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Different classes of biological targeted therapies (b-DMARDs) are available for psoriatic arthritis (PsA) and seronegative rheumatoid arthritis (RA) (TNF inhibitors, anti-IL23, anti-IL17). A variable percentage of subjects, however, does not respond the first b-DMARD. Musculoskeletal ultrasound (US) and synovial tissue analysis could provide useful information on the top of clinical variables to predict response. The primary aim of this project is to create a global single-cell RNA sequencing atlas of PsA synovitis and to evaluate the predictive value of clinical, US and synovial variables (inflammatory cells and synovial tissue-single cell signature) on disease trajectory outcome and treatment response.
Patients with PsA or seronegative RA at different disease stages will be enrolled. Clinical and US examination will be performed at baseline, 3, 6 and 12 months, while synovial biopsy at baseline and 6 months. The optimal combination of clinical, US and synovial variables to stratify treatment response will be developed. The sensitivity to change of US and synovial variables and their evaluation in patients achieving clinical remission will also be considered as secondary aims.
The expected results will help the optimisation of treatment strategies in patients with PsA and seronegative RA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PsO patients at risk of PsA development |
| ||
| naive to treatment PsA |
| ||
| TNF-inhibitor resistant PsA |
| ||
| IL-17-inhibitor resistant PsA |
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| TNF-inhibitor induced remission PsA |
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| IL-17-inhibitor induced remission PsA |
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| c-DMARDs resistant PsA |
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| c-DMARDs resistant RA |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenotyping of synovial immune and stromal cells | Other | Generate a comprehensive cellular and molecular atlas of PsA by CITE-Seq (single cell protein and transcriptomics) and spatial transcriptomics of synovium of PsO at risk of developing PsA and PsA patients across different disease stages. |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal Disease Activity status achievement | This outcome will be recorded for all study cohorts | 6 months |
| PsA development (Fulfilment of the CASPAR criteria) | This outcome will be recorded only for PsO patient with arthralgia at risk of PsA development | 12 months |
| Remission maintenance | This outcome will be recorded only for PsA patients in sustained remission | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Alivernini, MD, PhD | Contact | 00390630154503 | stefano.alivernini@policlinicogemelli.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Rheumatology | Recruiting | Rome | 00168 | Italy |
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|
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| School of Immunity and Infection | Active, not recruiting | Glasgow | United Kingdom |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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