A Study to Assess Treatment Patterns, Clinical Outcomes and Healthcare Resource Utilization Among Adult Participants With Moderate-To-Severe Plaque Psoriasis

Psoriasis Clinical Trial

Official title:

Treatment Patterns, Clinical Outcomes and Healthcare Resource Utilization Among Adult Patients With Moderate-To-Severe Plaque Psoriasis in Real-World Settings in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05547490
• Other study ID #: IM011-206
• Status: Completed
• Start date: October 31, 2022
• Est. completion date: April 28, 2023

Study information

• Verified date: December 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3506
• Est. completion date: April 28, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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) = 6.

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.

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
China	Local Institution - 0002	Beijing	Beijing
China	Local Institution - 0001	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of demographic characteristics: Age		Baseline
Primary	Distribution of demographic characteristics: Sex		Baseline
Primary	Distribution of clinical characteristics: Height		Baseline
Primary	Distribution of clinical characteristics: Weight		Baseline
Primary	Distribution of clinical characteristics: Body Mass Index (BMI)		Baseline
Primary	Distribution of clinical characteristics: Disease duration		Baseline
Primary	Distribution of clinical characteristics: Severity of PsO		Baseline
Primary	Distribution of clinical characteristics: Comorbidities		Baseline
Primary	Treatment patterns: Drug categories treated during study period		Up to 4 Years
Primary	Treatment patterns: Drug names treated during study period		Up to 4 Years
Primary	Treatment patterns: Medication dosage		Up to 4 Years
Primary	Treatment patterns: Drug's administration frequency		Up to 4 Years
Primary	Treatment patterns: Reason for treatment change during study period		Up to 4 Years
Primary	Treatment patterns: Treatment duration of each drug during study period		Up to 4 Years
Primary	Treatment patterns: Treatment sequence		Up to 4 Years
Primary	Treatment patterns: Change of treatment pattern		Up to 4 Years
Secondary	Number of participants achieving Body Surface Area of <3% during study period		Up to 4 Years
Secondary	Psoriasis Area and Severity (PASI) Index		Up to 4 Years
Secondary	Number of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period		Up to 4 Years
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   BMS Clinical Trial Information