A Multi-center, Open-label Study of the Human Anti−TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study

Trial Profile

A Multi-center, Open-label Study of the Human Anti−TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study

Completed
Phase of Trial: Phase III

Latest Information Update: 25 Apr 2017

At a glance

  • Drugs Adalimumab (Primary)
  • Indications Crohn's disease
  • Focus Therapeutic Use
  • Acronyms IMAgINE 2
  • Sponsors Abbott Laboratories; AbbVie
  • Most Recent Events

    • 13 Jul 2016 This trial was completed in Czech Republic (End date 2014-02-27 ) as reported by European Clinical Trials Database record.
    • 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.
    • 11 Aug 2015 As per ClinicalTrials.gov record dose of Adalimumab was changed to 40mg (> or = 40kg) and 20mg (< 40kg) as per body weight (previously it was 40 mg ew and eow) also the the treatment time was extended to 336 weeks from 264 weeks.
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