Results of a Randomized, Double-Blind, Parallel-Group Study Assessing Safety and Efficacy of 40 mg vs. 20 mg of Glatiramer Acetate on MRI-Measured Disease Activity in RRMS.

Copaxone® (20 mg glatiramer acetate; GA) is an approved therapy for patients with relapsing-remitting multiple sclerosis (RRMS). Its safety and efficacy are supported by three pivotal trials and over a decade of experience and clinical research. To evaluate safety and efficacy of 40 mg of GA given subcutaneously daily for 9 months vs. the approved drug formulation (20 mg), as reflected by the number of gadolinium (Gd)-enhancing lesions on serial T1-weighted magnetic resonance (MR) images of the brain. Key eligibility criteria included clinically-definite SM with a relapse in the prior year, EDSS score 0–5.0, no prior use of GA, and at least one Gd-enhancing lesion on a month -1 screening MRI. Subjects underwent MRI scans at baseline then months 3, 7, 8 and 9. Neurological examinations were performed according to the same schedule. Suspected on-trial relapses were confirmed at an unscheduled visit …