Efficacy criteria in phase III trials for relapsing-remitting multiple sclerosis

Primary end points(1) Annual relapse rate (2) % Relapse free patients(1) Time to onset of sustained (6 months) deterioration by 1.0 point on EDSS(1) Mean No of relapses(1) Mean change in EDSS in 2 years (2) % patients with increase/decrease by 1.0 point or no change on EDSS
Clinical secondary end points(1) Time to 1st relapse (2) Relapse severity (3) Relapse duration (4) Change in EDSS and NRS(1) % Patients progressing (2) Intrapatient EDSS change (3) No of relapses per patient(1) % Relapse free patients (2) Time to 1st relapse (3) % Sustained (3 months) 1.0 point EDSS change (4) Change in EDSS and AI in 2 years(1) Mean No of relapses (2) Annual relapse rate (3) % Relapse free patients (4) Time to 1st relapse
  • IFNβ-1b=interferon β-1b1; IFNβ-1a=interferon β-1a2; Cop-1=copolymer-13; IVIg= intravenous immunoglobulin4; EDSS=expanded disability status scale7; NRS= Scripps neurological rating scale19; AI=ambulation index.20