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The purpose of this study is to understand the comparative effectiveness of deucravacitinib versus apremilast in adults with plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants that have initiated deucravacitinib |
| |
| Cohort 2 | Participants that have initiated apremilast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | As prescribed by treating clinician |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body surface area (BSA) | At baseline and every 6 months up to 60 months or treatment discontinuation | |
| Investigator global assessment (IGA) response 0/1 | Up to 60 months | |
| Dermatology life quality index (DLQI) response 0/1 | Up to 60 months | |
| Time from date of treatment initiation to date of discontinuation | Up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| 75 percent improvement in Psoriasis area and severity index (PASI) score | At baseline and every 6 months up to 60 months or treatment discontinuation | |
| PASI score response ≤ 3 | At baseline to follow-up, up to 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adults diagnosed with moderate-to-severe plaque psoriasis who initiate deucravacitinib or apremilast within the CorEvitas Psoriasis Registry will be enrolled. Participants will be followed every 6 months from initiation up to 5 years or discontinuation, whichever occurs first. This is a real-world study and hence the follow-up are done based on the clinical practice done by dermatologists.
| 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 the NCT# and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Recruiting | Waltham | Massachusetts | 02451 | United States |
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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 |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
| C505730 | apremilast |
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| Apremilast |
| Drug |
As prescribed by treating clinician |
|
| PASI score response ≤ 5 | At baseline to follow-up, up to 60 months |
| PASI score change from baseline | At baseline to follow-up, up to 60 months |
| National psoriasis foundation (NPF) acceptable body surface area (BSA) response | At baseline to follow-up, up to 60 months |
| NPF target BSA response | At baseline to follow-up, up to 60 months |
| BSA ≤3% | At baseline to follow-up, up to 60 months |
| Change in investigator global assessment (IGA) score | Up to 60 months |
| Change in dermatology life quality index (DLQI) response | At baseline to follow-up, up to 60 months |
| Change in DLQI response ≤5 | At baseline to follow-up, up to 60 months |
| Change in visual analog scale (VAS): Itch response | At baseline to follow-up, up to 60 months |
| Change in VAS: Skin Pain response | At baseline to follow-up, up to 60 months |
| Change in VAS: Fatigue Response | At baseline to follow-up, up to 60 months |
| Merit-based Incentive Payment System (MIPS) Clinical Response to Oral Systemic or Biologic Medications | At baseline to follow-up, up to 60 months |