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

Study acronym: METRO
StatusRecruiting
PhasePhase 4
Started2022-11-25
View on ClinicalTrials.gov ↗

Amendment history

2025-05-21
Study Status, Oversight, Contacts/Locations v8
Study sitesdetails revised at 9 of 15 sites
2024-01-24
Study Status, Eligibility, Contacts/Locations v7
Study sites13→15
Eligibility criteria-12 characters
Inclusion Criteria: Patient over 18 years old DiagnosisNew onset or untreated relapsing of active idiopathic retroperitoneal fibrosis (IRF) defined [...] (Appendix 17.3),patients with IgG4 disease may be enrolled Relapse of an already treated IRF, Contraindication to perform FDG-PET/CT, Contraindication to [...]
2023-11-28
Study Status, Contacts/Locations v6
Study sitesdetails revised at 3 of 13 sites
2023-03-27
Study Status, Contacts/Locations v5
Study sitesdetails revised at 5 of 13 sites
2023-03-07
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 13 sites
Show 3 earlier versions
2023-01-16
Study Status, Study Description, Eligibility v3
Eligibility criteria+42 characters
[...] ciated vasculitis), Erdheim-Chester disease (Appendix 17.3),patients with IgG4 disease may be enrolled Relapse of an already treated IRF, Contraindication to perf [...]
Study description+5 characters
[...] during 1 month and then the dose will be tapered to obtain <10mg/day at 6 months and <10mg7,5mg/day at 9 months. Patients with a negative FDG-PET/CT (hyper [...] ed to the study. The patients who had a dose of prednisone ≥10mg7,5mg / day at M9 will also be excluded to the study. Patients wh [...] rosis visual score grade 0 or I under a dose of prednisone <10mg7,5mg / day will discontinue steroids treatment. Patients who ach [...] is visual score grade II or III under a dose of prednisone <10mg7,5mg / day will continue steroids treatment at the actual dose (medical judgment).
2022-12-07
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2026-11-09→2026-11-25
Completion date2028-11-09→2028-11-25
Start date2022-11-09→2022-11-25
Study sitesdetails revised at 13 of 13 sites
2022-11-21
Not Yet Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Active, Not Recruiting
Primary completion date2026-09-30→2026-11-09
Completion date2028-09-30→2028-11-09
Start dateestimated 2022-09-30→confirmed 2022-11-09
Study sites0→13
2022-06-17
Original filing
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.
Trial Details
NCT Number NCT05428826
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Idiopathic Retroperitoneal Fibrosis
Enrollment 41 participants
Start Date 2022-11-25
Primary Completion 2026-11-25 (estimated)
Study Completion 2028-11-25 (estimated)
Updated on ClinicalTrials.gov 2025-05-25