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NCT Number: NCT05547490

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0002, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Distribution of demographic characteristics: Age

    Time frame: Baseline

  2. Distribution of demographic characteristics: Sex

    Time frame: Baseline

  3. Distribution of clinical characteristics: Height

    Time frame: Baseline

  4. Distribution of clinical characteristics: Weight

    Time frame: Baseline

  5. Distribution of clinical characteristics: Body Mass Index (BMI)

    Time frame: Baseline

  6. Distribution of clinical characteristics: Disease duration

    Time frame: Baseline

  7. Distribution of clinical characteristics: Severity of PsO

    Time frame: Baseline

  8. Distribution of clinical characteristics: Comorbidities

    Time frame: Baseline

  9. Treatment patterns: Drug categories treated during study period

    Time frame: Up to 4 Years

  10. Treatment patterns: Drug names treated during study period

    Time frame: Up to 4 Years

  11. Treatment patterns: Medication dosage

    Time frame: Up to 4 Years

  12. Treatment patterns: Drug's administration frequency

    Time frame: Up to 4 Years

  13. Treatment patterns: Reason for treatment change during study period

    Time frame: Up to 4 Years

  14. Treatment patterns: Treatment duration of each drug during study period

    Time frame: Up to 4 Years

  15. Treatment patterns: Treatment sequence

    Time frame: Up to 4 Years

  16. Treatment patterns: Change of treatment pattern

    Time frame: Up to 4 Years

Secondary outcomes

  1. Number of participants achieving Body Surface Area of <3% during study period

    Time frame: Up to 4 Years

  2. Psoriasis Area and Severity (PASI) Index

    Time frame: Up to 4 Years

  3. Number of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period

    Time frame: Up to 4 Years

  4. Healthcare resource utilization (HCRU)

    Time frame: Up to 4 Years

    HCRU will include visit date, visit type, cost, inpatient visits, outpatient visits, length of stay, and direct medical cost.

  5. Evaluation of patient reported outcome measure: Patients' global assessment of disease activity (PtGA)

    Time frame: 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'.

  6. Evaluation of patient reported outcome measure: Dermatology life quality index (DLQI)

    Time frame: 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.

  7. Evaluation of patient reported outcome measure: EQ-5D-3L

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2022
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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