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Status:

COMPLETED

A Study of Multiple Sclerosis Routine Clinical Practice: Impact on Adherence and Clinical Outcomes of Ofatumumab Treated Patients

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Multiple Sclerosis, Relapsing-Remitting

Eligibility:

All Genders

18+ years

Brief Summary

This was a retrospective non-interventional study (NIS) of adult (≥18 years) multiple sclerosis (MS) patients on ofatumumab therapy in the United Kingdom (UK) using secondary data. UK MS centers with ...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Patients were included in the study if they met all of the following criteria:
  • Patient was prescribed ofatumumab within the UK approved marketing authorization
  • Patient initiated ofatumumab via participating MS clinic with or without KC PSP
  • Patients initiated ofatumumab during the index identification window
  • Authorized to collect study data:
  • Patient was alive at start of data collection and patient consented prior to start of their data collection or,
  • Patient was deceased at start of data collection and a member of the patient's direct care team had a pre-existing right to access patient medical record
  • Specifically for adherence analyses: Patients were required to have a minimum of 6 months of follow-up post index date available to make this assessment
  • Specifically for clinical effectiveness analyses: Patients were required to have a minimum of 6 months look-back pre-index date and minimum 6 months follow-up post index date available to make this assessment.
  • Exclusion criteria:
  • Patients were excluded from the study if they met the following criteria:
  • • Patient prescribed ofatumumab outside the approved marketing authorization (i.e., under off-label prescribing) at any point within the patients record

Exclusion

    Key Trial Info

    Start Date :

    November 6 2023

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    July 25 2024

    Estimated Enrollment :

    155 Patients enrolled

    Trial Details

    Trial ID

    NCT06897657

    Start Date

    November 6 2023

    End Date

    July 25 2024

    Last Update

    March 27 2025

    Active Locations (1)

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    Novartis

    East Hanover, New Jersey, United States, 07936