NCT00445939已完成2 期
A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease
Abbott18 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2007年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 18
- 主要终点
- The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.
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
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Crohn's Disease Activity Index (CDAI) score of >= 220 and <= 450
- •If subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy
排除标准
- •Ulcerative colitis or indeterminate colitis
- •History of cancer, lymphoma, leukemia or lymphoproliferative disease, active tuberculosis (TB), or Human immunodeficiency virus (HIV)
- •Body weight is below 30 kg
- •Surgical bowel resections within the past 6 months
- •Females who are pregnant or breast-feeding or considering becoming pregnant during the study
研究组 & 干预措施
Adalimumab 80 mg/40 mg
Experimental
干预措施: adalimumab (Biological)
Placebo
Placebo Comparator
干预措施: placebo (Biological)
Adalimumab 160 mg/80 mg
Experimental
干预措施: adalimumab (Biological)
结局指标
主要结局
The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4
时间窗: 4 Weeks
CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Comparison of the number of subjects with a clinical remission (CDAI \< 150) in the adalimumab 160 mg (Week 0)/ 80 mg (Week 2) and adalimumab 80 mg (Week 0)/ 40 mg (Week 2) groups at Week 4.
次要结局
- Clinical Remission (CDAI < 150) at Week 2(Week 2)
- Clinical Response (CR-70 and CR-100) in Period A(Weeks 2 and Week 4)
- Clinical Response (CR-70 and CR-100) in Period B(Week 6 and Week 8)
- Clinical Remission (CDAI <150) at Week 6 and Week 8(Week 6 and Week 8)
研究者
研究点 (18)
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