Status:
COMPLETED
Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
Lead Sponsor:
UCB Pharma
Conditions:
Crohn's Disease
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
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. Sec...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2017
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01190410
Start Date
August 1 2010
End Date
November 27 2017
Last Update
December 17 2020
Active Locations (10)
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1
114
Orange, California, United States
2
111
Aurora, Colorado, United States
3
103
Atlanta, Georgia, United States
4
116
Atlanta, Georgia, United States