At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 439 enrolled
Drug / intervention
certolizumab pegol (CDP870, CZP) +1 morebiological
Likely dose
certolizumab pegol (CDP870, CZP) 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating certolizumab pegol (CDP870, CZP) and Placebo for Crohn Disease. Completed, enrolled 439 participants across 116 sites in 20 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn Disease
CountriesAustralia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Estonia, Finland, Germany, Hungary, Israel, Italy, Latvia, New Zealand, Poland, Romania, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2007
Enrollment StartMar 2008
Primary CompletionOct 2009
Study CompletionNov 2009
TodayJul 2026
First PostedNov 1, 2007
Enrollment StartMar 1, 2008
Primary CompletionOct 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.7 years ago
Interventions
certolizumab pegol (CDP870, CZP)biological
Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4
Placeboother
Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4