NCT07779460Recruiting
A Study Comparing Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice
Comparative Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice: A Retrospective Study
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 7466 (estimated)
- First submitted
- 18 Aug 2026
- Start date
- 8 Apr 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Multiple sclerosis
- NCT number
- NCT07779460
What you commit to
- Study type: Observational
- Planned participants: 7466
- From 8 Apr 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patients who do not meet the study inclusion criteria.
- Other protocol-defined inclusion/exclusion criteria may apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Coordinator of this site? Confirm its status | East Hanover | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.