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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Psoriasis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings