Parent company: Sanofi-aventis
- Oral medication taken daily.
- This drug is an immunomodulator that affects the division of T cells.
- A Phase II trial of RRMS evaluated two dose levels versus placebo. The treated groups had significantly fewer enhancing lesions and a lower relapse rate; fewer patients in the high-dose group experienced an increase in disability versus placebo, and there was a trend toward more relapse-free patients. Treatment was well tolerated. An extension of this study will document the long-term safety in individuals who participated in this study, and will also document long-term efficacy on disability progression, MRI parameters, and EDSS. Based on the positive results from the Phase II study, a Phase III study with an estimated enrollment of 1,100 is currently recruiting participants. It will evaluate the effect of two doses of teriflunomide on the frequency of relapse; the effect on worsening of disability, fatigue, and safety will also be evaluated.
- Phase II combination studies of teriflunomide added to interferon beta and Copaxone are still ongoing. Both will evaluate tolerability and safety, the number of gadolinium-enhancing lesions, and burden of disease on MRI.
- A two-year Phase III study is still recruiting participants who have had a first episode (CIS) consistent with MS. Its primary outcome measure is conversion to CDMS. Secondary measures include relapse rate, burden of disease and other MRI variables, and the proportion of patients who remain free of disability.