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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RA patients in sustained clinical and ultrasound remission not changing treatment |
| ||
| RA patients in sustained clinical and ultrasound remission changing treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of subclinical inflammation | Procedure | 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; |
| Measure | Description | Time Frame |
|---|---|---|
| Disease flare rate | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Rheumatoid Arthritis in stable remission (DAS<1.6 for at least 6 months) and under treatment with stable dose of conventional, synthetic or biological DMARDs. All patients at the time of enrolment must fulfil the ultrasound criteria of Power Doppler negativity of knee, wrist, II-V MCP and II-V MTP bilaterally and any other reported painful joint not included in the screening ultrasound protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOC Reumatologia - Policlinico di Bari | Bari | Apulia | 70100 | Italy | ||
| Centro di Ricerca E. Menni - Fondazione Poliambulanza Brescia |
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| Brescia |
| Lombardy |
| 25121 |
| Italy |
| Division of Rheumatology | Rome | 00168 | Italy |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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