Back to resultsExtension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
certolizumab pegol
certolizumab pegol
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Certolizumab Pegol, Cimzia®, Crohn's Disease, Children and Adolescents with 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
Sites / Locations
- 114
- 111
- 103
- 116
- 112
- 104
- 126
- 301
- 203
- 204
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Certolizumab pegol: high-dose group
Certolizumab pegol: low-dose group (weight adjusted)
Arm Description
400 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg
200 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 100 mg for subjects 20 to < 40 kg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Subjects Discontinuing Treatment Due to a Treatment-Emergent Adverse Event (TEAE)
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.
Number of Subjects Who Develop Anti-nuclear Antibodies During the Study
Anti-nuclear antibodies (ANA) are autoantibodies. ANA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits.
Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study
Anti-dsDNA are autoantibodies. Anti-dsDNA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits.
Percentage of Subjects in Clinical Remission
Percentage of subjects in clinical remission (clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01190410
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 27, 2017 (Actual)
Study Completion Date
November 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Certolizumab Pegol, Cimzia®, Crohn's Disease, Children and Adolescents with Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Certolizumab pegol: high-dose group
Arm Type
Experimental
Arm Description
400 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg
Arm Title
Certolizumab pegol: low-dose group (weight adjusted)
Arm Type
Experimental
Arm Description
200 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 100 mg for subjects 20 to < 40 kg
Intervention Type
Drug
Intervention Name(s)
certolizumab pegol
Other Intervention Name(s)
Cimzia®, Crohn's Disease
Intervention Description
400 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg
Intervention Type
Drug
Intervention Name(s)
certolizumab pegol
Other Intervention Name(s)
Cimzia®, Crohn's Disease
Intervention Description
200 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 100 mg for subjects 20 to < 40 kg
Primary Outcome Measure Information:
Title
Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks)
Description
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.
Time Frame
During study treatment (up to 303 weeks)
Secondary Outcome Measure Information:
Title
Number of Subjects Discontinuing Treatment Due to a Treatment-Emergent Adverse Event (TEAE)
Description
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.
Time Frame
During study treatment (up to 303 weeks)
Title
Number of Subjects Who Develop Anti-nuclear Antibodies During the Study
Description
Anti-nuclear antibodies (ANA) are autoantibodies. ANA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits.
Time Frame
At the time of completion or termination visit (up to 298 weeks)
Title
Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study
Description
Anti-dsDNA are autoantibodies. Anti-dsDNA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits.
Time Frame
At the time of completion or termination visit (up to 298 weeks)
Title
Percentage of Subjects in Clinical Remission
Description
Percentage of subjects in clinical remission (clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10)
Time Frame
At the time of completion or termination visit (up to 298 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877-822-9493 UCB
Official's Role
Study Director
Facility Information:
Facility Name
114
City
Orange
State/Province
California
Country
United States
Facility Name
111
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
103
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
116
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
112
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
104
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
126
City
Morristown
State/Province
New Jersey
Country
United States
Facility Name
301
City
Parkville
State/Province
Victoria
Country
Australia
Facility Name
203
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
204
City
Hamilton
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
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