TEMSO

Treatment tested

• Teriflunomide

  Dihydroorotate dehydrogenase inhibitor

Placebo or sham

• Placebo (for teriflunomide)

Other measures (3)

Inclusion Criteria: * Multiple sclerosis [MS] subject who was ambulatory (EDSS of ≤ 5.5) * Exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing); * Meeting McDonald's criteria for MS diagnosis; * Experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial; * No relapse onset in the preceding 60 days prior to randomization; * Clinically stable during the 30 days prior to randomization, without adrenocorticotrophic hormone [ACTH] or systemic steroid treatment. Exclusion Criteria: * Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease; * Significantly impaired bone marrow function; * 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; * Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study;

The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS). Secondary objectives were: * to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale [EDSS], the burden of disease as measured by Magnetic Resonance Imaging [MRI] and patient-reported fatigue; * to evaluate the safety and tolerability of teriflunomide.