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Clinical Trials/NCT05547490
NCT05547490
Completed
N/A

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

Bristol-Myers Squibb2 sites in 1 country3,506 target enrollmentOctober 31, 2022
ConditionsPsoriasis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psoriasis
Sponsor
Bristol-Myers Squibb
Enrollment
3506
Locations
2
Primary Endpoint
Treatment patterns: Medication dosage
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 31, 2022
End Date
April 28, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Treatment patterns: Medication dosage

Time Frame: Up to 4 Years

Distribution of clinical characteristics: Body Mass Index (BMI)

Time Frame: Baseline

Treatment patterns: Drug names treated during study period

Time Frame: Up to 4 Years

Distribution of clinical characteristics: Weight

Time Frame: Baseline

Distribution of demographic characteristics: Age

Time Frame: Baseline

Distribution of demographic characteristics: Sex

Time Frame: Baseline

Distribution of clinical characteristics: Height

Time Frame: Baseline

Distribution of clinical characteristics: Comorbidities

Time Frame: Baseline

Distribution of clinical characteristics: Disease duration

Time Frame: Baseline

Treatment patterns: Treatment duration of each drug during study period

Time Frame: Up to 4 Years

Distribution of clinical characteristics: Severity of PsO

Time Frame: Baseline

Treatment patterns: Drug categories treated during study period

Time Frame: Up to 4 Years

Treatment patterns: Drug's administration frequency

Time Frame: Up to 4 Years

Treatment patterns: Change of treatment pattern

Time Frame: Up to 4 Years

Treatment patterns: Reason for treatment change during study period

Time Frame: Up to 4 Years

Treatment patterns: Treatment sequence

Time Frame: Up to 4 Years

Secondary Outcomes

  • Healthcare resource utilization (HCRU)(Up to 4 Years)
  • 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)
  • Evaluation of patient reported outcome measure: Patients' global assessment of disease activity (PtGA)(Up to 4 Years)
  • 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)
  • Evaluation of patient reported outcome measure: EQ-5D-3L(Up to 4 Years)

Study Sites (2)

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