Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol

Completed · Phase 2

Conditions studied: Crohn's Disease

In brief

The purpose of this study is to evaluate the long-term safety and tolerability of certolizumab pegol (CZP) treatment in children and adolescents with moderately to severely active Crohn's disease. Secondarily, to assess the long-term efficacy, pharmacokinetics (PK), and immunogenicity of CZP treatment in children and adolescents with moderately to severely active Crohn's disease.

Key facts

Study ID

NCT01190410

Run by

UCB Pharma

People needed

16

Starts

2010-08-01

Expected to finish

2017-11-27

Last updated by the study team

2020-12-17

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject who completed the C87035 study (NCT00899678) through Week 62 or assessments when their participation in C87035 was terminated when the study was stopped by UBC
• Subject completed all assessments required for Week 62/Visit 23 at the time of termination
• Subjects maintain stable regimen of concomitant medications for Crohn's Disease (CD) throughout study

You may not qualify if…

• Subject who did not complete the C87035 study (Week 62 Visit), was terminated or did not complete all of the Week 62 assessments when their participation from C87035 was terminated when the study was stopped by UCB but did not complete all assessments required for Week 62/Visit 23 at the time of termination

Where it is running

• 114 — Orange, California, United States
• 111 — Aurora, Colorado, United States
• 103 — Atlanta, Georgia, United States
• 116 — Atlanta, Georgia, United States
• 112 — Shreveport, Louisiana, United States
• 104 — Baltimore, Maryland, United States
• 126 — Morristown, New Jersey, United States
• 301 — Parkville, Victoria, Australia
• 203 — Edmonton, Alberta, Canada
• 204 — Hamilton, Ontario, Canada

Full record on ClinicalTrials.gov

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