Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis

This is a randomized, double-blind, double-dummy, active comparator-controlled,
parallel-group, multi-center 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