ALEVIATE 2018.

Trial name or title	Alemtuzumab for ANCA Associated Refractory Vasculitis (ALEVIATE)
Methods	Study design: parallel, open‐label RCT Study duration: 6 months Duration of follow‐up: 12 months
Participants	Inclusion criteria Diagnosis of AAV, according to a standardized definition Active vasculitis with at least 1 severe or 3 non‐severe items of BVAS/WG activity (equivalent to BVAS/WG > 3) Previous therapy with either CPA or MTX, in combination with prednisolone for at least 3 months. Exclusion criteria Aged < 18 or > 60 years Creatinine > 150μmol/L (1.7 mg/dL) Total white count < 4 x 109/L or lymphocyte count < 0.5 x 109/L, or IgG < 5g/L, or neutrophil count < 1.5 x 109/L Severe lung haemorrhage with hypoxia (< 85% on room air) Severe gastrointestinal, central nervous system or cardiac vasculitis Previous therapy with: Alemtuzumab at any time IVIg, infliximab, etanercept, adalimumab, abatacept, anti‐thymocyte globulin or plasma exchange in past 3 months; RTX within the past 6 months Intensive care unit requirement Active infection with HIV, hepatitis B or hepatitis C or other infection requiring parenteral or long‐term oral antibiotics History of ITP or platelet count at screening below 50,000 x 106/L Pregnancy or inadequate contraception in pre‐menopausal women Breast feeding Any condition judged by the investigator that would cause the study to be detrimental to the patient. Any other multisystem autoimmune disease including Churg Strauss angiitis, systemic lupus erythematosus, anti‐GBM disease and cryoglobulinaemia Any previous or current history of malignancy (other than resected basal cell carcinoma)
Interventions	Treatment group A Alemtuzumab: high dose (60 mg) 30 mg will be administered on Day 1 and Day 2 at 0 and 6 months Treatment group B Alemtuzumab: low dose (30 mg) 15 mg will be administered on Day 1 and Day 2 at 0 and 6 months
Outcomes	Primary outcomes Proportion of patients with a vasculitis response at 6 months (Time Frame: 6 months) Response includes patients in complete and partial remission. Complete remission (CR) is defined as a BVAS/WG of 0 for at least one month. Partial response (PR) is the absence of severe BVAS/WG items and at least 50% fall in BVAS/WG score from baseline. Proportion of patients with a severe adverse event (Time Frame: 6 months) Secondary outcomes Proportion of patients with treatment failure (Time Frame: 12 months) Treatment failure is defined as the failure to achieve a vasculitis response by six months or a vasculitis relapse between 6 and 12 months Combined damage assessment (CDA) scores (Time Frame: 12 months) Non severe adverse events (Time Frame: 12 months) Cumulative dose of corticosteroids (Time Frame: 12 months) Time to remission (Time Frame: 6 months) Complete and partial Relapse (Time Frame: 12 months) Change in SF‐36 (Time Frame: 12 months)
Starting date	February 2011
Contact information	Dr David Jayne, Cambridge University Hospitals NHS Foundation Trust
Notes	Abstract only publication. Recruitment status: unknown last updated July 2011.