Overview

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

Status:
Completed

Trial end date:
2017-11-27

Target enrollment:
0

Participant gender:
All

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. 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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

UCB Pharma

Treatments:

Certolizumab Pegol

Criteria

Inclusion Criteria:

- 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 Criteria:

- 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