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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 356
- 试验地点
- 38
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Guselkumab (Drug)
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.
干预措施: Guselkumab (Drug)
结局指标
主要结局
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
时间窗: 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
时间窗: 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.
次要结局
- Change from Baseline in Redness/Scaling/Thickness VAS Scores for the Facial 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)
- Change from Baseline in the SF-36 PCS Score for the Genital Region(Baseline, Week 12, Week 28, Week 52)
- Change from Baseline in the SF-36 Mental Component Summary (MCS) Score for the Facial Region(Baseline, Week 12, Week 28, Week 52)
- Change from Baseline in the SF-36 MCS Score for the Genital Region(Baseline, Week 12, Week 28, Week 52)
- Change from Baseline in Pain/Itch/Discomfort Visual Analogue Scale (VAS) Scores for the Facial Region(Baseline, Week 12, Week 28, Week 52)
- Change from Baseline in Pain/Itch/Discomfort VAS Scores for the Genital Region(Baseline, Week 12, Week 28, 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 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)
- Persistency with Guselkumab(Up to Week 52)
- 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)
- Percentage of Participants Achieving a PASI 90 Response Among Participants with a PASI Score >10 at Baseline(Baseline, Week 12, Week 28, Week 52)
- Percentage of Participants Achieving a PASI 75 Response Among Participants with a PASI Score >10 at Baseline(Baseline, Week 12, Week 28, Week 52)
- Mean Change in Percent Body Surface Area (BSA) from Baseline in Participants with BSA >10% at Baseline(Baseline, Week 12, Week 28, Week 52)
- 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)
- Change from Baseline in Redness/Scaling/Thickness VAS Scores for the Genital Region(Baseline, Week 12, Week 28, Week 52)
- 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)
- Mean Percent Change in PASI Score from Baseline(Baseline, Week 12, Week 28, Week 52)
- Treatment Satisfaction Questionnaire for Medication (TSQM-9)(Week 52)
- Narrative Plots at Enrollment and Week 52(Baseline (at enrollment) and Week 52)
- Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Week 52)