NCT00160706

A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease

A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Re-exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed at Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: UCB Pharma SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] due to an exacerbation of Crohn's Disease.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
BIOLOGICAL	Certolizumab Pegol (CDP870)	Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study.

Timeline

• Start date: 2004-02-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2005-09-12
• Last updated: 2018-08-07
• Results posted: 2013-07-04

Locations

141 sites across 24 countries: United States, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Czechia, Denmark, Estonia, Germany, Hungary, Israel, Italy, New Zealand, Norway, Poland, Russia, Serbia, Singapore, Slovenia, South Africa, Spain, Ukraine