Clinical trial NCT04727879: Immunopathology of Polymyalgia Rheumatica on Shoulder Bursae's Biopsies
Official title: Beyond Analysis Of Blood Sample, to Approach Immunopathology of Polymyalgia Rheumatica on Shoulder Bursae's Biopsies: the BAOBAB Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polymyalgia Rheumatica
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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


Eligibility criteria: 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

Exclusion criteria :

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

Primary outcomes:
measure: IL-6 marking
timeFrame: Day 0
Secondary outcomes:
measure: Cytokinic (other than IL-6) infiltration of tissues
timeFrame: Day 0
measure: Serum cytokine levels
timeFrame: Day 0
measure: Cytokine levels in joint or synovial fluid
timeFrame: Day 0
measure: Tissue distribution of lymphocyte subpopulations by using the Hyperion mass cytometer (analysis of the intensity of the markings)
timeFrame: Day 0
measure: Serum distribution of lymphocyte subpopulations by using the HELIOS mass cytometer (analysis of the intensity of the markings)
timeFrame: Day 0
measure: Analysis of immunosenescence markers in tissues by HYPERION technology
timeFrame: Day 0
measure: Analysis of target molecules of treatments under study in PPR by ELISA technique
timeFrame: Day 0
measure: Analysis of target molecules of treatments under study in PPR by proteomic techniques
timeFrame: Day 0
measure: Complications of subacromio-deltoid purse in the 72h after biopsies : M1 phone call
timeFrame: Month 1
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest - Service de rhumatologie
Study officials:
References: