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NCT Number: NCT07779460

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

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.

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Location status: Recruiting

Who can participate

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:

  • ≥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.

Treatment and study plan

Primary outcomes

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

    Time frame: Up to approximately 5 years, 4 months

    ARR is defined as the number of relapse episodes per patient-year (PPY).

Secondary outcomes

  1. ARR in All MS Patients

    Time frame: Up to approximately 5 years, 4 months

    ARR is defined as the number of relapse episodes PPY.

  2. Number of All-cause and MS-related Healthcare Visits PPY

    Time frame: Up to approximately 5 years, 4 months

    Healthcare visits include IP stays, IP days, emergency department (ED) visits, OP visits.

  3. Total All-cause and MS-related Healthcare Costs (HCC) PPY

    Time frame: Up to approximately 5 years, 4 months

    HCC include total, IP, ED, OP, and pharmacy costs.

  4. Time From Treatment Initiation to First Relapse

    Time frame: Up to approximately 5 years, 4 months

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

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
2026
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2026
Registry last updated
Aug 21, 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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