Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retrop… (NCT05428826) | Clinical Trial Compass
RecruitingPhase 4
Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis
France41 participantsStarted 2022-11-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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,…
What they're measuring
1
To compare the cumulative IRF relapse rate 12 months after discontinuation of steroids.
Timeframe: 12 months after discontinuation of steroids