RecruitingPhase 4NCT05428826

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

Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis. A Prospective Multicentric Study


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

41 participants

Start Date

Nov 25, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria15

  • 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

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Interventions

DRUGPrednisone

Phase 4 Prednisone Dose : 1mg/kg/day at inclusion Route of administration : oral Duration of treatment: 9 to 21 months.


Locations(15)

Médecine Interne

Agen, France, France

Médecine interne

Brest, France, France

Médecine interne et maladies infectieuses - GH Sud Haut Lévêque

Bordeaux, France

Médecine interne - Ambroise Paré

Boulogne-Billancourt, France

Médecine interne - Henri-Mondor

Créteil, France

Médecine interne et immunologie clinique - Dijon

Dijon, France

Médecine interne - Lille

Lille, France

Médecine Interne - La Timone

Marseille, France

Médecine interne - Saint Antoine

Paris, France

Médecine Interne, Vascularites et Myosites - La Pitié Salpêtrière

Paris, France

Médecine interne - Cochin

Paris, France

Médecine vasculaire - HEGP

Paris, France

Médecine Interne - Bichat

Paris, France

Néphrologie - Bichat

Paris, France

Médecine interne - Delafontaine

Saint-Denis, France

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NCT05428826


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