Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.

Trial Profile

Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Nov 2017

At a glance

  • Drugs Certolizumab pegol (Primary)
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors UCB
  • Most Recent Events

    • 12 Nov 2017 Outcomes of a population pharmacokinetic model assessing exposure-response relationship of of certolizumab pegol using pooled data from nine clinical trials of certolizumab pegol induction and maintenance therapy in patients with Crohns disease, including C87005,C87031,C87032, C87037, C87042, C87043,C87047, C87048 and C87085, published in the Alimentary Pharmacology and Therapeutics Journal.
    • 10 Jun 2017 Biomarkers information updated
    • 15 Mar 2012 According to the EudraCT2007-001913-41 record, this trial is completed in Hungary, Latvia, Belgium, Estonia, Italy, Germany, Austria and Czech Republic but has prematurely ended in Finland.
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