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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01240850
Recruitment Status : Unknown
Verified November 2010 by University of Parma.
Recruitment status was:  Recruiting
First Posted : November 15, 2010
Last Update Posted : November 15, 2010
Information provided by:
University of Parma

November 12, 2010
November 15, 2010
November 15, 2010
May 2007
May 2012   (Final data collection date for primary outcome measure)
Remission rate by the end of treatment
Same as current
No Changes Posted
  • Reduction in size of the retroperitoneal mass on CT/MRI scans
  • Rate of post-treatment relapses
  • Treatment-related toxicity
Same as current
Not Provided
Not Provided
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

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.

Not Provided
Phase 3
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
  • Idiopathic Retroperitoneal Fibrosis
  • Perianeurysmal Retroperitoneal Fibrosis
  • Chronic Periaortitis
  • Drug: Methotrexate+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
  • Drug: Prednisone
  • Active Comparator: Prednisone
    Intervention: Drug: Prednisone
  • Experimental: Methotrexate+Prednisone
    Intervention: Drug: Methotrexate+Prednisone

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2013
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
2008−007353−12 ( EudraCT Number )
Not Provided
Not Provided
Prof Carlo Buzio, University of Parma
University of Parma
Not Provided
Principal Investigator: Augusto Vaglio, MD, PhD University Hospitals Parma Medical Center
University of Parma
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP