Inflammatory ArthritisUTOPICNCT07302074
Understanding of Rare Inflammatory Arthritis in Comparison to Classical Inflammatory Arthritis : Tissular Observations and Immune Infiltrate Characterization : the UTOPIC Project
A study testing Biopsy in people with Inflammatory Arthritis and Rare Auto-immune Diseases, run by University Hospital, Brest at 2 sites in France.
Trial summary
The pathophysiology of certain inflammatory arthritides remains poorly understood, particularly when associated with rare systemic autoimmune diseases such as systemic sclerosis (SSc), or when emerging in the context of immune-related adverse events from cancer immunotherapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Arthritis, Rare Auto-immune Diseases, Immune Checkpoint Inhibitor Related Inflamamtory Arthritis
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Mar 2026to 3 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For all participants:
- Signed consent form
- Patients over 18 years old
- Affiliated with a social security scheme
- For cases:
- Referred for arthritis or bursitis occurring in the context of a rare systemic autoimmune disease (SAID) or drug-induced toxicity.
Show all 15Show fewer
- Presenting at least one clinical arthritis with synovial thickening confirmed by ultrasound (grade ≥2 in B-mode) and Doppler inflammation of grade ≥1, or synovial thickening ≥B2 associated with joint effusion.
- For bursitis: thickening ≥2mm of at least one periarticular bursa on ultrasound associated with Doppler inflammation of grade ≥1, or synovial thickening ≥2mm associated with joint effusion, with clinical evidence of inflammatory involvement.
- For the control group:
- For arthritis:
- Presenting clinical arthritis with synovial thickening confirmed by ultrasound (grade ≥2 in B-mode (B2)) and Doppler inflammation of grade ≥1, or synovial thickening ≥B2 associated with joint effusion.
- Diagnosed, according to disease-specific classification criteria, with either rheumatoid arthritis (according to ACR/EULAR 2010 criteria), axial or peripheral spondyloarthritis (according to ASAS 2009 criteria), psoriatic arthritis (according to CASPAR criteria), or reactive arthritis based on clinician assessment.
- For bursitis:
- Thickening ≥2mm of at least one periarticular bursa on ultrasound associated with Doppler inflammation of grade ≥1, or synovial thickening ≥2mm associated with joint effusion.
- Meeting the ACR/EULAR 2012 criteria for polymyalgia rheumatica.
Who cannot join
- For all participants:
- Patients under protective measures or unable to consent
- Pregnant or breastfeeding women
- Anticoagulant treatment: vitamin K antagonists (Coumadin, fluindione), direct oral anticoagulants (Eliquis, Pradaxa, Rivaroxaban), heparins at curative doses
- Contraindication to local procedure: lymphedema near the joint, chronic wound at the site of the joint, joint prosthesis on the affected joint, corticosteroid infiltration less than 3 months ago at the same site
- History of treatment with biotherapy or targeted therapy (JAK inhibitors) within the last 3 months, or within the last 6 months if treated with Rituximab
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
CHU bordeaux
Bordeaux, 33404
Marie-elise Truchetet, professeur, +(0) 0556794919, Marie-elise.truchetet@chu-bordeaux.fr
- Recruiting
CHU Brest - Hôpital Morvan
Brest, 29200
Alice Tison, Dr, + 33 (0)2 98 34 72 64, alice.tison@chu-brest.fr
About this study
The pathophysiology of certain inflammatory arthritides remains poorly understood, particularly when associated with rare systemic autoimmune diseases such as systemic sclerosis (SSc), or when emerging in the context of immune-related adverse events from cancer immunotherapies. These immunotherapy-induced arthritides represent a new and increasingly encountered clinical entity in rheumatology. A deeper understanding of the mechanisms underlying joint inflammation in these settings is essential for identifying specific therapeutic targets, especially given the limitations of current treatment options and the risks associated with broad immunosuppressive strategies such as prolonged corticosteroid use, which may impair anti-tumor immune responses.
Synovial biopsy analysis provides a powerful tool for dissecting the cellular and molecular components of joint inflammation, including immune cell infiltration, cytokine profiles, and cell-cell interactions. Advances in high-dimensional techniques such as multiplex immunofluorescence and mass cytometry now allow for the identification and spatial localization of numerous protein markers at the subcellular level. Additionally, spatial transcriptomics offers complementary insight into gene expression profiles within the tissue microenvironment, providing a comprehensive understanding of inflammatory processes.
The investigators propose a prospective, proof-of-concept study to characterize and compare rare and emerging inflammatory arthritides-including those linked to SSc and immunotherapy-related immune toxicity-with classical inflammatory rheumatic diseases such as rheumatoid arthritis (RA), psoriatic arthritis (PsA), spondyloarthritis (SpA), polymyalgia rheumatica (PMR), and reactive arthritis. Through detailed immunological and molecular profiling, this study aims to identify disease-specific signatures and novel therapeutic targets. These findings could pave the way for precision medicine approaches and inform the development of targeted therapies in both rare and common forms of inflammatory arthritis.
- Conditions
- Inflammatory Arthritis, Rare Auto-immune Diseases, Immune Checkpoint Inhibitor Related Inflamamtory Arthritis
- Being tested
- Biopsy
- Keywords
- immune checkpoint inhibitor related inflamamtory arthritis, Inflammatory arthritis, rare auto-immune diseases, connective tissue disease
- Medical subject headings
- Arthritis, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
"A synovial biopsy will be carried out as recommended
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Arthritis or bursitis occurring in the context of a rare MIS or drug-induced toxicity." Receives: Procedure: Biopsy |
| Arthritis or bursitis | Other | Not described Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
characterize the inflammatory infiltrate in synovial biopsies
Establishment of a biobank to characterize the inflammatory infiltrate in synovial biopsies from arthritis or bursitis occurring in the context of rare systemic autoimmune diseases (SAIDs) or immune-mediated drug toxicities, and to compare it with the infiltrate in the synovium of arthritis/bursitis associated with common inflammatory rheumatic conditions frequently encountered in rheumatology.
Measured: Day 1
Secondary outcomes (6)
Study of the cytokine environment
Study of the cytokine environment within synovial biopsies from arthritis/bursitis occurring in the context of rare autoimmune/inflammatory syndromes or drug toxicity
Measured: day 1
Study of the cytokine environment
Study of the cytokine environment within synovial biopsies fromarthritis/bursitis arising in common inflammatory rheumatic diseases.
Measured: day 1
comparison of the cytokine environment
comparison cytokine environment within synovial biopsies from arthritis/bursitis occurring in the context of rare autoimmune/inflammatory syndromes or drug toxicity, n with that of arthritis/bursitis arising in common inflammatory rheumatic diseases.
Measured: day 1
Study of the gene expression profile of immune cells
Study of the gene expression profile of immune cells present within synovial biopsies from arthritis/bursitis occurring in the context of rare autoimmune/inflammatory syndromes or drug toxicity,
Measured: day 1
Study of the gene expression profile of immune cells
Study of the gene expression profile of immune cells present that of arthritis/bursitis occurring in common inflammatory rheumatic diseases."
Measured: day 1
comparison of the gene expression profile of immune cells
comparison of the gene expression profile of immune cells in synovial biopsies from arthritis/bursitis occurring in the context of rare autoimmune/inflammatory syndromes or drug toxicity versus those from arthritis/bursitis occurring in common inflammatory rheumatic diseases
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start27 Mar 2026
- Primary completion3 Mar 2031 (estimated)
- Study completion3 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ArthritisStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302074
- Sponsor's protocol ID
- 29BRC24.037
- Acronym
- UTOPIC
- Status last verified
- Mar 2026
- First submitted
- 28 Nov 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding of Rare Inflammatory Arthritis in Comparison to Classical Inflammatory Arthritis : Tissular Observations and Immune Infiltrate Characterization : the UTOPIC Project
- ClinicalTrials.gov ID
- NCT07302074
- Acronym / sponsor ID
- UTOPIC / 29BRC24.037
- Conditions
- Inflammatory Arthritis, Rare Auto-immune Diseases, Immune Checkpoint Inhibitor Related Inflamamtory Arthritis
- Keywords
- immune checkpoint inhibitor related inflamamtory arthritis, Inflammatory arthritis, rare auto-immune diseases, connective tissue disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 3 Mar 2031 (estimated)
- Study completion
- 3 Mar 2031 (estimated)
- First posted
- 24 Dec 2025 (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 pathophysiology of certain inflammatory arthritides remains poorly understood, particularly when associated with rare systemic autoimmune diseases such as systemic sclerosis (SSc), or when emerging in the context of immune-related adverse events from cancer immunotherapies. These immunotherapy-induced arthritides represent a new and increasingly encountered clinical entity in rheumatology. A deeper understanding of the mechanisms underlying joint inflammation in these settings is essential for identifying specific therapeutic targets, especially given the limitations of current treatment options and the risks associated with broad immunosuppressive strategies such as prolonged corticosteroid use, which may impair anti-tumor immune responses.
Synovial biopsy analysis provides a powerful tool for dissecting the cellular and molecular components of joint inflammation, including immune cell infiltration, cytokine profiles, and cell-cell interactions. Advances in high-dimensional techniques such as multiplex immunofluorescence and mass cytometry now allow for the identification and spatial localization of numerous protein markers at the subcellular level. Additionally, spatial transcriptomics offers complementary insight into gene expression profiles within the tissue microenvironment, providing a comprehensive understanding of inflammatory processes.
The investigators propose a prospective, proof-of-concept study to characterize and compare rare and emerging inflammatory arthritides-including those linked to SSc and immunotherapy-related immune toxicity-with classical inflammatory rheumatic diseases such as rheumatoid arthritis (RA), psoriatic arthritis (PsA), spondyloarthritis (SpA), polymyalgia rheumatica (PMR), and reactive arthritis. Through detailed immunological and molecular profiling, this study aims to identify disease-specific signatures and novel therapeutic targets. These findings could pave the way for precision medicine approaches and inform the development of targeted therapies in both rare and common forms of inflammatory arthritis.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Procedure: BiopsyArthritis or bursitis occurring in the context of a rare MIS or drug-induced toxicity." |
| Arthritis or bursitis | Other | Procedure: Biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- For all participants:
- For cases:
- For bursitis: thickening ≥2mm of at least one periarticular bursa on ultrasound associated with Doppler inflammation of grade ≥1, or synovial thickening ≥2mm associated with joint effusion, with clinical evidence of inflammatory involvement.
- Presenting clinical arthritis with synovial thickening confirmed by ultrasound (grade ≥2 in B-mode (B2)) and Doppler inflammation of grade ≥1, or synovial thickening ≥B2 associated with joint effusion.
- Diagnosed, according to disease-specific classification criteria, with either rheumatoid arthritis (according to ACR/EULAR 2010 criteria), axial or peripheral spondyloarthritis (according to ASAS 2009 criteria), psoriatic arthritis (according to CASPAR criteria), or reactive arthritis based on clinician assessment.
Key exclusion criteria (6 listed)
- For all participants:
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 |
|---|---|---|
| Biopsy"A synovial biopsy will be carried out as recommended | Procedure or surgery | Arm A, Arthritis or bursitis |
Primary outcome
characterize the inflammatory infiltrate in synovial biopsies
Time frame: Day 1
Establishment of a biobank to characterize the inflammatory infiltrate in synovial biopsies from arthritis or bursitis occurring in the context of rare systemic autoimmune diseases (SAIDs) or immune-mediated drug toxicities, and to compare it with the infiltrate in the synovium of arthritis/bursitis associated with common inflammatory rheumatic conditions frequently encountered in rheumatology.
6 secondary outcomes
Study of the cytokine environment
Time frame: day 1
Study of the cytokine environment
Time frame: day 1
comparison of the cytokine environment
Time frame: day 1
Study of the gene expression profile of immune cells
Time frame: day 1
Study of the gene expression profile of immune cells
Time frame: day 1
comparison of the gene expression profile of immune cells
Time frame: day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Inflammatory Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Inflammatory Arthritis and Rare Auto-immune Diseases, run by University Hospital, Brest at 2 sites 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 15 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice Tison, Dr (+33(0)298347264, alice.tison@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characterize the inflammatory infiltrate in synovial biopsies (time frame: Day 1). 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 3 Apr 2026.