Methotrexate as a Steroid-sparing Agent in Idiopathic Retroperitoneal Fibrosis: a Randomised, Multicenter Trial
Status:
Unknown status
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
Chronic periaortitis is a clinico-pathological entity encompassing idiopathic retroperitoneal
fibrosis and perianeurysmal retroperitoneal fibrosis. The treatment of this disease is
generally based on the use of glucocorticoids, which are often effective. However, prolonged
steroid treatments are usually needed to achieve a sustained remission; additionally,
patients frequently develop disease relapses following treatment discontinuation, therefore
they may be exposed to high cumulative doses of glucocorticoids.
Preliminary data reported in the literature show that methotrexate may be effective in
combination with prednisone for retroperitoneal fibrosis. In addition, methotrexate is often
used as a steroid-sparing agent in different inflammatory diseases.
The aim of this study is to evaluate whether a treatment with low-dose prednisone plus
methotrexate is non-inferior to conventional dose-prednisone in achieving remission in
retroperitoneal fibrosis patients.