Measuring the Treatment Preferences of Participants in Japan With Moderate-to-Severe Psoriasis (PsO) Using Discrete Choice Experiment

NCT05065762 | Completed

• 1 other identifier: IM011-174
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this observational study is to identify and weight the treatment attributes from the moderate-to-severe Psoriasis (PsO) patients' perspective in Japan.

Conditions

Psoriasis

Keywords

Psoriasis; Japan; BMS-986165; Observational study; Moderate-to-severe PsO; DCE (discrete choice experiment); Preferences

Outcome Measures

Primary Outcomes (28)

• Psoriasis (PsO) patient preferences of moderate-to-severe systemic treatment atrribute

  Within 60 minutes of survey/interview

• Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 1: Sex

  At Baseline

• Distribution of socio-demographic characteristics of PsO participants in Phase 1: Age

  At Baseline

• Distribution of clinical characteristics of PsO participants in Phase 1: Time since PsO diagnosis

  At Baseline

• Distribution of clinical characteristics of PsO participants in Phase 1: Severity of PsO

  At Baseline

• Distribution of clinical characteristics of PsO participants in Phase 1: Current treatments for PsO

  At Baseline

• Distribution of clinical characteristics of PsO participants in Phase 1: Time on current PsO treatment

  At Baseline

• Distribution of socio-demographic characteristics of PsO participants in Phase 1: Residence

  At Baseline

• Distribution of socio-demographic characteristics of PsO participants in Phase 1: Employment status

  At Baseline

• Distribution of socio-demographic characteristics of PsO participants in Phase 1: Education

  At Baseline

• Distribution of clinical characteristics of PsO participants in Phase 1: Total number of previous treatments

  At Baseline

• Distribution of clinical characteristics of PsO participants in Phase 1: Previous treatments for PsO

  At Baseline

• Distribution of socio-demographic characteristics of PsO participants in Phase 1: Level of income

  At Baseline

• Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Sex

  At Baseline

• Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Age

  At Baseline

• Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Height

  At Baseline

• Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Weight

  At Baseline

• Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Residence

  At Baseline

• Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Employment status

  At Baseline

• Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Type of occupation

  At Baseline

• Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Education

  At Baseline

• Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Time since PsO diagnosis

  At Baseline

• Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Self-reported severity

  At Baseline

• Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Current treatments for PsO

  At Baseline

• Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Time on current PsO treatment

  At Baseline

• Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Previous treatments for PsO

  At Baseline

• Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Comorbid conditions of interest

  At Baseline

• Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Level of income

  At Baseline

Study Arms (2)

Phase 1

Participants with moderate-to-severe Psoriasis (PsO) in Japan who have been recruited based on eligibility criteria

Phase 2

Self-reported moderate-to-severe Psoriasis (PsO) participants in Japan

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 10 participants, diagnosed as moderate-to-severe Psoriasis (PsO) by a clinician were included in the Phase 1 qualitative interview A total of 200 participants, self-reported as moderate-to-severe PsO, were included in the Phase 2 online survey

You may qualify if:

• Diagnosis of moderate-to-severe Psoriasis (PsO) by physician (phase 1) or self-reported (phase 2)
• Currently taking systemic psoriasis treatment
• Japanese resident aged 20 years and older

You may not qualify if:

• Unable or unwilling to provide informed consent
• Diagnosis of guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Morrisville, North Carolina, 27560, United States

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 4, 2021
• Study Start: October 1, 2021
• Primary Completion: February 7, 2022
• Study Completion: February 7, 2022
• Last Updated: June 6, 2022

Record last verified: 2022-05

Locations

US (1)