The treatment of juvenile dermatomyositis (JDM), is unsatisfactory, and corticosteroids are the only agents currently approved by the US Food and Drug Administration for myositis. Many of JDM patients fail to respond adequately to corticosteroids and require additional immunosuppressive medications, none of which have been tested in controlled trials in children.
In order to solve this problem PRINTO designed a 5-year trial, involving 185 partners from 46 countries. This is a phase III single-blind randomised clinical trials in children with newly diagnosed JDM with 3 arms:
1. prednisone (PDN) versus
2. PDN plus methotrexate (MTX) versus
3. PDN plus cyclosporine A.
The study is designed as an effectiveness trial aimed to find out the treatment regimen associated with the lowest occurrence of flare and the lowest drug related toxicity.
IMPORTANT: thanks to a grant from the Italian Agency for Drug Evaluation (AIFA), the Myositis Association and other source of funding PRINTO is now able to provide 300 euro for every patient enrolled in the trial for whose forms are electronically submitted (200 euro if submitted on paper via fax).
If you are interested you can contact the PRINTO office. The complete set of information (material for ethics committee submission, protocols, consent forms, and internet case report forms) are available, for PRINTO members only, in the reserved Member area on the left.