PsoriasisDCENCT05065762
Measuring the Treatment Preferences of Participants in Japan With Moderate-to-Severe Psoriasis (PsO) Using Discrete Choice Experiment
An observational study of Psoriasis, run by Bristol-Myers Squibb at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 7 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Unable or unwilling to provide informed consent
- Diagnosis of guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis
Trial locations and contacts
1 site in 1 country.
United States1 site
Local Institution
Morrisville, North Carolina, 27560
About this study
Official title: 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.
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Japan, BMS-986165, Observational study, Moderate-to-severe PsO, DCE (discrete choice experiment), Preferences
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis (PsO) patient preferences of moderate-to-severe systemic treatment atrribute
Measured: Within 60 minutes of survey/interview
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 1: Sex
Measured: At Baseline
Distribution of socio-demographic characteristics of PsO participants in Phase 1: Age
Measured: At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Time since PsO diagnosis
Measured: At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Severity of PsO
Measured: At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Current treatments for PsO
Measured: At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Time on current PsO treatment
Measured: At Baseline
Distribution of socio-demographic characteristics of PsO participants in Phase 1: Residence
Measured: At Baseline
Distribution of socio-demographic characteristics of PsO participants in Phase 1: Employment status
Measured: At Baseline
Distribution of socio-demographic characteristics of PsO participants in Phase 1: Education
Measured: At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Total number of previous treatments
Measured: At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Previous treatments for PsO
Measured: At Baseline
Distribution of socio-demographic characteristics of PsO participants in Phase 1: Level of income
Measured: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Sex
Measured: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Age
Measured: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Height
Measured: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Weight
Measured: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Residence
Measured: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Employment status
Measured: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Type of occupation
Measured: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Education
Measured: At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Time since PsO diagnosis
Measured: At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Self-reported severity
Measured: At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Current treatments for PsO
Measured: At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Time on current PsO treatment
Measured: At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Previous treatments for PsO
Measured: At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Comorbid conditions of interest
Measured: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Level of income
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start1 Oct 2021
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065762
- Sponsor's protocol ID
- IM011-174
- Acronym
- DCE
- Status last verified
- May 2022
- First submitted
- 23 Sep 2021
- Last updated
- 6 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Preference for Treatment of Moderate-To-Severe Psoriasis in Japan
- ClinicalTrials.gov ID
- NCT05065762
- Acronym / sponsor ID
- DCE / IM011-174
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Japan, BMS-986165, Observational study, Moderate-to-severe PsO, DCE (discrete choice experiment), Preferences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unable or unwilling to provide informed consent
- Diagnosis of guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psoriasis (PsO) patient preferences of moderate-to-severe systemic treatment atrribute
Time frame: Within 60 minutes of survey/interview
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 1: Sex
Time frame: At Baseline
Distribution of socio-demographic characteristics of PsO participants in Phase 1: Age
Time frame: At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Time since PsO diagnosis
Time frame: At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Severity of PsO
Time frame: At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Current treatments for PsO
Time frame: At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Time on current PsO treatment
Time frame: At Baseline
Distribution of socio-demographic characteristics of PsO participants in Phase 1: Residence
Time frame: At Baseline
Distribution of socio-demographic characteristics of PsO participants in Phase 1: Employment status
Time frame: At Baseline
Distribution of socio-demographic characteristics of PsO participants in Phase 1: Education
Time frame: At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Total number of previous treatments
Time frame: At Baseline
Distribution of clinical characteristics of PsO participants in Phase 1: Previous treatments for PsO
Time frame: At Baseline
Distribution of socio-demographic characteristics of PsO participants in Phase 1: Level of income
Time frame: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Sex
Time frame: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Age
Time frame: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Height
Time frame: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Weight
Time frame: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Residence
Time frame: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Employment status
Time frame: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Type of occupation
Time frame: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Education
Time frame: At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Time since PsO diagnosis
Time frame: At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Self-reported severity
Time frame: At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Current treatments for PsO
Time frame: At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Time on current PsO treatment
Time frame: At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Previous treatments for PsO
Time frame: At Baseline
Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Comorbid conditions of interest
Time frame: At Baseline
Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Level of income
Time frame: At Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis (PsO) patient preferences of moderate-to-severe systemic treatment atrribute (time frame: Within 60 minutes of survey/interview). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.