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
Sites (38)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico di Bari Ospedale Giovanni XXIII Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Policlinico Sant'Orsola-Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Ospedale San Giovanni di Dio Coordinator of this site? Confirm its status | Cagliari | Italy | Unknown status |
| PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Azienda Ospedaliera Universitaria - OO.RR. San Giovanni di Dio Ruggi d'Aragona Coordinator of this site? Confirm its status | Cava de' Tirreni | Italy | Unknown status |
| Universita D Annunzio Coordinator of this site? Confirm its status | Chieti | Italy | Unknown status |
| Azienda Ospedaliero - Universitaria di Ferrara Coordinator of this site? Confirm its status | Cona | Italy | Unknown status |
| Ospedale Sant'Antonio Abate Coordinator of this site? Confirm its status | Erice | Italy | Unknown status |
| Azienda Sanitaria di Firenze-Ospedale Piero Palagi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| IRCCS Aor San Martino IST Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Ospedale San Salvatore Coordinator of this site? Confirm its status | L’Aquila | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Policlinico G. Martino Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| AO Papardo Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Az. Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| Azienda Ospedaliera Universitaria di Padova Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Ospedale Maggiore, Azienda Ospedaliero Universitaria di Parma Coordinator of this site? Confirm its status | Parma | Italy | Unknown status |
| Ospedale S. Maria della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria Coordinator of this site? Confirm its status | Reggio Calabria | Italy | Unknown status |
| Arcispedale Santa Maria Nuova - IRCCS Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Unknown status |
| ISG San Gallicano Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Policlinico Tor Vergata Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Policinico A Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| AOU Policlinico Umberto I Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Istituto Dermopatico dell'Immacolata Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Istituto Clinico Humanitas Coordinator of this site? Confirm its status | Rozzano | Italy | Unknown status |
| Azienda Ospedaliera Santa Maria Coordinator of this site? Confirm its status | Terni | Italy | Unknown status |
| Ospedale Alfredo Fiorini Coordinator of this site? Confirm its status | Terracina | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| A.O. Universitaria Ospedali Riuniti di Ancona Coordinator of this site? Confirm its status | Torrette Di Ancona | Italy | Unknown status |
| Azienda Ospedaliero Universitaria S.Maria Della Misericordia Coordinator of this site? Confirm its status | Udine | Italy | Unknown status |
| Ospedale S.S. Giovanni e Paolo Coordinator of this site? Confirm its status | Venezia | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.