Psoriasis
Conditions
Keywords
Real-world, Deucravacitinib, Observational
Brief summary
The purpose of this study is to understand the comparative effectiveness of deucravacitinib versus apremilast in adults with plaque psoriasis.
Interventions
DRUGDeucravacitinib
As prescribed by treating clinician
DRUGApremilast
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
Healthy volunteers
No
Inclusion criteria
* Have been diagnosed with plaque psoriasis by a dermatologist * Newly initiating an eligible medication for enrollment (i.e., deucravacitinib, apremilast) * Actively enrolled in the CorEvitas Psoriasis Registry and have documented consent to allow copies of information from the registry be used for research purposes
Exclusion criteria
* Participation (current or planned) in an interventional clinical trial (does not include observational registry or study) * Restart of treatments with the study eligible therapies previously received at any time during the participants' treatment history
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 75 percent improvement in Psoriasis area and severity index (PASI) score | At baseline and every 6 months up to 60 months or treatment discontinuation |
| 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 |
| Change in DLQI response ≤5 | At baseline to follow-up, up to 60 months |
| PASI score response ≤ 3 | At baseline to follow-up, up to 60 months |
| 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 |
Countries
United States
Contacts
Primary ContactBMS Study Connect Contact Center www.BMSStudyConnect.com
Backup ContactFirst line of the email MUST contain the NCT# and Site #.
Outcome results
None listed