A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFalpha Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis

Trial Profile

A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFalpha Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis

Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 27 Dec 2017

At a glance

  • Drugs Golimumab (Primary)
  • Indications Ulcerative colitis
  • Focus Pharmacokinetics
  • Acronyms PURSUIT-PEDS-PK
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 23 Dec 2017 trial has been completed in Denmark
    • 24 May 2016 Results assessing pharmacokinetics, efficacy, and safety of golimumab at week 14 presented at the Digestive Disease Week 2016.
    • 27 Nov 2015 Planned primary completion date changed from 1 Oct 2015 to 1 Feb 2017 as reported by ClinicalTrials.gov.
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