NCT00552058

Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 439 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
BIOLOGICAL	certolizumab pegol (CDP870, CZP)	Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4
OTHER	Placebo	Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-10-01
• Completion: 2009-11-01
• First posted: 2007-11-01
• Last updated: 2018-08-09
• Results posted: 2010-12-30

Locations

116 sites across 20 countries: United States, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Estonia, Finland, Germany, Hungary, Israel, Italy, Latvia, New Zealand, Poland, Romania, Russia, Ukraine