Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis. A Prospective Multicentric Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 41
- 试验地点
- 15
- 主要终点
- To compare the cumulative IRF relapse rate 12 months after discontinuation of steroids.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Prednisone
Dose : 1mg/kg/day at inclusion Route of administration : oral Duration of treatment: 9 to 21 months.
干预措施: Prednisone (Drug)
结局指标
主要结局
To compare the cumulative IRF relapse rate 12 months after discontinuation of steroids.
时间窗: 12 months after discontinuation of steroids
The primary endpoint is the cumulate IRF relapse rate 12 months after discontinuation of steroids. The diagnosis of IRF relapse is based on the association of a clinical or biological criterion with a radiological criterion (i.e. composite criteria): * Clinical or biological criteria * recurrent or new-onset disease related symptoms * increase in C-reactive protein (CRP) \>20mg/L without other cause * And a Radiological criterion o increased of retroperitoneal fibrosis size as compared with the CT scan performed at remission. The primary endpoint will be centrally adjudicated.
次要结局
- To assess the performance of hypermetabolism of IRF in FDG-PET/CT for diagnosis of disease activity,(21 months after the inclusion)
- To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at remission (M9)(9 months after the inclusion)
- To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at inclusion(at inclusion)
- To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at M21(21 months after the inclusion)
- To compare at M21 the corticosteroids therapy - related adverse events between patients who continue or discontinue the treatment at M9.(21 months after the inclusion)
- To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at relapse(between inclusion and 21 months after the inclusion)