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

Cambridge University Hospitals NHS Foundation Trust0 个研究点目标入组 140 人开始时间: 2008年3月19日最近更新: 2022年1月24日

适应症

试验速览

暂无简介。

•- New diagnosis of AASV (WG or MPA) (within the previous 6 months)
•- Active disease (defined by at least one major or three minor BVAS 2003 items (criteria listed in appendix 1 in the protocol)
•- ANCA positivity (c-ANCA and PR3-ANCA or p-ANCA and MPO-ANCA) or histology confirming active vasculitis from any organ (as defined in appendix 1 in the protocol)
•- Written informed consent
•As specified in amendment no. 1, Sweden:
•- only adult patients older than 18 years will be recruited
•- women can be recruited only if they have a negative pregnancy test (pregnancy test will be performed during the 1st visit)
•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

•- Previous treatment with:
•1. MMF: more than two doses 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
•- Active infection (including hepatitis B, C, HIV and tuberculosis)
•- Known hypersensitivity to MMF, AZA or CYC
•- Cancer or an individual history of cancer (other than resected basal cell skin carcinoma)
•- Females who are pregnant, breat feeding, or at risk of pregnancy and not using a medically acceptable form of contraception
•- Any condition judged by the investigator that would cause the study to be detrimental to the patient
•- Any other multi-system autoimmune disease including Churg Strauss angiitis, SLE, anti GBM disease and cryoglobulianemia
•- Active serious digestive system disease (e.g. inflammatory bowel disease)
•- Patients with imminently life threatening vasculitis (diffuse alveolar haemorrhage, intestinal perforation or major haemorrhage, cerebral vasculitis and cardiac vasculitis)
•- Patients with rapidly progressive glomerulonephritis and declining renal function. Defined as estimated GFR fall >20% in previous two weeks
•- GFR < 15mls/min at entry or on dialysis

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