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|Eligible Ages||18 Years and Over|
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Cagliari|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Annamaria Iagnocco, ProfAlen Zabotti, MDMarco CanzoniIgnazio Benedetto Olivieri|
|Principal Investigator Affiliation||Università di Torino, ItalyUniversity Hospital "Santa Maria della Misericordia", Udine, ItalyLocal Health Unit (ASL) Rome-1, Rome-4, Viterbo, ItalyItalian Society of Rheumatology|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Arthritis, Psoriatic, Ultrasonography, Minimal Disease, Residual|
BACKGROUND Psoriatic arthritis (PsA) is a systemic inflammatory disease with articular and extra-articular features. To date remission is considered to be the ultimate goal of therapy in PsA, however, due to the characteristics of the disease with involvement of different domains, remission may be difficult to achieve and maintain and so a minimal disease activity (MDA) could be an acceptable goal. In view of the therapeutic target of remission or MDA, the identification of adverse prognostic factors and the best treatment strategy are two of the most important items in research agenda of PsA. 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 (RA), the studies are still limited. Undoubtedly, the concept of treat-to-target (T2T) in PsA needs further studies, especially with longer follow up and larger samples. In T2T strategies, it is necessary to quantify the disease activity and this is possible by composite indices. The heterogeneity of PsA including axial and peripheral involvement and specific features (i.e. dactylitis, enthesitis) as well as extra-articular features makes the use of a single composite index (e.g. Disease Activity for Psoriatic Arthritis-DAPSA, Composite Psoriatic Disease Activity Index-CPDAI) a challenge not resolved yet. An interesting possibility is to integrate musculoskeletal ultrasonography (US) with clinical examination to stratify patients and to decide treatments in a T2T strategy. In the last years the role of imaging is grown up and EULAR recommendations on the use of imaging techniques in chronic arthritis recognize the high sensitivity of US to detect disease activity better than clinical examination alone although the utility of US in clinical practice is not supported by sufficient evidence yet AIM 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. Identifying prognostic factors of achieving remission or low disease activity will allow a better selection of patients with poorer outcome and a following improvement of the therapeutic strategies. Furthermore the possibility that US could be an added prognostic value makes this study a clear example of integration between the clinic and US. This study will respond to the need of tailoring treatment that would allow clinicians to practice a more effective and personalized medicine, optimizing the outcomes of patients with PsA as well as the treatments management. STUDY OBJECTIVES PRIMARY OBJECTIVE In clinically diagnosed PsA with clinically active joint disease starting a new course of therapy, to evaluate the additional value of US-score (US-score PsA-SIR) over clinical examination in detecting patients achieving MDA at 6 months. SECONDARY OBJECTIVES In clinically diagnosed PsA with clinically active joint disease starting a new course of therapy:
- - to evaluate the additional value of US over clinical examination in detecting patients: - achieving MDA at 12 months (including sustained) - achieving DAPSA remission at 6 and 12-months (including sustained) - achieving American College of Rheumatology (ACR) remission at 6 and 12 months (including sustained) - with X-ray structural progression using the modified Sharp-van der Heijde score (mSvHs) at 12 and 24 months - with US structural progression (US-damage score) at 12 and 24 months - with functional worsening measured using Health Assessment Questionnaire (delta HAQ>0.23) at 12 and 24 months - with impairment of Health Related Quality of Life (HRQoL) measured with Psoriatic Arthritis Impact of Disease (PsAID) questionnaire at 12 and 24 months; - to evaluate the relationship between time-integrated US-detected inflammation and US-detected damage at 12 and 24 months; - to evaluate the comparative effectiveness of different treatment strategies on MDA, DAPSA remission, HAQ>0.23, X-ray progression (mSvHs), US-inflammation score, US-damage score; - to evaluate residual US activity in patients in MDA remission; - to explore whether clinically-detected disease activity due to joint tenderness without swelling is related to joint or extra-articular US-detected inflammation evaluated by US; - to explore clinical features and US-lesions related to X-ray detected bony apposition.
- - is fatal or life-threatening - results in persistent or significant disability/incapacity - constitutes a congenital anomaly/birth defect - requires inpatient hospitalization or prolongation of existing hospitalization.
- - MDA at 12 months, sustained MDA at 6 AND 12 months - DAPSA <3.3 at 6 months, 12 months, 6 AND 12 months - deltam SvHs 0-12 and 0-24 months - delta HAQ 0-12 and 0-24 months - delta PSAID 0-12 and 0-24 months - US-score PsA-SIR damage subscore at 0-6-12 months US PREDICTORS - US-score PsA-SIR - US-score PsA-SIR inflammation subscore - US-score PsA-SIR damage subscore CLINICAL PREDICTORS Based on the relevant literature clinical variables to be considered in the model include: - Demographic and environmental factors: - Age - Gender - Smoking - BMI - Clinical factors: - subset of PsA - time from symptoms onset to diagnosis - disease duration - disease activity (DAPSA and BASDAI) - HAQ score - tender joints / pain - comorbidities (FM, MetS) - Serological factors: - Acute phase reactants - Therapy factors: - Treatment (NSAIDs, steroids, DMARDs) DESCRIPTIVE ANALYSES Descriptive data will be provided for all outcomes according to data type; number of patients (N), mean, standard deviation (for interval data), median 25% and 75% quartiles (for ordinal data).
: Patients with active Psoriatic Arthritis
Patients with clinically diagnosed PsA with clinically active joint disease starting a new course of treatment.
Drug: - New course of treatment
Prescription of new course of NSAIDs (monotherapy), steroid intra-articular injections (monotherapy), conventional DMARDs, biologic DMARDs, including switches or dose augmentations, indicated by the treating rheumatologist according to usual clinical practice.
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