Title: Onercept for moderate-to-severe Crohn's disease: a randomized, double-blind, placebo-controlled trial
Authors: Rutgeerts, Paul ×
Sandborn, William J
Fedorak, Richard N
Rachmilewitz, Daniel
Tarabar, Dino
Gibson, Peter
Haagen Nielsen, Ole
Wild, Gary
Schreiber, Stefan
Pena Rossi, Claudia
Zignani, Monia #
Issue Date: Jul-2006
Series Title: Clinical Gastroenterology and Hepatology vol:4 issue:7 pages:888-93
Abstract: BACKGROUND AND AIMS: Onercept is a recombinant, soluble human p55 receptor to tumor necrosis factor-alpha. METHODS: A randomized, double-blind, placebo-controlled, dose-ranging trial was performed to evaluate the efficacy of onercept induction therapy in patients with Crohn's disease (CD). Patients (n = 207) with moderate-to-severe acute or chronic active CD were randomized to receive subcutaneous onercept (10, 25, 35, or 50 mg) or placebo 3 times weekly for 8 weeks. Primary analysis was induction of remission (defined as a CD activity index score < or = 150) at week 8. RESULTS: A total of 104 patients had acute active CD. Remission rates at week 8 were 23.5% for placebo (n = 17), and 34.8%, 20.0%, 26.1%, and 28.6% for onercept 10 mg (n = 23), 25 mg (n = 20), 35 mg (n = 23), and 50 mg (n = 21), respectively (P = .98). A total of 103 patients had chronic active CD. Remission rates at week 8 were 23.8% for placebo (n = 21), and 23.8%, 9.1%, 35.3%, and 13.6% for onercept 10 mg (n = 21), 25 mg (n = 22), 35 mg (n = 17), and 50 mg (n = 22), respectively (P = .66). There were no differences between treatment groups in the incidence of adverse events. However, mild-to-moderate injection-site reactions occurred in up to 12% of onercept-treated patients. CONCLUSIONS: Onercept was well tolerated but was not effective at the doses studied in patients with active CD.
ISSN: 1542-3565
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Translational Research in GastroIntestinal Disorders
× corresponding author
# (joint) last author

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