NCT00152490

A Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo)

A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Safety and Efficacy of the Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed at Weeks 0, 2, 4 Then 4-weekly to Week 24), in the Treatment of Patients With Active Crohn's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 604 (planned)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

A 26 week study to examine the efficacy, safety and pharmacokinetics of CDP870 in Crohn's disease

Detailed description

Receiving immunosuppressants (azathioprine/6-MP/methotrexate) at Week 0 or not. 604 patients will be enrolled with 1006 patients screened (to allow for 25% screen failures between screening and Week 0 and expected presentation at Screening of 60% of patients with CRP \< 10 mg/L and 40% of patients with CRP ≥ 10 mg/L).

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Certolizumab Pegol (CDP870)

Timeline

• Start date: 2003-12-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2005-09-09
• Last updated: 2013-09-09