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

NCT07302074 | Not Yet Recruiting

• 1 other identifier: 29BRC24.037
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Immune Checkpoint Inhibitor Related Inflamamtory Arthritis; Inflammatory Arthritis; Rare Auto-immune Diseases

Keywords

immune checkpoint inhibitor related inflamamtory arthritis; Inflammatory arthritis; rare auto-immune diseases; connective tissue disease

Outcome Measures

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.

  Day 1

Secondary Outcomes (6)

• Study of the cytokine environment

  day 1

• Study of the cytokine environment

  day 1

• comparison of the cytokine environment

  day 1

• Study of the gene expression profile of immune cells

  day 1

• Study of the gene expression profile of immune cells

  day 1

Study Arms (2)

Arm A

EXPERIMENTAL

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

Procedure: Biopsy

Arthritis or bursitis

OTHER

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

"A synovial biopsy will be carried out as recommended

Arm A; Arthritis or bursitis

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead
• University Hospital, Bordeaux: collaborator

Study Sites (2)

CHU bordeaux

Bordeaux, 33404, France

Location

CHU Brest - Hôpital Morvan

Brest, 29200, France

Location

MeSH Terms

Conditions

Arthritis; Connective Tissue Diseases

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Alice Tison, Dr

CONTACT

+33(0)298347264; alice.tison@chu-brest.fr

Study Design

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

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 24, 2025
• Study Start: December 25, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

FR (2)