Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05428826

Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-05-25

41

Participants Needed

15

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Adult patients with a diagnosis of idiopathic retroperitoneal fibrosis Prospective multicentric cohort study Intervention : administration of prednisone during 9 to 21 months at 1mg/kg/day at inclusion.

CONDITIONS

Official Title

Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient over 18 years old
  • New onset or untreated relapsing of active idiopathic retroperitoneal fibrosis (IRF) defined by related disease symptoms or elevated CRP level (>20 mg/l)
  • Retroperitoneal peri-aortic mass surrounding abdominal vessels visible on CT scan
Not Eligible

You will not qualify if you...

  • Secondary retroperitoneal fibrosis including drug-related fibrosis, active infections (e.g., tuberculosis), malignancies, systemic vasculitis, or Erdheim-Chester disease
  • Contraindication to FDG-PET/CT or CT scan with contrast
  • Contraindication to prednisone treatment
  • Active infection
  • Severe acute or chronic liver disease
  • Active or history of malignancy within last 5 years (except treated skin or cervical carcinoma in situ)
  • Serum creatinine level >400 µmol/L unrelated to IRF
  • Live vaccination within 4 weeks before inclusion
  • Use of inhaled glucocorticoids except for documented asthma
  • Use of rituximab, methotrexate, alemtuzumab, cyclophosphamide, azathioprine, mycophenolate mofetil, infliximab, adalimumab, or etanercept within past 3 months
  • Pregnancy or breastfeeding
  • Lack of social security affiliation
  • Legal protective measures or deprivation of freedom
  • Refusal to participate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

Médecine Interne

Agen, France, France, 47000

Actively Recruiting

2

Médecine interne

Brest, France, France, 29200

Actively Recruiting

3

Médecine interne et maladies infectieuses - GH Sud Haut Lévêque

Bordeaux, France, 33604

Actively Recruiting

4

Médecine interne - Ambroise Paré

Boulogne-Billancourt, France, 92100

Actively Recruiting

5

Médecine interne - Henri-Mondor

Créteil, France, 94000

Actively Recruiting

6

Médecine interne et immunologie clinique - Dijon

Dijon, France, 21000

Actively Recruiting

7

Médecine interne - Lille

Lille, France, 59000

Active, Not Recruiting

8

Médecine Interne - La Timone

Marseille, France, 13005

Actively Recruiting

9

Médecine interne - Saint Antoine

Paris, France, 75012

Actively Recruiting

10

Médecine Interne, Vascularites et Myosites - La Pitié Salpêtrière

Paris, France, 75013

Actively Recruiting

11

Médecine interne - Cochin

Paris, France, 75014

Actively Recruiting

12

Médecine vasculaire - HEGP

Paris, France, 75015

Actively Recruiting

13

Médecine Interne - Bichat

Paris, France, 75018

Actively Recruiting

14

Néphrologie - Bichat

Paris, France, 75018

Active, Not Recruiting

15

Médecine interne - Delafontaine

Saint-Denis, France, 93200

Active, Not Recruiting

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Research Team

K

Karim SACRE

CONTACT

K

Khadija BENALI

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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