NCT01947816已完成不适用
HUMIRA® 40 mg Syringe 0.8 mL for Subcutaneous Injection Protocol for Special Investigation on Long-Term Administration Ulcerative Colitis
AbbVie0 个研究点目标入组 1,621 人开始时间: 2013年8月9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
- 1,621
- 主要终点
- Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions
研究概览
简要总结
This investigation will be conducted to obtain the following information regarding the use of Humira 40 mg Syringe 0.8 mL for Subcutaneous Injection in patients with Ulcerative Colitis.
- Unknown adverse reactions (in particular, clinically significant)
- 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
- 年龄范围
- — 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving Humira for the first time for the treatment of Ulcerative Colitis
排除标准
- •Contraindications according to the Package Insert include patients who have 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 and Serious Adverse Drug Reactions
时间窗: Up to Week 52
Adverse drug reactions are defined as adverse events for which the causal relation with Humira cannot be ruled out. Serious adverse drug reactions are adverse drug reaction(s) which have been assessed to be serious based on company criteria.
次要结局
- Change From Baseline in CRP Levels Over Time(Weeks 4, 8, 24, 52 of study drug administration, and at study drug discontinuation (up to Week 52))
- Change From Baseline in Mayo Score Over Time(Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52))
- Change From Baseline in Partial Mayo Score Over Time(Weeks 4, 8, 16, 24, 52, when discontinued (up to Week 52), at final assessment (up to Week 52))
- Mayo Endoscopic Sub-Score Over Time(Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52))
研究者
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