EUCTR2017-004645-24-GB进行中（未招募）1 期
A randomized, double blind, controlled mechanistic study of rituximab and belimumab combination therapy in PR3 ANCA-associated vasculitis - (COMBIVAS)
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge0 个研究点目标入组 30 人开始时间: 2019年6月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •1. Participant must be =18 of age at the time of signing the informed consent form.
- •Participants who have:
- •2. Have a diagnosis of AAV [granulomatosis with polyangiitis or microscopic polyangiitis]
- •3. Have PR3 ANCA positivity by ELISA at screening
- •4. Have active disease defined by one major or three minor disease activity items on BVAS/WG
- •5. Be capable of giving signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. MPO ANCA or anti–GBM antibody positivity by ELISA
- •2. Presence of pulmonary haemorrhage with hypoxia at screening
- •3. Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2 at screening
- •4. Have an acute or chronic infection at screening
- •5. Have received any B cell targeted therapy within 364 days of Day 1
- •6. Have received cyclophosphamide within 180 days of Day 1
- •7. Have received any steroid injection between 60 days of Day 1 and 14 days of screening (e.g., intramuscular [IM], intraarticular, or IV)
- •8. Have received oral prednisolone >10mg/day (or equivalent) on average over the 30 days prior to screening
研究者
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