作者
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, Onercept Study Group
发表日期
2006/7/1
期刊
Clinical Gastroenterology and Hepatology
卷号
4
期号
7
页码范围
888-893
出版商
WB Saunders
简介
Background & Aims
Onercept is a recombinant, soluble human p55 receptor to tumor necrosis factor-α.
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 ≤ 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 …
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