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

Recruiting now · Phase 4

Conditions studied: Idiopathic Retroperitoneal Fibrosis

In brief

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.

Key facts

Study ID

NCT05428826

Run by

Assistance Publique - Hôpitaux de Paris

People needed

41

Starts

2022-11-25

Expected to finish

2028-11-25

Last updated by the study team

2025-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient over 18 years old
• New onset or untreated relapsing of active idiopathic retroperitoneal fibrosis (IRF) defined by the association of:
• Related-disease symptoms (Appendix 17.2) or elevated CRP level (>20 mg/l) AND
• Retroperitoneal peri-aortic mass that surrounds the abdominal vessels on CT-scan

You may not qualify if…

• Secondary retroperitoneal fibrosis including drug-related retroperitoneal fibrosis, active infections (such as tuberculosis) or malignancies, systemic vasculitis (such as Anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis), Erdheim-Chester disease (Appendix 17.3),patients with IgG4 disease may be enrolled
• Contraindication to perform FDG-PET/CT,
• Contraindication to perform CT scan with injection of contrast agent,
• Contraindication to treatment by prednisone
• Active infection
• Acute or chronic liver disease that is deemed sufficiently severe to impair their ability to participate in the trial,
• Active or history of malignancy in last 5 years. Individuals with squamous cell or basal cell skin carcinomas and individuals with cervical carcinoma in situ may be enrolled if they have received curative surgical treatment,
• Serum creatinine level greater than 400 µmol/L that cannot be attributed to underlying IRF,
• Live vaccination received from 4 weeks before inclusion,
• Inhaled glucocorticoids (except for patients with documented asthma),
• Any previous treatment with rituximab, methotrexate, alemtuzumab, cyclophosphamide, azathioprine, mycophenolate mofetil, infliximab, adalimumab, etanercept within the past 3 months,
• Pregnancy or breastfeeding,
• Non-affiliation to a social security regime,
• Subject deprived of freedom, subject under a legal protective measure
• Refusal to participate

Where it is running

• Médecine Interne — Agen, France, France (enrolling)
• Médecine interne — Brest, France, France (enrolling)
• Médecine interne et maladies infectieuses - GH Sud Haut Lévêque — Bordeaux, France (enrolling)
• Médecine interne - Ambroise Paré — Boulogne-Billancourt, France (enrolling)
• Médecine interne - Henri-Mondor — Créteil, France (enrolling)
• Médecine interne et immunologie clinique - Dijon — Dijon, France (enrolling)
• Médecine interne - Cochin — Paris, France (enrolling)
• Médecine vasculaire - HEGP — Paris, France (enrolling)
• Médecine Interne - Bichat — Paris, France (enrolling)
• Médecine Interne - La Timone — Marseille, France (enrolling)
• Médecine interne - Saint Antoine — Paris, France (enrolling)
• Médecine Interne, Vascularites et Myosites - La Pitié Salpêtrière — Paris, France (enrolling)
• Médecine interne - Lille — Lille, France
• Néphrologie - Bichat — Paris, France
• Médecine interne - Delafontaine — Saint-Denis, France

Full record on ClinicalTrials.gov

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