NCT02916017已完成不适用
HUMIRA® Special Investigation (Long-term Treatment in Patients With Non-infectious Intermediate-, Posterior-, or Pan-uveitis)
AbbVie39 个研究点 分布在 1 个国家目标入组 259 人开始时间: 2016年11月15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
- 259
- 试验地点
- 39
- 主要终点
- Incidence of adverse drug reactions (ADR)
研究概览
简要总结
This study evaluates the long- term safety and effectiveness of adalimumab in participants with non-infectious intermediate-, posterior-, or pan-uveitis in daily practice in Japan.
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
- 0 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants receiving adalimumab for the treatment of Non-infectious Intermediate-, Posterior-, or Pan-uveitis
排除标准
- •Participants previously treated with adalimumab
结局指标
主要结局
Incidence of adverse drug reactions (ADR)
时间窗: Up to Week 52
ADR is the causal relationship between adalimumab and adverse events.
次要结局
- Change in retinal lesions in each eye(From Week 0 (baseline) to Week 52)
- Change in Visual Functioning Questionnaire (VFQ)-25 score(From Week 0 (baseline) to Week 52)
- Change in Anterior Chamber (AC) cell grade (standardization of uveitis nomenclature (SUN) criteria) in each eye(From Week 0 (baseline) to Week 52)
- Change in Visual acuity in each eye(From Week 0 (baseline) to Week 52)
- Percentage of Overall improvement(Up to Week 52)
- Change in central retinal thickness in each eye(From Week 0 (baseline) to Week 52)
- Change in Vitreous Haze grade in each eye(From Week 0 (baseline) to Week 52)
研究者
研究点 (39)
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