An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to Ofatumumab
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
ClinicalTrials.gov Identifier: NCT04353492
Novartis Reference Number: COMB157G23101
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Study Description
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.
Interventions
Eligibility Criteria
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
Study Locations
Contacts
Have a question?
Call 1-999-669-6682 or email [email protected]