Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis

  • STATUS
    Recruiting
  • End date
    Dec 21, 2021
  • participants needed
    414
  • sponsor
    Novartis Pharmaceuticals
Updated on 13 June 2021

Summary

This is an observational cross-sectional study of Ocrelizumab or Ofatumumab administrations for Relapsing forms of Multiple Sclerosis (RMS) in selected sites in the US, the UK and Australia.

Description

Patients with RMS receiving Ocrelizumab or Ofatumumab will be recruited to measure the time spend for Healthcare Providers (HCP) (neurologist, nurse and hospital pharmacist) on preparing, administering the medication and following up with the patient.

Details
Condition Relapsing Forms of Multiple Sclerosis
Treatment Ofatumumab, Ocrelizumab
Clinical Study IdentifierNCT04676555
SponsorNovartis Pharmaceuticals
Last Modified on13 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients of 18 or more years of age
Patients with confirmed diagnosis of RMS (CIS, RRMS or aSPMS) following 2017 McDonnald criteria
Patients currently prescribed with Ocrelizumab or Ofatumumab to treat MS according to the Summary of Product Characteristics (SmPC). The decision must be based on patient disease and taken before the decision of inviting the patient to participate in this study
Patients literate in English
Patients must provide informed consent to participate in the study

Exclusion Criteria

Patients currently participating in any other RMS clinical trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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