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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants with psoriasis |
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| Measure | Description | Time Frame |
|---|---|---|
| Distribution of participant background at first visit: Age | At Baseline | |
| Distribution of participant background at first visit: Sex | At Baseline | |
| Distribution of participant background at first visit: Duration with psoriasis | At Baseline | |
| Distribution of participant background at first visit: Comorbidities | At Baseline | |
| Distribution of participant background at first visit: Current status of phototherapy | At Baseline | |
| Treatment patterns: Drug names treated during study period | Up to 4 years | |
| Treatment patterns: Drug categories treated during study period | Up to 4 years | |
| Treatment patterns: Number of treatment changes during study period | Up to 4 years | |
| Treatment patterns: Treatment duration of each drug during study period | Up to 4 years | |
| Treatment patterns: Duration between withdrawal of one drug and start of a new drug during study period | Up to 4 years | |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of comorbidities that affect treatment choice and change | Up to 4 years | |
| Distribution of AEs that affect treatment choice and change | Up to 4 years | |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Minato-ku | Tokyo | 1070052 | Japan |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Treatment patterns: Adverse event (AE) at time of withdrawal of some drug |
| Up to 4 years |
| Treatment patterns: Psoriasis area severity index (PASI) at time of withdrawal | Up to 4 years |
| Treatment patterns: PASI at time of start of a new drug | Up to 4 years |
| Treatment patterns: PASI improvement from start of one drug to withdrawal of other drug | Up to 4 years |
| Treatment patterns: Reason for treatment change during study period | Up to 4 years |
| Treatment patterns: Status of phototherapy combination with systemic treatment | 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) |
| 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) | 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) | Up to 4 years |
| Total period until participants achieve PASI 75 during study period | Up to 4 years |
| Total period until participants achieve PASI 90 during study period | Up to 4 years |
| Total period until participants achieve PASI 100 during study period | Up to 4 years |
| Mean period of participants achieve PASI 75 by each systemic treatment | Up to 4 years |
| Mean period of participants achieve PASI 90 by each systemic treatment | Up to 4 years |
| Mean period of participants achieve PASI 100 by each systemic treatment | Up to 4 years |
| Description of relationship between the reasons for treatment change and period of withdrawal | Up to 4 years |
| Efficacy after re-start treatment measured by PASI | Up to 4 years |