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The purpose of this study is to achieve a better understanding of clinical characteristics, treatment patterns and clinical outcomes of participants with moderate-to-severe plaque psoriasis (PsO) as well as their unmet medical needs and disease burden in real-world setting in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate-to-severe Plaque PsO | Participants experiencing moderate-to-severe plaque PsO, who have had at least one clinical visit. |
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| Measure | Description | Time Frame |
|---|---|---|
| Distribution of demographic characteristics: Age | Baseline | |
| Distribution of demographic characteristics: Sex | Baseline | |
| Distribution of clinical characteristics: Height | Baseline | |
| Distribution of clinical characteristics: Weight | Baseline | |
| Distribution of clinical characteristics: Body Mass Index (BMI) | Baseline | |
| Distribution of clinical characteristics: Disease duration | Baseline | |
| Distribution of clinical characteristics: Severity of PsO | Baseline | |
| Distribution of clinical characteristics: Comorbidities | Baseline | |
| Treatment patterns: Drug categories treated during study period | Up to 4 Years | |
| Treatment patterns: Drug names treated during study period | Up to 4 Years | |
| Treatment patterns: Medication dosage | Up to 4 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants achieving Body Surface Area of <3% during study period | Up to 4 Years | |
| Psoriasis Area and Severity (PASI) Index | Up to 4 Years | |
| Number of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of participants experiencing moderate-to-severe plaque PsO, who have at least one clinical visit (either outpatient or inpatient visit) between 1st January 2018 and 31st December 2021.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0002 | Beijing | Beijing Municipality | 100050 | China | ||
| Local Institution - 0001 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Treatment patterns: Drug's administration frequency | Up to 4 Years |
| Treatment patterns: Reason for treatment change during study period | Up to 4 Years |
| Treatment patterns: Treatment duration of each drug during study period | Up to 4 Years |
| Treatment patterns: Treatment sequence | Up to 4 Years |
| Treatment patterns: Change of treatment pattern | Up to 4 Years |
| Up to 4 Years |
| Healthcare resource utilization (HCRU) | HCRU will include visit date, visit type, cost, inpatient visits, outpatient visits, length of stay, and direct medical cost. | Up to 4 Years |
| Evaluation of patient reported outcome measure: Patients' global assessment of disease activity (PtGA) | PtGA of psoriasis is an indicator of disease severity of PsO measured using a single-item, five- point scale ranging from 0 (clear) to 4 (severe). Category labels include 'clear', 'almost clear', 'mild', 'moderate' and 'severe'. | Up to 4 Years |
| Evaluation of patient reported outcome measure: Dermatology life quality index (DLQI) | DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. Each item has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30 and higher scores indicate greater HRQoL impairment. | Up to 4 Years |
| Evaluation of patient reported outcome measure: EQ-5D-3L | The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension, participant is asked to choose one of the 3 levels (no problems, some problems, and extreme problems) to indicate his/her health state. This decision results into a 1-digit number and the digits for the five dimensions can be combined into a 5-digit number that describes the participant's health state. | Up to 4 Years |
| Nanjing |
| Jiangsu |
| 210042 |
| China |