Five-Year Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus Nephritis
Status:
Withdrawn
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
Summary
This is a 5-year project, involving 185 partners from 46 countries (110 in 21 EU States and
75 in 25 extra-EU States), with a randomised clinical trials (RCT) in juvenile systemic lupus
erythematosus (JSLE): 5-year phase III single-blind, RCT in children with newly diagnosed,
WHO class III, IV JSLE proliferative nephritis: PDN and oral cyclophosphamide (CYC) versus
high dose intravenous (iv) CYC versus intermediate dose iv CYC, followed by maintenance with
azathioprine.The trial is aimed to find out the treatment regimen associated with the lowest
occurrence of flare and the lowest drug related toxicity.