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

Study Overview
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Brief Summary
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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.

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

Conditions
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Idiopathic Retroperitoneal Fibrosis, Perianeurysmal Retroperitoneal Fibrosis, Chronic Periaortitis

Intervention / Treatment
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* Drug: Methotrexate+Prednisone
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prednisone<br> | Drug: Prednisone<br> <br> |
| Experimental: Methotrexate+Prednisone<br> | Drug: Methotrexate+Prednisone<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate by the end of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in size of the retroperitoneal mass on CT/MRI scans |  |  | 
| Rate of post-treatment relapses |  |  | 
| Treatment-related toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retroperitoneal fibrosis, Inflammatory aneurysms, Methotrexate, Prednisone, Aorta