At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 539 enrolled
Drug / intervention
Certolizumab pegol +2 morebiological
Likely dose
Certolizumab pegol 400mgfrom 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 Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab
In Brief
A Phase 3 clinical trial evaluating Certolizumab pegol and Placebo for Crohn's Disease. Completed, enrolled 539 participants across 107 sites in 14 countries.
Detailed Summary
To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2006
Enrollment StartApr 2006
Primary CompletionApr 2008
TodayJul 2026
First PostedMar 29, 2006
Enrollment StartApr 1, 2006
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.3 years ago
Interventions
Certolizumab pegolbiological
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Certolizumab pegolbiological
400mg Certolizumab Pegol, Q2W, administered 2-weekly
Placeboother
placebo administered 4-weekly in Active 1