An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to Ofatumumab

  • STATUS
    Recruiting
  • End date
    Jan 6, 2025
  • participants needed
    550
  • sponsor
    Novartis Pharmaceuticals
Updated on 22 October 2021
Investigator
Novartis Pharmaceuticals
Primary Contact
Novartis Investigative Site (7.2 mi away) Contact
+121 other location
fingolimod
ofatumumab
dimethyl fumarate

Summary

The open label study to evaluate effectiveness of treatment with ofatumumab in patients transitioning from commonly used oral MS therapies - fingolimod or dimethyl fumarate, due to breakthrough disease.

Details
Condition Relapsing Multiple Sclerosis
Treatment Ofatumumab
Clinical Study IdentifierNCT04353492
SponsorNovartis Pharmaceuticals
Last Modified on22 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of multiple sclerosis (MS)
Relapsing MS (RRMS or SPMS) course
Subject transitioning from either fingolimod or dimethyl fumarate, following min 6 months treatment with either drug
Breakthrough disease as evidence by clinical relapses or MRI
EDSS score of 0 to 4

Exclusion Criteria

Primary progressive MS or SPMS without disease activity
Disease duration of more than 10 years since diagnosis
Patients with an active chronic disease of the immune system other than MS
Patients at risk of developing or having reactivation of hepatitis
Patients with active systemic infections or with neurological findings consistent with PML Other protocol-defined inclusion/exclusion criteria may apply
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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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