Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
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
1 other identifier
interventional
16
3 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2010
Longer than P75 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 25, 2010
CompletedFirst Posted
Study publicly available on registry
August 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2017
CompletedResults Posted
Study results publicly available
March 26, 2019
CompletedDecember 17, 2020
November 1, 2020
7.3 years
August 25, 2010
November 27, 2018
November 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks)
Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
During study treatment (up to 303 weeks)
Secondary Outcomes (4)
Number of Subjects Discontinuing Treatment Due to a Treatment-Emergent Adverse Event (TEAE)
During study treatment (up to 303 weeks)
Number of Subjects Who Develop Anti-nuclear Antibodies During the Study
At the time of completion or termination visit (up to 298 weeks)
Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study
At the time of completion or termination visit (up to 298 weeks)
Percentage of Subjects in Clinical Remission
At the time of completion or termination visit (up to 298 weeks)
Study Arms (2)
Certolizumab pegol: high-dose group
EXPERIMENTAL400 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
Certolizumab pegol: low-dose group (weight adjusted)
EXPERIMENTAL200 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 100 mg for subjects 20 to \< 40 kg
Interventions
400 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (10)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877-822-9493 UCB
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
August 25, 2010
First Posted
August 27, 2010
Study Start
August 1, 2010
Primary Completion
November 27, 2017
Study Completion
November 27, 2017
Last Updated
December 17, 2020
Results First Posted
March 26, 2019
Record last verified: 2020-11