Psoriasis
Conditions
Keywords
Psoriasis
Brief summary
The purpose of this study is to assess the real-world effectiveness of deucravacitinib treatment in adults diagnosed with moderate-to-severe plaque psoriasis
Interventions
DRUGDeucravacitinib
As prescribed by treating clinician
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* ≥18 years of age * Physician-reported diagnosis of moderate to severe plaque psoriasis * Be newly initiating deucravacitinib * Do not object to participate
Exclusion criteria
* Currently participating in or planning to participate in an interventional clinical trial * Previous treatment experience with deucravacitinib, including patients who received deucravacitinib as part of a blinded, randomized trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physician's Global Assessment (PGA) 0/1 response | Baseline and at months 4, 12, 18 (optional), and 24 |
| Dermatology Life Quality Index (DLQI) 0/1 response | Baseline and at months 4, 12, 18 (optional), and 24 |
| Time from date of treatment initiation to date of discontinuation | Up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in percentage involved Body Surface Area (BSA) from start of deucravacitinib treatment | Baseline and at months 4, 12, 18 (optional), and 24 |
| Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS) - Itch | Baseline and months 1, 4, 12, 18 (optional) and 24 |
| Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS) - Skin pain | Baseline and months 1, 4, 12, 18 (optional) and 24 |
| Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS)] - Fatigue | Baseline and months 1, 4, 12, 18 (optional) and 24 |
| Physician's Global Assessment (PGA) score change from start of deucravacitinib treatment to follow-up | Baseline and at months 4, 12, 18 (optional), and 24 |
| Dermatology Life Quality Index (DLQI) score of ≤5 | Baseline and at months 1, 4, 12 18 (optional) and 24 |
| Body Surface Area (BSA) of ≤ 3% | Baseline and at months 4, 12, 18 (optional), and 24 |
| Body Surface Area (BSA) of ≤ 1% | Baseline and at months 4, 12, 18 (optional), and 24 |
| Reasons for deucravacitinib treatment discontinuation | Up to 24 months |
Countries
France, Switzerland
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed