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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-007353-12-IT

Enrollment

Unknown

Registered

2008-11-19

Start date

2007-05-29

Completion date

Unknown

Last updated

2017-01-31

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

Conditions

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

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: Methotrexate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical Form: Tablet INN or Proposed INN:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026