Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

Treatment tested

• Teriflunomide

  Dihydroorotate dehydrogenase inhibitor

Other measures (6)

Inclusion Criteria: * Satisfactorily completion of HMR1726D/2001 study with respect to safety. * If female subject, non-childbearing potential or child bearing potential with adequate contraception. * Consent to practice/maintain adequate means of contraception throughout the study and for 24 months after the discontinuation of treatment. * Clinically definite Multiple Sclerosis (MS) as established on entry into HMR1726D/2001 study. * Extended Disability Status Score(EDSS) between 0 and 6 inclusively, when the subject entered HMR1726D/2001 study. * Magnetic Resonance Imaging (MRI) criteria must continue to support the diagnosis of clinically definite MS. * Willingness to participate in a long-term safety and efficacy trial. Exclusion Criteria: * Subject who did not complete HMR 1726D/2001 study for safety reasons. * Subject who developed clinically relevant cardiovascular, hepatic, endocrine or other major disease. * Pregnancy. * Breast-feeding. * Wish to parent. * Likelihood of requiring treatment during the study period with drugs not permitted. * Disallowed therapies such asw immunomodulators, immunosuppressants. * Recent history of drug or alcohol abuse. * Liver function impairment. * Abnormal mental conditions.

The primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects. The secondary objective is to assess the long-term efficacy.