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

June 2, 2022 updated by: Bristol-Myers Squibb

Patient Preference for Treatment of Moderate-To-Severe Psoriasis in Japan

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

232

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Morrisville, North Carolina, United States, 27560
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psoriasis (PsO) patient preferences of moderate-to-severe systemic treatment atrribute
Time Frame: Within 60 minutes of survey/interview
Within 60 minutes of survey/interview
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 1: Sex
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of PsO participants in Phase 1: Age
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Time since PsO diagnosis
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Severity of PsO
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Current treatments for PsO
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Time on current PsO treatment
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of PsO participants in Phase 1: Residence
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of PsO participants in Phase 1: Employment status
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of PsO participants in Phase 1: Education
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Total number of previous treatments
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Previous treatments for PsO
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of PsO participants in Phase 1: Level of income
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Sex
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Age
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Height
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Weight
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Residence
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Employment status
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Type of occupation
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Education
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Time since PsO diagnosis
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Self-reported severity
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Current treatments for PsO
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Time on current PsO treatment
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Previous treatments for PsO
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Comorbid conditions of interest
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Level of income
Time Frame: At Baseline
At Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

February 7, 2022

Study Completion (Actual)

February 7, 2022

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

September 23, 2021

First Posted (Actual)

October 4, 2021

Study Record Updates

Last Update Posted (Actual)

June 6, 2022

Last Update Submitted That Met QC Criteria

June 2, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM011-174

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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