NCT03339102已完成不适用
Post-marketing Surveillance Study of Adalimumab (Humira®) for Non-infectious Intermediate, Posterior, or Panuveitis Patients According to the Standard for "Re-examination of New Drugs"
AbbVie17 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2018年1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
- 158
- 试验地点
- 17
- 主要终点
- Percentage (%) of patients reported with serious adverse event
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of Humira® (Adalimumab) for the treatment of non-infectious intermediate, posterior, or panuveitis patients under a routine treatment practice.
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
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been diagnosed with Non-infectious intermediate, posterior and pan-uveitis
- •Patients voluntarily signed a patient authorization & informed consent form.
- •Decision on the treatment with Humira® was made prior to any decision to approach the patient to participate in this study.
- •Humira® treatment is indicated as per local Summary of Product Characteristics (SmPC) and professional and/or reimbursement guidelines.
排除标准
- •A patient who are contraindications to originator adalimumab (Humira®) as listed on the approved Korean label.
- •A patient who is participating on other interventional clinical trials
- •Prior treatment with Humira®, including current course of Humira® started prior to baseline visit assessments.
结局指标
主要结局
Percentage (%) of patients reported with serious adverse event
时间窗: Up to Week 32
The patients reported with serious adverse event will be collected.
次要结局
- Change in Visual acuity(Up to follow-up week 22)
- Assessing Treatment Response(Up to follow-up week 22)
- Assessing Presence /absence of new active inflammatory chorioretinal lesions(Up to follow-up week 22)
研究者
研究点 (17)
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