A randomised clinical trial of mycophenolat mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYC

Vasculitis Clinical Trial Office0 个研究点目标入组 140 人开始时间: 2008年7月2日最近更新: 2021年8月2日

研究概览

暂无简介。

•i) New diagnosis of AASV (WG or MPA) (within the previous six months)
•ii) Active disease (defined by at least one major or three minor BVAS 2003 items, see Appendix 1)
•iii) ANCA positivity (c-ANCA and PR3-ANCA or p-ANCA and MPO-ANCA) or histology confirming active vasculitis from any organ (see appendix)
•iv) 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

•v) previous treatment with
•(1) MMF: more than two weeks ever
•(2) Cyclophosphamide: more than two weeks daily oral or more than one pulse of IV CYC ( 15mg/kg)
•(3) Rituximab or high dose intravenous immunoglobulin within the last twelve months
•vi) active infection (including hepatitis B, C, HIV and tuberculosis)
•vii) known hypersensitivity to MMF, AZA or CYC
•viii) Cancer or an individual history of cancer ( other than resected basal cell skin carcinoma)
•ix) Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception
•x) Any condition judged by the investigator that would cause the study to be detrimental to the patient
•xi) Any other multi-system autoimmune disease including Churg Strauss angiitis, SLE, anti GBM disease and cryoglobulinaemia
•xii) Active serious digestive system disease ( e.g. inflammatory bowel disease)
•xiii) Patients with imminently life threatening vasculitis (diffuse alveolar haemorrhage, intestinal perforation or major haemorrhage, cerebral vasculitis and cardiac vasculitis).
•xiv) Patients with rapidly progressive glomerulonephritis and declining renal function. Defined as estimated GFR fall > 20% in previous two weeks.
•xv) GFR<15 mls/min at entry or on dialysis

发起方

Vasculitis Clinical Trial Office