Placebo cohorts in phase-3 MS treatment trials - predictors for on-trial disease activity 1990-2010 based on a meta-analysis and individual case data.

  • Jan-Patrick Stellmann
  • Anneke Neuhaus
  • Lena Herich
  • Sven Schippling
  • Matthias Roeckel
  • Martin Daumer
  • Roland Martin
  • Christoph Heesen

Abstract

Annualized relapse rates (ARR) in the placebo cohorts of phase-3 randomized controlled trials (RCT) of new treatments for relapsing remitting multiple sclerosis (RRMS) have decreased substantially during the last two decades. The causes of these changes are not clear. We consider a better understanding of this phenomenon essential for valuing the effects of new drugs and by designing new trials.

Bibliographical data

Original languageEnglish
Article number11
ISSN1932-6203
DOIs
Publication statusPublished - 2012
pubmed 23209717