EUCTR2008-007519-34-SE进行中(未招募)1 期
Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSIO
niversity of Leuven Hospitals, Division of Gastroenterology0 个研究点目标入组 50 人开始时间: 2009年3月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients age 18-80 years
- •Mb Crohn disease or Ulcerative colitis or IBD
- •Already on infliximab therapy treated with one hour infusion
- •sustained clinical respone to infliximab
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Documentation of suspected immediated or delayed infusion reaction to previous infliximab infusion.
- •Prophylactic therapy before infliximab infusion to prevent infusion reaction including corticosteroids, antihistamines and acetaminophen.
- •Need for dose increase or decrease of interval below 6 weeks for loss of response
- •Dosing interval longer than 12 weeks in the previous 12 months
- •Known allergic reactions to any theraputic protein or to murine proteins
- •Any other contraindication to infliximabtherapy at the time of screening
研究者
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