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)

Status: Completed
Location: See all (38) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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⁃ 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

Locations
Other Locations
Italy
Policlinico di Bari Ospedale Giovanni XXIII
Bari
Policlinico Sant'Orsola Malpighi
Bologna
Ospedale San Giovanni di Dio
Cagliari
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Catania
Azienda Ospedaliera Universitaria - OO.RR. San Giovanni di Dio Ruggi d'Aragona
Cava De' Tirreni
Università D'Annunzio
Chieti
Azienda Ospedaliero Universitaria di Ferrara
Cona
Ospedale Sant'Antonio Abate
Erice
Azienda Sanitaria di Firenze-Ospedale Piero Palagi
Florence
IRCCS Aor San Martino IST
Genova
Ospedale San Salvatore
L’aquila
AO Papardo
Messina
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan
IRCCS Ospedale San Raffaele
Milan
Az. Ospedaliero - Universitaria di Modena
Modena
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
Napoli
Azienda Ospedaliera Universitaria Federico II
Napoli
Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara
Novara
Azienda Ospedaliera Universitaria di Padova
Padua
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo
Ospedale Maggiore, Azienda Ospedaliero Universitaria di Parma
Parma
Ospedale S. Maria Della Misericordia
Perugia
Azienda Ospedaliero Universitaria Pisana
Pisa
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
Reggio Calabria
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia
AOU Policlinico Umberto I
Roma
ISG San Gallicano
Roma
Istituto Dermopatico dell'Immacolata
Roma
Policinico A Gemelli
Roma
Policlinico Tor Vergata
Roma
Istituto Clinico Humanitas
Rozzano
Azienda Ospedaliera Santa Maria
Terni
Ospedale Alfredo Fiorini
Terracina
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino
A.O. Universitaria Ospedali Riuniti di Ancona
Torrette Di Ancona
Azienda Ospedaliero Universitaria S.Maria Della Misericordia
Udine
Ospedale S.S. Giovanni e Paolo
Venezia
Time Frame
Start Date: 2020-06-10
Completion Date: 2023-11-21
Participants
Target number of participants: 356
Treatments
Participants with Facial Psoriasis
Participants with moderate facial psoriasis who are being treated with guselkumab in real world practice will be observed in this study.
Participants with Genital Psoriasis
Participants with moderate genital psoriasis who are being treated with guselkumab in real world practice will be observed in this study.
Related Therapeutic Areas
Sponsors
Leads: Janssen-Cilag S.p.A.

This content was sourced from clinicaltrials.gov