Multiple SclerosisNCT07821411
A Real-World Study of Ofatumumab in Multiple Sclerosis Patients in Germany and Japan
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial summary
This study aims to evaluate the real-world persistence and adherence to ofatumumab (OMB) treatment in adult patients with relapsing multiple sclerosis (RMS). This is a non-interventional study using administrative claims data available in Germany and Japan. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 5,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Jul 2026to 30 Nov 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult RMS patients who start new treatment with OMB or a DMT.
Who may be able to join
- Patients will be included in the OMB or disease modifying treatment (DMT) cohort if they meet the following criteria:
- Have an RMS diagnosis including relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS).
- Have a new start of OMB or DMT during the inclusion period (any time on or after the RMS diagnosis index date) that was not used during the baseline period (patients may be DMT-naïve or switch to new DMT).
- Age 18 years or older at index date. Index date is the date of first claim for OMB or DMT during the inclusion period.
- Have a continuous health plan enrollment from the start of the baseline period to 12 months after index date (excluding early death).
Who cannot join
- Patients will be excluded if they meet any of the following criteria:
- Have inactive SPMS or primary progressive multiple sclerosis (PPMS).
- Have any inpatient or outpatient diagnosis of other demyelinating diseases during the baseline period.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-World Outcomes of Ofatumumab: Relapse Rates, Disease Progression, and Treatment Patterns in Germany and Japan
This study aims to evaluate the real-world persistence and adherence to ofatumumab (OMB) treatment in adult patients with relapsing multiple sclerosis (RMS). This is a non-interventional study using administrative claims data available in Germany and Japan.
- Conditions
- Multiple Sclerosis
- Keywords
- Persistence, Adherence, Real world data
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OMB Cohort | Adult patients diagnosed with RMS and newly treated with OMB. | |
| OMB Treatment Naïve (OMBn) Cohort | A sub-group of the OMB Cohort. Patients with no record of treatment with a DMT before starting OMB treatment. | |
| OMB Treatment Switch (OMBs) Cohort | A sub-group of the OMB Cohort. Patients who used at least one DMT before starting OMB treatment. | |
| DMT Cohort | Adult patients diagnosed with RMS who began new treatment with a DMT and had no record of treatment with OMB. | |
| Low Efficacy Treatment (LET) Cohort | A sub-group of the DMT Cohort. Patients whose first DMT prescribed during the inclusion period is an LET. | |
| LET Treatment Naïve (LETn) Cohort | A sub-group of the LET Cohort. Patients with no record of a DMT before staring an LET. | |
| LET Treatment Switch (LETs) Cohort | A sub-group of the LET Cohort. Patients who used at least one DMT before starting an LET. | |
| Medium Efficacy Treatment (MET) Cohort | A sub-group of the DMT Cohort. Patients whose first DMT prescribed during the inclusion period is an MET. | |
| MET Treatment Naïve (METn) Cohort | A sub-group of the MET Cohort. Patients with no record of a DMT before staring an MET. | |
| MET Treatment Switch (METs) Cohort | A sub-group of the MET Cohort. Patients who used at least one DMT before starting an MET. | |
| High Efficacy Treatment (HET) Cohort | A sub-group of the DMT Cohort. Patients whose first DMT prescribed during the inclusion period is a HET. | |
| HET Treatment Naïve (HETn) Cohort | A sub-group of the HET Cohort. Patients with no record of a DMT before starting a HET. | |
| HET Treatment Switch (HETs) Cohort | A sub-group of the HET Cohort. Patients who used at least one DMT before starting a HET. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Persistent With OMB
Persistence is defined as the absence of evidence of treatment switch or discontinuation at pre-defined timepoints of interest (6 months, 12 months follow-up).
Measured: 6 months, 12 months
Proportion of Patients Adherent to OMB
Adherence measured using the proportion of days covered (PDC). PDC is defined as the number of days covered by the treatment divided by the period considered in the analysis, including overlaps between prescriptions.
Measured: 6 months, 12 months
Secondary outcomes (15)
Number of Treatments Used
Measured: Baseline, up to approximately 4 years
Number of Patients by Sequence of Treatments Used
Measured: Baseline, up to approximately 4 years
Number of Patients by Line of Therapy (LOT)
Measured: Baseline, up to approximately 4 years
Number of Patients by Type of Treatment
Measured: Baseline, up to approximately 4 years
Duration of Treatment
Measured: Baseline, up to approximately 4 years
Percentage of Patients Who Switch Treatment
Percentage of patients who switch from OMB treatment to another DMT.
Measured: Up to approximately 4 years
Percentage of Patients Who Discontinue OMB Treatment
Measured: Up to approximately 4 years
Number of Patients by Treatments Received After OMB Treatment
Measured: Up to approximately 4 years
Baseline Demographics
Measured: Baseline
Number of Patients by Index Year
Index year is the year of index date. Index date is the date of first claim for OMB or DMT.
Measured: Baseline
Charlson Comorbidity Index (CCI) Score
CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be classified as low (0-1) and high (≥2).
Measured: Baseline
Number of Patients per Top 10 Comorbidities Observed During the Baseline Period
Measured: Baseline
Frequency of at least One All-cause and MS-specific Hospitalization During the Baseline Period
Measured: Baseline
Number of Hospitalizations Per Person Year
RMS-specific and all-cause hospitalizations.
Measured: Baseline
Number of Relapses Per Person Year
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start31 Jul 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
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
- Retrospective
- Enrolment
- 5,000 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
- NCT07821411
- Sponsor's protocol ID
- COMB157G2020
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Outcomes of Ofatumumab: Relapse Rates, Disease Progression, and Treatment Patterns in Germany and Japan
- ClinicalTrials.gov ID
- NCT07821411
- Acronym / sponsor ID
- COMB157G2020
- Conditions
- Multiple Sclerosis
- Keywords
- Persistence, Adherence, Real world data
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 15 Sep 2026 (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 aims to evaluate the real-world persistence and adherence to ofatumumab (OMB) treatment in adult patients with relapsing multiple sclerosis (RMS). This is a non-interventional study using administrative claims data available in Germany and Japan.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| OMB Cohort | – | –Adult patients diagnosed with RMS and newly treated with OMB. |
| OMB Treatment Naïve (OMBn) Cohort | – | –A sub-group of the OMB Cohort. Patients with no record of treatment with a DMT before starting OMB treatment. |
| OMB Treatment Switch (OMBs) Cohort | – | –A sub-group of the OMB Cohort. Patients who used at least one DMT before starting OMB treatment. |
| DMT Cohort | – | –Adult patients diagnosed with RMS who began new treatment with a DMT and had no record of treatment with OMB. |
| Low Efficacy Treatment (LET) Cohort | – | –A sub-group of the DMT Cohort. Patients whose first DMT prescribed during the inclusion period is an LET. |
| LET Treatment Naïve (LETn) Cohort | – | –A sub-group of the LET Cohort. Patients with no record of a DMT before staring an LET. |
| LET Treatment Switch (LETs) Cohort | – | –A sub-group of the LET Cohort. Patients who used at least one DMT before starting an LET. |
| Medium Efficacy Treatment (MET) Cohort | – | –A sub-group of the DMT Cohort. Patients whose first DMT prescribed during the inclusion period is an MET. |
| MET Treatment Naïve (METn) Cohort | – | –A sub-group of the MET Cohort. Patients with no record of a DMT before staring an MET. |
| MET Treatment Switch (METs) Cohort | – | –A sub-group of the MET Cohort. Patients who used at least one DMT before starting an MET. |
| High Efficacy Treatment (HET) Cohort | – | –A sub-group of the DMT Cohort. Patients whose first DMT prescribed during the inclusion period is a HET. |
| HET Treatment Naïve (HETn) Cohort | – | –A sub-group of the HET Cohort. Patients with no record of a DMT before starting a HET. |
| HET Treatment Switch (HETs) Cohort | – | –A sub-group of the HET Cohort. Patients who used at least one DMT before starting a HET. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult RMS patients who start new treatment with OMB or a DMT.
Key inclusion criteria (5 listed)
- Patients will be included in the OMB or disease modifying treatment (DMT) cohort if they meet the following criteria:
- Have an RMS diagnosis including relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS).
- Have a new start of OMB or DMT during the inclusion period (any time on or after the RMS diagnosis index date) that was not used during the baseline period (patients may be DMT-naïve or switch to new DMT).
- Age 18 years or older at index date. Index date is the date of first claim for OMB or DMT during the inclusion period.
- Have a continuous health plan enrollment from the start of the baseline period to 12 months after index date (excluding early death).
Key exclusion criteria (4 listed)
- Have inactive SPMS or primary progressive multiple sclerosis (PPMS).
- Have any inpatient or outpatient diagnosis of other demyelinating diseases during the baseline period.
- Other protocol-defined inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Patients Persistent With OMB
Time frame: 6 months, 12 months
Persistence is defined as the absence of evidence of treatment switch or discontinuation at pre-defined timepoints of interest (6 months, 12 months follow-up).
Proportion of Patients Adherent to OMB
Time frame: 6 months, 12 months
Adherence measured using the proportion of days covered (PDC). PDC is defined as the number of days covered by the treatment divided by the period considered in the analysis, including overlaps between prescriptions.
15 secondary outcomes
Number of Treatments Used
Time frame: Baseline, up to approximately 4 years
Number of Patients by Sequence of Treatments Used
Time frame: Baseline, up to approximately 4 years
Number of Patients by Line of Therapy (LOT)
Time frame: Baseline, up to approximately 4 years
Number of Patients by Type of Treatment
Time frame: Baseline, up to approximately 4 years
Duration of Treatment
Time frame: Baseline, up to approximately 4 years
Percentage of Patients Who Switch Treatment
Time frame: Up to approximately 4 years
Percentage of Patients Who Discontinue OMB Treatment
Time frame: Up to approximately 4 years
Number of Patients by Treatments Received After OMB Treatment
Time frame: Up to approximately 4 years
Baseline Demographics
Time frame: Baseline
Number of Patients by Index Year
Time frame: Baseline
Charlson Comorbidity Index (CCI) Score
Time frame: Baseline
Number of Patients per Top 10 Comorbidities Observed During the Baseline Period
Time frame: Baseline
Frequency of at least One All-cause and MS-specific Hospitalization During the Baseline Period
Time frame: Baseline
Number of Hospitalizations Per Person Year
Time frame: Baseline
Number of Relapses Per Person Year
Time frame: Baseline
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 20 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
1 site 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 1 site in Switzerland.
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 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
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 Persistent With OMB (time frame: 6 months, 12 months). The study lists 2 primary outcomes in all. 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 20 Oct 2026.