NCT00899678

The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents

A Phase 2, Open-label, Multicenter Study to Assess the Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease (NURTURE Study)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: UCB Celltech · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of certolizumab pegol treatment in pediatric subjects, aged 6 to 17, with moderately to severely active Crohn's disease. The target enrollment is 160 subjects.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Certolizumab Pegol	400 mg administered subcutaneously at once every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg \*prior to this dosing regimen, subjects will undergo an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
DRUG	Certolizumab Pegol	200 mg administered subcutaneously at once every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg \*prior to this dosing regimen, subjects will undergo an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2009-05-12
• Last updated: 2018-08-07
• Results posted: 2013-11-21

Locations

35 sites across 4 countries: United States, Australia, Canada, New Zealand