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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01190410




Registration number
NCT01190410
Ethics application status
Date submitted
25/08/2010
Date registered
27/08/2010
Date last updated
17/12/2020

Titles & IDs
Public title
Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
Scientific 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
Secondary ID [1] 0 0
CR0012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - certolizumab pegol
Treatment: Drugs - certolizumab pegol

Experimental: Certolizumab pegol: high-dose group - 400 mg administered subcutaneously every 4 weeks for subjects = 40 kg or 200 mg for subjects 20 to \< 40 kg

Experimental: Certolizumab pegol: low-dose group (weight adjusted) - 200 mg administered subcutaneously every 4 weeks for subjects = 40 kg or 100 mg for subjects 20 to \< 40 kg


Treatment: Drugs: certolizumab pegol
400 mg administered subcutaneously every 4 weeks for subjects = 40 kg or 200 mg for subjects 20 to \< 40 kg

Treatment: Drugs: certolizumab pegol
200 mg administered subcutaneously every 4 weeks for subjects = 40 kg or 100 mg for subjects 20 to \< 40 kg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks)
Timepoint [1] 0 0
During study treatment (up to 303 weeks)
Secondary outcome [1] 0 0
Number of Subjects Discontinuing Treatment Due to a Treatment-Emergent Adverse Event (TEAE)
Timepoint [1] 0 0
During study treatment (up to 303 weeks)
Secondary outcome [2] 0 0
Number of Subjects Who Develop Anti-nuclear Antibodies During the Study
Timepoint [2] 0 0
At the time of completion or termination visit (up to 298 weeks)
Secondary outcome [3] 0 0
Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study
Timepoint [3] 0 0
At the time of completion or termination visit (up to 298 weeks)
Secondary outcome [4] 0 0
Percentage of Subjects in Clinical Remission
Timepoint [4] 0 0
At the time of completion or termination visit (up to 298 weeks)

Eligibility
Key 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
Minimum age
6 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/11/2017
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
301 - Parkville
Recruitment postcode(s) [1] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
Canada
State/province [7] 0 0
Alberta
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Pharma
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT01190410
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
+1 877-822-9493 UCB
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01190410