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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 16
- 试验地点
- 10
- 主要终点
- Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: certolizumab pegol (Drug)
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
干预措施: certolizumab pegol (Drug)
结局指标
主要结局
Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks)
时间窗: 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.
次要结局
- 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 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))
- Number of Subjects Who Develop Anti-nuclear Antibodies During the Study(At the time of completion or termination visit (up to 298 weeks))