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2016年4月29日

适应症Ulcerative Colitis (UC)

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Ulcerative Colitis (UC)
发起方: AbbVie
入组人数: 265
试验地点: 80
主要终点: Time to loss of clinical benefit
状态: 已完成
最后更新: 去年

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2016年4月29日

结束日期

2023年12月15日

最后更新

去年

研究类型

Observational

性别

All

研究者

发起方

AbbVie

责任方

Sponsor

入排标准

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)