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NCT04439526Completed

A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis

Observational Study on GUselkumab: Effectiveness and Impact on quaLity of LIfe in naïVE or Bio Experienced Patients With Regional (Facial and Genital) Psoriasis (GULLIVER Study)

Source: ClinicalTrials.gov · Last updated 5 Jan 2024

Brief summary (registry, in English)

The purpose of this study is to investigate the effectiveness profile of guselkumab used in a real-life setting in participants with moderate facial and/or genital psoriasis. Effectiveness will be evaluated using the static Physicians Global Assessment (sPGA) for the facial region and the sPGA for the genital region.

Status (registry)
Completed
Study type
Observational
Enrollment
356 (actual)
First submitted
18 Jun 2020
Start date
10 Jun 2020
Primary completion date
21 Nov 2023
Lead sponsor
Janssen-Cilag S.p.A.
Diseases
Psoriasis
NCT number
NCT04439526

What you commit to

  • Study type: Observational
  • Participants enrolled: 356
  • From 10 Jun 2020 to the primary completion date, 21 Nov 2023
  • 38 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of guselkumab treatment

Other

  • Participants will be excluded from the study if they:
  • have any contraindication to the use of guselkumab, as stated in the current SmPC of the product approved in Italy
  • are currently enrolled in another clinical trial or investigational study
  • are currently enrolled in an observational study sponsored or managed by a Janssen company
  • participant unable to read, to write, to understand and sign the informed consent form (ICF)

Who the study is looking for

  • Participants included in the study:
  • must have a first or confirmed diagnosis of psoriasis, requiring systemic treatment with significant involvement (defined as a Static Physician's Global Assessment \[sPGA\] score greater than or equal to \[\>=\] 3) involving the facial and/or genital regions
  • must have started treatment according to the approved indication as described in the current version of summary of product characteristics (SmPC) of the product approved in Italy. Enrollment may occur at any time after the first injection of guselkumab but before completion of the next visit at week 4 or 12 as scheduled according to common clinical practice
  • must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (38)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Policlinico di Bari Ospedale Giovanni XXIII
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BariItalyUnknown status
Policlinico Sant'Orsola-Malpighi
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BolognaItalyUnknown status
Ospedale San Giovanni di Dio
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CagliariItalyUnknown status
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
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CataniaItalyUnknown status
Azienda Ospedaliera Universitaria - OO.RR. San Giovanni di Dio Ruggi d'Aragona
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Cava de' TirreniItalyUnknown status
Universita D Annunzio
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ChietiItalyUnknown status
Azienda Ospedaliero - Universitaria di Ferrara
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ConaItalyUnknown status
Ospedale Sant'Antonio Abate
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EriceItalyUnknown status
Azienda Sanitaria di Firenze-Ospedale Piero Palagi
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FlorenceItalyUnknown status
IRCCS Aor San Martino IST
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GenovaItalyUnknown status
Ospedale San Salvatore
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L’AquilaItalyUnknown status
Azienda Ospedaliera Universitaria Policlinico G. Martino
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MessinaItalyUnknown status
AO Papardo
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MessinaItalyUnknown status
IRCCS Ospedale San Raffaele
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MilanItalyUnknown status
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyUnknown status
Az. Ospedaliero - Universitaria di Modena
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ModenaItalyUnknown status
Azienda Ospedaliera Universitaria Federico II
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NaplesItalyUnknown status
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
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NaplesItalyUnknown status
Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara
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NovaraItalyUnknown status
Azienda Ospedaliera Universitaria di Padova
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PadovaItalyUnknown status
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
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PalermoItalyUnknown status
Ospedale Maggiore, Azienda Ospedaliero Universitaria di Parma
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ParmaItalyUnknown status
Ospedale S. Maria della Misericordia
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PerugiaItalyUnknown status
Azienda Ospedaliero Universitaria Pisana
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PisaItalyUnknown status
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
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Reggio CalabriaItalyUnknown status
Arcispedale Santa Maria Nuova - IRCCS
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Reggio EmiliaItalyUnknown status
ISG San Gallicano
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RomaItalyUnknown status
Policlinico Tor Vergata
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RomaItalyUnknown status
Policinico A Gemelli
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RomaItalyUnknown status
AOU Policlinico Umberto I
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RomaItalyUnknown status
Istituto Dermopatico dell'Immacolata
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RomaItalyUnknown status
Istituto Clinico Humanitas
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RozzanoItalyUnknown status
Azienda Ospedaliera Santa Maria
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TerniItalyUnknown status
Ospedale Alfredo Fiorini
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TerracinaItalyUnknown status
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
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TorinoItalyUnknown status
A.O. Universitaria Ospedali Riuniti di Ancona
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Torrette Di AnconaItalyUnknown status
Azienda Ospedaliero Universitaria S.Maria Della Misericordia
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UdineItalyUnknown status
Ospedale S.S. Giovanni e Paolo
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VeneziaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.