METHOTREXATE AS STEROID-SPARING AGENT IN IDIOPATHIC RETROPERITONEAL FIBROSIS: A MULTICENTRE RANDOMISED CONTROLLED TRIAL - FARM79BKPY

Phase 1

Conditions: Pazient affected by idiopathic retroperitoneal fibrosis
MedDRA version: 9.1Level: LLTClassification code 10046587Term: Urinary tract obstruction NOS

Registration Number: EUCTR2008-007353-12-IT

Lead Sponsor: IVERSITA` DEGLI STUDI DI PARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Diagnosis of IRF (new diagnosis)
Males and females (not nursing and not pregnant), 18-80 years of age; women of child bearing potential are eligible if they are
practicing effective contraceptive measures
Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Retroperitoneal fibrosis secondary to drugs (for a comprehensive list of these drugs see ref. 1)
Retroperitoneal fibrosis secondary to infections, malignancies, previous surgery, trauma, radiotherapy, systemic autoimmune
diseases, systemic hematologic diseases (e.g. Erdheim-Chester disease)
Previous medical treatment for IRF
Renal insufficiency, acute or chronic (serum creatinine >2 mg/dL), not reversible after relieving ureteral obstruction
Serious active bacterial, fungal or viral infections
Concurrent neoplasms, with the exception of non-melanoma skin malignancies, adequately treated
Pregnancy or nursing
Subjects with a history of intolerance to MTX
Subjects participating concurrently in another clinical trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary end-point is the rate of patients in disease remission at the end of treatment.;Secondary Objective: Secondary end-points include the post-treatment relapse rate, the reduction in size of IRF- assessed by computed tomography (CT) or magnetic resonance imaging (MRI)- and treatment-related toxicity.;Primary end point(s): The primary end-point is the rate of patients in disease remission at the end of treatment.

Secondary Outcome Measures