A Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands

Study Overview
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Brief Summary
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This is a multicenter, prospective, non-interventional, observational single arm study. 100 patients will be recruited in the Netherlands over a one year period. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into this study. Treatment will be according to routine clinical practice and based on recommendations as per the Summary of Product Characteristics (SPC) of apremilast (Otezla®). Each patient will be followed up for a maximum of 24 months.

Detailed Description
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The objective of this non-interventional study is to describe patient reported outcomes, effectiveness and real-life use of apremilast treatment in patients with psoriatic arthritis (PsA).

Official Title
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Observational Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands

Conditions
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Arthritis, Psoriatic

Participation Criteria
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Eligibility Criteria
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Inclusion Criter Patients ≥ 18 years of age who understand and voluntarily sign an informed consent form. Patients starting treatment with apremilast for psoriatic arthritis. Exclusion Criteria: Refusal to participate in the study. Language barrier for completing the questionnaires. Women who are pregnant or breast-feeding. Hypersensitivity to the active substance or to any of the excipients. Prior exposure to apremilast Initiation of apremilast treatment by a dermatologist for psoriasis

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 |
| --- | --- |
| Psoriatic arthritis patients treated with apremilast<br>Psoriatic arthritis patients who are treated with apremilast according to daily practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with a Health Assessment Questionnaire - Disability Index (HAQ-DI) score of ≤ 0.5 or with a decrease of ≥ 0.3 of the HAQ-DI score compared with baseline | The HAQ is a general questionnaire to assess physical functioning. | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Psoriatic Arthritis Impact of Disease (PsAID) at various time point | PsAID is a general questionnaire that measures the health impact of psoriatic arthritis. | Up to 24 months | 
| Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at various time points | The TSQM questionnaire is a general measure of treatment satisfaction across medication types and patient conditions. | Up to 24 months | 
| Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at month 6 | The BASDAI is used for measuring and evaluating disease activity in Ankylosing Spondylitis. | Up to 6 months | 
| Change from Baseline in Dermatology Life Quality Index (DLQI) at month 6 | The DLQI is a dermatology specific Quality of Life instrument. | Up to 6 months | 
| Change from Baseline in Short Form 36 (SF36) at 12 months | The SF-36v2® Health Survey measures functional health and well-being from the patients point of view. It can be used across age (18 and older), disease and treatments. | Up to 12 months | 
| Change from Baseline in EuroQol-5 dimensions (EQ5D) at 12 months | EQ-5D is a standard instrument to measure of health status. | Up to 12 months | 
| Change from Baseline in visual analogue scales (VAS) at various time point | VAS is a simple assessment of the global health, itch and pain severity using a visual analogue scale | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriatic Arthritis, Apremilast, CC-10004