At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 403 enrolled
Drug / intervention
Cimziabiological
Likely dose
Cimzia 200 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.
A Phase IIIb, Multinational, Open-label, follow-on Trial to C87085 Designed to Assess the Long-term Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-TNF-alpha Monoclonal Antibody, Administered at Weeks 0, 2 and 4, and Then Every 4 Weeks Thereafter, in Subjects With Moderately to Severely Active Crohn's Disease Who Have Participated in Study C87085
In Brief
A Phase 3 clinical trial evaluating Cimzia for Crohn Disease. Completed, enrolled 403 participants across 100 sites in 18 countries.
Detailed Summary
The primary objective of the study is to assess the safety of long term therapy with Certolizumab Pegol in those subjects participating in study C87085 \[NCT00552058\].
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn Disease
CountriesAustralia, Austria, Belgium, Brazil, Canada, Czechia, Estonia, Germany, Hungary, Israel, Italy, Latvia, New Zealand, Poland, Romania, Russia, Ukraine, United States
CollaboratorsPPD Development, LP
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2007
Enrollment StartMay 2008
Primary CompletionDec 2014
TodayJul 2026
First PostedNov 1, 2007
Enrollment StartMay 1, 2008
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 18.7 years ago
Interventions
Cimziabiological
* Active substance: Certolizumab Pegol * Pharmaceutical form:first reconstituted, lyophilized powder formulation of CZP and after implementation of Amendment 2 (after 401 subjects were enrolled) prefilled syringe * Concentration: 200 mg/ml * Route of Administration: Subcutaneous use