DEFINE (Determination of the Efficacy and safety of oral Fumarate IN rElapsing-remitting MS) a global, randomized, double-blind, placebo-controlled, dose-comparison trial enrolled 1,237 patients between 18 and 55 years of age.
The study demonstrated that 240 mg of BG-12, administered either twice a day (BID) or three times a day (TID), reduced the proportion of patients who relapsed by 49% and 50%, respectively, at two years as compared with placebo.
BG-12 also showed a reduction in the annualized relapse rate (ARR) and the risk of disability progression as measured by the Expanded Disability Status Scale (EDSS) at two years compared to patients on placebo.