PsoriasisNCT04826536
A Study of Treatment Patterns and Clinical Outcomes of Psoriasis in Japan
An observational study of Psoriasis, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
The purpose of this study is to understand current real-world treatment patterns and clinical outcomes, reasons for switching treatment, and participant characteristics using each systemic psoriasis treatment 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
- 114 participants
- Where
- 1 siteJapan
- Study dates
- 25 Jun 2021to 8 Oct 2021
- 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: 120 participants, from 2 to 4 institutes which have a central role of psoriasis therapy in Japan, will be entered into the study if they started systemic treatment after 01/01/2017 and followed until either 12/31/2020, death, or lost to follow-up, whichever occurs first.
Who may be able to join
- Diagnosis of psoriasis
- Can be followed for at least 2 years
- Treated with any of the following systemic therapy for psoriasis at time of follow-up start: Tumor Necrosis Factor (TNF) inhibitors (infliximab, adalimumab, and certolizumab pegol), Interleukin (IL)-12/23 inhibitors (ustekinumab), IL-23 inhibitors(guselkumab, risankizumab, and tildrakizumab), IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab), Apremilast, Methotrexate, Cyclosporine, Etretinate
Who cannot join
- Enrolled in any clinical trials for psoriasis in their follow-up period
- Developed psoriatic arthritis, guttate psoriasis, erythrodermic psoriasis, and pustular psoriasis at time of start date
- Treated with any of the following systemic therapy before they were diagnosed with psoriasis: TNF inhibitors (infliximab, adalimumab, and certolizumab pegol), IL-12/23 inhibitors (ustekinumab), IL-23 inhibitors(guselkumab, risankizumab, and tildrakizumab), IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab), Apremilast, Methotrexate, Cyclosporine, Etretinate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Patterns and Outcomes Study for Psoriasis (PSO) in Japan
The purpose of this study is to understand current real-world treatment patterns and clinical outcomes, reasons for switching treatment, and participant characteristics using each systemic psoriasis treatment in Japan.
- Conditions
- Psoriasis
- Keywords
- Japan, Observational, Psoriasis, Retrospective
- 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 |
|---|---|---|
| Cohort 1 | Participants with psoriasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of participant background at first visit: Age
Measured: At Baseline
Distribution of participant background at first visit: Sex
Measured: At Baseline
Distribution of participant background at first visit: Duration with psoriasis
Measured: At Baseline
Distribution of participant background at first visit: Comorbidities
Measured: At Baseline
Distribution of participant background at first visit: Current status of phototherapy
Measured: At Baseline
Treatment patterns: Drug names treated during study period
Measured: Up to 4 years
Treatment patterns: Drug categories treated during study period
Measured: Up to 4 years
Treatment patterns: Number of treatment changes during study period
Measured: Up to 4 years
Treatment patterns: Treatment duration of each drug during study period
Measured: Up to 4 years
Treatment patterns: Duration between withdrawal of one drug and start of a new drug during study period
Measured: Up to 4 years
Treatment patterns: Adverse event (AE) at time of withdrawal of some drug
Measured: Up to 4 years
Treatment patterns: Psoriasis area severity index (PASI) at time of withdrawal
Measured: Up to 4 years
Treatment patterns: PASI at time of start of a new drug
Measured: Up to 4 years
Treatment patterns: PASI improvement from start of one drug to withdrawal of other drug
Measured: Up to 4 years
Treatment patterns: Reason for treatment change during study period
Measured: Up to 4 years
Treatment patterns: Status of phototherapy combination with systemic treatment
Measured: Up to 4 years
Secondary outcomes (13)
Distribution of comorbidities that affect treatment choice and change
Measured: Up to 4 years
Distribution of AEs that affect treatment choice and change
Measured: Up to 4 years
Mean number of drug changes until participants achieve PASI 75 during study period
75% reduction in the Psoriasis Area and Severity Index score (PASI 75)
Measured: Up to 4 years
Mean number of drug changes until participants achieve PASI 90 during study period
90% reduction in the Psoriasis Area and Severity Index score (PASI 90)
Measured: Up to 4 years
Mean number of drug changes until participants achieve PASI 100 during study period
100% reduction in the Psoriasis Area and Severity Index score (PASI 100)
Measured: Up to 4 years
Total period until participants achieve PASI 75 during study period
Measured: Up to 4 years
Total period until participants achieve PASI 90 during study period
Measured: Up to 4 years
Total period until participants achieve PASI 100 during study period
Measured: Up to 4 years
Mean period of participants achieve PASI 75 by each systemic treatment
Measured: Up to 4 years
Mean period of participants achieve PASI 90 by each systemic treatment
Measured: Up to 4 years
Mean period of participants achieve PASI 100 by each systemic treatment
Measured: Up to 4 years
Description of relationship between the reasons for treatment change and period of withdrawal
Measured: Up to 4 years
Efficacy after re-start treatment measured by PASI
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start25 Jun 2021
- Primary completion8 Oct 2021
- Study completion8 Oct 2021
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 114 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
- NCT04826536
- Sponsor's protocol ID
- IM011-166
- Status last verified
- May 2022
- First submitted
- 31 Mar 2021
- Last updated
- 3 Jun 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns and Outcomes Study for Psoriasis (PSO) in Japan
- ClinicalTrials.gov ID
- NCT04826536
- Acronym / sponsor ID
- IM011-166
- Conditions
- Psoriasis
- Keywords
- Japan, Observational, Psoriasis, Retrospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 1 Apr 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 study is to understand current real-world treatment patterns and clinical outcomes, reasons for switching treatment, and participant characteristics using each systemic psoriasis treatment in Japan.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants with psoriasis |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 120 participants, from 2 to 4 institutes which have a central role of psoriasis therapy in Japan, will be entered into the study if they started systemic treatment after 01/01/2017 and followed until either 12/31/2020, death, or lost to follow-up, whichever occurs first.
Key inclusion criteria (3 listed)
- Diagnosis of psoriasis
- Can be followed for at least 2 years
- Treated with any of the following systemic therapy for psoriasis at time of follow-up start: Tumor Necrosis Factor (TNF) inhibitors (infliximab, adalimumab, and certolizumab pegol), Interleukin (IL)-12/23 inhibitors (ustekinumab), IL-23 inhibitors(guselkumab, risankizumab, and tildrakizumab), IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab), Apremilast, Methotrexate, Cyclosporine, Etretinate
Key exclusion criteria (3 listed)
- Enrolled in any clinical trials for psoriasis in their follow-up period
- Developed psoriatic arthritis, guttate psoriasis, erythrodermic psoriasis, and pustular psoriasis at time of start date
- Treated with any of the following systemic therapy before they were diagnosed with psoriasis: TNF inhibitors (infliximab, adalimumab, and certolizumab pegol), IL-12/23 inhibitors (ustekinumab), IL-23 inhibitors(guselkumab, risankizumab, and tildrakizumab), IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab), Apremilast, Methotrexate, Cyclosporine, Etretinate
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
Distribution of participant background at first visit: Age
Time frame: At Baseline
Distribution of participant background at first visit: Sex
Time frame: At Baseline
Distribution of participant background at first visit: Duration with psoriasis
Time frame: At Baseline
Distribution of participant background at first visit: Comorbidities
Time frame: At Baseline
Distribution of participant background at first visit: Current status of phototherapy
Time frame: At Baseline
Treatment patterns: Drug names treated during study period
Time frame: Up to 4 years
Treatment patterns: Drug categories treated during study period
Time frame: Up to 4 years
Treatment patterns: Number of treatment changes during study period
Time frame: Up to 4 years
Treatment patterns: Treatment duration of each drug during study period
Time frame: Up to 4 years
Treatment patterns: Duration between withdrawal of one drug and start of a new drug during study period
Time frame: Up to 4 years
Treatment patterns: Adverse event (AE) at time of withdrawal of some drug
Time frame: Up to 4 years
Treatment patterns: Psoriasis area severity index (PASI) at time of withdrawal
Time frame: Up to 4 years
Treatment patterns: PASI at time of start of a new drug
Time frame: Up to 4 years
Treatment patterns: PASI improvement from start of one drug to withdrawal of other drug
Time frame: Up to 4 years
Treatment patterns: Reason for treatment change during study period
Time frame: Up to 4 years
Treatment patterns: Status of phototherapy combination with systemic treatment
Time frame: Up to 4 years
13 secondary outcomes
Distribution of comorbidities that affect treatment choice and change
Time frame: Up to 4 years
Distribution of AEs that affect treatment choice and change
Time frame: Up to 4 years
Mean number of drug changes until participants achieve PASI 75 during study period
Time frame: Up to 4 years
Mean number of drug changes until participants achieve PASI 90 during study period
Time frame: Up to 4 years
Mean number of drug changes until participants achieve PASI 100 during study period
Time frame: Up to 4 years
Total period until participants achieve PASI 75 during study period
Time frame: Up to 4 years
Total period until participants achieve PASI 90 during study period
Time frame: Up to 4 years
Total period until participants achieve PASI 100 during study period
Time frame: Up to 4 years
Mean period of participants achieve PASI 75 by each systemic treatment
Time frame: Up to 4 years
Mean period of participants achieve PASI 90 by each systemic treatment
Time frame: Up to 4 years
Mean period of participants achieve PASI 100 by each systemic treatment
Time frame: Up to 4 years
Description of relationship between the reasons for treatment change and period of withdrawal
Time frame: Up to 4 years
Efficacy after re-start treatment measured by PASI
Time frame: Up to 4 years
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 3 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 Japan.
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 3 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 3 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 Japan. 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?
Distribution of participant background at first visit: Age (time frame: At Baseline). The study lists 16 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 3 Jun 2022.