Table 2.

Summary of pivotal trials

Study	Study design	Treatment arms	Primary end point	Main result
TRANSFORMS4	n=1,292, 12-month, double-blind, parallel-group, active comparator, multicenter	Fingolimod 0.5 mg orally, daily	ARR reduction over 12 months	ARR: 0.16–0.20 (vs 0.33; P<0.001 for each dose vs IFNβ-1a)
		Fingolimod 1.25 mg orally, daily IFNβ-1a 30 μg intramuscularly, weekly		Relapse free: 80%–83% of patients (vs 69%; P<0.0001 for each dose vs IFNβ-1a)
FREEDOMS3	n=1,272, 24-month, double-blind, parallel-group, placebo-controlled, multicenter	Fingolimod 0.5 mg orally, daily Placebo	ARR reduction over 24 months	ARR: 0.16–0.18 (vs 0.40; P<0.001 for each dose vs placebo) Relapse free: 70%–75% of patients (vs 46%; P<0.001 for each dose vs placebo)

Abbreviations: ARR, annualized relapse rate for confirmed relapses; IFNβ-1a, interferon beta-1a.