A Study of Guselkumab Given After Ustekinumab in Participants With Moderate to Severe Psoriasis in Routine Clinical Practice (G-START)
2026年8月27日 更新者：Janssen-Cilag Kft.
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
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.
研究概览
地位
招聘中
条件
研究类型
观察性的
注册 (估计的)
100
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Study Contact
- 电话号码：844-434-4210
- 邮箱：Participate-In-This-Study1@its.jnj.com
学习地点
-
-
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Budapest、匈牙利、1088
- 招聘中
- Semmelweis University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
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 Guselkumab can be included in this study.
描述
Inclusion criteria:
- 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
Exclusion criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants Achieving Absolute Psoriasis Area Severity Index (aPASI) <=3 at Week 20 Following Switch from Ustekinumab to Guselkumab
大体时间：At Week 20
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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.
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At Week 20
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants Achieving aPASI <= 3 at Weeks 4, 12, 36 and 52
大体时间：At Weeks 4, 12, 36 and 52
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Percentage of participants achieving aPASI <= 3 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.
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At Weeks 4, 12, 36 and 52
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Percentage of Participants Achieving >= 75% Improvement in PASI (PASI 75) at Weeks 4, 12, 20, 36 and 52
大体时间：At Weeks 4, 12, 20, 36 and 52
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Participants with an absolute percentage improvement of at least 75% will be considered having achieved PASI 75 at Weeks 4, 12, 20, 36 and 52.
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.
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At Weeks 4, 12, 20, 36 and 52
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Percentage of Participants Achieving >= 90% Improvement in PASI (PASI 90) at Weeks 4, 12, 20, 36, and 52
大体时间：At Weeks 4, 12, 20, 36 and 52
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Participants with an absolute percentage improvement of at least 90% will be considered having achieved PASI 90 at Weeks 4, 12, 20, 36 and 52.
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.
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At Weeks 4, 12, 20, 36 and 52
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Percentage of Participants Achieving 100% Improvement in PASI (PASI 100) at Weeks 4, 12, 20, 36, and 52
大体时间：At Weeks 4, 12, 20, 36 and 52
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Participants with an absolute percentage improvement of 100% will be considered having achieved PASI 100 at Weeks 4, 12, 20, 36 and 52.
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.
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At Weeks 4, 12, 20, 36 and 52
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Absolute Changes in PASI Score from Baseline up to Weeks 4, 12, 20, 36 and 52
大体时间：Baseline up to Weeks 4, 12, 20, 36 and 52
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Absolute changes in PASI scores from baseline to Weeks 4, 12, 20, 36 and 52 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.
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Baseline up to Weeks 4, 12, 20, 36 and 52
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Absolute Changes in Body Surface Area (BSA) Score from Baseline up to Weeks 4, 12, 20, 36 and 52
大体时间：Baseline up to Weeks 4, 12, 20, 36 and 52
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Absolute changes in BSA scores from baseline upto Weeks 4, 12, 20, 36 and 52 will be reported.
BSA indicates the percentage of the total body surface area affected by psoriasis.
For small-spotted psoriasis lesions, healthy skin between the lesions is not included in the assessment.
BSA ranges from 0-100 in which the maximum value is 100.
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Baseline up to Weeks 4, 12, 20, 36 and 52
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Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) <=5 at Weeks 4, 12, 20, 36 and 52
大体时间：At Weeks 4, 12, 20, 36 and 52
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DLQI is a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life.
Each question is evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life.
Scores from all 10 questions are added up to give DLQI total score range from 0 (not at all) to 30 (very much).
Higher scores indicate more impact on quality of life of participants.
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At Weeks 4, 12, 20, 36 and 52
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Percentage of Participants Achieving Dermatology Life Quality Index Relevant (DLQI-R) <=5 at Weeks 4, 12, 20, 36 and 52
大体时间：At Weeks 4, 12, 20, 36 and 52
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The DLQI-R is calculated by summing the scores of all answered items on the 10-question DLQI questionnaire (each scored 0-3), excluding those marked as "not relevant" (NRR).
The total DLQI-R score ranges from 0 (not at all) to 30 (very much).
Higher scores indicate more impact on quality of life of participants.
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At Weeks 4, 12, 20, 36 and 52
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Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52
大体时间：At Weeks 4, 12, 20, 36 and 52
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DLQI is a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life.
Each question is evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life.
Scores from all 10 questions are added up to give DLQI total score range from 0 (not at all) to 30 (very much).
Higher scores indicate more impact on quality of life of participants.
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At Weeks 4, 12, 20, 36 and 52
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Percentage of Participants Achieving DLQI-R score of 0 or 1 at Weeks 4, 12, 20, 36 and 52
大体时间：At Weeks 4, 12, 20, 36 and 52
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The DLQI-R is calculated by summing the scores of all answered items on the 10-question DLQI questionnaire (each scored 0-3), excluding those marked as "not relevant" (NRR).
The total DLQI-R score ranges from 0 (not at all) to 30 (very much).
Higher scores indicate more impact on quality of life of participants.
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At Weeks 4, 12, 20, 36 and 52
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Absolute Changes in DLQI Scores from Baseline up to Weeks 4, 12, 20, 36 and 52
大体时间：Baseline up to Weeks 4, 12, 20, 36 and 52
|
Absolute changes in DLQI scores from baseline to Week 4, 12, 20, 36 and 52 will be reported.
DLQI is a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life.
The total DLQI score ranges from 0 (not at all) to 30 (very much).
Higher scores indicate more impact on quality of life of participants.
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Baseline up to Weeks 4, 12, 20, 36 and 52
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Absolute Changes in DLQI-R Scores from Baseline up to Weeks 4, 12, 20, 36 and 52
大体时间：Baseline up to Weeks 4, 12, 20, 36 and 52
|
Absolute changes in DLQI-R scores from baseline to Week 4, 12, 20, 36 and 52 will be reported.
The DLQI-R is calculated by summing the scores of all answered items on the 10-question DLQI questionnaire (each scored 0-3), excluding those marked as "not relevant" (NRR).
The total DLQI-R score ranges from 0 (not at all) to 30 (very much).
Higher scores indicate more impact on quality of life of participants.
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Baseline up to Weeks 4, 12, 20, 36 and 52
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Absolute Change in Static Physician's Global Assessment of Genitalia (sPGA-G) Score Over Time
大体时间：Baseline up to Weeks 4, 12, 20, 36 and 52
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In participants with anogenital psoriasis at baseline, absolute change in sPGA-G score over time will be reported.
The sPGA-G describes the severity of psoriasis using 6 categories.
Accordingly, the score ranges from 0-5, with higher scores indicating more severe psoriasis.
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Baseline up to Weeks 4, 12, 20, 36 and 52
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Percentage of Participants Achieving sPGA-G Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52
大体时间：At Weeks 4, 12, 20, 36 and 52
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In participants with anogenital psoriasis at baseline, the percentage of participants achieving sPGA-G score of 0 or 1 amongst the participants who had a >= 2 sPGA-G score at baseline will be reported.
The sPGA-G describes the severity of psoriasis using 6 categories.
Accordingly, the score ranges from 0-5, with higher scores indicating more severe psoriasis.
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At Weeks 4, 12, 20, 36 and 52
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Absolute Change in Physician´s Global Assessment of Hands and/or Feet (hf-PGA) Score Over Time
大体时间：Baseline up to Weeks 4, 12, 20, 36 and 52
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In participants with palmoplantar psoriasis at baseline, absolute change in hf-PGA score over time will be reported.
The hf-PGA describes the severity of psoriasis using 5 categories.
Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis.
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Baseline up to Weeks 4, 12, 20, 36 and 52
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Percentage of Participants Achieving hf-PGA Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52
大体时间：At Weeks 4, 12, 20, 36 and 52
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In participants with palmoplantar psoriasis at baseline, percentage of participants achieving hf-PGA = 0 or 1 amongst the participants who had a >= 2 hf-PGA at baseline will be reported.
The hf-PGA describes the severity of psoriasis using 5 categories.
Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis.
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At Weeks 4, 12, 20, 36 and 52
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Absolute Change in Scalp-Specific Investigator Global Assessment (ss-IGA) Score Over Time
大体时间：Baseline up to Weeks 4, 12, 20, 36, and 52
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In participants with scalp psoriasis at baseline, the absolute change in ss-IGA score over time will be reported.
The ss-IGA describes the severity of psoriasis using 5 categories.
Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis.
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Baseline up to Weeks 4, 12, 20, 36, and 52
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Percentage of Participants Achieving ss-IGA Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52
大体时间：At Weeks 4, 12, 20, 36, and 52
|
In participants with scalp psoriasis at baseline, the percentage of participants achieving ss-IGA of 0 or 1 amongst the participants who had a >= 2 ss-IGA score at baseline will be reported.
The ss-IGA describes the severity of psoriasis using 5 categories.
Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis.
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At Weeks 4, 12, 20, 36, and 52
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Absolute Change in Fingernail Physician's Global Assessment (PGA-F) Score Over Time
大体时间：Baseline up to Weeks 4, 12, 20, 36, and 52
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In participants with fingernail psoriasis at baseline, absolute change in PGA-F score over time will be reported.
The PGA-F describes the severity of psoriasis using 5 categories and consists of scores ranging from 0 (Clear), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Severe).
Here, higher scores indicate more severity of psoriasis.
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Baseline up to Weeks 4, 12, 20, 36, and 52
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Percentage of Participants Achieving PGA-F Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52
大体时间：At Weeks 4, 12, 20, 36, and 52
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In participants with fingernail psoriasis at baseline, the percentage of participants achieving PGA-F score of 0 or 1 amongst participants who had a >=2 PGA-F at baseline will be reported.
The PGA-F describes the severity of psoriasis using 5 categories and consists of scores ranging from 0 (Clear), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Severe).
Here, higher scores indicate more severity of psoriasis.
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At Weeks 4, 12, 20, 36, and 52
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Demographic Characteristics: Age
大体时间：At Baseline
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Participant's age at the time of starting guselkumab treatment will be reported.
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At Baseline
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Demographic Characteristics: Sex
大体时间：At Baseline
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Sex (male, female) of participants at the time of starting guselkumab treatment will be reported.
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At Baseline
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Demographic Characteristics: Weight
大体时间：At Baseline
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Weight of participants at the time of starting guselkumab treatment will be reported.
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At Baseline
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Demographic Characteristics: Height
大体时间：At Baseline
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Height of participants at the time of starting guselkumab treatment will be reported.
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At Baseline
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Clinical Characteristics: Time Since Psoriasis Diagnosis
大体时间：At Baseline
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Time since psoriasis diagnosis (years), in participants starting guselkumab treatment will be reported.
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At Baseline
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Clinical Characteristics: Time Since First Symptoms
大体时间：At Baseline
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Time since first symptoms (years), in participants starting guselkumab treatment will be reported.
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At Baseline
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Clinical Characteristics: Severity of Psoriasis
大体时间：At Baseline
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Severity of psoriasis (mild, moderate, severe) in participants starting guselkumab treatment will be reported.
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At Baseline
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Clinical Characteristics: Affected Areas
大体时间：At Baseline
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Affected areas (anogenital, nail, scalp, palmoplantar), in participants starting guselkumab treatment will be reported.
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At Baseline
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Clinical Characteristics: Prior and Baseline Treatments for Moderate to Severe Psoriasis
大体时间：At Baseline
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Prior and baseline treatments for moderate-to-severe psoriasis, including start and stop dates (in years) in participants starting guselkumab treatment will be reported.
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At Baseline
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Number of Participants Switching from Ustekinumab or Biosimilars to Guselkumab
大体时间：At Baseline
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Participants switching treatment and reason for switching treatment from Ustekinumab or biosimilars to Guselkumab will be reported.
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At Baseline
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Reason for Guselkumab Discontinuation
大体时间：Up to Week 52
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Number of participants discontinuing guselkumab and reason for guselkumab discontinuation if happens during the study will be reported.
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Up to Week 52
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Number of Participants with Specific Psoriatic Comorbidities
大体时间：At Baseline
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Specific psoriatic comorbidities at baseline will be reported.
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At Baseline
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Number of Participants with Adverse Events (AE)
大体时间：Up to Week 52
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An AE is any untoward medical occurrence in a participant administered with a pharmaceutical product.
An AE does not necessarily have a causal relationship with the treatment.
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Up to Week 52
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Janssen-Cilag Kft. Clinical Trial、Janssen-Cilag Kft.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月15日
初级完成 (估计的)
2029年1月30日
研究完成 (估计的)
2029年3月15日
研究注册日期
首次提交
2026年7月29日
首先提交符合 QC 标准的
2026年8月4日
首次发布 (实际的)
2026年8月5日
研究记录更新
最后更新发布 (实际的)
2026年8月28日
上次提交的符合 QC 标准的更新
2026年8月27日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他研究编号
- CNTO1959PSO4038 (其他标识符：Janssen Research & Development, LLC)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.