Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta

Inclusion criteria :

Patient with relapsing forms of MS treated with IFN-beta
Stable dose of IFN-beta (approved brand) for at least 6 months prior to randomization
Disease activity in the 12 months prior to randomization and after first 3 months of IFN-beta treatment (defined by at least 1 relapse supported by EDSS or equivalent neurological examination, or, at least 1 brain or spinal cord MRI with at least one T1 gadolinium enhancing lesion)

Exclusion criteria:

McDonald criteria for MS diagnosis not met at time of screening visit
EDSS score greater than (>) 5.5 at randomization visit
A relapse within 30 days prior randomization
Persistent significant or severe infection
Patients must not have used adrenocorticotrophic hormone or systemic corticosteroids for 2 weeks prior to randomization
Prior or concomitant use of cytokine therapy (except baseline interferons), glatiramer acetate or intravenous immunoglobulins in the 3 months preceding randomization
Liver function impairment or persisting elevations (confirmed by retest) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or direct bilirubin greater than 2 times the upper limit of normal range (ULN)
Active hepatitis or hepatobiliary disease or known history of severe hepatitis
Pregnant or breast-feeding women or those who were planning to become pregnant during the study
Significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia
Human Immunodeficiency Virus (HIV) positive
Known history of active tuberculosis not adequately treated
Prior use within 2 years preceding randomization or concomitant use of cladribine and mitoxantrone
Prior use within 6 months preceding randomization or concomitant use of natalizumab, or any other immunosuppressive agents such as azathioprine, cyclophosphamide, cyclosporine, methotrexate, mycophenolate, or fingolimod

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.