A Study of Guselkumab Given After Ustekinumab in Participants With Moderate to Severe Psoriasis in Routine Clinical Practice (G-START)
27 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Tipo de estudo
Observacional
Inscrição (Estimado)
100
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Study Contact
- Número de telefone: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Locais de estudo
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Budapest, Hungria, 1088
- Recrutamento
- Semmelweis University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants Achieving Absolute Psoriasis Area Severity Index (aPASI) <=3 at Week 20 Following Switch from Ustekinumab to Guselkumab
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants Achieving aPASI <= 3 at Weeks 4, 12, 36 and 52
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline up to Weeks 4, 12, 20, 36 and 52
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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
Prazo: Baseline up to Weeks 4, 12, 20, 36 and 52
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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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: At Weeks 4, 12, 20, 36, and 52
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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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Janssen-Cilag Kft. Clinical Trial, Janssen-Cilag Kft.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
15 de setembro de 2026
Conclusão Primária (Estimado)
30 de janeiro de 2029
Conclusão do estudo (Estimado)
15 de março de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
29 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de agosto de 2026
Primeira postagem (Real)
5 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
28 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CNTO1959PSO4038 (Outro identificador: Janssen Research & Development, LLC)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
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
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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