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临床试验/ISRCTN49793874
ISRCTN49793874进行中(未招募)未知

BIO BEHÇET’S: Optimal utilisation of biologic drugs in Behçet’s Disease: a randomised controlled trial of infliximab vs alpha interferon, with genotyping and metabolomic profiling, towards a stratified medicines approach to treatment

niversity of Liverpool0 个研究点目标入组 79 人开始时间: 2016年3月9日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
发起方
入组人数
79

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Diagnosed to have BD by International Study Group (ISG) criteria or International Criteria for BD (ICBD)
  • 2. Have refractory disease as defined by the UK Centres of Excellence criteria (failure to respond to steroid and/or immunosuppressive therapy with significant or major organ­threatening disease) and therefore qualify for biologic therapy with either IFX or aIFN
  • 3. Able to give informed consent
  • 4. Have not previously received a biologic agent
  • 5. Aged over 18 years

排除标准

  • 1. Have a contraindication to either IFX or aIFN (eg active infection, severe liver disease, neutropenia, previous malignancy)
  • 2. Are likely to not comply: for example cannot attend assessments because of excessive travel requirements
  • 3. Are already, or likely to become, pregnant during the study
  • 4. Express a strong preference for one of the two potential therapies
  • 5. Have heart disease or severe heart failure
  • 6. Have been diagnosed with Multiple sclerosis
  • 7. Have evidence of infection with HIV

研究者

发起方
niversity of Liverpool

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