Which and How Many Patients Should Be Included in Randomised Controlled Trials to Demonstrate the Efficacy of Biologics in Primary Sjögren's Syndrome?

OBJECTIVE:The goal of this study was to determine how the choice of the primary endpoint influenced sample size estimates in randomised controlled trials (RCTs) of treatments for primary Sjögren's syndrome (pSS). METHODS:We reviewed all studies evaluating biotechnological therapies in pSS to id...

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Main Authors: Valérie Devauchelle-Pensec, Jacques-Eric Gottenberg, Sandrine Jousse-Joulin, Jean-Marie Berthelot, Aleth Perdriger, Eric Hachulla, Pierre Yves Hatron, Xavier Puechal, Véronique Le Guern, Jean Sibilia, Laurent Chiche, Vincent Goeb, Olivier Vittecoq, Claire Larroche, Anne Laure Fauchais, Gilles Hayem, Jacques Morel, Charles Zarnitsky, Jean Jacques Dubost, Philippe Dieudé, Jacques Olivier Pers, Divi Cornec, Raphaele Seror, Xavier Mariette, Emmanuel Nowak, Alain Saraux
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2015-01-01
Series:PLoS ONE
Online Access:http://europepmc.org/articles/PMC4569343?pdf=render