Prednisolone for Idiopathic retroperitoneal fibrosis

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- 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), patients with IgG4 disease may be enrolled\n- Inhaled glucocorticoids (except for patients with documented asthma),\n- Any previous treatment with rituximab, methotrexate, alemtuzumab, cyclophosphamide, azathiorpine, mycophenolate mofetil, infliximab, adalimumab, etanercept within the past 3 months,\n- Pregnancy or breastfeeding,\n- Non-affiliation to a social security regime,\n- Subject deprived of freedom, subject under a legal protective measure\n- Refusal to participate\n- Contraindication to perform FDG-PET/CT,\n- Contraindication to perform CT scan with injection of contrast agent,\n- Contraindication to treatment by prednisone\n- Active infection,\n- Acute or chronic liver disease that is deemed sufficiently severe to impair their ability to participate in the trial,\n- 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,\n- Serum creatinine level greater than 400 µmol/L that cannot be attributed to underlying IRF,\n- Live vaccination received from 4 weeks before inclusion,"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the cumulate IRF relapse rate measured at the end of the study (M21). The diagnosis of IRF relapse is based on the association of a clinical or biological criterion with a radiological criterion (i.e. composite criteria):","definition_or_measurement_approach":"Measured at end of study (M21). Diagnosis of IRF relapse based on composite criteria: association of a clinical or biological criterion with a radiological criterion."}

Secondary endpoints

• {"endpoint_text":"- 1.\ta. Visual grades of retroperitoneal fibrosis FDG uptake as compared to liver FDG uptake (which consist of one item that yields a score of 0 to III), maximal standardized uptake value (SUVmax) within the retroperitoneal fibrosis (regions of interest- ROI) at diagnosis (M0), remission (M9), M21 and relapse, b. Metabolic volume (i.e. ratio of metabolically active volume (MAV) to global lesion volume) of retroperitoneal fibrosis FDG uptake at diagnosis (M0), remission (M9), M21 and relapse,","definition_or_measurement_approach":"Visual grading versus liver uptake (score 0 to III); SUVmax measured within ROI at M0, M9, M21 and relapse; metabolic volume as ratio MAV to global lesion volume at specified timepoints."}
• {"endpoint_text":"- 2.\tDiagnostic performance of SUVmax and MAV (area under the curve (AUC) and performance values for the Youden index) for the disease activity,","definition_or_measurement_approach":"Assess diagnostic performance using AUC and Youden index for SUVmax and MAV to determine disease activity."}
• {"endpoint_text":"- 3.\tFrequency of diabetes, severe infection, osteoporotic fracture and major cardiovascular events 12 months after remission (M21). Serious cardiovascular adverse events are defined as a composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death and will be assessed at M12,M15 and M21","definition_or_measurement_approach":"Frequency of listed events assessed at M12, M15 and M21; serious cardiovascular events defined as composite of nonfatal stroke, nonfatal MI, and cardiovascular death."}

France

Earliest CTIS Part Ii Submission Date

12-06-2024

Latest Decision Or Authorization Date

29-09-2025

Processing Time Days

474

Number Of Sites

15

Number Of Participants

41

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"French Ministry","duties_or_roles":"Source of monetary support","organisation_type":""}