A Study Comparing Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice
Recruiting · NCT07779460 · Observational (researchers observe without assigning treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
- ther protocol-defined inclusion/exclusion criteria may apply.
Where it is running
1 location listed across 1 US state.
- Novartis - East Hanover, New Jersey, United States