Methotrexate as a Steroid-sparing Agent in Idiopathic Retroperitoneal Fibrosis: a Randomised, Multicenter Trial — FIPREDEX  

Idiopathic Retroperitoneal Fibrosis Clinical Trial

Official title: Medical Therapy in Idiopathic Retroperitoneal Fibrosis: a Multicenter, Randomized, Controlled Trial of Prednisone vs Low-dose Prednisone Plus Methotrexate

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periaortitis
• Fibrosis
• Idiopathic Retroperitoneal Fibrosis
• Perianeurysmal Retroperitoneal Fibrosis
• Retroperitoneal Fibrosis

• NCT number: NCT01240850
• Study type: Interventional
• Source: University of Parma
• Contact: Carlo Buzio, MD
• Phone: +39 0521 702345
• Email: carlo.buzio@unipr.it
• Status: Recruiting
• Phase: Phase 3
• Start date: May 2007
• Completion date: December 2013