Clinical trial NCT01190410: Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Certolizumab Pegol
Cimzia®
Crohn's Disease
Children and Adolescents with Crohn's Disease
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-08-27
Enrollment: 16
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


Eligibility 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

Primary outcomes:
measure: Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks)
timeFrame: During study treatment (up to 303 weeks)
Secondary outcomes:
measure: Number of Subjects Discontinuing Treatment Due to a Treatment-Emergent Adverse Event (TEAE)
timeFrame: During study treatment (up to 303 weeks)
measure: Number of Subjects Who Develop Anti-nuclear Antibodies During the Study
timeFrame: At the time of completion or termination visit (up to 298 weeks)
measure: Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study
timeFrame: At the time of completion or termination visit (up to 298 weeks)
measure: Percentage of Subjects in Clinical Remission
timeFrame: At the time of completion or termination visit (up to 298 weeks)
Other outcomes:
Locations:
city: Orange
country: United States
facility: 114
state: California
city: Aurora
country: United States
facility: 111
state: Colorado
city: Atlanta
country: United States
facility: 103
state: Georgia
city: Atlanta
country: United States
facility: 116
state: Georgia
city: Shreveport
country: United States
facility: 112
state: Louisiana
city: Baltimore
country: United States
facility: 104
state: Maryland
city: Morristown
country: United States
facility: 126
state: New Jersey
city: Parkville
country: Australia
facility: 301
state: Victoria
city: Edmonton
country: Canada
facility: 203
state: Alberta
city: Hamilton
country: Canada
facility: 204
state: Ontario
Study officials:
affiliation: +1 877-822-9493 UCB
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: