Multiple SclerosisNCT07779460
A Study Comparing Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study aims to generate real-world evidence on the clinical effectiveness and economic burden of ofatumumab (OMB) versus ocrelizumab (OCR) in patients diagnosed with multiple sclerosis (MS) in the United States (US). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 7,466 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2026to 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with MS newly initiated on OMB or OCR in real-world practice.
Who may be able to join
- Patients in the pooled OMB and pooled OCR cohorts are required to meet the following eligibility criteria:
- ≥1 incident claim for OMB (pooled OMB cohort) or OCR (pooled OCR cohort) in the patient identification period.
- No claims for OMB or OCR within the 12 months prior to the index date. The index date is the date of the first OMB or OCR claim.
- ≥2 outpatient (OP) medical claims (at least 30 days apart) with a diagnosis code for MS (International Classification of Diseases, Tenth 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 MS recorded as the primary diagnosis 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 and ≥6 months after index date.
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- Persistent use of OMB (pooled OMB cohort) or OCR (pooled OCR cohort) for ≥6 months after index date.
- Patients in the treatment-naïve OMB and treatment-naïve OCR cohorts are required to meet the following eligibility criteria:
- Included in pooled OMB cohort or pooled OCR cohort.
- No claims for a disease-modifying therapy (DMT) used for the treatment of MS in the 12-month baseline period.
Who cannot join
- Patients who do not meet the study inclusion criteria.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
United States1 site, 1 recruiting
- Recruiting
Novartis
East Hanover, New Jersey, 07936
About this study
Official title: Comparative Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice: A Retrospective Study
This study aims to generate real-world evidence on the clinical effectiveness and economic burden of ofatumumab (OMB) versus ocrelizumab (OCR) in patients diagnosed with multiple sclerosis (MS) in the United States (US). Clinical effectiveness will be assessed using annualized relapse rate (ARR), while economic burden will be assessed using healthcare resource utilization (HCRU) and healthcare costs (HCC). This study will use two primary data sources that capture longitudinal, de-identified healthcare utilization derived from claims submitted for reimbursement.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Ofatumumab, Ocrelizumab, Anti-CD20 therapy, Comparative effectiveness, Real-world evidence
- 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 |
|---|---|---|
| Treatment-naïve OMB Cohort | MS patients initiated on OMB who have not used a DMT for the treatment of MS in the 12-month period prior to index date. | |
| Treatment-naïve OCR Cohort | MS patients initiated on OCR who have not used a DMT for the treatment of MS in the 12-month period prior to index date. | |
| Pooled OMB Cohort | All patients diagnosed with MS initiated on OMB including treatment-naïve and -experienced patients. | |
| Pooled OCR Cohort | All patients diagnosed with MS initiated on OCR including treatment-naïve and -experienced patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Relapse Rate (ARR) in Treatment-naïve MS Patients
ARR is defined as the number of relapse episodes per patient-year (PPY).
Measured: Up to approximately 5 years, 4 months
Secondary outcomes (4)
ARR in All MS Patients
ARR is defined as the number of relapse episodes PPY.
Measured: Up to approximately 5 years, 4 months
Number of All-cause and MS-related Healthcare Visits PPY
Healthcare visits include IP stays, IP days, emergency department (ED) visits, OP visits.
Measured: Up to approximately 5 years, 4 months
Total All-cause and MS-related Healthcare Costs (HCC) PPY
HCC include total, IP, ED, OP, and pharmacy costs.
Measured: Up to approximately 5 years, 4 months
Time From Treatment Initiation to First Relapse
Measured: Up to approximately 5 years, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start8 Apr 2026
- Primary completion31 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 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
- 7,466 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
- NCT07779460
- Sponsor's protocol ID
- COMB157GUS43
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 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
- NCT07779460
- Acronym / sponsor ID
- COMB157GUS43
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Ofatumumab, Ocrelizumab, Anti-CD20 therapy, Comparative effectiveness, Real-world evidence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,466 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Aug 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 generate real-world evidence on the clinical effectiveness and economic burden of ofatumumab (OMB) versus ocrelizumab (OCR) in patients diagnosed with multiple sclerosis (MS) in the United States (US). Clinical effectiveness will be assessed using annualized relapse rate (ARR), while economic burden will be assessed using healthcare resource utilization (HCRU) and healthcare costs (HCC). This study will use two primary data sources that capture longitudinal, de-identified healthcare utilization derived from claims submitted for reimbursement.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment-naïve OMB Cohort | – | –MS patients initiated on OMB who have not used a DMT for the treatment of MS in the 12-month period prior to index date. |
| Treatment-naïve OCR Cohort | – | –MS patients initiated on OCR who have not used a DMT for the treatment of MS in the 12-month period prior to index date. |
| Pooled OMB Cohort | – | –All patients diagnosed with MS initiated on OMB including treatment-naïve and -experienced patients. |
| Pooled OCR Cohort | – | –All patients diagnosed with MS initiated on OCR including treatment-naïve and -experienced patients. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with MS newly initiated on OMB or OCR in real-world practice.
Key inclusion criteria (10 listed)
- Patients in the pooled OMB and pooled OCR cohorts are required to meet the following eligibility criteria:
- ≥1 incident claim for OMB (pooled OMB cohort) or OCR (pooled OCR cohort) in the patient identification period.
- No claims for OMB or OCR within the 12 months prior to the index date. The index date is the date of the first OMB or OCR claim.
- ≥2 outpatient (OP) medical claims (at least 30 days apart) with a diagnosis code for MS (International Classification of Diseases, Tenth 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 MS recorded as the primary diagnosis in the 12 months prior to or on index date.
- ≥18 years of age on index date.
Key exclusion criteria (2 listed)
- Patients who do not meet the study inclusion criteria.
- 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
Annualized Relapse Rate (ARR) in Treatment-naïve MS Patients
Time frame: Up to approximately 5 years, 4 months
ARR is defined as the number of relapse episodes per patient-year (PPY).
4 secondary outcomes
ARR in All MS Patients
Time frame: Up to approximately 5 years, 4 months
Number of All-cause and MS-related Healthcare Visits PPY
Time frame: Up to approximately 5 years, 4 months
Total All-cause and MS-related Healthcare Costs (HCC) PPY
Time frame: Up to approximately 5 years, 4 months
Time From Treatment Initiation to First Relapse
Time frame: Up to approximately 5 years, 4 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 21 Aug 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
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 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 21 Aug 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?
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?
Annualized Relapse Rate (ARR) in Treatment-naïve MS Patients (time frame: Up to approximately 5 years, 4 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 21 Aug 2026.