Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05428826 En recrutement IDF

Titre

Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis. A Prospective Multicentric Study

Type

Interventional

Pathologie

Fibrose
Fibrose rétropéritonéale

Phase

Phase 4

Promoteur

Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)

Date de début

novembre 2022

Date de fin

novembre 2028

Dernière mise à jour

18 septembre 2025

Résumé

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.

Détail

Voir le détail 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 be performed. At inclusion visit: After verification of inclusion and non inclusion criteria, if the patient meets the eligibility criteria, the investigator, will provide the patient with information and details regarding the trial. The consent is obtained and signed after a reflection period of 30 minutes. The following procedure will be scheduled within 7 days: - 18F-fluorodeoxyglucose-positron emission tomography (FDG-PET/CT) (pregnancy test if mandatory) - Specimens for the biocollection Patients with positive FDG PET/CT (hypermetabolism grade II or III) at M0 will receive oral steroids (prednisone) at 1mg/kg/day during 1 month and then the dose will be tapered to obtain <10mg/day at 6 months and <7,5mg/day at 9 months. Patients with a negative FDG-PET/CT (hypermetabolism grade 0 or I) at M0 will be excluded of the study. Follow-up visits : M6, M9,M12,M15,M21, relapse At M6, M12, and M15: During these visits clinical examination (blood pressure measurement, body temperature, heart rate, weight and clinical signs or symptoms related to IRF) will be performed. An abdominal CT scan may be performed as part of the care depending on the clinician's judgment. Glucocorticoid compliance and tapering, concomitant medications and adverse events (including serious cardiovascular adverse events) will be assessed and recorded. A nurse will collect blood and urine. At M9, M21 or relapse : During these visits clinical examination, an abdominal CT scan, a FDG-PET/CT blood and urine biological tests will be performed. At M9: The patients who failed to reach remission at M9 are considered as treatment failure and will be treated on best medical judgment by the investigator and excluded to the study. The patients who had a dose of prednisone ≥7,5mg / day at M9 will also be excluded to the study. Patients who achieved remission at M9 and have a retroperitoneal fibrosis visual score grade 0 or I under a dose of prednisone <7,5mg / day will discontinue steroids treatment. Patients who achieved remission at M9 and have a retroperitoneal fibrosis visual score grade II or III under a dose of prednisone <7,5mg / day will continue steroids treatment at the actual dose (medical judgment). Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CENTRE HOSPITALIER DE ST-DENIS	SACRE Karim	En recrutement IDF	18/09/2025 17:32:15	Contacter
AP-HP Assistance publique - Hôpitaux de Paris		En recrutement IDF	18/09/2025 17:32:15	Contacter
	AP-HP - Hôpital Ambroise Paré
	AP-HP - Hôpital Bichat
	AP-HP - Hôpital Cochin
	AP-HP - Hôpital Europeen Georges Pompidou
	AP-HP - Hôpital Henri Mondor-Albert Chenevier
	AP-HP - Hôpital La Pitié-Salpêtrière
	AP-HP - Hôpital Saint Antoine
	AP-HP - Hôpital Tenon
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
			18/09/2025 17:32:14	Contact (sur clinicalTrials)
			18/09/2025 17:32:14	Contact (sur clinicalTrials)
			18/09/2025 17:32:15	Contact (sur clinicalTrials)
			18/09/2025 17:32:15	Contact (sur clinicalTrials)
			18/09/2025 17:32:15	Contact (sur clinicalTrials)
			18/09/2025 17:32:15	Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Médecine interne - 29200 - Brest - France	POGIOSSIAN Alexan	En recrutement		Contact (sur clinicalTrials)
Médecine Interne - 47000 - Agen - France	RORIZ Mélanie	En recrutement		Contact (sur clinicalTrials)
Médecine interne - Ambroise Paré - 92100 - Boulogne-Billancourt - France	KAHN Jean-Emmanuel	En recrutement		Contact (sur clinicalTrials)
Médecine interne - Delafontaine - 93200 - Saint-Denis - France		Active, sans recrutement		Contact (sur clinicalTrials)
Médecine Interne - La Timone - 13005 - Marseille - France	SCHLEINITZ Nicolas	En recrutement		Contact (sur clinicalTrials)
Médecine interne - Lille - 59000 - Lille - France		Active, sans recrutement		Contact (sur clinicalTrials)
Médecine interne et immunologie clinique - Dijon - 21000 - Dijon - France	BONNOTTE Bernard	En recrutement		Contact (sur clinicalTrials)
Médecine interne et maladies infectieuses - GH Sud Haut Lévêque - 33604 - Bordeaux - France	VIALLARD Jean-François	En recrutement		Contact (sur clinicalTrials)
Médecine Interne, Vascularites et Myosites - La Pitié Salpêtrière - 75013 - Paris - France	CACOUB Patrice	En recrutement		Contact (sur clinicalTrials)
Médecine vasculaire - HEGP - 75015 - Paris - France	MIRAULT Tristan	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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

Critère de non inclusion

- 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

NCT05428826 - Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis. A Prospective Multicentric Study

Informations générales
Etablissements
Critères
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