A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis
NCT ID: NCT04439526
Last Updated: 2024-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
356 participants
OBSERVATIONAL
2020-06-10
2023-11-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Guselkumab
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.
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.
Guselkumab
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.
Interventions
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Guselkumab
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Janssen-Cilag S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen-Cilag S.p.A., Italy Clinical Trial
Role: STUDY_DIRECTOR
Janssen-Cilag S.p.A.
Locations
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Policlinico di Bari Ospedale Giovanni XXIII
Bari, , Italy
Policlinico Sant'Orsola Malpighi
Bologna, , Italy
Ospedale San Giovanni di Dio
Cagliari, , Italy
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Catania, , Italy
Azienda Ospedaliera Universitaria - OO.RR. San Giovanni di Dio Ruggi d'Aragona
Cava de' Tirreni, , Italy
Università D'Annunzio
Chieti, , Italy
Azienda Ospedaliero Universitaria di Ferrara
Cona, , Italy
Ospedale Sant'Antonio Abate
Erice, , Italy
Azienda Sanitaria di Firenze-Ospedale Piero Palagi
Florence, , Italy
IRCCS Aor San Martino IST
Genova, , Italy
Ospedale San Salvatore
L’Aquila, , Italy
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, , Italy
AO Papardo
Messina, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Az. Ospedaliero - Universitaria di Modena
Modena, , Italy
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
Napoli, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara
Novara, , Italy
Azienda Ospedaliera Universitaria di Padova
Padua, , Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, , Italy
Ospedale Maggiore, Azienda Ospedaliero Universitaria di Parma
Parma, , Italy
Ospedale S. Maria Della Misericordia
Perugia, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
Reggio Calabria, , Italy
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, , Italy
ISG San Gallicano
Roma, , Italy
AOU Policlinico Umberto I
Roma, , Italy
Istituto Dermopatico dell'Immacolata
Roma, , Italy
Policinico A Gemelli
Roma, , Italy
Policlinico Tor Vergata
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Azienda Ospedaliera Santa Maria
Terni, , Italy
Ospedale Alfredo Fiorini
Terracina, , Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino, , Italy
A.O. Universitaria Ospedali Riuniti di Ancona
Torrette Di Ancona, , Italy
Azienda Ospedaliero Universitaria S.Maria Della Misericordia
Udine, , Italy
Ospedale S.S. Giovanni e Paolo
Venezia, , Italy
Countries
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Other Identifiers
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CNTO1959PSO4013
Identifier Type: OTHER
Identifier Source: secondary_id
CR108761
Identifier Type: -
Identifier Source: org_study_id
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