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Early discontinuation of steroid treatment in negative FDG-PET/CT patients with idiopathic retroperitoneal fibrosis
EU CTIS ID: 2024-514353-30-00
What this study is testing
To compare the cumulative IRF relapse rate 12 months after discontinuation of steroids.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Patient over 18 years old
- New onset or untreated relapsing of active idiopathic retroperitoneal fibrosis (IRF) defined by the association of: o Related-disease symptoms (Appendix 17.2) or elevated CRP level (>20 mg/l) AND o Retroperitoneal peri-aortic mass that surrounds the abdominal vessels on CT-scan
You likely can't join if
- • 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
- • Inhaled glucocorticoids (except for patients with documented asthma),
- • Any previous treatment with rituximab, methotrexate, alemtuzumab, cyclophosphamide, azathiorpine, 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
See the full eligibility criteria
- • Patient over 18 years old
- New onset or untreated relapsing of active idiopathic retroperitoneal fibrosis (IRF) defined by the association of: o Related-disease symptoms (Appendix 17.2) or elevated CRP level (>20 mg/l) AND o Retroperitoneal peri-aortic mass that surrounds the abdominal vessels on CT-scan
- • 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
- • Inhaled glucocorticoids (except for patients with documented asthma),
- • Any previous treatment with rituximab, methotrexate, alemtuzumab, cyclophosphamide, azathiorpine, 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
- • 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,
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.