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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Travel or expenses covered

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Travel or expenses covered
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares Kesimpta (ofatumumab) and Ocrevus (ocrelizumab) in adults with multiple sclerosis (MS) in the United States. It uses health insurance records, with personal details removed, to compare yearly MS flare-ups, use of health care, and costs.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a first insurance claim for Kesimpta or Ocrevus during the study’s set time period. This claim date is called the start date.
  • Have no claims for either drug in the 12 months before the start date.
  • Have at least 2 outpatient claims showing MS, at least 30 days apart. The first must be within 12 months before or on the start date, and the second no later than 6 months after it. Or, have at least 1 hospital stay claim with MS as the main diagnosis within 12 months before or on the start date.
  • Be at least 18 years old on the start date.
  • Have health plan coverage without a break for at least 12 months before and 6 months after the start date.
  • Keep using Kesimpta or Ocrevus for at least 6 months after the start date.
  • For the groups labeled new to treatment, also have no claims for MS disease-modifying drugs in the 12 months before the start date. These drugs help change the course of MS.

Who can't join

  • Do not meet the study’s entry rules.
  • Other study rules may also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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. Other protocol-defined inclusion/exclusion criteria may apply.

Study sites (1)

NJ