Overview

This trial is active, not recruiting.

Condition crohn's disease
Treatments certolizumab pegol
Phase phase 2
Sponsor UCB Pharma
Start date August 2010
End date December 2017
Trial size 16 participants
Trial identifier NCT01190410, CR0012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
400 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg
certolizumab pegol Cimzia®
400 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg
(Experimental)
200 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg
certolizumab pegol Cimzia®
200 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 100 mg for subjects 20 to < 40 kg

Primary Outcomes

Measure
Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) during study treatment (up to 416 weeks)
time frame: During study treatment (up to 416 weeks)

Secondary Outcomes

Measure
Number of subjects discontinuing treatment due to a Treatment-emergent Adverse Event (TEAE)
time frame: During study treatment (up to 416 weeks)
Number of subjects who develop anti-nuclear antibodies during the study
time frame: During study treatment (up to 416 weeks)
Number of subjects who develop double-stranded deoxyribonucleic acid (dsDNA) antibodies during the study
time frame: During study treatment (up to 416 weeks)
Percentage of subjects in clinical remission
time frame: During study treatment (up to 416 weeks)

Eligibility Criteria

Male or female participants from 6 years up to 17 years old.

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

Additional Information

Official title An Open-label, Multicenter Study to Assess the Safety of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease Who Completed C87035 (NCT00899678) or Who Were Terminated From C87035
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by UCB Pharma.