Clinical trial NCT05744466: A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
Official title: A Real-world, Prospective, Observational Study of the Comparative Effectiveness of Deucravacitinib Versus Apremilast in Adults With Plaque Psoriasis - North American Region
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriasis
Keywords: Real-world
Deucravacitinib
Observational
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-02-27
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: The purpose of this study is to understand the comparative effectiveness of deucravacitinib versus apremilast in adults with plaque psoriasis.


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

Primary outcomes:
measure: Change in body surface area (BSA)
timeFrame: At baseline and every 6 months up to 60 months or treatment discontinuation
measure: Investigator global assessment (IGA) response 0/1
timeFrame: Up to 60 months
measure: Dermatology life quality index (DLQI) response 0/1
timeFrame: Up to 60 months
measure: Time from date of treatment initiation to date of discontinuation
timeFrame: Up to 60 months
Secondary outcomes:
measure: 75 percent improvement in Psoriasis area and severity index (PASI) score
timeFrame: At baseline and every 6 months up to 60 months or treatment discontinuation
measure: PASI score response ≤ 3
timeFrame: At baseline to follow-up, up to 60 months
measure: PASI score response ≤ 5
timeFrame: At baseline to follow-up, up to 60 months
measure: PASI score change from baseline
timeFrame: At baseline to follow-up, up to 60 months
measure: National psoriasis foundation (NPF) acceptable body surface area (BSA) response
timeFrame: At baseline to follow-up, up to 60 months
measure: NPF target BSA response
timeFrame: At baseline to follow-up, up to 60 months
measure: BSA ≤3%
timeFrame: At baseline to follow-up, up to 60 months
measure: Change in investigator global assessment (IGA) score
timeFrame: Up to 60 months
measure: Change in dermatology life quality index (DLQI) response
timeFrame: At baseline to follow-up, up to 60 months
measure: Change in DLQI response ≤5
timeFrame: At baseline to follow-up, up to 60 months
measure: Change in visual analog scale (VAS): Itch response
timeFrame: At baseline to follow-up, up to 60 months
measure: Change in VAS: Skin Pain response
timeFrame: At baseline to follow-up, up to 60 months
measure: Change in VAS: Fatigue Response
timeFrame: At baseline to follow-up, up to 60 months
measure: Merit-based Incentive Payment System (MIPS) Clinical Response to Oral Systemic or Biologic Medications
timeFrame: At baseline to follow-up, up to 60 months
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Local Institution
state: Massachusetts
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: