Effectiveness of Treatment With Tofacitinib in Patients With Psoriatic Arthritis in Routine Clinical Practice

Study Overview
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Brief Summary
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This is a Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis in order to evaluate the effectiveness of treatment with tofacitinib on disease activity, remission, and Quality of Life, in a real-world setting over a 12-month observation period

Official Title
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A Non-Interventional Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis

Conditions
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Psoriatic Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: Patients aged ≥ 18 years Moderate to severe PsA disease activity diagnosed Patients for whom the physician's decision has been made to initiate treatment with tofacitinib, in usual clinical practice conditions and in compliance with the local label Patients are treatment naïve to tofacitinib on the date of providing informed consent Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study Patients on DMARDs must have not had a treatment change in the past 3 months Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study: Contraindications according to the Xeljanz® (tofacitinib) Prescribing Information Receipt of any investigational drug within 3 months before study inclusion Patient is pregnant or breastfeeding Recent herpes zoster infection (within past 6 months) or history of severe disseminated herpes zoster infection Active treatment for a malignancy Concomitant treatment with a biological disease-modifying antirheumatic drugs (bDMARD)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achievinglow disease activity (LDA) defined as psoriatic arthritis disease activity score (PASDAS) score ≤3.2 |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving low disease activity (LDA) defined as psoriatic arthritis disease activity score (PASDAS) score ≤3.2 |  | at 3 and 12 Months | 
| Proportion of patients achieving minimal disease activity (MDA) defined as at least 5 of 7 criteria met |  | Months 3, 6, 12 | 
| Proportion of patients achieving remission defined as psoriatic arthritis disease activity score (PASDAS) score ≤1.9 |  | Months 3, 6, 12 | 
| Proportion of patients achieving remission defined as disease activity in psoriatic arthritis (DAPSA) score ≤4.0 |  | Months 3, 6,12 | 
| Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID12) score |  | Months 3, 6,12 | 
| Change from baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) score |  | Months 3, 6,12 | 
| Proportion of patients achieving low disease activity (LDA) at Months 3, 6, and 12 based on presence of prognostic factors |  | Months 3, 6, 12 | 
| Change from baseline in quality of life (QoL) using Patient reported outcomes (PRO ) scores |  | Months 3, 6,12 |