Clinical trial · Observational
Ultrasound in Psoriatic Arthritis Treatment
Ultrasound in PSoriatic Arthritis TREAtMent - UPSTREAM
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
BACKGROUND Psoriatic arthritis (PsA) is a systemic inflammatory disease with articular and extra-articular features. Establishing the prognosis of a patient with PsA is hence important to define the treatment strategy. Currently, observational and prospective cohort studies have identified prognostic factors correlating with the achievement of therapeutic response. Nevertheless, despite the importance of identifying prognostic factors in a disease with a functional disability comparable to rheumatoid arthritis, the studies are still limited. PRIMARY OBJECTIVE In PsA with clinically active joint disease starting a new course of therapy, to evaluate the additional value of UltraSound(US)-score over clinical examination in detecting patients achieving MDA at 6 months. STUDY DESIGN The study follows a multi-centre observational prospective cohort study design. PATIENTS AND METHODS INCLUSION CRITERIA * Adult \> 18 years of age with PsA (PsA according to the ClASsification criteria for Psoriatic Arthritis (CASPAR) - with joint involvement) * At least one joint clinically involved (both swelling and tenderness); * prescription of new course of d NSAIDs (monotherapy), steroid intra-articular injections (monotherapy), conventional Disease-Modifying AntiRheumatic Drugs (DMARDs), biologic DMARDs, including switches or dose augmentations indicated by the treating rheumatologist according to usual clinical practice before US acquisition; * Stable treatment before treatment modification (6 weeks); * Signed informed consent form. CLINICAL ASSESSMENT Patient's clinical assessment will be performed according to the core set of domains for PsA proposed by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT). ULTRASOUND ASSESSMENT Sonographic evaluations will be performed by expert ultrasonographers in 44 joints, 36 tendons, 12 entheses and 2 bursae according to the score developed for psoriatic arthritis by the study group ultrasound of the Italian Society of Rheumatology (US-score PsA-SIR) EXPECTED RESULTS AND SIGNIFICANCE The aim of this study is to identify clinical and US predictors of achieving MDA in PsA patients with active peripheral arthritis starting a new course of therapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthritis, Psoriatic | — | UNRESOLVED | — |
| Minimal Disease, Residual | — | UNRESOLVED | — |
| Ultrasonography | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| New course of treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with active Psoriatic Arthritis
- description
- Patients with clinically diagnosed PsA with clinically active joint disease starting a new course of treatment.
- interventionNames
- Drug: New course of treatment
Primary outcomes (1)
- measure
- Minimal disease activity
- timeFrame
- 6 months
- description
- The Minimal disease activity (MDA) calculation will be based on the evaluation of 7 variables: 1. 68 tender joints count (≤1) 2. 66 swollen joint count (≤1) 3. Body Surface Area (BSA) ≤3 4. Patient pain VAS (≤15 mm); 5. Patient global disease activity VAS (≤20 mm); 6. HAQ (≤0.5); 7. Leeds Enthesitis Index (LEI) tender entheseal points (≤1) Patients will be classified as having MDA if they meet 5 out of these 7 criteria (value in brackets).
Secondary outcomes (7)
- measure
- Minimal disease activity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult \> 18 years of age with PsA (according to the CASPAR classification Criteria) * Clinically active arthritis, with at least one joint clinically involved (both swelling and tenderness) in patient not achieving the MDA; * Subject newly prescribed NSAIDs (monotherapy), steroid intra-articular injections (monotherapy), conventional DMARD, biologic DMARDs as indicated by the treating rheumatologist according to usual clinical practice before US acquisition; * Stable treatment before treatment modification (6 weeks); * Signed informed consent form; Exclusion Criteria: * Minimal disease activity a the time of enrolment
References
Publications (10)
- BACKGROUNDMoll JM, Wright V. Psoriatic arthritis. Semin Arthritis Rheum. 1973;3(1):55-78. doi: 10.1016/0049-0172(73)90035-8. No abstract available. PMID 4581554
- BACKGROUNDCoates LC, Helliwell PS. Validation of minimal disease activity criteria for psoriatic arthritis using interventional trial data. Arthritis Care Res (Hoboken). 2010 Jul;62(7):965-9. doi: 10.1002/acr.20155. PMID 20589696
- BACKGROUNDGossec L, Smolen JS, Ramiro S, de Wit M, Cutolo M, Dougados M, Emery P, Landewe R, Oliver S, Aletaha D, Betteridge N, Braun J, Burmester G, Canete JD, Damjanov N, FitzGerald O, Haglund E, Helliwell P, Kvien TK, Lories R, Luger T, Maccarone M, Marzo-Ortega H, McGonagle D, McInnes IB, Olivieri I, Pavelka K, Schett G, Sieper J, van den Bosch F, Veale DJ, Wollenhaupt J, Zink A, van der Heijde D. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016 Mar;75(3):499-510. doi: 10.1136/annrheumdis-2015-208337. Epub 2015 Dec 7. PMID 26644232
- BACKGROUNDSaber TP, Ng CT, Renard G, Lynch BM, Pontifex E, Walsh CA, Grier A, Molloy M, Bresnihan B, Fitzgerald O, Fearon U, Veale DJ. Remission in psoriatic arthritis: is it possible and how can it be predicted? Arthritis Res Ther. 2010;12(3):R94. doi: 10.1186/ar3021. Epub 2010 May 18. PMID 20482783
- BACKGROUNDGlintborg B, Ostergaard M, Krogh NS, Andersen MD, Tarp U, Loft AG, Lindegaard HM, Holland-Fischer M, Nordin H, Jensen DV, Olsen CH, Hetland ML. Clinical response, drug survival, and predictors thereof among 548 patients with psoriatic arthritis who switched tumor necrosis factor alpha inhibitor therapy: results from the Danish Nationwide DANBIO Registry. Arthritis Rheum. 2013 May;65(5):1213-23. doi: 10.1002/art.37876. PMID 23460467
- BACKGROUNDCoates LC, Moverley AR, McParland L, Brown S, Navarro-Coy N, O'Dwyer JL, Meads DM, Emery P, Conaghan PG, Helliwell PS. Effect of tight control of inflammation in early psoriatic arthritis (TICOPA): a UK multicentre, open-label, randomised controlled trial. Lancet. 2015 Dec 19;386(10012):2489-98. doi: 10.1016/S0140-6736(15)00347-5. Epub 2015 Oct 1.