Table 1.

The teriflunomide clinical program

Study	Phase	Main objective of study	Comparator	Treatment duration	Patients randomized (n)
Monotherapy studies
Phase II	II	Assess the effect of teriflunomide on the number of combined unique active lesions on magnetic resonance imaging	Placebo	36 weeks	179
TEMSO	III	Evaluate the efficacy and safety of teriflunomide in reducing frequency of relapses	Placebo	108 weeks	1088
TOWER	III	Evaluate the efficacy and safety of teriflunomide in reducing frequency of relapses	Placebo	Fixed end for all patients, 48 weeks for last patient randomized	1096
TENERE	III	Assess time to failure, defined as the first occurrence of relapse or permanent study treatment discontinuation for any cause	IFNβ-1a	Fixed end for all patients, 48 weeks for last patient randomized	324
TOPIC	III	Determine whether the effects of early intervention with teriflunomide in patients with clinically isolated syndrome prevent or delay conversion to multiple sclerosis	Placebo	108 weeks	618
TERIVA	II	Investigate the immune response to seasonal influenza vaccination in patients treated with teriflunomide	None	Teriflunomide ≥ 6 months, influenza vaccine at day 1	128
Adjunctive therapy studies
Teriflunomide + IFNβ	II	Assess the safety and tolerability of teriflunomide and a stable dose of IFNβ compared with placebo and IFNβ	Placebo	48 weeks	118
Teriflunomide + GA	II	Assess the safety and tolerability of teriflunomide and a stable dose of GA compared with placebo and GA	Placebo	48 weeks	123
TERACLES	III	Assess the effectiveness of teriflunomide in reducing frequency of relapses in patients treated with IFNβ	Placebo	Approximately 118 weeks	535

GA, glatiramer acetate; IFNβ, interferon beta.