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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01240850
Acronym
FIPREDEX
Enrollment
200
Registered
2010-11-15
Start date
2007-05-31
Completion date
2013-12-31
Last updated
2010-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periaortitis, Idiopathic Retroperitoneal Fibrosis, Perianeurysmal Retroperitoneal Fibrosis

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

DRUGMethotrexate+Prednisone

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

DRUGPrednisone

Sponsors

University of Parma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

MeasureTime frame
Remission rate by the end of treatment

Secondary

MeasureTime frame
Reduction in size of the retroperitoneal mass on CT/MRI scans
Rate of post-treatment relapses
Treatment-related toxicity

Countries

Italy

Contacts

Primary ContactCarlo Buzio, MD
carlo.buzio@unipr.it+39 0521 702345
Backup ContactAugusto Vaglio, MD, PhD
augusto.vaglio@virgilio.it+39 0521 702345

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026