NCT02896985已完成不适用
A Cohort Study to Evaluate the Effectiveness of Drug Concentrations in Predicting Recapture of Response With Weekly ADAlimumab in Crohn's Disease Subjects With Secondary Loss of Response (PRADA)
AbbVie24 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2016年12月16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
- 98
- 试验地点
- 24
- 主要终点
- Explore the relationship between drug concentration at baseline and recapture of response
研究概览
简要总结
This is a multi-center study that explores the relationship between recapture of response with escalation to weekly adalimumab and trough adalimumab concentration before escalation in patients experiencing lack of response (LOR).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of Crohn's Disease.
- •Treatment with adalimumab, for a minimum of 16 weeks, as per clinical practice, at a dose of 160 mg at week 0, 80 mg at week 2, and then 40 mg q2w with a documented response as defined by the investigator.
- •Current evidence of active inflammatory disease/LOR defined as the presence of active inflammation (confirmed with a CRP ≥ 5 mg/L and/or a fecal calprotectin ≥ 250µg/g.
- •Ability of subject to participate fully in all aspects of this clinical trial.
- •Written informed consent must be obtained and documented.
排除标准
- •Primary non-responders to 16 weeks of adalimumab therapy.
- •Received any investigational drug within the 16 weeks of adalimumab therapy.
- •Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study.
- •History of alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures.
- •Stools positive for Clostridium difficile.
- •Pregnant or lactating women.
- •Current enrolment in any other interventional research study.
- •Presence of perianal or abdominal abscess.
结局指标
主要结局
Explore the relationship between drug concentration at baseline and recapture of response
时间窗: At Week 12
Logistic regression analysis will be used to model the relationship between drug concentration at baseline and recapture of response.
次要结局
- Explore the relationship between trough adalimumab concentrations at baseline and change in fecal calprotectin(From Week 0 to Week 12)
- Proportion of participants requiring steroids or additional therapy(Up to Week 12)
- Proportion of participants with 50% drop from screening in CRP or calprotectin(At Week 12)
- Explore the relationship between changes in HBI between screening and final trough adalimumab concentrations(At Week 12)
- Explore the relationship between trough adalimumab concentrations at baseline and change in patient reported outcome 2 (PRO2)(From Week 0 to Week 12)
- Explore the relationship between trough adalimumab concentrations at baseline and change in C-reactive protein (CRP)(From Week 0 to Week 12)
- Proportion of participants with normalization of CRP or fecal calprotectin(At Week 12)
- Proportion of participants with clinical remission PRO2 < 8(At Week 12)
研究者
研究点 (24)
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