Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis

Inclusion Criteria:

Definite MS diagnosis according to McDonald's criteria;
Relapsing clinical course, with or without progression;
Expanded Disability Status Scale [EDSS] less or equal to 5.5 (ambulatory);
Stable dose of IFN-β for at least 26 weeks prior to the screening visit;
No onset of MS relapse in the preceding 60 days prior to randomization;
Clinically stable for 4 weeks prior to randomization.

Exclusion Criteria:

Other chronic disease of the immune system, liver function impairment or chronic pancreatic disease;
Pregnant or nursing woman;
Alcohol or drug abuse;
Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
Human immunodeficiency virus [HIV] positive status;
Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.

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