Clinical trial NCT04439526: A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Facial
Genital
Lead sponsor: Janssen-Cilag S.p.A.
Sponsor class: INDUSTRY
First posted: 2020-06-19
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients with facial and/or genital psoriasis, receiving guselkumab treatment as standard of care (SOC) in clinical practice, will be observed. The primary data source for the study will be the medical records of each participating participant.

Brief 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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) and at Least a 2-grade Improvement for the Facial Region
timeFrame: Week 52
measure: Percentage of Participants Achieving a sPGA Score of Clear (0) or Almost Clear (1) and at Least a 2-grade Improvement for the Genital Region
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving a sPGA Score of Clear (0) or Almost Clear (1) and at least a 2-grade Improvement for the Facial Region
timeFrame: Week 12, Week 28
measure: Percentage of Participants Achieving a sPGA Score of Clear (0) or Almost Clear (1) and at least a 2-grade Improvement for the Genital Region
timeFrame: Week 12, Week 28
measure: Change from Baseline in the Dermatology Quality of life Index (DLQI) Total Score for the Facial Region
timeFrame: Baseline, Week 12, Week 28, Week 52
measure: Change from Baseline in the DLQI Total Score for the Genital Region
timeFrame: Baseline, Week 12, Week 28, Week 52
measure: Change from Baseline in the SF-36 Physical Component Summary (PCS) Score for the Facial Region
timeFrame: Baseline, Week 12, Week 28, Week 52
measure: Change from Baseline in the SF-36 PCS Score for the Genital Region
timeFrame: Baseline, Week 12, Week 28, Week 52
measure: Change from Baseline in the SF-36 Mental Component Summary (MCS) Score for the Facial Region
timeFrame: Baseline, Week 12, Week 28, Week 52
measure: Change from Baseline in the SF-36 MCS Score for the Genital Region
timeFrame: Baseline, Week 12, Week 28, Week 52
measure: Change from Baseline in Pain/Itch/Discomfort Visual Analogue Scale (VAS) Scores for the Facial Region
timeFrame: Baseline, Week 12, Week 28, Week 52
measure: Change from Baseline in Pain/Itch/Discomfort VAS Scores for the Genital Region
timeFrame: Baseline, Week 12, Week 28, Week 52
measure: Change from Baseline in Redness/Scaling/Thickness VAS Scores for the Facial Region
timeFrame: Baseline, Week 12, Week 28, Week 52
measure: Change from Baseline in Redness/Scaling/Thickness VAS Scores for the Genital Region
timeFrame: Baseline, Week 12, Week 28, Week 52
measure: Percentage of Participants Achieving an Overall sPGA Score of Clear (0) or Almost Clear (1) and at least a 2-grade Improvement Among Participants with an Overall sPGA Score greater than or equal to (>=) 3 at baseline
timeFrame: Baseline, Week 12, Week 28, Week 52
measure: Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 100 Response Among Participants with a PASI Score >10 at Baseline
timeFrame: Baseline, Week 12, Week 28, Week 52
measure: Percentage of Participants Achieving a PASI 90 Response Among Participants with a PASI Score >10 at Baseline
timeFrame: Baseline, Week 12, Week 28, Week 52
measure: Percentage of Participants Achieving a PASI 75 Response Among Participants with a PASI Score >10 at Baseline
timeFrame: Baseline, Week 12, Week 28, Week 52
measure: Mean Percent Change in PASI Score from Baseline
timeFrame: Baseline, Week 12, Week 28, Week 52
measure: Mean Change in Percent Body Surface Area (BSA) from Baseline in Participants with BSA >10% at Baseline
timeFrame: Baseline, Week 12, Week 28, Week 52
measure: Percentage of Participants Achieving an Absolute PASI Score of Less Than (<) 3 Among Participants with a PASI Score of >10 at Baseline
timeFrame: Baseline, Week 12, Week 28, Week 52
measure: Treatment Satisfaction Questionnaire for Medication (TSQM-9)
timeFrame: Week 52
measure: Persistency with Guselkumab
timeFrame: Up to Week 52
measure: Narrative Plots at Enrollment and Week 52
timeFrame: Baseline (at enrollment) and Week 52
measure: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Policlinico di Bari Ospedale Giovanni XXIII
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola Malpighi
city: Cagliari
country: Italy
facility: Ospedale San Giovanni di Dio
city: Catania
country: Italy
facility: PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
city: Cava de' Tirreni
country: Italy
facility: Azienda Ospedaliera Universitaria - OO.RR. San Giovanni di Dio Ruggi d'Aragona
city: Chieti
country: Italy
facility: Università D'Annunzio
city: Cona
country: Italy
facility: Azienda Ospedaliero Universitaria di Ferrara
city: Erice
country: Italy
facility: Ospedale Sant'Antonio Abate
city: Firenze
country: Italy
facility: Azienda Sanitaria di Firenze-Ospedale Piero Palagi
city: Genova
country: Italy
facility: IRCCS Aor San Martino IST
city: L'Aquila
country: Italy
facility: Ospedale San Salvatore
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico G. Martino
city: Messina
country: Italy
facility: AO Papardo
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Modena
country: Italy
facility: Az. Ospedaliero - Universitaria di Modena
city: Napoli
country: Italy
facility: Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Novara
country: Italy
facility: Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova
city: Palermo
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
city: Parma
country: Italy
facility: Ospedale Maggiore, Azienda Ospedaliero Universitaria di Parma
city: Perugia
country: Italy
facility: Ospedale S. Maria Della Misericordia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova - IRCCS
city: Roma
country: Italy
facility: ISG San Gallicano
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
city: Roma
country: Italy
facility: Istituto Dermopatico dell'Immacolata
city: Roma
country: Italy
facility: Policinico A Gemelli
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria
city: Terracina
country: Italy
facility: Ospedale Alfredo Fiorini
city: Torino
country: Italy
facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
city: Torrette Di Ancona
country: Italy
facility: A.O. Universitaria Ospedali Riuniti di Ancona
city: Udine
country: Italy
facility: Azienda Ospedaliero Universitaria S.Maria Della Misericordia
city: Venezia
country: Italy
facility: Ospedale S.S. Giovanni e Paolo
Study officials:
affiliation: Janssen-Cilag S.p.A.
name: Janssen-Cilag S.p.A., Italy Clinical Trial
role: STUDY_DIRECTOR
References: