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

Part of paid clinical trials in East Hanover, New Jersey.

Sponsor: Novartis Pharmaceuticals
Study ID: NCT07779460
Status: Recruiting

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: ALL
Age: 18 Years - 100 Years
Healthy Volunteers: Not accepted

Study Details

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.

Key Dates

First listed: Aug 21, 2026
Start date: Apr 8, 2026
Status verified: Aug 2026
Primary completion: Dec 31, 2026
Completion: Dec 31, 2026

Study Design

Enrollment: 7,466 participants (estimated)

Arms

Arm: 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.
Arm: 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.
Arm: Pooled OMB Cohort
All patients diagnosed with MS initiated on OMB including treatment-naïve and -experienced patients.
Arm: Pooled OCR Cohort
All patients diagnosed with MS initiated on OCR including treatment-naïve and -experienced patients.