NCT05547490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,506

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 31, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2023

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

September 16, 2022

Last Update Submit

December 12, 2023

Conditions

Psoriasis

Keywords

Moderate to Severe Plaque PsO

Outcome Measures

Primary Outcomes (16)

  • 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 Outcomes (7)

  • 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

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

    Up to 4 Years

  • +2 more secondary outcomes

Study Arms (1)

Moderate-to-severe Plaque PsO

Participants experiencing moderate-to-severe plaque PsO, who have had at least one clinical visit.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Institution - 0002

Beijing, Beijing Municipality, 100050, China

Location

Local Institution - 0001

Nanjing, Jiangsu, 210042, China

Location

Related Links

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 21, 2022

Study Start

October 31, 2022

Primary Completion

April 28, 2023

Study Completion

April 28, 2023

Last Updated

December 18, 2023

Record last verified: 2023-12

Locations

CN(2)