NCT00349752

Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease

A Phase IIIb Multicenter, Double-blind, Placebo-controlled,Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe Crohn's disease. Subjects had to be in remission (CDAI\<=150) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
BIOLOGICAL	certolizumab pegol 400 mg	Certolizumab pegol 400 mg provided in solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.
OTHER	Placebo	Placebo (commercially available sodium chloride 0.9% (preservative free)) provided for subcutaneous injection in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.

Timeline

• Start date: 2006-11-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2006-07-10
• Last updated: 2018-08-09
• Results posted: 2010-12-01

Locations

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