At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 310 enrolled
Drug / intervention
Certolizumab Pegol (CDP870)biological
Likely dose
Certolizumab pegol 400 mg subcutaneous injection at weeks 0, 2, 4, then every 4 weeksAI-extracted
Key inclusion· 4
- ✓Prior participation in CDP870-031 or CDP870-032 clinical studies, having completed Week 2 assessment (CDP870-031) or Week 6 randomization (CDP870-032)
- ✓Crohn's disease significantly worse as determined by investigator at re-entry
- ✓CDAI score ≥70 points higher than baseline from parent study OR CDAI >350 points absolute at study entry
- ✓Able to understand study information and provide written informed consent
Key exclusion· 1
- ✕Any exclusion criterion from the qualifying pivotal study (CDP870-031 or CDP870-032), except the upper CDAI limit of 450 and prior certolizumab pegol trial participation criteria do not apply
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Re-exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed at Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease.
In Brief
A Phase 3 clinical trial evaluating Certolizumab Pegol (CDP870) for Crohn's Disease. Completed, enrolled 310 participants across 141 sites in 24 countries.
Detailed Summary
A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] due to an exacerbation of Crohn's Disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustralia, Austria, Belarus, Belgium, Bulgaria, Canada, Czechia, Denmark, Estonia, Germany, Hungary, Israel, Italy, New Zealand, Norway, Poland, Russia, Serbia, Singapore, Slovenia, South Africa, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2004
First PostedSep 2005
Primary CompletionMay 2012
TodayJul 2026
First PostedSep 12, 2005
Enrollment StartFeb 1, 2004
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 20.8 years ago
Interventions
Certolizumab Pegol (CDP870)biological
Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study.