Certolizumab pegol for the treatment of Crohn's disease.
William J Sandborn, Brian G Feagan, Simeon Stoinov, Pieter J Honiball, Paul Rutgeerts, David Mason, Ralph Bloomfield, Stefan Schreiber, undefined PRECISE 1 Study Investigators
New England Journal of Medicine | Published : 2007
BACKGROUND: Certolizumab pegol is a pegylated humanized Fab' fragment that binds tumor necrosis factor alpha. METHODS: In a randomized, double-blind, placebo-controlled trial, we evaluated the efficacy of certolizumab pegol in 662 adults with moderate-to-severe Crohn's disease. Patients were stratified according to baseline levels of C-reactive protein (CRP) and were randomly assigned to receive either 400 mg of certolizumab pegol or placebo subcutaneously at weeks 0, 2, and 4 and then every 4 weeks. Primary end points were the induction of a response at week 6 and a response at both weeks 6 and 26. RESULTS: Among patients with a baseline CRP level of at least 10 mg per liter, 37% of patient..View full abstract
Awarded by NCRR NIH HHS