Journal article

A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn's disease

S Schreiber, P Rutgeerts, RN Fedorak, M Khaliq-Kareemi, MA Kamm, M Boivin, CN Bernstein, M Staun, OO Thomsen, A Innes

GASTROENTEROLOGY | W B SAUNDERS CO-ELSEVIER INC | Published : 2005

Abstract

BACKGROUND & AIMS: To investigate the efficacy and safety of certolizumab pegol (a polyethylene-glycolated Fab' fragment of anti-tumor necrosis factor, CDP870) in Crohn's disease. METHODS: In a placebo-controlled, phase II study, 292 patients with moderate to severe Crohn's disease received subcutaneous certolizumab 100, 200, or 400 mg or placebo at weeks 0, 4, and 8. The primary end point was the percentage of patients with a clinical response at week 12 (a Crohn's Disease Activity Index decrease of > or = 100 points or remission [Crohn's Disease Activity Index < or = 150 points]) in the intent-to-treat population. RESULTS: All certolizumab doses produced significant clinical benefit over p..

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