Methotrexate plus Prednisone in patients with relapsing Idiopathic Retroperitoneal Fibrosis.

For patients affected by relapsing Idiopathic Retroperitoneal Fibrosis, will treatment with Methotrexate plus Prednisone be effective in achieving and mantaining disease remission.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000845831

Acronym

rIRF-MTXPDN01

Enrollment

Registered

2012-08-13

Start date

2004-07-28

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The study aims to demonstrate that the combination of an immunosuppressant (methotrexate) and a cortisonic (prednisone) is effective for patients who suffer from relapsing idiopathic retroperitoneal fibrosis.

Interventions

We enrolled all relapsing idiopathic retroperitoneal fibrosis patients seen at our Department between July 2004 and April 2011. The patients received Prednisone and Methotrexate for one year. The enrolled patients received prednisone (PDN) at a starting dose of 0.5-1 mg/Kg/day depending on relapse severity then tapered to 5 mg/day within 6-8 months and kept at a maintenance dose of 2.5-5 mg/day until month 12. The tapering schedule was left at the discretion of the treating clinician. PDN was given as oral tablets once daily for one year. Methotrexate (MTX) was given orally (or intramuscularly if the oral administration was not tolerated) at a starting dose of 10-15 mg/week, rapidly titrated up to 15-20 mg/week; the MTX dose was kept unchanged until month 12.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

Diagnosis of relapsing idiopathic retroperitoneal fibrosis and an age between 18 and 85 years.

Exclusion criteria

Pregnancy, active infections or malignancies, known hypersensitivity to the study drugs, uncontrolled diabetes and retroperitoneal fibrosis secondary to known causes.

Outcome results