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Multicenter, randomized, double-blind, active controlled trial comparing Remicade (infliximab) and Remicade plus azathioprine to azathioprine in the treatment of patients with Crohn's disease naive to both immunomodulators and biologic therapy

Trial Profile

Multicenter, randomized, double-blind, active controlled trial comparing Remicade (infliximab) and Remicade plus azathioprine to azathioprine in the treatment of patients with Crohn's disease naive to both immunomodulators and biologic therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2021

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At a glance

  • Drugs Infliximab (Primary) ; Azathioprine
  • Indications Crohn's disease
  • Focus Therapeutic Use
  • Acronyms SONIC
  • Sponsors Centocor; Janssen Biotech
  • Most Recent Events

    • 23 May 2021 Results of a post-hoc analysis from four clinical trials: SONIC, UNITI-1, UNITI-2 and IM-UNITI assessing clinical and endoscopic outcomes of CD patients with non-passable strictures presented at the Digestive Disease Week 2021
    • 13 Oct 2020 Results (n=158) of post-hoc analysis relationship of baseline PRO variables, AP and SF with week 26 clinical remission, PRO2 remission, and corticosteroid-free clinical remission , presented at the 28th United European Gastroenterology Week.
    • 05 Jun 2018 Results of a pooled analysis of ACCENT-I, SONIC, ACT-1, and ACT-2 (n=1205) assessing the association between obesity and response to infliximab, published in the American Journal of Gastroenterology
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