EUCTR2005-003610-15-GB进行中（未招募）1 期
An international, randomised, open trial comparing a rituximab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of 'generalised' ANCA associated vasculitis. - RITUXVAS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •(all four must be present)
- •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 or a typical cANCA pattern by indirect immunofluorescence (IIF), preferably confirmed by anti-PR3 ELISA.
- •(b) MPO-ANCA determined by ELISA requires demonstration of pANCA, and pANCA by IIF requires confirmation by anti-MPO ELISA .
- •4. Written 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 oral or one IV pulse = 15mg/kg cyclophosphamide
- •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
研究者
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