NCT00356408

Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease

An Open-label, Multi-center Trial to Examine the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease Previously Enrolled in C87059 (COSPAR I, NCT00349752).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label extension study designed to measure the safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol (CDP870) in patients with moderate to severe Crohn's disease previously enrolled in C87059 (COSPAR I, NCT00349752).

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
BIOLOGICAL	Certolizumab pegol	Certolizumab pegol (CDP870), an anti-tumor necrosis factor (TNF)α, humanized antibody Fab' fragment - polyethylene glycol conjugate, solution for injection, in 10 mM sodium acetate buffer and 125 mM sodium chloride, pH 4.7, supplied in 3 mL vials with a fill of 1.4 mL (an extractable volume of 1 mL corresponds to a dose of 200 mg). Dosing is every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2.

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2006-07-26
• Last updated: 2018-08-09
• Results posted: 2011-05-25

Locations

63 sites across 3 countries: United States, Canada, Germany