Synovial Tissue and Blood Signature of Rheumatoid Arthritis Patients With Disease Flare After Treatment Discontinuation for Sustained Remission.

Study Overview
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Brief Summary
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Flares of immune-mediated inflammatory diseases, as Rheumatoid Arthritis (RA), are a major burden for patients in routine care. They occur unpredictably, adding to the physical and psychological burden of the condition. In this study we will deeply dissect the synovial tissue and peripheral blood signature of RA in sustained remission eligible to treatment discontinuation to better understand the individualized factors determining disease flare once biological treatment is discontinued. We expect that the combined study of synovial tissue, imaging and peripheral blood derived biomarkers, associated with disease flare after treatment discontinuation in RA in remission, will provide a tool for the routine assessment of RA eligible to treatment discontinuation reducing the relapse rate and increasing the optimization of the use of expensive pharmacological treatments only for patients still needing them.

Official Title
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Synovial Tissue and Blood Signature to Personalize the Management of Rheumatoid Arthritis Patients With Disease Flare After Biological DMARDs Discontinuation for Sustained Remission.

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Procedure: Evaluation of subclinical inflammation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of RA following the 2010 ACR/EULAR classification criteria Age ≥18 and ≤75 years Sustained remission (DAS<1.6 for at least 3 sequential evaluations 6months apart). Without evidence of ultrasound detected synovitis (Power Doppler negative in knee, wrist, II-V MCP, II-V PIP and II-V MTP bilaterally). Patients under treatment with stable dose of conventional, synthetic or biological DMARDs. Patients without steroid treatment in the last 6 months. Exclusion Criteria: With other diagnosis of chronic joint diseases rather than RA. Unable to participate to the clinical outpatient follow-up. Exposed to steroid treatment within 6 months from study screening. With evidence of ultrasound detected synovitis (Power Doppler positivity) in other joints than the ones included in the screening visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RA patients in sustained clinical and ultrasound remission not changing treatment<br> | Procedure: Evaluation of subclinical inflammation<br>* Minimally invasive synovial tissue biopsy for the semiquantitative and qualitative assessment of synovial immune and stromal cells; Peripheral blood collection for MBDA assessment and phenotyping of immune cells;<br>|
| RA patients in sustained clinical and ultrasound remission changing treatment<br> | Procedure: Evaluation of subclinical inflammation<br>* Minimally invasive synovial tissue biopsy for the semiquantitative and qualitative assessment of synovial immune and stromal cells; Peripheral blood collection for MBDA assessment and phenotyping of immune cells;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease flare rate |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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synovial tissue, disease flare, sustained remission, peripheral blood