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Recruiting NCT07582783

A Study of Persistence to Guselkumab Treatment in Participants With Moderate-to-Severe Plaque Psoriasis in Romania

— Observational Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Psoriasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Romania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Persistence to Treatment With Guselkumab in Bio-Naive Patients With Moderate-to-Severe Plaque Psoriasis: A Romanian Non-Interventional Multi-center Observational Study

Overview

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.

Primary outcome measures

  • Time to Guselkumab Discontinuation Throughout 2 Years [Time frame: Up to 2 years]
Secondary outcome measures (12)
  • Percentage of Participants Achieving Absolute Psoriasis Area and Severity Index (PASI) Scores Among Participants Remaining on Treatment [Time frame: At Weeks 12, 24, 52 and 104]
  • Percentage of Participants Achieving PASI 90 Response Score [Time frame: At Weeks 0, 12, 24, 52 and 104]
  • Percentage of Participants Achieving PASI 75 Response Score [Time frame: At Weeks 0, 12, 24, 52 and 104]
  • Percentage of Participants Achieving PASI 100 Response Score [Time frame: At Weeks 0, 12, 24, 52 and 104]
  • Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 [Time frame: At Weeks 0, 12, 24, 52 and 104]
  • Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1 [Time frame: At Weeks 0, 12, 24, 52 and 104]
  • Percentage of Participants Achieving IGA Score of 0 [Time frame: At Weeks 0, 12, 24, 52 and 104]
  • Participant Baseline Characteristics: Age [Time frame: Baseline]
  • Participant Baseline Characteristics: Gender [Time frame: Baseline]
  • Participant Baseline Characteristics: Height [Time frame: Baseline]
  • Participant Baseline Characteristics: Weight [Time frame: Baseline]
  • Number of Participants Reporting Disease Severity [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Romania · 19 centers
  • Mihaila G. Georgiana - Cabinet Medical Individual Dermatovenerologie — Bârlad
  • Qualimed SRL — Brasov
  • Spitalul Universitar de Urgenta Elias, Clinica de Cardiologie — Bucharest
  • Spitalul Clinic Colentina 1 — Bucharest
  • Spitalul Clinic Colentina — Bucharest
  • Alin Nicolescu Medic Primar Dermato Venerologie — Bucharest
  • OptiDerm Estet — Bucharest
  • Spitalul Clinic Judetean de Urgenta Cluj Napoca — Cluj-Napoca
  • … and 11 more centers

Identifiers

NCT: NCT07582783 · CNTO1959PSO4036

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗