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

Research output: Contribution to journalJournal articleResearchpeer-review

  • Paul Rutgeerts
  • William J Sandborn
  • Richard N Fedorak
  • Daniel Rachmilewitz
  • Dino Tarabar
  • Peter Gibson
  • Nielsen, Ole Haagen
  • Gary Wild
  • Stefan Schreiber
  • Claudia Pena Rossi
  • Monia Zignani
  • Onercept Study Group

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.

Original languageEnglish
JournalClinical Gastroenterology and Hepatology
Issue number7
Pages (from-to)888-93
Number of pages6
Publication statusPublished - Jul 2006

    Research areas

  • Adult, Crohn Disease, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Injections, Subcutaneous, Male, Middle Aged, Receptors, Tumor Necrosis Factor, Receptors, Tumor Necrosis Factor, Type I, Severity of Illness Index, Treatment Outcome, Tumor Necrosis Factor Decoy Receptors, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

ID: 166455579