Immunopathology of Polymyalgia Rheumatica on Shoulder Bursae's Biopsies

NCT04727879 | Completed

• 1 other identifier: 29BRC20.0158
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Polymyalgia Rheumatica

Outcome Measures

Primary Outcomes (1)

• IL-6 marking

  The main evaluation criterion is the intensity of the tissue IL-6 marking on the subacromio-deltoid bursa sections using the Hyperion technique.

  Day 0

Secondary Outcomes (9)

• Cytokinic (other than IL-6) infiltration of tissues

  Day 0

• Serum cytokine levels

  Day 0

• Cytokine levels in joint or synovial fluid

  Day 0

• Tissue distribution of lymphocyte subpopulations by using the Hyperion mass cytometer (analysis of the intensity of the markings)

  Day 0

• Serum distribution of lymphocyte subpopulations by using the HELIOS mass cytometer (analysis of the intensity of the markings)

  Day 0

Study Arms (2)

PMR

OTHER

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.

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

Control

OTHER

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

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

Interventions

Synovial membrane biopsy with puncture of synovial fluid PROCEDURE

The biopsy of the shoulder bursae will be carried out thanks to a device Tru-cut (Tru-Cut Biopsy Needle), minimally invasive, introduced, as during an infiltration, within the bursa serosa.

Control; PMR

Joint fluid sampling PROCEDURE

In case of associated peripheric arthritis, the patient will also be offered a sample of joint fluid during a cortisonic infiltration for analgesic purposes, performed as part of routine care.

PMR

Blood sample PROCEDURE

A blood sample taken during routine care and unused will also be collected from patients and controls for immunoassays.

Control; PMR

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHU de Brest - Service de rhumatologie

Brest, 29200, France

Location

MeSH Terms

Conditions

Polymyalgia Rheumatica

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 27, 2021
• Study Start: April 7, 2021
• Primary Completion: July 13, 2022
• Study Completion: August 13, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)