NCT00338650已完成3 期
A Multi-Center, Open-Label Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Patients With Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 1,000
- 试验地点
- 97
- 主要终点
- AEs, laboratory data, physical examinations and vital signs
研究概览
简要总结
The primary objective of this study is to make adalimumab available to patients suffering from moderately to severely active Crohn's Disease who have failed to respond to, lost response to, or are intolerant to infliximab, and to evaluate safety
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with moderate to severe Crohn's Disease.
- •Failed prior infliximab therapy.
- •Patient is judged to be in generally good health as determined by the principal investigator.
排除标准
- •Previous treatment with adalimumab.
- •Patient considered by the investigator, for any reason, to be an unsuitable candidate
结局指标
主要结局
AEs, laboratory data, physical examinations and vital signs
次要结局
- Efficacy variables will be assessed from Outcomes Questionnaires
研究者
研究点 (97)
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