NCT00160524

A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]

A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed 4-weekly), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Completed Studies CDP870-031 or CDP870-032

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 596 (actual)
• Sponsor: UCB Pharma SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open-label follow-on safety study of CDP870 (400 mg every 4 weeks) in patients with Crohn's Disease who have completed a 26-week blinded study (CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\]).

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
BIOLOGICAL	Certolizumab Pegol (CDP870)	Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.

Timeline

• Start date: 2004-07-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2005-09-12
• Last updated: 2018-08-01
• Results posted: 2013-10-10

Locations

206 sites across 29 countries: United States, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Czechia, Denmark, Estonia, Georgia, Germany, Hong Kong, Hungary, Israel, Italy, Latvia, Lithuania, New Zealand, Norway, Poland, Russia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Ukraine