NCT07746583招募中不适用
A Non-Interventional, Multi-Centric, Single Country Observational Study to Assess the Safety and Effectiveness of Guselkumab After Ustekinumab (Originator or Biosimilar) in Moderate to Severe Psoriasis Patients in Clinical Routine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving Absolute Psoriasis Area Severity Index (aPASI) <=3 at Week 20 Following Switch from Ustekinumab to Guselkumab
研究概览
简要总结
The main purpose of this study is to describe how well Guselkumab works after switching from Ustekinumab in participants with moderate to severe psoriasis in a routine clinical setting. A long-term skin disease that causes red, scaly and sometimes painful, itchy patches on the skin.
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
- •Must have a confirmed diagnosis of moderate-to-severe plaque psoriasis requiring systemic treatment
- •Participants who are currently being treated with Ustekinumab (either the originator or its biosimilar) and who are medically indicated to switch to Guselkumab, or for whom this switch is medically indicated, based on the current and valid national psoriasis (PsO) therapeutic protocol
- •Participants who, based on the Investigator's decision, should initiate treatment with Guselkumab
- •Participants must sign an informed consent form (ICF) allowing for data collection and source data verification in accordance with local requirements
排除标准
- •Contraindication or hypersensitivity to Guselkumab or any other ingredient in the injection solution
- •Pregnancy or breastfeeding
- •Currently enrolled in an interventional study
- •Currently enrolled in an observational study sponsored or managed by a Janssen company
- •Previous use of guselkumab in any indication in participant history
研究组 & 干预措施
Moderate to Severe Psoriasis: Guselkumab Switching From Ustekinumab
Participants with moderate-to-severe psoriasis who are candidates for systemic treatment (according to the guselkumab label) and who are medically indicated to switch from Ustekinumab or its biosimilar to receive Guselkumab in routine clinical practice will be enrolled. No drug will be provided as a part of this study. Only data available from routine clinical practice will be collected.
结局指标
主要结局
Percentage of Participants Achieving Absolute Psoriasis Area Severity Index (aPASI) <=3 at Week 20 Following Switch from Ustekinumab to Guselkumab
时间窗: At Week 20
Percentage of participants achieving aPASI less than or equal to (\<=) 3 at Week 20 following the switch from Ustekinumab to Guselkumab will be reported. PASI is a widely used measurement tool used to assess the severity of psoriasis. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
次要结局
- Clinical Characteristics: Severity of Psoriasis(At Baseline)
- Percentage of Participants Achieving aPASI <= 3 at Weeks 4, 12, 36 and 52(At Weeks 4, 12, 36 and 52)
- Percentage of Participants Achieving >= 75% Improvement in PASI (PASI 75) at Weeks 4, 12, 20, 36 and 52(At Weeks 4, 12, 20, 36 and 52)
- Percentage of Participants Achieving >= 90% Improvement in PASI (PASI 90) at Weeks 4, 12, 20, 36, and 52(At Weeks 4, 12, 20, 36 and 52)
- Percentage of Participants Achieving 100% Improvement in PASI (PASI 100) at Weeks 4, 12, 20, 36, and 52(At Weeks 4, 12, 20, 36 and 52)
- Absolute Changes in PASI Score from Baseline up to Weeks 4, 12, 20, 36 and 52(Baseline up to Weeks 4, 12, 20, 36 and 52)
- Absolute Changes in Body Surface Area (BSA) Score from Baseline up to Weeks 4, 12, 20, 36 and 52(Baseline up to Weeks 4, 12, 20, 36 and 52)
- Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) <=5 at Weeks 4, 12, 20, 36 and 52(At Weeks 4, 12, 20, 36 and 52)
- Percentage of Participants Achieving Dermatology Life Quality Index Relevant (DLQI-R) <=5 at Weeks 4, 12, 20, 36 and 52(At Weeks 4, 12, 20, 36 and 52)
- Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52(At Weeks 4, 12, 20, 36 and 52)
- Percentage of Participants Achieving DLQI-R score of 0 or 1 at Weeks 4, 12, 20, 36 and 52(At Weeks 4, 12, 20, 36 and 52)
- Absolute Changes in DLQI Scores from Baseline up to Weeks 4, 12, 20, 36 and 52(Baseline up to Weeks 4, 12, 20, 36 and 52)
- Absolute Changes in DLQI-R Scores from Baseline up to Weeks 4, 12, 20, 36 and 52(Baseline up to Weeks 4, 12, 20, 36 and 52)
- Absolute Change in Static Physician's Global Assessment of Genitalia (sPGA-G) Score Over Time(Baseline up to Weeks 4, 12, 20, 36 and 52)
- Percentage of Participants Achieving sPGA-G Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52(At Weeks 4, 12, 20, 36 and 52)
- Absolute Change in Physician´s Global Assessment of Hands and/or Feet (hf-PGA) Score Over Time(Baseline up to Weeks 4, 12, 20, 36 and 52)
- Clinical Characteristics: Time Since Psoriasis Diagnosis(At Baseline)
- Percentage of Participants Achieving hf-PGA Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52(At Weeks 4, 12, 20, 36 and 52)
- Absolute Change in Scalp-Specific Investigator Global Assessment (ss-IGA) Score Over Time(Baseline up to Weeks 4, 12, 20, 36, and 52)
- Percentage of Participants Achieving ss-IGA Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52(At Weeks 4, 12, 20, 36, and 52)
- Absolute Change in Fingernail Physician's Global Assessment (PGA-F) Score Over Time(Baseline up to Weeks 4, 12, 20, 36, and 52)
- Clinical Characteristics: Time Since First Symptoms(At Baseline)
- Percentage of Participants Achieving PGA-F Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52(At Weeks 4, 12, 20, 36, and 52)
- Demographic Characteristics: Age(At Baseline)
- Demographic Characteristics: Sex(At Baseline)
- Demographic Characteristics: Weight(At Baseline)
- Demographic Characteristics: Height(At Baseline)
- Clinical Characteristics: Affected Areas(At Baseline)
- Clinical Characteristics: Prior and Baseline Treatments for Moderate to Severe Psoriasis(At Baseline)
- Number of Participants Switching from Ustekinumab or Biosimilars to Guselkumab(At Baseline)
- Reason for Guselkumab Discontinuation(Up to Week 52)
- Number of Participants with Specific Psoriatic Comorbidities(At Baseline)
- Number of Participants with Adverse Events (AE)(Up to Week 52)
研究者
研究点 (1)
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