RecruitingMS (type not specified)NCT07779460

What it found

Still running

No result yet.

What it measured

Main measures

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

    Up to approximately 5 years, 4 months

    Relapses

Other measures (4)

  • ARR in All MS Patients

    Up to approximately 5 years, 4 months

    Relapses
  • Number of All-cause and MS-related Healthcare Visits PPY

    Up to approximately 5 years, 4 months

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

    Up to approximately 5 years, 4 months

  • Time From Treatment Initiation to First Relapse

    Up to approximately 5 years, 4 months

    Relapses

Who could take part

MS (type not specified) · 18 to 100

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

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History

    1. Started

      Apr 2026

    2. Main results due

      Dec 2026

    3. Finished

      Dec 2026

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