NCT01960790已完成不适用
Humira® 40mg Syringe 0.8mL Subcutaneous Injection Special Investigation in Patients With Intestinal Behcet's Disease
AbbVie0 个研究点目标入组 473 人开始时间: 2013年5月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 473
- 主要终点
- Number of Participants With Adverse Drug Reactions
研究概览
简要总结
This investigation was conducted to obtain the following information regarding the use of Adalimumab (Humira®) 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Intestinal Behcet's Disease.
- Incidence and conditions of occurrence of adverse reactions in clinical practice
- Factors likely to affect the safety and effectiveness
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who received Adalimumab for the treatment of Intestinal Behcet's disease (not sufficiently responsive to existing therapies, e.g. steroids, immunomodulator)
排除标准
- •Contraindications according to the Package Insert include patients who had any of the following:
- •serious infections
- •tuberculosis
- •a history of hypersensitivity to any ingredient of Humira®
- •demyelinating disease or a history of demyelinating disease
- •congestive cardiac failure
结局指标
主要结局
Number of Participants With Adverse Drug Reactions
时间窗: Up to Week 156
The number of participants with adverse drug reactions with evaluation beginning upon administration of Humira® is assessed.
次要结局
- Global Assessment of Gastrointestinal Symptoms of Behcet's Disease(Up to Week 156)
- Number of Participants With Cardinal Symptoms of Behcet's Disease(Up to Week 156)
- Changes in C-reactive Protein (CRP)(Up to Week 156)
- Number of Participants With Accessory Symptoms of Behcet's Disease(Up to Week 156)
- Number of Participants With Degree of Improvement of Endoscopic Findings(Up to Week 156)
- Global Assessment of Gastrointestinal Symptoms(Up to Week 156)
研究者
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