A Study to Assess the Change in Disease State in Adult Participants Being Treated With Oral Upadacitinib Tablets in Participants With Oligo- or Poly-artIcular Psoriatic Arthritis

Study Overview
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Brief Summary
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Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by the body's immune system mistakenly attacking healthy joint tissue causing inflammation, joint damage, disability, and a reduced life expectancy. The main objective of this study is to characterize attainment of minimal disease activity (MDA) at week 24 under continuous treatment with upadacitinib in participants with oligo- or polyarticular PsA as part of real-world practice. Upadacitinib is a drug approved for the treatment of Psoriatic arthritis (PsA) in Germany and Canada. Approximately 380 adult participants with PsA at multiple sites in Germany and Canada. Participants will receive oral Upadacitinib tablets per current local label, according to local standard of care and international guidelines. There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and by questionnaire.

Official Title
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Real-World Effectiveness of Upadacitinib in Patients Joining Subgroups Either With Oligo- or Poly-ArtIcular Psoriatic Arthritis on Minimal Disease Activity

Conditions
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Psoriatic Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of active Psoriatic Arthritis (PsA) upon judgment of the treating physician. Swollen joint count (SJC) >= 1 out of 66 joints. Decision on the treatment with Upadacitinib was made prior to any decision to approach the participant to participate in this study. Exclusion Criteria: Cannot be treated with Upadacitinib according to the local Upadacitinib Summary of Product Characteristics (SmPC). Prior treatment with Upadacitinib. Currently participating in interventional research or within the last 30 days.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants Receiving Upadacitinib<br>Participants receiving Upadacitinib for psoriatic arthritis (PsA). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Receiving Upadacitinib who Attain Minimal Disease Activity (MDA) | MDA will be determined based on participants fulfilling 5 of 7 outcome measures: tender joint count 68 (TJC68) <= 1, swollen joint count (SJC66) ≤ 1, body surface area (BSA) <= 3%; Patient's Assessment of Pain numeric rating scale (NRS) <= 1.5, Patient's Global Assessment of Disease Activity (PtGA) NRS <= 2.0, Health Assessment Questionnaire Disability Index (HAQ-DI) <= 0.5, tender entheseal points <= 1. | At Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Maintaining MDA Under Upadacitinib Treatment, in Participants who had Achieved MDA at Week 24 | MDA will be determined based on participants fulfilling 5 of 7 outcome measures: TJC68 <= 1, SJC66 ≤ 1, BSA <= 3%; Patient's Assessment of Pain NRS <= 1.5, PtGA NRS <= 2.0, HAQ-DI <= 0.5, tender entheseal points <= 1. | At Week 48 | 
| Mean change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 (Pain in Neck, Back or Hip) | The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem). | Baseline to Week 48 | 
| Mean Change in Disease Activity in PSoriatic Arthritis score (DAPSA) | The DAPSA is a numerical sum of the 66 swollen and 68 tender joint counts, the participant pain and global assessments (each on a 0-10 scale) and C-reactive protein (CRP) (in mg/dL), thus ranging from 0 to about 160. | Baseline to Week 48 | 
| Mean Change in Percentage of Participants with Dactylitis | Mean change in percentage of participants with dactylitis. | Baseline to Week 48 | 
| Mean Change in Number of Fingernails Affected with Psoriasis | Mean change in number of fingernails affected with psoriasis. | Baseline to Week 48 | 
| Mean Change in 12-Item Short Form Health Survey (SF-12) | The SF-12 is a 12-item, patient-reported, generic, non-disease specific, overall HRQoL instrument with extensive use in multiple disease states. | Baseline to Week 48 | 
| Mean Change in Dermatology Life Quality Index (DLQI) [in Participants with Skin Involvement] | The DLQI consists of 10 questions concerning participants' perception of the impact of the skin disease on different aspects of their HRQoL over the previous week. | Baseline to Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriatic Arthritis, Oligoarticular Psoriatic Arthritis, Polyarticular Psoriatic Arthritis, Upadacitinib, Rinvoq