Clinical trial NCT05547490: A Study to Assess Treatment Patterns, Clinical Outcomes and Healthcare Resource Utilization Among Adult Participants With Moderate-To-Severe Plaque Psoriasis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Moderate to Severe Plaque PsO
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-09-21
Enrollment: 3506
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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) ≥ 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.

Primary outcomes:
measure: Distribution of demographic characteristics: Age
timeFrame: Baseline
measure: Distribution of demographic characteristics: Sex
timeFrame: Baseline
measure: Distribution of clinical characteristics: Height
timeFrame: Baseline
measure: Distribution of clinical characteristics: Weight
timeFrame: Baseline
measure: Distribution of clinical characteristics: Body Mass Index (BMI)
timeFrame: Baseline
measure: Distribution of clinical characteristics: Disease duration
timeFrame: Baseline
measure: Distribution of clinical characteristics: Severity of PsO
timeFrame: Baseline
measure: Distribution of clinical characteristics: Comorbidities
timeFrame: Baseline
measure: Treatment patterns: Drug categories treated during study period
timeFrame: Up to 4 Years
measure: Treatment patterns: Drug names treated during study period
timeFrame: Up to 4 Years
measure: Treatment patterns: Medication dosage
timeFrame: Up to 4 Years
measure: Treatment patterns: Drug's administration frequency
timeFrame: Up to 4 Years
measure: Treatment patterns: Reason for treatment change during study period
timeFrame: Up to 4 Years
measure: Treatment patterns: Treatment duration of each drug during study period
timeFrame: Up to 4 Years
measure: Treatment patterns: Treatment sequence
timeFrame: Up to 4 Years
measure: Treatment patterns: Change of treatment pattern
timeFrame: Up to 4 Years
Secondary outcomes:
measure: Number of participants achieving Body Surface Area of <3% during study period
timeFrame: Up to 4 Years
measure: Psoriasis Area and Severity (PASI) Index
timeFrame: Up to 4 Years
measure: Number of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period
timeFrame: Up to 4 Years
measure: Healthcare resource utilization (HCRU)
timeFrame: Up to 4 Years
measure: Evaluation of patient reported outcome measure: Patients' global assessment of disease activity (PtGA)
timeFrame: Up to 4 Years
measure: Evaluation of patient reported outcome measure: Dermatology life quality index (DLQI)
timeFrame: Up to 4 Years
measure: Evaluation of patient reported outcome measure: EQ-5D-3L
timeFrame: Up to 4 Years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Local Institution - 0002
state: Beijing
city: Nanjing
country: China
facility: Local Institution - 0001
state: Jiangsu
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: