A Study to Assess Treatment Patterns, Clinical Outcomes and Healthcare Resource Utilization Among Adult Participants With Moderate-To-Severe Plaque Psoriasis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Moderate-to-severe Plaque PsO Participants experiencing moderate-to-severe plaque PsO, who have had at least one clinical visit. |
Outcome Measures
Primary Outcome Measures
- 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]
- 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]
Secondary Outcome Measures
- 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 [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'.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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) ≥
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Nanjing | Jiangsu | China | 210042 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- IM011-206