Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190410
• Other study ID #: CR0012
• Status: Completed
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: November 27, 2017

Study information

• Verified date: November 2020
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 27, 2017
• Est. primary completion date: November 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• certolizumab pegol
400 mg administered subcutaneously every 4 weeks for subjects = 40 kg or 200 mg for subjects 20 to < 40 kg
• certolizumab pegol
200 mg administered subcutaneously every 4 weeks for subjects = 40 kg or 100 mg for subjects 20 to < 40 kg

Locations

Country	Name	City	State
Australia	301	Parkville	Victoria
Canada	203	Edmonton	Alberta
Canada	204	Hamilton	Ontario
United States	103	Atlanta	Georgia
United States	116	Atlanta	Georgia
United States	111	Aurora	Colorado
United States	104	Baltimore	Maryland
United States	126	Morristown	New Jersey
United States	114	Orange	California
United States	112	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	During study treatment (up to 303 weeks)
Secondary	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.	At the time of completion or termination visit (up to 298 weeks)
Secondary	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.	At the time of completion or termination visit (up to 298 weeks)
Secondary	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)	At the time of completion or termination visit (up to 298 weeks)

External Links

•   FDA Safety Alerts and Recalls
•   Product Information