A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China

Study Overview
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Brief Summary
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The objective of this non-interventional, observational study is to assess the effectiveness and patient reported outcome of adalimumab in patients with moderate to severe psoriasis in real world clinical practice in China.

Official Title
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Postmarketing Observational Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China

Conditions
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Psoriasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant who is in compliance with eligibility for adalimumab based on the local label; Moderate to severe plaque psoriasis patients eligible to use adalimumab according to the local label without any contraindication Patients have signed the authorization (or informed consent where applicable) to disclose and use personal health information after been prescribed with adalimumab. Exclusion Criteria: Patients who are pregnant or breast feeding at enrolment or wish to become pregnant during the following adalimumab treatment and within 150 days since adalimumab discontinuation; Patients in any psoriasis related clinical trial at the time of enrolment, at baseline or at any point during the study follow-up; Patients with active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections) as well as moderate to severe cardiac insufficiency. Patients with difficulties for adequately reading, understanding and completing patient questionnaires.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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 with moderate to severe plaque psoriasis in China<br>Participants with moderate to severe plaque psoriasis in China receiving adalimumab in daily clinical practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving at least a 75% reduction in Psoriasis Area Severity Index (PASI) relative to the baseline PASI score | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. | At Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Dermatology Life Quality Index (DLQI) | The DLQI is a self administered short, simple and practical dermatology-specific quality of life (QoL) questionnaire. | From Week 0 to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, effectiveness, safety, adalimumab