Actively Recruiting
Registry of Psoriasis Health Outcomes: A Longitudinal Real-world Collaboration (RePhlect) - A Real-World, Prospective, Observational Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan
Led by Bristol-Myers Squibb · Updated on 2024-04-25
600
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a real-world, prospective observational study in Japan to compare the effectiveness of two treatments, deucravacitinib and apremilast, for adults diagnosed with plaque psoriasis. This study focuses on participants who have begun treatment under normal medical care, aiming to gather data on how these therapies perform outside controlled clinical trial settings. Participants in this study are adults with plaque psoriasis who have recently started treatment with either deucravacitinib or apremilast as prescribed by their doctors. The study observes these participants over time without assigning treatments, tracking outcomes according to routine care. Data is collected at multiple follow-up points: 1 month, 3 months, 6 months, and every 6 months up to 5 years. During the study, researchers will measure changes in the percentage of body surface area affected by psoriasis, improvements in physician assessments, severity indexes, and quality of life scores. Treatment duration and various clinical scores will be recorded regularly to understand long-term effects. Participants will be followed for up to five years, with data collected through regular visits and assessments to monitor treatment outcomes and disease progress.
CONDITIONS
Brief Title
A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Japanese adult participants aged 18 years old or older
- Physician-reported diagnosis of plaque psoriasis
- Newly initiating deucravacitinib or apremilast according to the label
- Participants who have signed informed consent
You will not qualify if you...
- Participants currently participating in or planning to participate in an interventional clinical trial
- Patients enrolled in deucravacitinib post-marketing surveillance study (ClinicalTrial.gov ID: NCT05633264)
- Previous treatment experience with the treatment of interest (e.g. patients who have history of apremilast will not be eligible to be enrolled in apremilast arm of the study and similar for deucravacitinib)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants receive deucravacitinib or apremilast treatment according to the product label and are assessed for effectiveness and quality of life changes.
Visits at 1 month, 3 months, 6 months, and every 6 months up to 5 years
Trial Site Locations
Total: 2 locations
1
Mebix. Inc.
Minato-ku, Tokyo, Japan, 1070052
Actively Recruiting
2
Fukuoka University Hospital
Fukuoka, Japan
Actively Recruiting
Research Team
B
BMS Study Connect Contact Center www.BMSStudyConnect.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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