JPRN-jRCT2080220357未知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
Abbott Japan Co., Ltd.0 个研究点目标入组 80 人开始时间: 2007年3月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 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
入排标准
- 年龄范围
- >= 15age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •- 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
- •Exclusion criteria:
- •- Ulcerative colitis or indeterminate colitis
- •- History of cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, 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
排除标准
- •Exclusion Criteria:
- •- Subject with a current diagnosis of ulcerative colitis or indeterminate colitis as determined by the investigator
- •- Subject has a history of cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
- •- Subject's body weight is below 30 kg
- •- Subject who has had surgical bowel resections within the past 6 months
- •- Pregnant women
研究者
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