Chronic Periaortitis, Idiopathic Retroperitoneal Fibrosis, Perianeurysmal Retroperitoneal Fibrosis
Conditions
Keywords
Retroperitoneal fibrosis, Inflammatory aneurysms, Methotrexate, Prednisone, Aorta
Brief 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.
Interventions
Methotrexate will be added at a dose of 0.3 mg/kg/week (maximum dose, 20 mg/week, orally) to a reduced-dose prednisone regimen
Sponsors
Study design
Eligibility
Inclusion criteria
* New diagnosis of idiopathic retroperitoneal fibrosis or chronic periaortitis; written informed consent
Exclusion criteria
* Secondary forms of retroperitoneal fibrosis (e.g. drugs, surgery, neoplasms, infections) * Previous medical therapy for retroperitoneal fibrosis * Renal failure with creatinine \>2 mg/dl which proved not to be reversible after ureteral decompression * Hypersensitivity to the study drugs * Pregnancy * Active infections or malignant neoplasms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate by the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in size of the retroperitoneal mass on CT/MRI scans | — |
| Rate of post-treatment relapses | — |
| Treatment-related toxicity | — |
Countries
Italy