Onercept for moderate-to-severe Crohn's disease: a randomized, double-blind, placebo-controlled trial.

Authors:
Paul Rutgeerts, William J Sandborn, Richard N Fedorak, Daniel Rachmilewitz, Dino Tarabar, Peter Gibson, Ole Haagen Nielsen, Gary Wild, Stefan Schreiber, Claudia Pena Rossi, Monia Zignani, - -
Year of publication:
2006
Volume:
4
Issue:
7
Issn:
1542-3565
Journal title abbreviated:
CLIN GASTROENTEROL H
Journal title long:
Clinical gastroenterology and hepatology the official clinical practice journal of the American Gastroenterological Association
Impact factor:
7.680
Abstract: 
Onercept was well tolerated but was not effective at the doses studied in patients with active CD.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.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.Onercept is a recombinant, soluble human p55 receptor to tumor necrosis factor-alpha.