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A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient Reported Outcomes in Patients With Relapsing Multiple Sclerosis Transitioning From Dimethyl Fumarate or Fingolimod Therapy


Brief 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.


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


  • Novartis Investigative Site, Fullerton, California, United States, 92835
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