A Study to Assess Treatment Patterns, Clinical Outcomes and Healthcare Resource Utilization Among Adult Participants With Moderate-To-Severe Plaque Psoriasis
- Conditions
- Psoriasis
- Registration Number
- NCT05547490
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3506
- Diagnosis of moderate-to-severe plaque PsO either confirmed by a dermatologist or meeting criteria of: BSA ≥ 3% or PASI ≥ 3 or Dermatology Life Quality Index (DLQI) ≥ 6.
- Participating in Randomized controlled trial (RCT) between 1st January 2018 and 31st December 2021, if there was any.
- Diagnosis of erythrodermic psoriasis, pustular psoriasis or guttate psoriasis.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Distribution of clinical characteristics: Body Mass Index (BMI) Baseline Treatment patterns: Drug names treated during study period Up to 4 Years Distribution of clinical characteristics: Weight Baseline Distribution of demographic characteristics: Age Baseline Distribution of demographic characteristics: Sex Baseline Distribution of clinical characteristics: Height Baseline Distribution of clinical characteristics: Comorbidities Baseline Distribution of clinical characteristics: Disease duration Baseline Treatment patterns: Treatment duration of each drug during study period Up to 4 Years Distribution of clinical characteristics: Severity of PsO Baseline Treatment patterns: Drug categories treated during study period Up to 4 Years Treatment patterns: Drug's administration frequency Up to 4 Years Treatment patterns: Change of treatment pattern Up to 4 Years Treatment patterns: Reason for treatment change during study period Up to 4 Years Treatment patterns: Treatment sequence Up to 4 Years Treatment patterns: Medication dosage Up to 4 Years
- Secondary Outcome Measures
Name Time Method 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 Healthcare resource utilization (HCRU) Up to 4 Years HCRU will include visit date, visit type, cost, inpatient visits, outpatient visits, length of stay, and direct medical cost.
Evaluation of patient reported outcome measure: Patients' global assessment of disease activity (PtGA) Up to 4 Years 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'.
Number of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period Up to 4 Years Evaluation of patient reported outcome measure: Dermatology life quality index (DLQI) Up to 4 Years 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.
Evaluation of patient reported outcome measure: EQ-5D-3L Up to 4 Years 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.
Trial Locations
- Locations (2)
Local Institution - 0002
🇨🇳Beijing, Beijing, China
Local Institution - 0001
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0002🇨🇳Beijing, Beijing, China