Polymyalgia RheumaticaBAOBABNCT04727879
Immunopathology of Polymyalgia Rheumatica on Shoulder Bursae's Biopsies
A study testing Synovial membrane biopsy with puncture of synovial fluid, Joint fluid sampling and Blood sample in people with Polymyalgia Rheumatica, run by University Hospital, Brest at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Polymyalgia Rheumatica
- What is being tested?
- Synovial membrane biopsy with puncture of synovial fluid, Joint fluid sampling and Blood sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2021to 13 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 10Show fewer
- History of biotherapy treatment
- For witnesses:
- History of inflammatory rheumatism
- Active inflammatory rheumatism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beyond Analysis Of Blood Sample, to Approach Immunopathology of Polymyalgia Rheumatica on Shoulder Bursae's Biopsies: the BAOBAB Study
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
- Being tested
- Synovial membrane biopsy with puncture of synovial fluid, Joint fluid sampling, Blood sample
- Medical subject headings
- Polymyalgia Rheumatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synovial membrane biopsy with puncture of synovial fluidProcedure or surgery
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 samplingProcedure or surgery
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 sampleProcedure or surgery
A blood sample taken during routine care and unused will also be collected from patients and controls for immunoassays.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Synovial membrane biopsy with puncture of synovial fluid; Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (9)
Cytokinic (other than IL-6) infiltration of tissues
Measured: Day 0
Serum cytokine levels
Measured: Day 0
Cytokine levels in joint or synovial fluid
Measured: Day 0
Tissue distribution of lymphocyte subpopulations by using the Hyperion mass cytometer (analysis of the intensity of the markings)
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.
Measured: Day 0
Serum distribution of lymphocyte subpopulations by using the HELIOS mass cytometer (analysis of the intensity of the markings)
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.
Measured: Day 0
Analysis of immunosenescence markers in tissues by HYPERION technology
Analysis of membrane markers related to immunosenescence in percent of cells expressing the marker and in MFI (Mean fluorescence intensity) by hyperion technology.
Measured: Day 0
Analysis of target molecules of treatments under study in PPR by ELISA technique
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).
Measured: Day 0
Analysis of target molecules of treatments under study in PPR by proteomic techniques
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)
Measured: Day 0
Complications of subacromio-deltoid purse in the 72h after biopsies : M1 phone call
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.
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start7 Apr 2021
- Primary completion13 Jul 2022
- Study completion13 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymyalgia RheumaticaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727879
- Sponsor's protocol ID
- 29BRC20.0158
- Acronym
- BAOBAB
- Status last verified
- Jul 2023
- First submitted
- 7 Jan 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond Analysis Of Blood Sample, to Approach Immunopathology of Polymyalgia Rheumatica on Shoulder Bursae's Biopsies: the BAOBAB Study
- ClinicalTrials.gov ID
- NCT04727879
- Acronym / sponsor ID
- BAOBAB / 29BRC20.0158
- Conditions
- Polymyalgia Rheumatica
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Aug 2022 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMR | Other | Procedure: Synovial membrane biopsy with puncture of synovial fluid, Procedure: Joint fluid sampling, Procedure: Blood samplePatients 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. |
| Control | Other | Procedure: Synovial membrane biopsy with puncture of synovial fluid, Procedure: Blood sampleWitnesses recruited into the orthopedic surgery department will be offered a synovial membrane biopsy during a shoulder surgery in the context of mechanical pathology. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Shoulder surgery scheduled for mechanical pathology
Key exclusion criteria (10 listed)
- 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
- History of biotherapy treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synovial membrane biopsy with puncture of synovial fluidThe 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. | Procedure or surgery | Control, PMR |
| Joint fluid samplingIn 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. | Procedure or surgery | PMR |
| Blood sampleA blood sample taken during routine care and unused will also be collected from patients and controls for immunoassays. | Procedure or surgery | Control, PMR |
Primary outcome
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.
9 secondary outcomes
Cytokinic (other than IL-6) infiltration of tissues
Time frame: Day 0
Serum cytokine levels
Time frame: Day 0
Cytokine levels in joint or synovial fluid
Time frame: Day 0
Tissue distribution of lymphocyte subpopulations by using the Hyperion mass cytometer (analysis of the intensity of the markings)
Time frame: Day 0
Serum distribution of lymphocyte subpopulations by using the HELIOS mass cytometer (analysis of the intensity of the markings)
Time frame: Day 0
Analysis of immunosenescence markers in tissues by HYPERION technology
Time frame: Day 0
Analysis of target molecules of treatments under study in PPR by ELISA technique
Time frame: Day 0
Analysis of target molecules of treatments under study in PPR by proteomic techniques
Time frame: Day 0
Complications of subacromio-deltoid purse in the 72h after biopsies : M1 phone call
Time frame: Month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synovial membrane biopsy with puncture of synovial fluid, Joint fluid sampling and Blood sample in people with Polymyalgia Rheumatica, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-6 marking (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.