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)

Mihaila G. Georgiana - Cabinet Medical Individual Dermatovenerologie

Bârlad, Romania

Qualimed SRL

Brasov, Romania

Spitalul Clinic Colentina 1

Bucharest, Romania

Spitalul Clinic Colentina

Bucharest, Romania

Derma Lux SRL

Iași, Romania

Dr Tirziu Dermato Chirurgie SRL

Timișoara, Romania

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NCT07582783


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