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A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis

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Trial Profile

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2023

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ENVISION I
  • Sponsors AbbVie; AbbVie Germany

Most Recent Events

  • 22 Apr 2021 According to an AbbVie media release, Dr. Anne Griffiths (Inflammatory Bowel Disease Centre at the Hospital for Sick Children) is a Co-Lead.
  • 22 Apr 2021 According to an AbbVie media release, based on the results from this study. the Health Canada has approved HUMIRA (adalimumab) for inducing and maintaining clinical remission in pediatric patients five years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids and/or azathioprine or 6-mercaptopurine or who are intolerant to such therapies.
  • 24 Feb 2021 Results published in the AbbVie Media Release

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