NCT07582783招募中不适用
Persistence to Treatment With Guselkumab in Bio-Naive Patients With Moderate-to-Severe Plaque Psoriasis: A Romanian Non-Interventional Multi-center Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 20
- 主要终点
- Time to Guselkumab Discontinuation Throughout 2 Years
研究概览
简要总结
This study aims to assess the proportion of participants with moderate-to-severe plaque psoriasis who continue treatment with guselkumab over a two-year period.
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
- •Has a confirmed diagnosis of moderate-to-severe plaque psoriasis
- •Participant must sign an informed consent form allowing source data verification in accordance with local requirements
- •Is able to read, understand, and complete the patient reported outcomes (PRO) instruments in local language and comply with completion of all PRO instruments
- •No previous exposure to biological treatment, including guselkumab (bio-naive patient)
- •Intended for the treatment with guselkumab according to the approved indication
排除标准
- •Meets any of the contraindications according to the latest version of the locally approved summary of product characteristics (SmPC)
- •Is pregnant or lactating
- •Current or recent (in the last 30 days prior to first SC dose of guselkumab) participation in any interventional study with investigational product.
- •Currently enrolled in another observational study sponsored or managed by a Johnson & Johnson company
研究组 & 干预措施
Group 1: Participants with Moderate-to-Severe Plaque Psoriasis
Participants with confirmed diagnosis of moderate-to-severe plaque psoriasis who have never been treated with biological treatment before, and receiving guselkumab as per routine clinical practice will be enrolled. Only data available per clinical practice will be collected within this study. The primary data source for this study will be the medical records of each participant.
结局指标
主要结局
Time to Guselkumab Discontinuation Throughout 2 Years
时间窗: Up to 2 years
Time to guselkumab discontinuation is defined as the time (days) from the date of the first guselkumab administration to the date of the last administered dose preceding permanent cessation.
次要结局
- Participant Baseline Characteristics: Height(Baseline)
- Percentage of Participants Achieving Absolute Psoriasis Area and Severity Index (PASI) Scores Among Participants Remaining on Treatment(At Weeks 12, 24, 52 and 104)
- Percentage of Participants Achieving PASI 90 Response Score(At Weeks 0, 12, 24, 52 and 104)
- Percentage of Participants Achieving PASI 75 Response Score(At Weeks 0, 12, 24, 52 and 104)
- Percentage of Participants Achieving PASI 100 Response Score(At Weeks 0, 12, 24, 52 and 104)
- Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1(At Weeks 0, 12, 24, 52 and 104)
- Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1(At Weeks 0, 12, 24, 52 and 104)
- Percentage of Participants Achieving IGA Score of 0(At Weeks 0, 12, 24, 52 and 104)
- Participant Baseline Characteristics: Age(Baseline)
- Participant Baseline Characteristics: Gender(Baseline)
- Participant Baseline Characteristics: Weight(Baseline)
- Number of Participants Reporting Disease Severity(Baseline)
- Number of Participants Reporting Smoking History and Alcohol Use(Baseline)
- Hazard Ratio Between Baseline Factors and Time to Guselkumab Treatment Discontinuation(Up to Week 104)
- Number of Participants with Adverse Events (AEs)(Up to Week 104)
研究者
研究点 (20)
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