Status:
COMPLETED
A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis
Lead Sponsor:
Janssen-Cilag S.p.A.
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
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 eva...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 21 2023
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT04439526
Start Date
June 10 2020
End Date
November 21 2023
Last Update
January 5 2024
Active Locations (38)
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1
Policlinico di Bari Ospedale Giovanni XXIII
Bari, Italy, 70124
2
Policlinico Sant'Orsola Malpighi
Bologna, Italy, 40138
3
Ospedale San Giovanni di Dio
Cagliari, Italy, 09124
4
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Catania, Italy, 95123