EUCTR2014-004560-38-Outside-EU/EEA进行中（未招募）不适用
A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease.
Abbott Deutschland GmbH & Co. KG0 个研究点目标入组 80 人开始时间: 2014年11月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
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
研究者
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未知
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A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease.Crohn's DiseaseEUCTR2014-004531-39-Outside-EU/EEAAbbott Deutschland GmbH & Co. KG80
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