NCT01787786撤回不适用
Defining and Predicting the Ideal Infliximab Pharmacokinetic Profile Associated With Treatment Efficacy in Patients With Inflammatory Bowel Disease
University of Western Ontario, Canada0 个研究点开始时间: 2013年2月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Pharmacokinetic Analysis of Infliximab in patients with moderate to severely active ulcerative colitis and Crohn's Disease
研究概览
简要总结
The purpose of this study is to develop a predictive model that will allow optimized dosing of infliximab for individual patients
详细描述
The use of pharmacokinetic analyses incorporating relevant determinants of the infliximab serum concentration can be used to develop a predictive model that will allow optimized dosing for individual patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of CD or UC by usual criteria,
- •moderate to severely active CD defined by a CDAI ≥ 220, with confirmed endoscopic activity (CDEIS ≥ 6) or moderate to severely active UC, defined by a Mayo Score ≥ 6, with a Mayo endoscopic subscore ≥ 2,
- •a need for treatment with IFX for induction of remission as clinically indicated
- •patients previously exposed to adalimumab and/or certolizumab who are naïve to infliximab will be allowed to participate.
排除标准
- •perianal CD exclusively
- •disease limited to the rectum in patients with UC (i.e., disease must extend ≥ 15 cm from the anal verge)
- •patients with known antibodies to IFX (ADAs) at baseline
- •a contraindication to infliximab therapy
- •a contraindication to endoscopy
- •an ostomy
- •planned surgery
- •evidence of severe or unstable hepatic, gastrointestinal, cardiovascular, respiratory, neurological, psychiatric, hematological or renal disease at the discretion of the investigator,
- •Pregnancy or breastfeeding,
- •treatment with any investigational drug in the past 30 days, or 5 half lives (whichever is longer).
结局指标
主要结局
Pharmacokinetic Analysis of Infliximab in patients with moderate to severely active ulcerative colitis and Crohn's Disease
时间窗: 24 weeks
The primary objective of this study is to define the PK profile of IFX in patients with CD and UC and to determine covariates influencing drug clearance.
次要结局
- Quantification of relative strengths of individual determinants of infliximab pharmacokinetics(24 weeks)
研究者
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