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OpenTrials
Completed

NCT Number: NCT07566988

A Real-world Study Comparing the Effectiveness of Ofatumumab and Ocrelizumab Treatment in Multiple Sclerosis Patients

The aim of this study was to compare the effectiveness and economic burden of ofatumumab (OMB) and ocrelizumab (OCR) treatment in multiple sclerosis (MS) patients in the United States using data from an administrative claims database.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pooled OMB and OCR Cohorts:

  • ≥1 incident claim for OMB (Pooled OMB Cohort) or OCR (Pooled OCR Cohort) in the patient identification period (index date = first claim date).
  • No claims for OMB or OCR within the 12 months prior to the index date.
  • ≥2 outpatient (OP) medical claims (at least 30 days apart) with a diagnosis code for MS (International Classification of Diseases, 10th 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 a diagnosis of MS in the first position 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 (baseline period) and ≥6 months after index date (follow-up period).
  • Persistent use of OMB (Pooled OMB Cohort) or OCR (Pooled OCR Cohort) for ≥6 months after index date.

Treatment-naïve OMB and OCR Cohorts:

  • Included in Pooled OMB Cohort or Pooled OCR Cohort.
  • No claims for a disease modifying therapy (DMT) used for the treatment of MS within the 12-month baseline period.

Exclusion criteria

  • None.

Treatment and study plan

Primary outcomes

  1. Annualized Relapse Rate (ARR) in Treatment-Naïve Patients

    Time frame: Up to approximately 3 years and 11 months

    ARR was defined as the number of relapse episodes per patient-year (PPY) during the follow-up period.

Secondary outcomes

  1. ARR in All Patients

    Time frame: Up to approximately 3 years and 11 months

    ARR was defined as the number of relapse episodes per PPY during the follow-up period.

  2. Healthcare Visits PPY

    Time frame: Up to approximately 3 years and 11 months

    Healthcare visits included IP stays, OP visits, and emergency department visits.

  3. Inpatient Days PPY

    Time frame: Up to approximately 3 years and 11 months

  4. Difference in Healthcare Costs in OMB Versus OCR

    Time frame: Up to approximately 3 years and 11 months

    Healthcare costs included IP, OP, emergency department, and pharmacy costs.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 5, 2026
Registry last updated
May 11, 2026

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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