Brian G Feagan, William J Sandborn, Geert D'Haens, Suresh Pola, John W D McDonald, Paul Rutgeerts, Pia Munkholm, Ulrich Mittmann, Debra King, Cindy J Wong, Guangyong Zou, Allan Donner, Lisa M Shackelton, Denise Gilgen, Sigrid Nelson, Margaret K Vandervoort, Marianne Fahmy, Edward V Loftus, Remo Panaccione, Simon P Travis, Gert A Van Assche, Séverine Vermeire, Barrett G Levesque
BACKGROUND & AIMS: Interobserver differences in endoscopic assessments contribute to variations in rates of response to placebo in ulcerative colitis (UC) trials. We investigated whether centralized review of images could reduce these variations. METHODS: We performed a 10-week, randomized, double-blind, placebo-controlled study of 281 patients with mildly to moderately active UC, defined by an Ulcerative Colitis Disease Activity Index (UCDAI) sigmoidoscopy score ≥2, that evaluated the efficacy of delayed-release mesalamine (Asacol 800-mg tablet) 4...
July 2013: Gastroenterology