Multiple SclerosisNCT07566988
A Real-world Study Comparing the Effectiveness of Ofatumumab and Ocrelizumab Treatment in Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The aim of this study was to compare the effectiveness and economic burden of ofatumumab (OMB) and ocrelizumab (OCR) treatment in multiple sclerosis (MS) patients in the United States using data from an administrative claims database. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 2,604 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2024to 30 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who had a first claim for either ofatumumab or ocrelizumab from August 20, 2020, with no claim for either drug during the preceding 12 months.
Who may be able to join
- Pooled OMB and OCR Cohorts:
- ≥1 incident claim for OMB (Pooled OMB Cohort) or OCR (Pooled OCR Cohort) in the patient identification period (index date = first claim date).
- No claims for OMB or OCR within the 12 months prior to the index date.
- ≥2 outpatient (OP) medical claims (at least 30 days apart) with a diagnosis code for MS (International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM] code: G35) in any position, with the first claim occurring in the 12 months prior to or on index date and the second claim up to 6 months after index date, or ≥1 inpatient (IP) claim with a diagnosis of MS in the first position in the 12 months prior to or on index date.
- ≥18 years of age on index date.
- Continuous healthcare plan enrollment for ≥12 months prior to index date (baseline period) and ≥6 months after index date (follow-up period).
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- Persistent use of OMB (Pooled OMB Cohort) or OCR (Pooled OCR Cohort) for ≥6 months after index date.
- Treatment-naïve OMB and OCR Cohorts:
- Included in Pooled OMB Cohort or Pooled OCR Cohort.
- No claims for a disease modifying therapy (DMT) used for the treatment of MS within the 12-month baseline period.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice: A Retrospective Study
The aim of this study was to compare the effectiveness and economic burden of ofatumumab (OMB) and ocrelizumab (OCR) treatment in multiple sclerosis (MS) patients in the United States using data from an administrative claims database.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Anti-CD20 monoclonal antibody, Ofatumumab, Ocrelizumab, Real-world evidence, Comparative effectiveness, Annualized relapse rate, Healthcare resource utilization
- 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 |
|---|---|---|
| Pooled OMB Cohort | Adult MS patients, including treatment-naïve and treatment-experienced patients, with a first claim for OMB from August 20, 2020. | |
| Pooled OCR Cohort | Adult MS patients, including treatment-naïve and treatment-experienced patients, with a first claim for OCR from August 20, 2020. | |
| Treatment-naïve OMB Cohort | Adult MS patients who initiated OMB treatment and who did not use a DMT for MS treatment in the 12-month period before starting OMB. | |
| Treatment-naïve OCR Cohort | Adult MS patients who initiated OCR treatment and who did not use a DMT for MS treatment in the 12-month period before starting OCR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Relapse Rate (ARR) in Treatment-Naïve Patients
ARR was defined as the number of relapse episodes per patient-year (PPY) during the follow-up period.
Measured: Up to approximately 3 years and 11 months
Secondary outcomes (4)
ARR in All Patients
ARR was defined as the number of relapse episodes per PPY during the follow-up period.
Measured: Up to approximately 3 years and 11 months
Healthcare Visits PPY
Healthcare visits included IP stays, OP visits, and emergency department visits.
Measured: Up to approximately 3 years and 11 months
Inpatient Days PPY
Measured: Up to approximately 3 years and 11 months
Difference in Healthcare Costs in OMB Versus OCR
Healthcare costs included IP, OP, emergency department, and pharmacy costs.
Measured: Up to approximately 3 years and 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start25 Oct 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 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
- Retrospective
- Enrolment
- 2,604 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
- NCT07566988
- Sponsor's protocol ID
- COMB157GUS37
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice: A Retrospective Study
- ClinicalTrials.gov ID
- NCT07566988
- Acronym / sponsor ID
- COMB157GUS37
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Anti-CD20 monoclonal antibody, Ofatumumab, Ocrelizumab, Real-world evidence, Comparative effectiveness, Annualized relapse rate, Healthcare resource utilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,604 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 5 May 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.
The aim of this study was to compare the effectiveness and economic burden of ofatumumab (OMB) and ocrelizumab (OCR) treatment in multiple sclerosis (MS) patients in the United States using data from an administrative claims database.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pooled OMB Cohort | – | –Adult MS patients, including treatment-naïve and treatment-experienced patients, with a first claim for OMB from August 20, 2020. |
| Pooled OCR Cohort | – | –Adult MS patients, including treatment-naïve and treatment-experienced patients, with a first claim for OCR from August 20, 2020. |
| Treatment-naïve OMB Cohort | – | –Adult MS patients who initiated OMB treatment and who did not use a DMT for MS treatment in the 12-month period before starting OMB. |
| Treatment-naïve OCR Cohort | – | –Adult MS patients who initiated OCR treatment and who did not use a DMT for MS treatment in the 12-month period before starting OCR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who had a first claim for either ofatumumab or ocrelizumab from August 20, 2020, with no claim for either drug during the preceding 12 months.
Key inclusion criteria (10 listed)
- ≥1 incident claim for OMB (Pooled OMB Cohort) or OCR (Pooled OCR Cohort) in the patient identification period (index date = first claim date).
- No claims for OMB or OCR within the 12 months prior to the index date.
- ≥2 outpatient (OP) medical claims (at least 30 days apart) with a diagnosis code for MS (International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM] code: G35) in any position, with the first claim occurring in the 12 months prior to or on index date and the second claim up to 6 months after index date, or ≥1 inpatient (IP) claim with a diagnosis of MS in the first position in the 12 months prior to or on index date.
- ≥18 years of age on index date.
- Continuous healthcare plan enrollment for ≥12 months prior to index date (baseline period) and ≥6 months after index date (follow-up period).
Key exclusion criteria (1 listed)
- None.
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
Annualized Relapse Rate (ARR) in Treatment-Naïve Patients
Time frame: Up to approximately 3 years and 11 months
ARR was defined as the number of relapse episodes per patient-year (PPY) during the follow-up period.
4 secondary outcomes
ARR in All Patients
Time frame: Up to approximately 3 years and 11 months
Healthcare Visits PPY
Time frame: Up to approximately 3 years and 11 months
Inpatient Days PPY
Time frame: Up to approximately 3 years and 11 months
Difference in Healthcare Costs in OMB Versus OCR
Time frame: Up to approximately 3 years and 11 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 11 May 2026.
- Link to study resultsLink provided by the sponsor.
- 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 United States.
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 10 inclusion and 1 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 11 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 1 site in United States. 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?
Annualized Relapse Rate (ARR) in Treatment-Naïve Patients (time frame: Up to approximately 3 years and 11 months). 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 May 2026.