BridgeMD
New treatment option for Idiopathic Retroperitoneal Fibrosis
Official title Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis
ClinicalTrials.gov ID: NCT05428826
What this study is testing
What is Prednisone?
Prednisone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for idiopathic retroperitoneal fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 1 month
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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:
- 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
You likely can't join if
- Secondary retroperitoneal fibrosis including drug-related retroperitoneal fibrosis, active infections (such as tuberculosis) or malignancies...
- 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,
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:
- 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
- Secondary retroperitoneal fibrosis including drug-related retroperitoneal fibrosis, active infections (such as tuberculosis) or malignancies, systemic vasculitis (such as Anti-neutrophil cytoplasmic autoantibody...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Agen, France, France
- Brest, France, France
- Bordeaux, France
- Boulogne-Billancourt, France
- Créteil, France
- Dijon, France
- Lille, France
- Marseille, France
- Paris, France
- Saint-Denis, France
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 study runs about 1 month per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Agen, France, France; Brest, France, France; Bordeaux, France; Boulogne-Billancourt, France; Créteil, France; Dijon, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.