Novartis
East Hanover, New Jersey, 07936, United States
Location status: Recruiting
NCT Number: NCT07779460
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Observational
East Hanover, New Jersey, 07936, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients in the pooled OMB and pooled OCR cohorts are required to meet the following eligibility criteria:
Patients in the treatment-naïve OMB and treatment-naïve OCR cohorts are required to meet the following eligibility criteria:
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply.
Time frame: Up to approximately 5 years, 4 months
ARR is defined as the number of relapse episodes per patient-year (PPY).
Time frame: Up to approximately 5 years, 4 months
ARR is defined as the number of relapse episodes PPY.
Time frame: Up to approximately 5 years, 4 months
Healthcare visits include IP stays, IP days, emergency department (ED) visits, OP visits.
Time frame: Up to approximately 5 years, 4 months
HCC include total, IP, ED, OP, and pharmacy costs.
Time frame: Up to approximately 5 years, 4 months
Contact information is provided by the study sponsor or research team.
Novartis Pharmaceuticals
Industry
Comparative Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice: A Retrospective Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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