Five-year Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis
Status:
Completed
Trial end date:
2015-11-29
Target enrollment:
Participant gender:
Summary
This is a 5-year project, involving 185 partners from 46 countries ((110 in 21 European Union
(EU) States and 75 in 25 extra-EU States)), with a randomised clinical trials (RCT) in
juvenile dermatomyositis (JDM): 5-year phase III single-blind, RCT in children with newly
diagnosed JDM: prednisone (PDN) versus PDN plus methotrexate (MTX) versus PDN plus
Cyclosporine A. The trial is aimed to find out the treatment regimen associated with the
lowest occurrence of flare and the lowest drug related toxicity
Phase:
Phase 3
Details
Lead Sponsor:
Istituto Giannina Gaslini
Collaborator:
Pediatric Rheumatology International Trials Organization