NCT00308581已完成3 期
Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 539
- 试验地点
- 107
- 主要终点
- Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase
研究概览
简要总结
To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Crohn's Disease
- •Previous treatment failure to Infliximab (intolerance and/or no response)
排除标准
- •Obstructive intestinal strictures
- •Recent bowel resection
- •Proctocolectomy or total colectomy
- •Current total parenteral nutrition
- •Short bowel syndrome
- •All concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
- •Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
研究组 & 干预措施
Active 1
Experimental
Q4W regimen
- every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol
干预措施: Placebo (Other)
Active 1
Experimental
Q4W regimen
- every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol
干预措施: Certolizumab pegol (Biological)
Active 2
Experimental
Q2W regimen
- every 2 weeks: 400 mg Certolizumab Pegol
干预措施: Certolizumab pegol (Biological)
结局指标
主要结局
Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase
时间窗: Baseline to Week 6
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
次要结局
- Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase(Baseline to Week 26)
- Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase(Week 6)
- Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase(Baseline to Week 6)
- Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase(Baseline to Week 26)
- Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase(Week 26)
- CDAI Score at Week 2 of the Induction Phase(Week 2)
- CDAI Score at Week 4 of the Induction Phase(Week 4)
- CDAI Score at Week 6 of the Induction Phase(Week 6)
- CDAI Score at Week 8 in the Randomized Maintenance Phase(Week 8)
- CDAI Score at Week 10 in the Randomized Maintenance Phase(Week 10)
- CDAI Score at Week 12 in the Randomized Maintenance Phase(Week 12)
- CDAI Score at Week 14 in the Randomized Maintenance Phase(Week 14)
- CDAI Score at Week 16 in the Randomized Maintenance Phase(Week 16)
- CDAI Score at Week 18 in the Randomized Maintenance Phase(Week 18)
- CDAI Score at Week 20 in the Randomized Maintenance Phase(Week 20)
- CDAI Score at Week 22 in the Randomized Maintenance Phase(Week 22)
- CDAI Score at Week 26 in the Randomized Maintenance Phase(Week 26)
- Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase(Baseline to Week 14)
- Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase(Baseline to Week 16)
- CDAI Score at Week 24 in the Randomized Maintenance Phase(Week 24)
- Change From Baseline in CDAI Score at Week 2 of the Induction Phase(Baseline to Week 2)
- Change From Baseline in CDAI Score at Week 4 of the Induction Phase(Baseline to Week 4)
- Change From Baseline in CDAI Score at Week 6 of the Induction Phase(Baseline to Week 6)
- Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase(Baseline to Week 8)
- Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase(Baseline to Week 10)
- Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase(Baseline to Week 12)
- Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase(Baseline to Week 18)
- Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase(Baseline to Week 20)
- Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase(Baseline to Week 22)
- Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase(Baseline to Week 26)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 20)
- Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase(Baseline to Week 24)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 10)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 14)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 16)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 12)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 18)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 22)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 24)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 26)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 12)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 14)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 10)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 16)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 18)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 20)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 22)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 24)
- C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase(Week 0)
- CRP Level at Week 2 of the Induction Phase(Week 2)
- CRP Level at Week 6 of the Induction Phase(Week 6)
- Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.(Week 26)
- CRP Level at Week 4 of the Induction Phase(Week 4)
- CRP Level at Week 8 in the Randomized Maintenance Phase(Week 8)
- CRP Level at Week 16 in the Randomized Maintenance Phase(Week 16)
- CRP Level at Week 18 in the Randomized Maintenance Phase(Week 18 (optional measurement))
- CRP Level at Week 10 in the Randomized Maintenance Phase(Week 10 (optional measurement))
- CRP Level at Week 12 in the Randomized Maintenance Phase(Week 12)
- CRP Level at Week 14 in the Randomized Maintenance Phase(Week 14 (optional measurement))
- CRP Level at Week 20 in the Randomized Maintenance Phase(Week 20)
- CRP Level at Week 22 in the Randomized Maintenance Phase(Week 22 (optional measurement))
- CRP Level at Week 24 in the Randomized Maintenance Phase(Week 24)
- CRP Level at Week 26 in the Randomized Maintenance Phase(Week 26)
- CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase(Last visit on or before Week 26)
研究者
研究点 (107)
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