SHS_543111 REPP CNOV 16097

A Randomized, Double-blind, Double-Dummy, Parallel-Group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis

To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis. This is a randomized, double-blind, double-dummy, active comparator-controlled, parallel-group, multicenter study with variable treatment duration in approximately 900 patients with relapsing MS. The maximal treatment duration in the study for an individual patient will be 2.5 years. Eligible patients will be randomized to receive either experimental ofatumumab subcutaneous (sc) injections every 4 weeks or active comparator teriflunomide orally once daily. In order to blind for the different formulations, double-dummy masking will be used i.e., all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo).

Inclusion Criteria:

•Diagnosis of multiple sclerosis (MS)
•Relapsing MS (RRMS or SPMS) course
•At least 1 relapse during the previous 1 year or 2 relapses during the previous 2 years or a positive gadolinium-enhancing MRI scan in previous year
•EDSS score of 0 to 5.5

Exclusion Criteria:

•Primary progressive MS
•Disease duration of more than 10 years in patients with an EDSS score of 2 or less
•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
Phase III
Multiple Sclerosis
Pavle Repovic, M.D.
Desiree Iriarte
  • Swedish Medical Center