CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 233 enrolled
Drug / intervention
Certolizumab pegol (CDP870)biological
Likely dose
Certolizumab pegol 400 mg subcutaneous injection every 2 or 4 weeksAI-extracted
Key inclusion· 1
  • ✓Completion of the C87042 study (prior certolizumab pegol trial, patients previously treated with infliximab)
Key exclusion· 4
  • ✕Withdrawal from the C87042 study
  • ✕Receipt of treatments other than certolizumab pegol and medications permitted in C87042
  • ✕Residency in countries where certolizumab pegol is already authorized for Crohn's disease treatment
  • ✕Childbearing-age females not practicing effective birth control, or with positive pregnancy tests

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00333788
NCT00333788Phase 3Completed
CompareCT.gov

Open Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study.

UCB Pharma·interventional·Posted Jun 6, 2006·Updated Aug 7, 2018

In Brief

A Phase 3 clinical trial evaluating Certolizumab pegol (CDP870) for Crohn's Disease. Completed, enrolled 233 participants across 65 sites in 12 countries.

Detailed Summary

The study will continue to assess the safety of certolizumab pegol (CDP870) as well as examine the evolution of long term efficacy in Crohn's disease patients who completed study C87042 \[NCT00308581\]. It will also assess the effect of subcutaneous CDP870 400 mg on direct cost parameters.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustria, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 6, 2006
Enrollment StartOct 1, 2006
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.1 years ago

Interventions

Certolizumab pegol (CDP870)biological

400 mg subcutaneous (sc) injection of Certolizumab pegol (CDP870) every 2 (Q2W) or 4 (Q4W) weeks