RecruitingNCT07582783
A Study of Persistence to Guselkumab Treatment in Participants With Moderate-to-Severe Plaque Psoriasis in Romania
Persistence to Treatment With Guselkumab in Bio-Naive Patients With Moderate-to-Severe Plaque Psoriasis: A Romanian Non-Interventional Multi-center Observational Study
Sponsor
Janssen Research & Development, LLC
Enrollment
200 participants
Start Date
May 15, 2026
Study Type
OBSERVATIONAL
Conditions
Summary
This study aims to assess the proportion of participants with moderate-to-severe plaque psoriasis who continue treatment with guselkumab over a two-year period.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- Has a confirmed diagnosis of moderate-to-severe plaque psoriasis
- Participant must sign an informed consent form allowing source data verification in accordance with local requirements
- Is able to read, understand, and complete the patient reported outcomes (PRO) instruments in local language and comply with completion of all PRO instruments
- No previous exposure to biological treatment, including guselkumab (bio-naive patient)
- Intended for the treatment with guselkumab according to the approved indication
Exclusion Criteria4
- Meets any of the contraindications according to the latest version of the locally approved summary of product characteristics (SmPC)
- Is pregnant or lactating
- Current or recent (in the last 30 days prior to first SC dose of guselkumab) participation in any interventional study with investigational product.
- Currently enrolled in another observational study sponsored or managed by a Johnson \& Johnson company
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Locations(6)
View Full Details on ClinicalTrials.gov
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NCT07582783
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