CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Certolizumab pegol (CZP) +2 morebiological
Likely dose
Certolizumab pegol (CZP) 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/NCT00329550
NCT00329550Phase 2Completed
CompareCT.gov

A 26-week, Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed Clinical Efficacy in a Remission Induction Study (Study C87037 [NCT00291668]), at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week Intervals

UCB Japan Co. Ltd.·interventional·Posted May 24, 2006·Updated Mar 18, 2015

In Brief

A Phase 2 clinical trial evaluating Certolizumab pegol (CZP) for Crohn's Disease. Completed, enrolled 40 participants across 23 sites.

Detailed Summary

This is a multi-centre, open-label extension study in subjects who showed clinical response to induction therapy in the treatment of subjects with active Crohn's disease in the double-blind main study C87037 (NCT00291668).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 24, 2006
Enrollment StartMay 1, 2006
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 20.1 years ago

Interventions

Certolizumab pegol (CZP)biological

Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Placebo at Weeks 0, 2 and 4.

Certolizumab pegol (CZP)biological

Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received certolizumab pegol (CZP) 200 mg at Weeks 0, 2 and 4.

Certolizumab pegol (CZP)biological

Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received certolizumab pegol 400 mg at Weeks 0, 2 and 4.