Psoriasis
Conditions
Keywords
Moderate/Severe Psoriasis
Brief summary
The purpose of this study is to characterize the real-life experience of patients with moderate/severe psoriasis receiving deucravacitinib treatment, in terms of efficacy, safety, and health-related quality of life (HRQoL) in Italy
Interventions
DRUGDeucravacitinib
According to the product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants have initiated treatment with deucravacitinib monotherapy 4 to 8 weeks earlier according to clinical practice and to reimbursement criteria determined by National Drug Agency in Italy (AIFA) * Patients have moderate to severe plaque psoriasis * Patients have signed informed consent form (ICF)
Exclusion criteria
* Simultaneous participation in any interventional study for their moderate-to-severe psoriasis * Inability to participate to the study for the following reasons: patients unable to understand the aim of the study, patients unable to understand and sign the ICF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of participants still receiving deucravacitinib treatment | Week 24 and 52 |
| Absolute Psoriasis Area and Severity Index (PASI) | Baseline and Weeks 16, 24 and 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant height in cm | Baseline | — |
| Participant body mass index in kg/m2 | Baseline | — |
| Participant previous pathologies | Baseline | — |
| Participan previous surgical procedures | Baseline | — |
| Date of psoriasis diagnosis | Baseline | — |
| Number of participants with physical examination according to body systems | Baseline | — |
| Participant treatment history | Baseline | Treatment history to describe participants previous treatment(s) received for psoriasis and participants previous treatment(s) received not related to psoriasis |
| Participant comorbidities | Baseline | — |
| Participant age in years | Baseline | — |
| Change in symptoms as assessed by the Itch Numerical Rating Scale (Itch-NRS) score | Baseline and Weeks 16, 24 and 52 | — |
| Body Surface Area (BSA) | Baseline and Weeks 16, 24 and 52 | — |
| Static Physician's Global Assessment (sPGA) score | Baseline and Weeks 16, 24 and 52 | — |
| Scalp Specific Physician Global Assessment (ssPGA) score | Baseline and Weeks 16, 24 and 52 | — |
| Scalp Specific Physician Global Assessment (ssPGA) score 0/1 | Baseline and Weeks 16, 24 and 52 | — |
| Absolute Psoriasis Area and Severity Index (PASI) 75 and 90 | Baseline and Weeks 16, 24 and 52 | — |
| Concomitant psoriasis therapies received | Baseline and Weeks 16, 24 and 52 | — |
| Quality of life as assessed by the Dermatology Life Quality Index (DLQI) questionnaire | Baseline and Weeks 16, 24 and 52 | — |
| Participant sex | Baseline | — |
Countries
Italy
Contacts
Primary ContactBMS Study Connect Contact Center www.BMSStudyConnect.com
Backup ContactFirst line of the email MUST contain NCT # and Site #
Outcome results
None listed