Immunopathology of Polymyalgia Rheumatica on Shoulder Bursae's Biopsies (BAOBAB)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Polymyalgia Rheumatica

Treatments: Procedure: Synovial membrane biopsy with puncture of synovial fluid; Procedure: Joint fluid sampling; Procedure: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT04727879

29BRC20.0158

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

PMR

Other group

Description:

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.

Treatment:

Procedure: Joint fluid sampling

Procedure: Synovial membrane biopsy with puncture of synovial fluid

Procedure: Blood sample

Control

Other group

Description:

Witnesses recruited into the orthopedic surgery department will be offered a synovial membrane biopsy during a shoulder surgery in the context of mechanical pathology.

Treatment:

Procedure: Synovial membrane biopsy with puncture of synovial fluid

Procedure: Blood sample