TY - JOUR
T1 - Placebo-Controlled Phase 3 Study of Oral BG-12 for Relapsing Multiple Sclerosis
AU - Gold, Ralf
AU - Kappos, Ludwig
AU - Arnold, Douglas L.
AU - Bar-Or, Amit
AU - Giovannoni, Gavin
AU - Selmaj, Krzysztof W.
AU - Tornatore, Carlo
AU - Sweetser, Marianne T.
AU - Yang, Minhua
AU - Sheikh, Sarah I.
AU - Define Study Investigators
AU - Hupperts, Raymond
AU - Dawson, Katherine T.
PY - 2012/9/20
Y1 - 2012/9/20
N2 - BG-12 (dimethyl fumarate) was shown to have antiinflammatory and cytoprotective properties in preclinical experiments and to result in significant reductions in disease activity on magnetic resonance imaging (MRI) in a phase 2, placebo-controlled study involving patients with relapsing-remitting multiple sclerosis.We conducted a randomized, double-blind, placebo-controlled phase 3 study involving patients with relapsing-remitting multiple sclerosis. Patients were randomly assigned to receive oral BG-12 at a dose of 240 mg twice daily, BG-12 at a dose of 240 mg three times daily, or placebo. The primary end point was the proportion of patients who had a relapse by 2 years. Other end points included the annualized relapse rate, the time to confirmed progression of disability, and findings on MRI.The estimated proportion of patients who had a relapse was significantly lower in the two BG-12 groups than in the placebo group (27% with BG-12 twice daily and 26% with BG-12 thrice daily vs. 46% with placebo, P
AB - BG-12 (dimethyl fumarate) was shown to have antiinflammatory and cytoprotective properties in preclinical experiments and to result in significant reductions in disease activity on magnetic resonance imaging (MRI) in a phase 2, placebo-controlled study involving patients with relapsing-remitting multiple sclerosis.We conducted a randomized, double-blind, placebo-controlled phase 3 study involving patients with relapsing-remitting multiple sclerosis. Patients were randomly assigned to receive oral BG-12 at a dose of 240 mg twice daily, BG-12 at a dose of 240 mg three times daily, or placebo. The primary end point was the proportion of patients who had a relapse by 2 years. Other end points included the annualized relapse rate, the time to confirmed progression of disability, and findings on MRI.The estimated proportion of patients who had a relapse was significantly lower in the two BG-12 groups than in the placebo group (27% with BG-12 twice daily and 26% with BG-12 thrice daily vs. 46% with placebo, P
U2 - 10.1056/NEJMoa1114287
DO - 10.1056/NEJMoa1114287
M3 - Article
C2 - 22992073
VL - 367
SP - 1098
EP - 1107
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 12
ER -