ClinicalTrials.gg
RecruitingNCT07302074UTOPICUpdated Apr 3, 2026

Understanding of Rare Inflammatory Arthritis in Comparison to Classical Inflammatory Arthritis : Tissular Observations and Immune Infiltrate Characterization : the UTOPIC Project

An interventional study of Biopsy in Inflammatory Arthritis, Rare Auto-immune Diseases and Immune Checkpoint Inhibitor Related Inflamamtory Arthritis, sponsored by University Hospital, Brest. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by University Hospital, Brest · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 70 studies in Arthritis with a site in France — 9 open to participants now, 16 under way, 4 of them phase 3. Arthritis · France.

Planned enrollment
26th of 39
100 · median 220
Started
2026
with 1 other
No phase
8 of 70
2 open now
Primary completion
2031-03
later than 11 of 15 live
Registered
68th of 70
by date

Among the 70 studies in Arthritis with a site in France, this one is the 26th largest by planned enrollment of the 39 interventional ones, is one of 2 that started in 2026, is one of 8 with no phase, reaches primary completion later than 11 of the 15 other live ones, and was the 68th registered.

By phase

70 studies; the count open now beside each. This study's row is marked.

Observational31 · 3 open
Phase 320 · 2 open
No phasethis study8 · 2 open
Phase 44 · 0 open
Phase 23 · 0 open
Phase 12 · 1 open
Phase 2/32 · 1 open

By the year they started

First in 2000; this study’s year is marked. 2 started in 2026.

Size and results

Median enrollment 220 across the 39 interventional studies, 201 across the 31 observational. Of the 45 that completed or were terminated, 22 (49%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 70 studies in Arthritis with a site in France, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 disease (SAID) or drug-induced toxicity.
    • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
    • to local procedure: lymphedema near the joint, chronic wound at the site of the joint, joint prosthesis on the affected joint, 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Arm A

    Arthritis or bursitis occurring in the context of a rare MIS or drug-induced toxicity."

    Procedure: Biopsy

  • Other
    Arthritis or bursitis

    Procedure: Biopsy

Interventions

  • ProcedureBiopsy

    "A synovial biopsy will be carried out as recommended

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1

Secondary outcomes

  1. 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

    Time frame: day 1

  2. Study of the cytokine environment

    Study of the cytokine environment within synovial biopsies fromarthritis/bursitis arising in common inflammatory rheumatic diseases.

    Time frame: day 1

  3. 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.

    Time frame: day 1

  4. 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,

    Time frame: day 1

  5. 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."

    Time frame: day 1

  6. 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

    Time frame: day 1

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Mar 2031, 59 months after the start.

Of 134 non-industry interventional studies with no phase under Arthritis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 57. This study's planned 59 months is above that.

Counting every sponsor, half of 167 studies reached it within 31 months; a quarter within 13 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2025
First posted
Dec 24, 2025
StartActual
Mar 27, 2026
Primary completionEst.
Mar 3, 2031
CompletionEst.
Mar 3, 2031
Last update
Apr 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07302074
Responsible party
Sponsor
First posted
Dec 24, 2025
Start date
Mar 27, 2026
Primary completion
Mar 3, 2031 (estimated)
Completion
Mar 3, 2031 (estimated)
Last update
Apr 3, 2026

Study contacts

Alice Tison, Dr
Contact
alice.tison@chu-brest.fr
+33(0)298347264

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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