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This is a prospective, observational, real-world study of adult participants in Japan with physician-reported diagnosis of plaque psoriasis treated with deucravacitinib or apremilast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants that have initiated deucravacitinib treatment |
| ||
| Participants that have initiated apremilast treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | According to the product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib. | 1 month, 3 months, 6 months and every 6 months up to 5 years | |
| Number of participants who achieved Physician's Global Assessment (PGA) of 0/1 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years | |
| Number of participants who achieved Absolute Psoriasis Area and Severity Index (aPASI) of ≤2 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years | |
| Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0 /1 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years | |
| Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib or apremilast | 1 month, 3 months, 6 months and every 6 months up to 5 years | |
| Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0/1 from baseline to follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include Japanese adults with a physician-reported diagnosis of plaque psoriasis who start treated with either deucravacitinib or apremilast. Study participants will be enrolled from Japanese Dermatological Association (JDA)-certified hospitals and clinics that are allowed to prescribe molecular targeted agents for patients with psoriasis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Connect Contact Center www.BMSStudyConnect.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mebix. Inc. | Recruiting | Minato-ku | Tokyo | 1070052 | Japan |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
| C505730 | apremilast |
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| Apremilast | Drug | According to the product label |
|
| 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants treated with deucravacitinib with a change in Physician's Global Assessment (PGA) from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants treated with deucravacitinib with a change in Dermatology Life Quality Index (DLQI) from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants achieving a Dermatology Life Quality Index (DLQI) score of ≤5 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 75 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 90 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤5 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤3 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieve a National Psoriasis Foundation (NPF) Acceptable Body Surface Area response from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieve an absolute scalp-specific Physician's Global Assessment (ss-PGA) of 0/1 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieve an absolute Physician's Global Assessment-Fingernail (PGA-F) of 0/1 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Number of participants who achieve an absolute Palmoplantar Physician's Global Assessment (pp-PGA) of 0/1 from baseline to follow-up | 1 month, 3 months, 6 months and every 6 months up to 5 years |
| Fukuoka University Hospital | Recruiting | Fukuoka | Japan |