EUCTR2006-001663-33-ES进行中（未招募）1 期
ENSAYO CLÍNICO ALEATORIZADO COMPARANDO EL USO DE MICOFENOLATO MOFETILO vs CICLOFOSFAMIDA PARA INDUCIR REMISIÓN EN VASCULITIS ASOCIADAS A ANCA (anticuerpos anti-citoplasma del neutrófilo) - MYCYC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
- •Inclusion (requires all)
- •i) Age > 18 years old
- •ii) New diagnosis of AASV (WG or MPA) (within the previous six months)
- •iii) Active disease (defined by at least one major or three minor BVAS 2003 items, see appendix 1)
- •iv) ANCA positivity (c-ANCA and PR3-ANCA or p-ANCA and MPO-ANCA) or histology confirming active vasculitis from any organ (see appendix )
- •v) 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
- •i)Previous treatment with:
- •(1)MMF: more than two weeks ever.
- •(2)Cyclophosphamide: more than two weeks daily oral or more than 1 pulse of IV CYC (15mg/kg)
- •(3)Rituximab or high dose intravenous immunoglobulin within the last twelve months
- •ii)Active infection (including hepatitis B, C, HIV and tuberculosis).
- •iii)Known hypersensitivity to MMF, AZA or CYC.
- •iv)Cancer or an individual history of cancer (other than resected basal cell skin carcinoma).
- •v)Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
- •vi)Any condition judged by the investigator that would cause the study to be detrimental to the patient.
- •vii)Any other multi-system autoimmune disease including Churg Strauss angiitis, SLE, anti GBM disease and cryoglobulinaemia.
- •viii) Active serious digestive system disease (e.g. inflammatory bowel disease)
- •ix) Patients with imminently life threatening vasculitis (diffuse aleolar haemorrhage, intestinal perforation or major haemorrhage, cerebral vasculitis and cardiac vasculitis).
- •x) Patients with rapidly progressive glomerulonephritis and declining renal function. Defined as estimated GFR fall >20% in previous two weeks.
- •xi) GFR <15mls/min at entry or on dialysis.
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