title: Onercept for moderate-to-severe Crohn's disease: a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  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.
authors.affiliation: University Hospital Gasthuisberg, Leuven, Belgium. Paul.Rutgeerts@uz.kuleuven.ac.be
authors.forename: Paul
authors.initials: P
authors.lastname: Rutgeerts
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Richard N
authors.initials: RN
authors.lastname: Fedorak
authors.forename: Daniel
authors.initials: D
authors.lastname: Rachmilewitz
authors.forename: Dino
authors.initials: D
authors.lastname: Tarabar
authors.forename: Peter
authors.initials: P
authors.lastname: Gibson
authors.forename: Ole
authors.initials: O
authors.lastname: Haagen Nielsen
authors.forename: Gary
authors.initials: G
authors.lastname: Wild
authors.forename: Stefan
authors.initials: S
authors.lastname: Schreiber
authors.forename: Claudia
authors.initials: C
authors.lastname: Pena Rossi
authors.forename: Monia
authors.initials: M
authors.lastname: Zignani
mesh_terms: D000328:Adult; D003424:Crohn Disease / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage*; D047888:Receptors, Tumor Necrosis Factor, Type I; D012720:Severity of Illness Index; D016896:Treatment Outcome; D053319:Tumor Necrosis Factor Decoy Receptors
chemical_list: D018124:Receptors, Tumor Necrosis Factor; D047888:Receptors, Tumor Necrosis Factor, Type I; D053319:Tumor Necrosis Factor Decoy Receptors; C069521:recombinant human tumor necrosis factor-binding protein-1