A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis
GULLIVER
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)
2 other identifiers
observational
356
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Typical duration for all trials
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2020
CompletedFirst Submitted
Initial submission to the registry
June 18, 2020
CompletedFirst Posted
Study publicly available on registry
June 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2023
CompletedJanuary 5, 2024
January 1, 2024
3.4 years
June 18, 2020
January 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
The sPGA for the facial region is a physician global rating of psoriasis severity, which evaluates plaque thickness, scaling and erythema, at a given point in time. The sPGA comprises a 6-point rating scale from 0 to 5 where 0 = clear, 1 = minimal/ almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
Week 52
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
The sPGA for the genital region is a physician global ratings of psoriasis severity, which evaluates plaque thickness, scaling and erythema, at a given point in time. The sPGA comprises a 6-point rating scale from 0 to 5 where 0 = clear, 1 = minimal/ almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
Week 52
Secondary Outcomes (23)
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
Week 12, Week 28
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
Week 12, Week 28
Change from Baseline in the Dermatology Quality of life Index (DLQI) Total Score for the Facial Region
Baseline, Week 12, Week 28, Week 52
Change from Baseline in the DLQI Total Score for the Genital Region
Baseline, Week 12, Week 28, Week 52
Change from Baseline in the SF-36 Physical Component Summary (PCS) Score for the Facial Region
Baseline, Week 12, Week 28, Week 52
- +18 more secondary outcomes
Study Arms (2)
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.
Interventions
Participants with moderate facial and/or genital psoriasis treated with guselkumab (as prescribed by their physician) in real world practice will be observed in this study.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Policlinico di Bari Ospedale Giovanni XXIII
Bari, 70124, Italy
Policlinico Sant'Orsola Malpighi
Bologna, 40138, Italy
Ospedale San Giovanni di Dio
Cagliari, 09124, Italy
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Catania, 95123, Italy
Azienda Ospedaliera Universitaria - OO.RR. San Giovanni di Dio Ruggi d'Aragona
Cava de' Tirreni, 84013, Italy
Università D'Annunzio
Chieti, 66100, Italy
Azienda Ospedaliero Universitaria di Ferrara
Cona, 44124, Italy
Ospedale Sant'Antonio Abate
Erice, 91016, Italy
Azienda Sanitaria di Firenze-Ospedale Piero Palagi
Florence, 50125, Italy
IRCCS Aor San Martino IST
Genova, 16132, Italy
Ospedale San Salvatore
L’Aquila, 67100, Italy
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, 98125, Italy
AO Papardo
Messina, 98158, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Az. Ospedaliero - Universitaria di Modena
Modena, 41124, Italy
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
Napoli, 80131, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, 80131, Italy
Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara
Novara, 28100, Italy
Azienda Ospedaliera Universitaria di Padova
Padua, 35128, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
Ospedale Maggiore, Azienda Ospedaliero Universitaria di Parma
Parma, 43126, Italy
Ospedale S. Maria Della Misericordia
Perugia, 06129, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
Reggio Calabria, 89124, Italy
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, 42123, Italy
ISG San Gallicano
Roma, 00144, Italy
AOU Policlinico Umberto I
Roma, 00161, Italy
Istituto Dermopatico dell'Immacolata
Roma, 00167, Italy
Policinico A Gemelli
Roma, 00168, Italy
Policlinico Tor Vergata
Roma, 00183, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Azienda Ospedaliera Santa Maria
Terni, 05100, Italy
Ospedale Alfredo Fiorini
Terracina, 04019, Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino, 10126, Italy
A.O. Universitaria Ospedali Riuniti di Ancona
Torrette Di Ancona, 60030, Italy
Azienda Ospedaliero Universitaria S.Maria Della Misericordia
Udine, 33100, Italy
Ospedale S.S. Giovanni e Paolo
Venezia, 30122, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag S.p.A., Italy Clinical Trial
Janssen-Cilag S.p.A.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2020
First Posted
June 19, 2020
Study Start
June 10, 2020
Primary Completion
November 21, 2023
Study Completion
November 21, 2023
Last Updated
January 5, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share