Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
- Registration Number
- NCT01190410
- Lead Sponsor
- UCB Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Certolizumab pegol: high-dose group certolizumab pegol 400 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) certolizumab pegol 200 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 100 mg for subjects 20 to \< 40 kg
- Primary Outcome Measures
Name Time Method Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks) 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
Name Time Method Number of Subjects Discontinuing Treatment Due to a 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.
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) 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 At the time of completion or termination visit (up to 298 weeks) Percentage of subjects in clinical remission (clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10)
Number of Subjects Who Develop Anti-nuclear Antibodies During the Study At the time of completion or termination visit (up to 298 weeks) 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.
Trial Locations
- Locations (10)
126
🇺🇸Morristown, New Jersey, United States
104
🇺🇸Baltimore, Maryland, United States
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
301
🇦🇺Parkville, Victoria, Australia
203
🇨🇦Edmonton, Alberta, Canada
204
🇨🇦Hamilton, Ontario, Canada