A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis
- Registration Number
- NCT04439526
- Lead Sponsor
- Janssen-Cilag S.p.A.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 356
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
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with Facial Psoriasis Guselkumab 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 Guselkumab Participants with moderate genital psoriasis who are being treated with guselkumab in real world practice will be observed in this study.
- Primary Outcome Measures
Name Time Method 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 52 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.
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 Week 52 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Redness/Scaling/Thickness VAS Scores for the Facial Region Baseline, Week 12, Week 28, Week 52 Each VAS is a patient-rated assessment designed to evaluate the intensity of redness, scaling, and thickness on a linear scale of 0-100. Operationally, each VAS is represented by a 100 mm horizontal line anchored by extreme descriptors at each end, where 0 = "No Sign" and 100 = "Worst Sign Imaginable".
Change from Baseline in the SF-36 Physical Component Summary (PCS) Score for the Facial Region Baseline, Week 12, Week 28, Week 52 The SF-36 is a survey that measures 8 domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Each item is scored on a scale of 0 to 100. Worst value is 0 and best value is 100.
Change from Baseline in the SF-36 PCS Score for the Genital Region Baseline, Week 12, Week 28, Week 52 The SF-36 is a survey that measures 8 domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Each item is scored on a scale of 0 to 100. Worst value is 0 and best value is 100.
Change from Baseline in the SF-36 Mental Component Summary (MCS) Score for the Facial Region Baseline, Week 12, Week 28, Week 52 The SF-36 is a survey that measures 8 domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Each item is scored on a scale of 0 to 100. Worst value is 0 and best value is 100.
Change from Baseline in the SF-36 MCS Score for the Genital Region Baseline, Week 12, Week 28, Week 52 The SF-36 is a survey that measures 8 domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Each item is scored on a scale of 0 to 100. Worst value is 0 and best value is 100.
Change from Baseline in Pain/Itch/Discomfort Visual Analogue Scale (VAS) Scores for the Facial Region Baseline, Week 12, Week 28, Week 52 Each VAS is a patient-rated assessment designed to evaluate the intensity of pain, itch or discomfort on a linear scale of 0-100. Operationally, each VAS is represented by a 100 mm horizontal line anchored by extreme descriptors at each end, where 0 = "No Symptom" and 100 = "Worst Symptom Imaginable".
Change from Baseline in Pain/Itch/Discomfort VAS Scores for the Genital Region Baseline, Week 12, Week 28, Week 52 Each VAS is a patient-rated assessment designed to evaluate the intensity of pain, itch or discomfort on a linear scale of 0-100. Operationally, each VAS is represented by a 100 mm horizontal line anchored by extreme descriptors at each end, where 0 = "No Symptom" and 100 = "Worst Symptom Imaginable".
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 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.
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 The sPGA for the genital 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.
Change from Baseline in the Dermatology Quality of life Index (DLQI) Total Score for the Facial Region Baseline, Week 12, Week 28, Week 52 The DLQI is a 10-item questionnaire that measures the impact of skin disease on participants' quality of life. Each question is evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate greater impact on quality of life. The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30 where 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate greater impact on quality of life of participants.
Change from Baseline in the DLQI Total Score for the Genital Region Baseline, Week 12, Week 28, Week 52 The DLQI is a 10-item questionnaire that measures the impact of skin disease on participants' quality of life. Each question is evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate greater impact on quality of life. The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30 where 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate greater impact on quality of life of participants.
Persistency with Guselkumab Up to Week 52 Persistency with treatment is defined as duration of time from initiation to last dose of therapy, as well as the percentage of participants still on treatment at the end of the observation period.
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 Baseline, Week 12, Week 28, Week 52 The overall sPGA is defined as 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.
Percentage of Participants Achieving a PASI 90 Response Among Participants with a PASI Score >10 at Baseline Baseline, Week 12, Week 28, Week 52 The PASI is a tool to assess and grade the severity of psoriasis and response to therapy. In the PASI, the body is divided into four areas: the head, trunk, upper extremities and lower extremities. Each of these areas is assessed separately for the percentage of surface area involved, which translates to a numeric score that ranges from 0 to 6, and for degree of erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher score indicating more severe disease status. A PASI 90 response is defined as \>=90% improvement in PASI score from baseline.
Percentage of Participants Achieving a PASI 75 Response Among Participants with a PASI Score >10 at Baseline Baseline, Week 12, Week 28, Week 52 The PASI is a tool to assess and grade the severity of psoriasis and response to therapy. In the PASI, the body is divided into four areas: the head, trunk, upper extremities and lower extremities. Each of these areas is assessed separately for the percentage of surface area involved, which translates to a numeric score that ranges from 0 to 6, and for degree of erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher score indicating more severe disease status. A PASI 75 response is defined as \>=75% improvement in PASI score from baseline.
Mean Change in Percent Body Surface Area (BSA) from Baseline in Participants with BSA >10% at Baseline Baseline, Week 12, Week 28, Week 52 BSA affected by psoriasis of \<5% is considered mild psoriasis, 5-10% moderate psoriasis, and \>10% severe psoriasis.
Percentage of Participants Achieving an Absolute PASI Score of Less Than (<) 3 Among Participants with a PASI Score of >10 at Baseline Baseline, Week 12, Week 28, Week 52 The PASI is a tool to assess and grade the severity of psoriasis and response to therapy. In the PASI, the body is divided into four areas: the head, trunk, upper extremities and lower extremities. Each of these areas is assessed separately for the percentage of surface area involved, which translates to a numeric score that ranges from 0 to 6, and for degree of erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher score indicating more severe disease status. Percentage of participants who achieve an absolute PASI score \<3 will be assessed.
Change from Baseline in Redness/Scaling/Thickness VAS Scores for the Genital Region Baseline, Week 12, Week 28, Week 52 Each VAS is a patient-rated assessment designed to evaluate the intensity of redness, scaling, and thickness on a linear scale of 0-100. Operationally, each VAS is represented by a 100 mm horizontal line anchored by extreme descriptors at each end, where 0 = "No Sign" and 100 = "Worst Sign Imaginable".
Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 100 Response Among Participants with a PASI Score >10 at Baseline Baseline, Week 12, Week 28, Week 52 The PASI is a tool to assess and grade the severity of psoriasis and response to therapy. In the PASI, the body is divided into four areas: the head, trunk, upper extremities and lower extremities. Each of these areas is assessed separately for the percentage of surface area involved, which translates to a numeric score that ranges from 0 to 6, and for degree of erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher score indicating more severe disease status. A PASI 100 response is defined as 100 percent (%) improvement in PASI score from baseline.
Mean Percent Change in PASI Score from Baseline Baseline, Week 12, Week 28, Week 52 The PASI is a tool to assess and grade the severity of psoriasis and response to therapy. In the PASI, the body is divided into four areas: the head, trunk, upper extremities and lower extremities. Each of these areas is assessed separately for the percentage of surface area involved, which translates to a numeric score that ranges from 0 to 6, and for degree of erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher score indicating more severe disease status. Mean percent change from baseline in PASI score will be assessed.
Treatment Satisfaction Questionnaire for Medication (TSQM-9) Week 52 The TSQM-9 is a 9-item generic participant-reported outcome instrument to assess participants' satisfaction with medication and covers domains of effectiveness, convenience and global satisfaction. The instrument is scored by domain with scores ranging from 0-100, where a lower score indicates lower satisfaction.
Narrative Plots at Enrollment and Week 52 Baseline (at enrollment) and Week 52 Participants will be invited to fill in two narrative plots; one at the enrollment visit and one at the week 52 visit.
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to Week 52 An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Trial Locations
- Locations (38)
Azienda Ospedaliera Universitaria - OO.RR. San Giovanni di Dio Ruggi d'Aragona
🇮🇹Cava de' Tirreni, Italy
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
🇮🇹Napoli, Italy
Ospedale San Giovanni di Dio
🇮🇹Cagliari, Italy
IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Arcispedale Santa Maria Nuova - IRCCS
🇮🇹Reggio Emilia, Italy
Istituto Dermopatico dell'Immacolata
🇮🇹Roma, Italy
AO Papardo
🇮🇹Messina, Italy
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
🇮🇹Reggio Calabria, Italy
Policlinico Tor Vergata
🇮🇹Roma, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
🇮🇹Milano, 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
🇮🇹Padova, Italy
ISG San Gallicano
🇮🇹Roma, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Azienda Ospedaliera Santa Maria
🇮🇹Terni, Italy
Ospedale Alfredo Fiorini
🇮🇹Terracina, Italy
AOU Policlinico Umberto I
🇮🇹Roma, Italy
Policinico A Gemelli
🇮🇹Roma, Italy
A.O. Universitaria Ospedali Riuniti di Ancona
🇮🇹Torrette Di Ancona, Italy
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
🇮🇹Catania, Italy
Azienda Ospedaliero Universitaria di Ferrara
🇮🇹Cona, Italy
Policlinico di Bari Ospedale Giovanni XXIII
🇮🇹Bari, Italy
Policlinico Sant'Orsola Malpighi
🇮🇹Bologna, Italy
Università D'Annunzio
🇮🇹Chieti, Italy
IRCCS Aor San Martino IST
🇮🇹Genova, Italy
Azienda Ospedaliera Universitaria Policlinico G. Martino
🇮🇹Messina, Italy
Ospedale Sant'Antonio Abate
🇮🇹Erice, Italy
Ospedale San Salvatore
🇮🇹L'Aquila, Italy
Azienda Sanitaria di Firenze-Ospedale Piero Palagi
🇮🇹Firenze, Italy
Az. Ospedaliero - Universitaria di Modena
🇮🇹Modena, Italy
Ospedale Maggiore, Azienda Ospedaliero Universitaria di Parma
🇮🇹Parma, Italy
Ospedale S. Maria Della Misericordia
🇮🇹Perugia, Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Azienda Ospedaliero Universitaria S.Maria Della Misericordia
🇮🇹Udine, Italy
Ospedale S.S. Giovanni e Paolo
🇮🇹Venezia, Italy