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
Sponsor:
Brief Summary:
transitioning from commonly used oral MS therapies – fingolimod or dimethyl fumarate, due to
breakthrough disease.
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
Locations
- Novartis Investigative Site, Fullerton, California, United States, 92835