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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

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.

Eligibility criteria

Qualifiers

≥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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

7,466 Participants
are grouped into 4 trial groups

Sponsors and collaborators