Beyond Analysis Of Blood Sample, to Approach Immunopathology of Polymyalgia Rheumatica on Shoulder Bursae's Biopsies: the BAOBAB Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- IL-6 marking
研究概览
简要总结
The work carried out at the Brest University Hospital on serum immunological changes in patients with polymyalgia rheumatica (PMR) (based on clinical protocols TENOR, SEMAPHORE, THEN) made it possible to describe the changes in the distribution of lymphocyte subpopulations and cytokine levels during PPR, before and then under treatment compared to controls.
However, in systemic autoimmune or inflammatory pathologies, serum immunological mechanisms are rarely a reflection of intra-tissue mechanisms.
In the specific case of PMR, there are few data concerning muscular or joint immunological modifications. The investigators now wish to study the immunological modifications occurring at the tissue sites of interest, in particular in the shoulder bursae
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For everyone :
- •Signed consent
- •Patients over 50
- •Inclusion criteria :
- •For case patients:
- •Addressed for PMR (diagnosis OR relapse)
- •Score greater than or equal to 4 (without ultrasound criteria) or greater than or equal to 6 (with ultrasound criteria), according to the ACR / EULAR 2012 criteria for polymyalgia rheumatica, and suffering from bilateral scapular pain as well as an increased CRP level .
- •Thickening of more than 2mm at least one shoulder bursae in ultrasound
- •DAS-PPR> = 10
- •For witnesses:
- •Shoulder surgery scheduled for mechanical pathology
排除标准
- •For everyone :
- •MRI with Gadolinium injection in the previous month- Clinical or paraclinical signs of giant cell arteritis
- •Patient under protective measure or unable to consent
- •Active cancer
- •Active infection
- •For the cases:
- •History of biotherapy treatment
- •For witnesses:
- •History of inflammatory rheumatism
- •Active inflammatory rheumatism
研究组 & 干预措施
PMR
Patients with PMR will be offered biopsy of the synovial membrane with puncture of synovial fluid during cortisone infiltration for analgesic purposes. In case of associated peripheric arthritis, the patient will also be offered a joint fluid sample during a cortisonic infiltration for analgesic purposes, performed as part of routine care
The study-specific examination that is not part of current practice is the synovial biopsy performed during the cortisonic infiltration procedure.
干预措施: Synovial membrane biopsy with puncture of synovial fluid (Procedure)
PMR
Patients with PMR will be offered biopsy of the synovial membrane with puncture of synovial fluid during cortisone infiltration for analgesic purposes. In case of associated peripheric arthritis, the patient will also be offered a joint fluid sample during a cortisonic infiltration for analgesic purposes, performed as part of routine care
The study-specific examination that is not part of current practice is the synovial biopsy performed during the cortisonic infiltration procedure.
干预措施: Joint fluid sampling (Procedure)
PMR
Patients with PMR will be offered biopsy of the synovial membrane with puncture of synovial fluid during cortisone infiltration for analgesic purposes. In case of associated peripheric arthritis, the patient will also be offered a joint fluid sample during a cortisonic infiltration for analgesic purposes, performed as part of routine care
The study-specific examination that is not part of current practice is the synovial biopsy performed during the cortisonic infiltration procedure.
干预措施: Blood sample (Procedure)
Control
Witnesses recruited into the orthopedic surgery department will be offered a synovial membrane biopsy during a shoulder surgery in the context of mechanical pathology.
干预措施: Synovial membrane biopsy with puncture of synovial fluid (Procedure)
Control
Witnesses recruited into the orthopedic surgery department will be offered a synovial membrane biopsy during a shoulder surgery in the context of mechanical pathology.
干预措施: Blood sample (Procedure)
结局指标
主要结局
IL-6 marking
时间窗: Day 0
The main evaluation criterion is the intensity of the tissue IL-6 marking on the subacromio-deltoid bursa sections using the Hyperion technique.
次要结局
- Cytokine levels in joint or synovial fluid(Day 0)
- Cytokinic (other than IL-6) infiltration of tissues(Day 0)
- Tissue distribution of lymphocyte subpopulations by using the Hyperion mass cytometer (analysis of the intensity of the markings)(Day 0)
- Analysis of immunosenescence markers in tissues by HYPERION technology(Day 0)
- Analysis of target molecules of treatments under study in PPR by ELISA technique(Day 0)
- Analysis of target molecules of treatments under study in PPR by proteomic techniques(Day 0)
- Serum cytokine levels(Day 0)
- Serum distribution of lymphocyte subpopulations by using the HELIOS mass cytometer (analysis of the intensity of the markings)(Day 0)
- Complications of subacromio-deltoid purse in the 72h after biopsies : M1 phone call(Month 1)