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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2021

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At a glance

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

    • Most Recent Events

    • 02 Dec 2018 Results of post hoc analysis of IMAGINE1 study assessing efficacy of adalimumab in patients with Crohn's disease, published in the Alimentary Pharmacology and Therapeutics.
    • 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.

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