Clinical trial NCT06701513: A Real-world Study to Evaluate the Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in France (RePhlect)
Official title: Registry of Psoriasis Health Outcomes: A Longitudinal Real-world Collaboration (RePhlect) - A Real-world, Prospective, Observational Study of the Effectiveness of Deucravacitinib in Adults With Moderate-to-Severe Plaque Psoriasis in France
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriasis
Keywords: Psoriasis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-11-22
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who have been diagnosed with moderate-to-severe plaque psoriasis and who intend to start deucravacitinib treatment in France

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


Eligibility criteria: 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

Primary outcomes:
measure: Physician's Global Assessment (PGA) 0/1 response
timeFrame: Baseline and at months 4, 12, 18 (optional), and 24
measure: Dermatology Life Quality Index (DLQI) 0/1 response
timeFrame: Baseline and at months 4, 12, 18 (optional), and 24
measure: Time from date of treatment initiation to date of discontinuation
timeFrame: Up to 24 months
Secondary outcomes:
measure: Change in percentage involved Body Surface Area (BSA) from start of deucravacitinib treatment
timeFrame: Baseline and at months 4, 12, 18 (optional), and 24
measure: Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS) - Itch
timeFrame: Baseline and months 1, 4, 12, 18 (optional) and 24
measure: Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS) - Skin pain
timeFrame: Baseline and months 1, 4, 12, 18 (optional) and 24
measure: Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS)] - Fatigue
timeFrame: Baseline and months 1, 4, 12, 18 (optional) and 24
measure: Physician's Global Assessment (PGA) score change from start of deucravacitinib treatment to follow-up
timeFrame: Baseline and at months 4, 12, 18 (optional), and 24
measure: Dermatology Life Quality Index (DLQI) score of ≤5
timeFrame: Baseline and at months 1, 4, 12 18 (optional) and 24
measure: Body Surface Area (BSA) of ≤ 3%
timeFrame: Baseline and at months 4, 12, 18 (optional), and 24
measure: Body Surface Area (BSA) of ≤ 1%
timeFrame: Baseline and at months 4, 12, 18 (optional), and 24
measure: Reasons for deucravacitinib treatment discontinuation
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Amiens cedex 1
country: France
facility: Local Institution - 060
city: Angers
country: France
facility: Cabinet Médical Elisabeth Lion
city: Argenteuil
country: France
facility: Local Institution - 045
city: Arras
country: France
facility: CH ARRAS
city: Bordeaux
country: France
facility: Local Institution - 041
city: Bordeaux
country: France
facility: Local Institution - 048
city: Chalon sur Saone
country: France
facility: Centre Hospitalier William Morey - Hématologie
city: Dijon
country: France
facility: CHU Dijon
city: Dijon
country: France
facility: Local Institution - 077
city: La Tronche
country: France
facility: Local Institution - 011
city: Le Puy En Velay
country: France
facility: Local Institution - 074
city: Lens Cedex
country: France
facility: Local Institution - 039
city: Marcq En Baroeul
country: France
facility: Local Institution - 004
city: Montpellier
country: France
facility: Local Institution - 036
city: Nice
country: France
facility: Local Institution - 012
city: Nimes
country: France
facility: Local Institution - 062
city: Niort
country: France
facility: Local Institution - 008
city: Niort
country: France
facility: Local Institution - 070
city: Paris
country: France
facility: Local Institution - 073
city: Perigueux
country: France
facility: Local Institution - 078
city: Roubaix
country: France
facility: Local Institution - 046
city: Roubaix
country: France
facility: Local Institution - 047
city: Saint-mandé
country: France
facility: Local Institution - 051
city: Saint-maur-des-fosses
country: France
facility: Local Institution - 072
city: Toulon
country: France
facility: Hia Sainte Anne
city: Toulon
country: France
facility: Local Institution - 054
city: Toulouse cedex 9
country: France
facility: Local Institution - 021
city: Toulouse cedex 9
country: France
facility: Local Institution - 037
city: Toulouse
country: France
facility: Local Institution - 005
city: Vandœuvre-lès-nancy
country: France
facility: Local Institution - 061
city: Vandœuvre-lès-nancy
country: France
facility: Local Institution - 064
city: Villeurbanne
country: France
facility: Local Institution - 003
city: Villeurbanne
country: France
facility: Local Institution - 006
city: La chaux de fonds
country: Switzerland
facility: Cabinet Medical
city: La chaux de fonds
country: Switzerland
facility: Cabinet Medical
city: La chaux de fonds
country: Switzerland
facility: Local Institution - 007
city: La chaux de fonds
country: Switzerland
facility: Local Institution - 025
city: La chaux de fonds
country: Switzerland
facility: Local Institution - 029
city: La chaux de fonds
country: Switzerland
facility: Local Institution - 038
city: La chaux de fonds
country: Switzerland
facility: Local Institution - 044
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: