NCT02499783已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction and Maintenance of Clinical Remission in Chinese Patients With Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive Protein
AbbVie0 个研究点目标入组 205 人开始时间: 2015年8月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 主要终点
- Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4
研究概览
简要总结
This study will evaluate the efficacy and safety of adalimumab induction and maintenance treatment in subjects with moderately to severely active Crohn's disease in China.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of Chinese descent with full Chinese parentage.
- •Diagnosis of Crohn's disease (CD) for at least 3 months prior to Week
- •Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450 despite treatment with oral corticosteroids and/or immunosuppressants.
- •Subject has a negative Tuberculosis (TB) Screening Assessment.
- •Subject has elevated high sensitivity C-reactive protein (hs-CRP) during the Screening Period.
排除标准
- •Subject with ulcerative colitis or indeterminate colitis.
- •Subject who has had a surgical bowel resection within the past 6 months or who is planning any resection at any time point in the future.
- •Subject with an ostomy or ileoanal pouch.
- •Subject who has short bowel syndrome.
- •Subject with symptomatic known obstructive strictures.
- •Subject with an internal or external fistula (with the exception of an anal fistula without abscess).
- •Active, or chronic or recurring infections, or active tuberculosis.
研究组 & 干预措施
Placebo Induction Regimen
Experimental
Double-blind period (Weeks 0-8): Placebo at Weeks 0 and 2, followed by adalimumab 160 mg at Week 4, 80 mg at Week 6.
Open label period: adalimumab 40 mg every other week (eow) from Week 8 through last dose at Week 24.
干预措施: adalimumab (Biological)
Placebo Induction Regimen
Experimental
Double-blind period (Weeks 0-8): Placebo at Weeks 0 and 2, followed by adalimumab 160 mg at Week 4, 80 mg at Week 6.
Open label period: adalimumab 40 mg every other week (eow) from Week 8 through last dose at Week 24.
干预措施: placebo (Other)
Adalimumab Induction Regimen
Experimental
Double-blind period (Weeks 0-8): adalimumab 160 mg at Weeks 0 and 80 mg at Week 2, followed by adalimumab 40 mg at Week 4 and Week 6.
Open label period: adalimumab 40 mg eow from Week 8 through last dose at Week 24.
干预措施: adalimumab (Biological)
结局指标
主要结局
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4
时间窗: Week 4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
次要结局
- Percentage of Participants Who Discontinued Corticosteroid Use and Achieved CDAI < 150 Plus a Reduction in Hs-CRP of ≥ 50% From Baseline (BL) at Week 26 in Participants Taking Steroids at BL and Who Achieved CDAI Decrease and Hs-CRP Reduction at Week 8(Week 26)
- Percentage of Participants Who Achieved Clinical Remission at Week 26 (CDAI < 150) in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8(Week 26)
- Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline at Week 4(Week 4)
- Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4(Week 4)
- Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) and Hs-CRP < 3 mg/L at Week 4(Week 4)
- Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of At Least 50% From Baseline at Week 26 in Participants Who Achieved Clinical Response Plus at Least 30% Reduction in Hs-CRP From Baseline at Week 8(Week 26)
- Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 26 in Participants Who Were Taking Steroids at Baseline and Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8(Week 26)
- Change From Baseline in Fecal Calprotectin Level at Week 4(Baseline, Week 4)
- Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4(Week 4)
- Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 26 in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8(Week 26)
- Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Double-Blind Weeks 0-4(Weeks 2, 4)
- Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L at Week 26 in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8(Week 26)
- Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 4(Week 4)
- Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Double-Blind Weeks 0-4(Weeks 2, 4)
- Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set)(Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26)
- Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set)(Weeks 2, 4, 6, 8, 12, 16, 20, 26)
- Change From Baseline in CDAI Over Double-Blind Weeks 0-4(Baseline, Weeks 2, 4)
- Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170 Points) at Week 4(Week 4)
- Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus A Reduction in Hs-CRP of at Least 50% From Baseline Over Double-Blind Weeks 0-4(Weeks 2, 4)
- Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set)(Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26)
- Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Double-Blind Weeks 0-4(Weeks 2, 4)
- Change From Baseline in CDAI Over Time (Any Adalimumab Set)(Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26)
- Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set)(Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 12, 16 20, 26)
- Change From Baseline in Fecal Calprotectin Level Over Time (Any Adalimumab Set)(Baseline (Week 0 of adalimumab), Weeks 4, 8, 26)
- Percentage of Participants Who Achieved IBDQ Remission (IBDQ ≥ 170 Points) at Week 26 in Participants With Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8(Week 26)
- Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set)(Weeks 2, 4, 6, 8, 12, 16, 20, 26)
- Change From Baseline in Hs-CRP Level Over Double-Blind Weeks 0-4(Baseline, Weeks 2, 4)
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