CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 89 enrolled
Drug / intervention
Certolizumab pegolbiological
Likely dose
Certolizumab pegol 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.

Search/NCT00297648
NCT00297648Phase 3Completed
CompareCT.gov

A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.

UCB Pharma·interventional·Posted Feb 28, 2006·Updated Aug 31, 2011

In Brief

A Phase 3 clinical trial evaluating Certolizumab pegol for Crohn's Disease. Completed, enrolled 89 participants across 19 sites in 3 countries.

Detailed Summary

The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesBelgium, France, Germany
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 28, 2006
Enrollment StartFeb 1, 2006
Primary CompletionJan 1, 2008
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 20.3 years ago

Interventions

Certolizumab pegolbiological

Certolizumab pegol (CDP870) 400 mg administered subcutaneously (sc) at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug end, either Q4W or Q2W, according to their administration frequency at Week 52.