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临床试验/EUCTR2008-007519-34-SE
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

发起方
niversity of Leuven Hospitals, Division of Gastroenterology

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