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NCT Number: NCT04727879

Immunopathology of Polymyalgia Rheumatica on Shoulder Bursae's Biopsies

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

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Key information

Conditions

Polymyalgia Rheumatica Connective Tissue Diseases Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Brest - Service de rhumatologie

Brest, 29200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Blood sample

Procedure

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

Primary outcomes

  1. IL-6 marking

    Time frame: 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.

Secondary outcomes

  1. Cytokinic (other than IL-6) infiltration of tissues

    Time frame: Day 0

  2. Serum cytokine levels

    Time frame: Day 0

  3. Cytokine levels in joint or synovial fluid

    Time frame: Day 0

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

    Time frame: Day 0

    Fragments of the synovial membrane taken from patients and controls will be sent to the pathology laboratory. They will be fixed and slides covering the inflammatory region of interest will be prepared. These slides will be marked with antibodies directed against: - CD20, CD27, CD38, CD24, CD21, CD95, CD23, IgM, Tbet for B lymphocytes; - CD3, CD4, CD8, CD25, CD45RA, CD62L, CD28, FoxP3, CCR7, CD45RO and Bcl-2 for T lymphocytes; - CD14, CD11b and CD11c for monocytes; - CD66b for granulocytes and coupled to heavy metals and analyzed by the Hyperion mass cytometer. The intensity of the markings will be analyzed using the usual Hyperion analysis techniques.

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

    Time frame: Day 0

    Whole blood will be centrifuged and serum will be collected. Antibodies directed against: - CD20, CD27, CD38, CD24, CD21, CD95, CD23, IgM, Tbet for B lymphocytes; - CD3, CD4, CD8, CD25, CD45RA, CD62L, CD28, FoxP3, CCR7, CD45RO and Bcl-2 for T lymphocytes; - CD14, CD11b and CD11c for monocytes; - CD66b for granulocytes, aand Hnd coupled with heavy metals will be added to it before analysis by the HELIOS mass cytometer. The intensity of the markings will be analyzed using the usual HELIOS analysis techniques.

  6. Analysis of immunosenescence markers in tissues by HYPERION technology

    Time frame: Day 0

    Analysis of membrane markers related to immunosenescence in percent of cells expressing the marker and in MFI (Mean fluorescence intensity) by hyperion technology.

  7. Analysis of target molecules of treatments under study in PPR by ELISA technique

    Time frame: Day 0

    The target molecules of treatments under study in PPR (CTLA-4 for abatacept, janus kinases 1 and 2 for baricitinib) will be analyzed by ELISA techniques (concentration).

  8. Analysis of target molecules of treatments under study in PPR by proteomic techniques

    Time frame: Day 0

    The target molecules of treatments under study in PPR (CTLA-4 for abatacept, janus kinases 1 and 2 for baricitinib) will be analyzed by protéomic techniques (cytometry, % of cells expressing the marker, MFI)

  9. Complications of subacromio-deltoid purse in the 72h after biopsies : M1 phone call

    Time frame: Month 1

    The expected complications related to the synovial biopsy are:

    Pain at the biopsy site, Hematoma at the biopsy site, Functional impotence of the shoulder, on the biopsy side, greater than 72h, Hypoesthesia, dysesthesia at the biopsy site, Skin rash within 72h following the infiltration, Hypertensive surge documented within 72 hours of the infiltration, In case of pre-existing diabetes, diabetes imbalance within 72 hours of the infiltration.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Beyond Analysis Of Blood Sample, to Approach Immunopathology of Polymyalgia Rheumatica on Shoulder Bursae's Biopsies: the BAOBAB Study

Acronym: BAOBAB

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2021
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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