A Multi-center, Randomized, Double-blinded, Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease.

Trial Profile

A Multi-center, Randomized, Double-blinded, Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease.

Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jul 2018

At a glance

  • Drugs Adalimumab (Primary)
  • Indications Crohn's disease; Fistula
  • Focus Registrational; Therapeutic Use
  • Acronyms IMAgINE 1
  • Sponsors Abbott Laboratories
  • Most Recent Events

    • 25 Jul 2018 Results (n=577) evalauting the totality of safety findings from 7 clinical trials (NCT00048542, NCT00775437, NCT00690573, NCT01166282, NCT01251614, NCT00409682 and NCT00686374) published in the Journal of Pediatrics
    • 07 Mar 2018 Results of pooled data from 11 induction, maintenance and open-label extension studies of adalimumab, were published in the Advances in Therapy.
    • 19 May 2016 Results from this trial will be presented at the Digestive Disease Week (DDW) Annual Meeting 2016, according to an AbbVie media release.
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