Evaluate tHe Effectiveness and Patient-Reported Outcomes of Ofatumumab (Kesimpta®) in patieNts With Relapsing Multiple sclerOsis Treated in Routine Care Settings in Greece (CHRONOS)
- ClinicalTrials.gov ID
- NCT06486779
- Acronym / sponsor ID
- CHRONOS / COMB157GGR01
- Conditions
- Relapsing Multiple Sclerosis (RMS)
- Keywords
- Relapsing Multiple Sclerosis (RMS), RMS, NIS, Greece, Ofatumumab, Kesimpta
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 5 Jul 2024 (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 study is a single-country, non-interventional, multicenter, observational study, mainly based on primary data collection to assess the effect of ofatumumab on clinical parameters of Multiple Sclerosis (MS) in a routine medical care setting, as compared to the standard of care (SoC) arm of a closely monitored phase-IIIb study (STHENOS, which includes glatiramer acetate, interferons, teriflunomide, or dimethyl fumarate)
Detailed description
Primary data from MS adult patients who initiate ofatumumab early in their disease course will be collected over a period of two years, and will be compared to the ofatumumab and Standard of Care (SoC) arms of the STHENOS trial, a closely monitored phase-IIIb trial. Eligible patients are those with Relapsing Multiple Sclerosis (RMS) diagnosis, with 1st MS symptom within 5 years prior to ofatumumab's initiation and on treatment with ofatumumab for at least 3 months, but not longer than 6 months prior to inclusion in the study. The overall study duration is expected to be 48 months, including a recruitment period and a per-patient observation period of 24 months each. Follow-up visit frequency will be determined by the treating physician, however study-related data will be collected at study enrollment and at 6-, 12-, 18-, and 24-month data collection timepoints post with an allowable time window of ±1 month for all data collection timepoints. NEDA-3 status, MS Relapse, EDSS, MRI, PROs questionnaires, MSIS-29, SDMT, Adherence and persistence, AEs will be assessed during the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHRONOS cohort | – | Other: OfatumumabPatients prescribed with ofatumumab in a real world setting |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients with RMS who have initiated treatment with ofatumumab early in their disease course. Patients will have been administered ofatumumab (Kesimpta®) three to six months prior to informed consent (IC) and will continue to be treated according to the local product's prescribing information and routine medical practice in terms of visit frequency and type of assessments performed, after enrolment.
Key inclusion criteria (7 listed)
- Written IC must be obtained before participating in the study.
- Patients with diagnosis of RMS per McDonald Criteria (2017) and <5 years since first MS symptom prior to initiation of ofatumumab.
- Patients who have been on treatment with ofatumumab for at least 3 months, but not longer than 6 months prior to inclusion in the study.
- Ofatumumab treatment in line with the European Product Information of Kesimpta (i.e., adult patients with relapsing forms of MS with active disease defined by clinical or imaging features).
- Patients with at least one available brain MRI scan performed at least 3 months after ofatumumab initiation OR for whom the physician (as per her/his routine practice and independently of his/her decision to include the patient in the current study) plans to perform such scanning within 31 days after patient's inclusion in the study.
Key exclusion criteria (2 listed)
- Use of investigational drugs during the study, OR between ofatumumab initiation and inclusion into 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.
- Currently pregnant (or intention to become pregnant within the study period), breastfeeding or lactating women.
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 |
|---|---|---|
| OfatumumabThis is an observational study. There is no treatment allocation. The decision to initiate ofatumumab will be based solely on clinical judgement. | Other | CHRONOS cohort |
Primary outcome
Proportion of patients with no evidence of disease activity (NEDA-3) compared to SoC arm of STHENOS
Time frame: 12 months post-enrollment for Chronos cohort and 15 months post-baseline for SoC arm of Sthenos
Achievement of NEDA-3 status (no evidence of disease activity based on three components): A) No confirmed multiple sclerosis clinical relapse B) No new MRI brain activity (no new or enlarging T2 lesions, no gadolinium positive (Gd+) T1 lesions) C) No six-month confirmed disability worsening (6m-CDW).
8 secondary outcomes
Proportion of patients achieving NEDA-3 status compared to Ofatumumab arm of STHENOS
Time frame: 12 months post-enrollment for Chronos cohort and 15 months post-baseline for ofatumumab arm of Sthenos
Proportion of patients achieving each individual component of NEDA-3 compared to Ofatumumab arm of STHENOS
Time frame: 12 months post-enrollment for Chronos cohort and 15 months post-baseline for ofatumumab arm of Sthenos
Proportion of patients achieving NEDA-3 status (no comparator)
Time frame: 18 months post-enrollment
Proportion of patients achieving each individual component of NEDA-3 (no comparator)
Time frame: 18 months post-enrollment
Proportion of patients free of 6m-RAW and 6m-PIRA - no comparator
Time frame: 12 and 18 months post-enrollment
Change in MSIS-29 impact score from enrollment.
Time frame: Enrollment, 12, 18 and 24 months post-enrollment
Persistence and treatment discontinuation
Time frame: 24 months post-enrollment
Time from the start of ofatumumab to all-cause treatment discontinuation
Time frame: 24 months post-enrollment
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 11 Jun 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.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Multiple Sclerosis (RMS), run by Novartis Pharmaceuticals at 15 sites in Greece.
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 2 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Greece. 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?
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?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with no evidence of disease activity (NEDA-3) compared to SoC arm of STHENOS (time frame: 12 months post-enrollment for Chronos cohort and 15 months post-baseline for SoC arm of Sthenos). 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 11 Jun 2026.