At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 596 enrolled
Drug / intervention
Certolizumab Pegol (CDP870)biological
Likely dose
Certolizumab pegol 400 mg subcutaneously at Week 2, then every 4 weeks until Week 362 (up to 84 months)AI-extracted
Key inclusion· 2
- ✓Must have completed Week 26 of either CDP870-031 or CDP870-032 clinical trial (could have received active drug or placebo)
- ✓Able to understand study information and provide written informed consent
Key exclusion· 1
- ✕Any exclusion criterion from the qualifying pivotal studies CDP870-031 or CDP870-032 applies, except prior Certolizumab Pegol trial participation is not an exclusion
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 Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed 4-weekly), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Completed Studies CDP870-031 or CDP870-032
In Brief
A Phase 3 clinical trial evaluating Certolizumab Pegol (CDP870) for Crohn's Disease. Completed, enrolled 596 participants across 206 sites in 29 countries.
Detailed Summary
An open-label follow-on safety study of CDP870 (400 mg every 4 weeks) in patients with Crohn's Disease who have completed a 26-week blinded study (CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\]).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustralia, Austria, Belarus, Belgium, Bulgaria, Canada, Czechia, Denmark, Estonia, Georgia, Germany, Hong Kong, Hungary, Israel, Italy, Latvia, Lithuania, New Zealand, Norway, Poland, Russia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2004
First PostedSep 2005
Primary CompletionAug 2012
TodayJul 2026
First PostedSep 12, 2005
Enrollment StartJul 1, 2004
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 20.8 years ago
Interventions
Certolizumab Pegol (CDP870)biological
Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.