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Wolinsky and colleagues exhaustively assessed whether glatiramer acetate (GA) can delay progression in primary progressive multiple sclerosis (PPMS). This multicenter, international, and multifaceted double-blind trial was designed to last 3 years. Clinical, laboratory, and statistical assessments were extremely thorough. Patients were classified into two strata according to Expanded Disability Scale (EDSS) score, but all post-entry data are given for the EDSS-score strata combined. There were 627 patients randomized to receive GA and 316 to receive placebo (PBO).
The second planned interim analysis of the data safety monitoring board indicated both that disease progression was much slower than expected and that the groups did not differ in …