An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis

The study consists in:

- A core treatment period: Teriflunomide 7 mg or Teriflunomide 14 mg or placebo is
administered in double-blind fashion until a fixed common end date which is
approximately 48 weeks after randomization of the last participant.

- An extension treatment period: the highest dose of teriflunomide is administered in
open-label fashion to participants who successfully complete the core treatment period
and wish to continue.

The overall treatment period is followed by a 4-week elimination follow-up period.

Inclusion Criteria:

- Relapsing multiple sclerosis,

- Two relapses in prior 2 years or one relapse in prior year.

Exclusion Criteria:

- Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major
systemic disease,

- Significantly impaired bone marrow function or, significant anemia, leukopenia or
thrombocytopenia,

- Pregnant or nursing woman,

- Alcohol or drug abuse,

- Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant
agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or
mycophenolate,

- Human immunodeficiency virus (HIV) positive,

- 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.