Early discontinuation of steroid treatment in negative FDG-PET/CT patients with idiopathic retroperitoneal fibrosis. A prospective multicentric study

Phase 1

• Conditions: Idiopathic retroperitoneal fibrosis (IRF); MedDRA version: 20.1Level: LLTClassification code 10021244Term: Idiopathic retroperitoneal fibrosisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2022-001692-13-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (APHP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-03
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

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

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

Exclusion Criteria

•Secondary retroperitoneal fibrosis including drug-related retroperitoneal fibrosis, active infections (such as tuberculosis) or malignancies, systemic vasculitis (such as ANCA-associated vasculitis), Erdheim-Chester disease (Appendix 17.3),
•Relapse of an already treated IRF,
•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, azathiorpine, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified