Stopping steroid treatment early in patients with idiopathic retroperitoneal fibrosis
Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis. A Prospective Multicentric Study
This study tests if stopping steroid treatment early can be safe and effective for adults with idiopathic retroperitoneal fibrosis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 41 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | rituximab, alemtuzumab, infliximab, adalimumab, methotrexate, cyclophosphamide, prednisone |
| Locations | 15 sites (Agen, France and 14 other locations) |
| Trial ID | NCT05428826 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of early discontinuation of steroid treatment in adult patients diagnosed with idiopathic retroperitoneal fibrosis. Eligible participants will receive prednisone for a period of 9 to 21 months, with monitoring through clinical examinations and imaging tests. Patients will be screened based on their FDG-PET/CT results, and those with negative results will be excluded from the study. Follow-up visits will assess treatment compliance, adverse events, and disease progression.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with new onset or untreated relapsing idiopathic retroperitoneal fibrosis.
Not a fit: Patients with secondary retroperitoneal fibrosis or contraindications to prednisone treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective management of idiopathic retroperitoneal fibrosis with reduced steroid exposure.
How similar studies have performed: Other studies have explored steroid treatments in similar conditions, but this specific approach of early discontinuation in negative FDG-PET/CT patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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, 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
Where this trial is running
Agen, France and 14 other locations
- Médecine Interne — Agen, France, France (Recruiting)
- Médecine interne — Brest, France, France (Recruiting)
- Médecine interne et maladies infectieuses - GH Sud Haut Lévêque — Bordeaux, France (Recruiting)
- Médecine interne - Ambroise Paré — Boulogne-Billancourt, France (Recruiting)
- Médecine interne - Henri-Mondor — Créteil, France (Recruiting)
- Médecine interne et immunologie clinique - Dijon — Dijon, France (Recruiting)
- Médecine interne - Lille — Lille, France (Active_not_recruiting)
- Médecine Interne - La Timone — Marseille, France (Recruiting)
- Médecine interne - Saint Antoine — Paris, France (Recruiting)
- Médecine Interne, Vascularites et Myosites - La Pitié Salpêtrière — Paris, France (Recruiting)
- Médecine interne - Cochin — Paris, France (Recruiting)
- Médecine vasculaire - HEGP — Paris, France (Recruiting)
- Médecine Interne - Bichat — Paris, France (Recruiting)
- Néphrologie - Bichat — Paris, France (Active_not_recruiting)
- Médecine interne - Delafontaine — Saint-Denis, France (Active_not_recruiting)
Study contacts
- Study coordinator: Karim SACRE
- Email: karim.sacre@aphp.fr
- Phone: 01.40.25.60.19
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.