ClinicalTrials.gg
RecruitingNCT07779460Updated Aug 21, 2026

A Study Comparing Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice

An observational study in Multiple Sclerosis, sponsored by Novartis Pharmaceuticals. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
7,466
Ages
18 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 107 studies in Multiple Sclerosis by Novartis — 9 open to participants now, 25 under way, 7 of them phase 3. Multiple Sclerosis · Novartis.

Planned enrollment
Largest of 41
7,466 · median 312
Started
2026
with 3 others
Observational
41 of 107
7 open now
Primary completion
2026-12
later than 10 of 24 live
Registered
105th of 107
by date

Among the 107 studies in Multiple Sclerosis by Novartis, this one has the largest planned enrollment of the 41 observational ones that give a count, is one of 4 that started in 2026, is one of 41 observational ones, reaches primary completion later than 10 of the 24 other live ones, and was the 105th registered.

Multiple Sclerosis

3,267 studies on the registry are indexed under Multiple Sclerosis; 662 are open to participants now.

Browse Multiple Sclerosis studies →

Open to participants now

9 of the 107 studies in Multiple Sclerosis by Novartis are open now, in 12 countries. Recruiting first, the newest first:

3 more — sign in →

By country, each count listing its studies:

All 9 open studies →

Who these studies take

Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.

This study: 18 Years to 100 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 107 studies in Multiple Sclerosis by Novartis, or all of them as a file.
02

Study 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). 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.

03

Conditions studied

  • Multiple Sclerosis

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Keywords

  • Multiple sclerosis
  • Ofatumumab
  • Ocrelizumab
  • Anti-CD20 therapy
  • Comparative effectiveness
  • Real-world evidence
04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with MS newly initiated on OMB or OCR in real-world practice.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.
  • 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.

Exclusion criteria

Exclusion criteria:

  • Patients who do not meet the study inclusion criteria.

Other protocol-defined inclusion/exclusion criteria may apply.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
7,466 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Annualized Relapse Rate (ARR) in Treatment-naïve MS Patients

    ARR is defined as the number of relapse episodes per patient-year (PPY).

    Time frame: Up to approximately 5 years, 4 months

Secondary outcomes

  1. ARR in All MS Patients

    ARR is defined as the number of relapse episodes PPY.

    Time frame: Up to approximately 5 years, 4 months

  2. Number of All-cause and MS-related Healthcare Visits PPY

    Healthcare visits include IP stays, IP days, emergency department (ED) visits, OP visits.

    Time frame: Up to approximately 5 years, 4 months

  3. Total All-cause and MS-related Healthcare Costs (HCC) PPY

    HCC include total, IP, ED, OP, and pharmacy costs.

    Time frame: Up to approximately 5 years, 4 months

  4. Time From Treatment Initiation to First Relapse

    Time frame: Up to approximately 5 years, 4 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2026 (actual). Primary completion is estimated for Dec 2026, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2026
First posted
Aug 21, 2026
StartActual
Apr 8, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07779460
Responsible party
Sponsor
First posted
Aug 21, 2026
Start date
Apr 8, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 21, 2026

Study contacts

Novartis Pharmaceuticals
Contact
novartis.email@novartis.com
+41613241111
Novartis Pharmaceuticals
Contact
Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

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