Alemtuzumab for ANCA-Associated Refractory Vasculitis - A study of safety and efficacy (ALEVIATE). - Alemtuzumab for ANCA-Associated Refractory Vasculitis

Addenbrooke's Hospital0 个研究点目标入组 24 人开始时间: 2010年7月19日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•1) A diagnosis of ANCA associated vasculitis
•2) Active vasculitis with a least one severe or three non-severe items of BVAS/WG activity (a validated disease activity measure)
•3) Previous therapy with either cyclophosphamide or methotrexate, in combination with prednisolone, for at least 3 months
•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) no
•F.1.3.1 Number of subjects for this age range

•1) Age less than 18 years or greater than 60 years
•2) Creatinine > 150µmol/l
•3) Total white cell count < 4x10^9/l or lymphocyte count < 0.5x10^9/l or neutrophil count < 1.5x10^9/l or IgG < 5g/l
•4) Severe lung haemorrhage with hypoxia (oxygen saturations < 85% on room air)
•5) Severe gastrointestinal, central nervous system or cardiac vasculitis
•6) Previous therapy with:
•a) Alemtuzumab at any time
•b) IVIg, infliximab, etanercept, adalimumab, abatacept, anti-thymocyte globulin or plasma exchange in the past 3 months
•c) Rituximab within the past 6 months
•7) Intensive care unit requirement
•8) Active infection with HIV, hepatitis B or C or other infection requiring parenteral or long term oral antibiotics
•9) History of ITP or platelet count at screening below 50,000 x10^6/l
•10) Pregnancy or inadequate contraception in pre-menopausal women
•11) Breast feeding
•12) Previous history of malignancy
•13) Any other mulitsystem autoimmune disease, including Churg Strauss angiitis, systemic lupus erythematosus, anti-GBM disease and cryoglobulinaemia
•14) Any condition judged by the investigator that would cause the study to be detrimental to the patient

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