Recruiting NCT05744466
A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deucravacitinib, Apremilast.
- Who it may be relevant to
- Registry conditions: Psoriasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Real-world, Prospective, Observational Study of the Comparative Effectiveness of Deucravacitinib Versus Apremilast in Adults With Plaque Psoriasis - North American Region
Overview
The purpose of this study is to understand the comparative effectiveness of deucravacitinib versus apremilast in adults with plaque psoriasis.
Interventions
- Drug Deucravacitinib
As prescribed by treating clinician - Drug Apremilast
As prescribed by treating clinician
Primary outcome measures
- Change in body surface area (BSA) [Time frame: At baseline and every 6 months up to 60 months or treatment discontinuation]
- Investigator global assessment (IGA) response 0/1 [Time frame: Up to 60 months]
- Dermatology life quality index (DLQI) response 0/1 [Time frame: Up to 60 months]
- Time from date of treatment initiation to date of discontinuation [Time frame: Up to 60 months]
Secondary outcome measures (12)
- 75 percent improvement in Psoriasis area and severity index (PASI) score [Time frame: At baseline and every 6 months up to 60 months or treatment discontinuation]
- PASI score response ≤ 3 [Time frame: At baseline to follow-up, up to 60 months]
- PASI score response ≤ 5 [Time frame: At baseline to follow-up, up to 60 months]
- PASI score change from baseline [Time frame: At baseline to follow-up, up to 60 months]
- National psoriasis foundation (NPF) acceptable body surface area (BSA) response [Time frame: At baseline to follow-up, up to 60 months]
- NPF target BSA response [Time frame: At baseline to follow-up, up to 60 months]
- BSA ≤3% [Time frame: At baseline to follow-up, up to 60 months]
- Change in investigator global assessment (IGA) score [Time frame: Up to 60 months]
- Change in dermatology life quality index (DLQI) response [Time frame: At baseline to follow-up, up to 60 months]
- Change in DLQI response ≤5 [Time frame: At baseline to follow-up, up to 60 months]
- Change in visual analog scale (VAS): Itch response [Time frame: At baseline to follow-up, up to 60 months]
- Change in VAS: Skin Pain response [Time frame: At baseline to follow-up, up to 60 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Local Institution — Waltham
Identifiers
NCT: NCT05744466 · IM011-1105