Status:
RECRUITING
Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Idiopathic Retroperitoneal Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 inclusio...
Detailed Description
At baseline visit: Eligible patients will be screen during a standard visit care (consultation or hospitalization). A clinical examination, an abdominal CT scan, blood and urine biological tests will ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 25 2028
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT05428826
Start Date
November 25 2022
End Date
November 25 2028
Last Update
May 25 2025
Active Locations (15)
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1
Médecine Interne
Agen, France, France, 47000
2
Médecine interne
Brest, France, France, 29200
3
Médecine interne et maladies infectieuses - GH Sud Haut Lévêque
Bordeaux, France, 33604
4
Médecine interne - Ambroise Paré
Boulogne-Billancourt, France, 92100