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
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