Understanding of Rare Inflammatory Arthritis in Comparison to Classical Inflammatory Arthritis : Tissular Observations and Immune Infiltrate Characterization : the UTOPIC Project
New study compares rare inflammatory arthritis to common types
Plain English Summary
Understanding of Rare Inflammatory Arthritis in Comparison to Classical Inflammatory Arthritis : Tissular Observations and Immune Infiltrate Characterization : the UTOPIC Project is a Not Applicable clinical trial sponsored by University Hospital, Brest studying Inflammatory Arthritis, Rare Auto-immune Diseases, Immune Checkpoint Inhibitor Related Inflamamtory Arthritis. This study tests how inflammation in the joints differs between rare autoimmune diseases or drug-related arthritis and common types like rheumatoid arthritis. It's for adults over 18 who have inflammatory arthritis, including those linked to rare conditions or cancer treatments, and a control group with common inflammatory arthritis. Participation involves providing consent, undergoing a minimally invasive joint fluid or tissue sample (biopsy), and potentially other tests. Alternatives may include standard treatments for your specific condition, but this study offers a deeper look into the inflammation itself. The trial aims to enroll 100 participants.
Official 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 deve
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older who have been diagnosed with inflammatory arthritis. Patients with arthritis or bursitis related to rare autoimmune diseases or drug side effects (like from cancer immunotherapy). Patients with common inflammatory arthritis like rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, or polymyalgia rheumatica. Individuals cannot participate if they are pregnant, breastfeeding, on certain blood thinners, have contraindications to a biopsy, or have recently received specific advanced arthritis treatments. This trial is studying Inflammatory Arthritis, Rare Auto-immune Diseases, Immune Checkpoint Inhibitor Related Inflamamtory Arthritis, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures will help doctors understand the specific types of immune cells and molecules causing inflammation in the joint, which can guide the development of more precise treatments The specific primary outcome measures are: characterize the inflammatory infiltrate in synovial biopsies (Day 1). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because understanding the specific causes of rare inflammatory arthritis, especially those linked to new cancer therapies, can lead to better, more targeted treatments and reduce re This research targets Inflammatory Arthritis, Rare Auto-immune Diseases, Immune Checkpoint Inhibitor Related Inflamamtory Arthritis, where improved treatment options are needed.
Investor Insight
This study addresses a growing clinical need for understanding immunotherapy-related inflammatory arthritis, a niche but expanding area with potential for novel drug development and precision medicine
Is This Trial Right for Me?
Ask your doctor about the risks and benefits of a synovial biopsy and what the procedure involves. Understand how the study will collect and use your tissue and health information. Be prepared for potential follow-up appointments and tests related to the study. This trial is currently recruiting participants. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 100 participants
Interventions
- PROCEDURE: Biopsy — "A synovial biopsy will be carried out as recommended
Primary Outcomes
- characterize the inflammatory infiltrate in synovial biopsies (Day 1)
Secondary Outcomes
- 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)
Full Eligibility Criteria
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 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. 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 * 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
- CHU bordeaux, Bordeaux, France
- CHU Brest - Hôpital Morvan, Brest, France
Frequently Asked Questions
What is clinical trial NCT07302074?
NCT07302074 is a Not Applicable INTERVENTIONAL study titled "Understanding of Rare Inflammatory Arthritis in Comparison to Classical Inflammatory Arthritis : Tissular Observations and Immune Infiltrate Characterization : the UTOPIC Project." It is currently recruiting and is sponsored by University Hospital, Brest. The trial targets enrollment of 100 participants.
What conditions does NCT07302074 study?
This trial investigates treatments for Inflammatory Arthritis, Rare Auto-immune Diseases, Immune Checkpoint Inhibitor Related Inflamamtory Arthritis. The primary condition under study is Inflammatory Arthritis.
What treatments are being tested in NCT07302074?
The interventions being studied include: Biopsy (PROCEDURE). "A synovial biopsy will be carried out as recommended
What does Not Applicable mean for NCT07302074?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07302074?
This trial is currently "Recruiting." It started on 2026-03-27. The estimated completion date is 2031-03-03.
Who is sponsoring NCT07302074?
NCT07302074 is sponsored by University Hospital, Brest. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07302074?
The trial aims to enroll 100 participants. The trial is currently recruiting and accepting new participants.
How is NCT07302074 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07302074?
The primary outcome measures are: characterize the inflammatory infiltrate in synovial biopsies (Day 1). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07302074 being conducted?
This trial is being conducted at 2 sites, including Bordeaux; Brest (France).
Where can I find official information about NCT07302074?
The official record for NCT07302074 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07302074. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07302074 testing in simple terms?
This study tests how inflammation in the joints differs between rare autoimmune diseases or drug-related arthritis and common types like rheumatoid arthritis. It's for adults over 18 who have inflammatory arthritis, including those linked to rare conditions or cancer treatments, and a control group with common inflammatory arthritis.
Why is this trial significant?
This trial matters because understanding the specific causes of rare inflammatory arthritis, especially those linked to new cancer therapies, can lead to better, more targeted treatments and reduce re
What are the potential risks of participating in NCT07302074?
The main risk is related to the biopsy procedure, which can include pain, bleeding, or infection at the sample site. There's a small risk of temporary worsening of joint pain or swelling after the biopsy. Potential side effects from the diagnostic tests used to analyze the samples are generally minimal. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07302074?
Ask your doctor about the risks and benefits of a synovial biopsy and what the procedure involves. Understand how the study will collect and use your tissue and health information. Be prepared for potential follow-up appointments and tests related to the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07302074 signal from an investment perspective?
This study addresses a growing clinical need for understanding immunotherapy-related inflammatory arthritis, a niche but expanding area with potential for novel drug development and precision medicine This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves providing consent, undergoing a minimally invasive joint fluid or tissue sample (biopsy), and potentially other tests. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.