EUCTR2005-003610-15-CZ进行中（未招募）1 期
An international, randomised, open label trial comparing a rituximab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, ‘generalised’ ANCA associated vasculitis. - RITUXVAS
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust0 个研究点目标入组 0 人开始时间: 2006年2月23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
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
- •1.A new diagnosis of WG, MP or renal-limited vasculitis (RLV)(appendix 1)
- •2.Renal involvement attributable to active WG, MP or RLV with at least one of the following:
- •a)Biopsy demonstrating necrotizing glomerulonephritis.
- •b)Red cell casts on urine microscopy or = ++ haematuria
- •3.ANCA positivity ANCA positivity requires either (a) or (b)
- •(a) PR3-ANCA by ELISA or a typical cANCA pattern by indirect immunofluorescence (IIF), or both.
- •(b) MPO-ANCA by ELISA. A positive pANCA by IIF requires confirmation by MPO-ANCA ELISA.
- •4Written informed consent
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Previous cyclophosphamide, (greater than 2 weeks of an oral or IV pulse cyclophosphamide regimen).
- •2.Co-existence of another multisystem autoimmune disease, e.g. SLE, Churg Strauss Syndrome, Henoch Schonlein Purpura, rheumatoid vasculitis, essential mixed cryoglobulinaemia, anti-glomerular basement membrane antibody positivity
- •3.Hepatitis B e antigen positive or Hepatitis C antibody positive.
- •4.Known HIV positive (HIV testing will not be a requirement for this trial).
- •5.Previous malignancy (usually exclude unless agreed with trial co-ordinator).
- •6.Pregnancy, breast feeding or inadequate contraception if female.
- •7Allergy to a study medication
- •8Live Vaccine within last 4 weeks
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An international, randomised, open trial comparing a rituximab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of 'generalised' ANCA associated vasculitis. - RITUXVASAnti neutophil cytoplasmic antibody (ANCA) associated vasculitisEUCTR2005-003610-15-GBCambridge University Hospitals NHS Foundation Trust
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