ISRCTN28528813已完成不适用
An international, randomised, open label trial comparing a rituximab-based regimen with a standard cyclophosphamide/azathioprine based regimen in the treatment of active, generalised anti-neutrophilic cytoplasmic antibodies associated vasculitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
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. A new diagnosis of Wegener's Granulomatosis (WG), Microscopic Polyangiitis (MP) or Renal-Limited Vasculitis (RLV)
- •2. Renal involvement attributable to active WG, MP or RLV with at least one of the following:
- •2.1. Biopsy demonstrating necrotizing glomerulonephritis
- •2.2. Red cell casts on urine microscopy or =++ haematuria
- •3. Anti-Neutrophilic Cytoplasmic Antibodies (ANCA) positivity; ANCA positivity requires either:
- •3.1. Proteinase 3 anti-neutrophilic cytoplasmic antibody (PR3-ANCA) by Enzyme-Linked Immunosorbent Assay (ELISA) or a typical antineutrophil cytoplasmic antibody (cANCA) pattern by indirect immunofluorescence (IIF), or both
- •3.2. Myeloperoxidase- anti-neutrophilic cytoplasmic antibody (MPO-ANCA) by ELISA. A positive perinuclear anti-neutrophilic cytoplasmic antibody (pANCA) by IIF requires confirmation by MPO-ANCA ELISA
- •4. Written informed consent
排除标准
- •1. Previous cyclophosphamide, (greater than two weeks of an oral or intravenous [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 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
- •7. Allergy to a study medication
- •8. Live vaccine within last four weeks
研究者
相似试验
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. - RITUXVASThe ANCA associated vasculitides (AASV), namely Wegener’s granulomatosis, microscopic polyangiitis, and renal limited vasculitis.EUCTR2005-003610-15-CZAddenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
已完成
2 期
An international, randomised, open label trial comparing a rituxmab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, 'generalised' ANCA associated vasculitisWegener granulomatosis1000381610038430NL-OMON29858Academisch Medisch Centrum2
已完成
4 期
Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan (LixiRam)CTRI/2017/03/007979SanofiSynthelabo India Private Limited150
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. - RITUXVASAnti neutophil cytoplasmic antibody (ANCA) associated vasculitisEUCTR2005-003610-15-GBCambridge University Hospitals NHS Foundation Trust
尚未招募
3 期
A prospective, randomised, open label trial on the effect of metformin on in-vitro fertilisation outcome in women with polycystic ovary syndromePolycystic ovary syndromeReproductive Health and Childbirth - Fertility including in vitro fertilisationMetabolic and Endocrine - Other metabolic disordersInfertilityACTRN12609000510246Fertility Society of Australia124