NCT02738125已完成不适用
Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions
AbbVie80 个研究点 分布在 1 个国家目标入组 265 人开始时间: 2016年4月29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
- 265
- 试验地点
- 80
- 主要终点
- Time to loss of clinical benefit
研究概览
简要总结
This study assesses the long?term effectiveness of adalimumab in subjects starting a treatment for ulcerative colitis in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suffering from ulcerative colitis
- •Naïve from Adalimumab
- •Starting a treatment with adalimumab
- •Capable of and willing to grant authorization for use/disclosure of data collected
- •Able to read, understand, and complete patients questionnaires
排除标准
- 未提供
结局指标
主要结局
Time to loss of clinical benefit
时间窗: Up to Month 120
Loss of clinical benefit will be defined as one of the following: loss of efficacy leading to adalimumab discontinuation or introduction/reinforcement of aminosalicylates, 6-mercaptopurine, or azathioprine, introduction or reinforcement of corticosteroids (any route), UC-related surgery, discontinuation of adalimumab due to adverse event, death.
次要结局
- Change from Baseline (Month 0) in Steroid-free remission(From Month 0 to Month 120)
- Change from Baseline (Month 0) in Clinical Remission(From Month 0 to Month 120)
- Change from Baseline (Month 0) in Clinical Response(From Month 0 to Month 120)
研究者
研究点 (80)
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