RecruitingN/AOther

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

Sponsored by Novartis Pharmaceuticals

NCT ID
NCT07779460
Target Enrollment
7,466 participants
Start Date
2026-04-08
Est. Completion
2026-12-31

About This 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 Studied

Multiple Sclerosis

Eligibility

Age:18 Years - 100 Years
Healthy Volunteers:No
View full eligibility criteria
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:

• Patients who do not meet the study inclusion criteria.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations (1)

Novartis
East Hanover, New Jersey, United States

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Novartis Pharmaceuticals
CONTACT
+41613241111novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source