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A Study of Guselkumab Given After Ustekinumab in Participants With Moderate to Severe Psoriasis in Routine Clinical Practice (G-START)

27. srpna 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Typ studie

Pozorovací

Zápis (Odhadovaný)

100

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Maďarsko
      • Budapest, Maďarsko, 1088
        • Nábor
        • Semmelweis University

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants Achieving Absolute Psoriasis Area Severity Index (aPASI) <=3 at Week 20 Following Switch from Ustekinumab to Guselkumab
Časové okno: 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.
At Week 20

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants Achieving aPASI <= 3 at Weeks 4, 12, 36 and 52
Časové okno: At Weeks 4, 12, 36 and 52
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.
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
Časové okno: At Weeks 4, 12, 20, 36 and 52
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.
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
Časové okno: At Weeks 4, 12, 20, 36 and 52
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.
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
Časové okno: At Weeks 4, 12, 20, 36 and 52
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.
At Weeks 4, 12, 20, 36 and 52
Absolute Changes in PASI Score from Baseline up to Weeks 4, 12, 20, 36 and 52
Časové okno: Baseline up to Weeks 4, 12, 20, 36 and 52
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.
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
Časové okno: Baseline up to Weeks 4, 12, 20, 36 and 52
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.
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
Časové okno: At Weeks 4, 12, 20, 36 and 52
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.
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
Časové okno: At Weeks 4, 12, 20, 36 and 52
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.
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
Časové okno: At Weeks 4, 12, 20, 36 and 52
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.
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
Časové okno: At Weeks 4, 12, 20, 36 and 52
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.
At Weeks 4, 12, 20, 36 and 52
Absolute Changes in DLQI Scores from Baseline up to Weeks 4, 12, 20, 36 and 52
Časové okno: 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.
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
Časové okno: 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.
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
Časové okno: Baseline up to Weeks 4, 12, 20, 36 and 52
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.
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
Časové okno: At Weeks 4, 12, 20, 36 and 52
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.
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
Časové okno: Baseline up to Weeks 4, 12, 20, 36 and 52
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.
Baseline up to Weeks 4, 12, 20, 36 and 52
Percentage of Participants Achieving hf-PGA Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52
Časové okno: At Weeks 4, 12, 20, 36 and 52
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.
At Weeks 4, 12, 20, 36 and 52
Absolute Change in Scalp-Specific Investigator Global Assessment (ss-IGA) Score Over Time
Časové okno: Baseline up to Weeks 4, 12, 20, 36, and 52
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.
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
Časové okno: 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.
At Weeks 4, 12, 20, 36, and 52
Absolute Change in Fingernail Physician's Global Assessment (PGA-F) Score Over Time
Časové okno: Baseline up to Weeks 4, 12, 20, 36, and 52
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.
Baseline up to Weeks 4, 12, 20, 36, and 52
Percentage of Participants Achieving PGA-F Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52
Časové okno: At Weeks 4, 12, 20, 36, and 52
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.
At Weeks 4, 12, 20, 36, and 52
Demographic Characteristics: Age
Časové okno: At Baseline
Participant's age at the time of starting guselkumab treatment will be reported.
At Baseline
Demographic Characteristics: Sex
Časové okno: At Baseline
Sex (male, female) of participants at the time of starting guselkumab treatment will be reported.
At Baseline
Demographic Characteristics: Weight
Časové okno: At Baseline
Weight of participants at the time of starting guselkumab treatment will be reported.
At Baseline
Demographic Characteristics: Height
Časové okno: At Baseline
Height of participants at the time of starting guselkumab treatment will be reported.
At Baseline
Clinical Characteristics: Time Since Psoriasis Diagnosis
Časové okno: At Baseline
Time since psoriasis diagnosis (years), in participants starting guselkumab treatment will be reported.
At Baseline
Clinical Characteristics: Time Since First Symptoms
Časové okno: At Baseline
Time since first symptoms (years), in participants starting guselkumab treatment will be reported.
At Baseline
Clinical Characteristics: Severity of Psoriasis
Časové okno: At Baseline
Severity of psoriasis (mild, moderate, severe) in participants starting guselkumab treatment will be reported.
At Baseline
Clinical Characteristics: Affected Areas
Časové okno: At Baseline
Affected areas (anogenital, nail, scalp, palmoplantar), in participants starting guselkumab treatment will be reported.
At Baseline
Clinical Characteristics: Prior and Baseline Treatments for Moderate to Severe Psoriasis
Časové okno: At Baseline
Prior and baseline treatments for moderate-to-severe psoriasis, including start and stop dates (in years) in participants starting guselkumab treatment will be reported.
At Baseline
Number of Participants Switching from Ustekinumab or Biosimilars to Guselkumab
Časové okno: At Baseline
Participants switching treatment and reason for switching treatment from Ustekinumab or biosimilars to Guselkumab will be reported.
At Baseline
Reason for Guselkumab Discontinuation
Časové okno: Up to Week 52
Number of participants discontinuing guselkumab and reason for guselkumab discontinuation if happens during the study will be reported.
Up to Week 52
Number of Participants with Specific Psoriatic Comorbidities
Časové okno: At Baseline
Specific psoriatic comorbidities at baseline will be reported.
At Baseline
Number of Participants with Adverse Events (AE)
Časové okno: Up to Week 52
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.
Up to Week 52

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Janssen-Cilag Kft.

Vyšetřovatelé

  • Ředitel studie: Janssen-Cilag Kft. Clinical Trial, Janssen-Cilag Kft.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

15. září 2026

Primární dokončení (Odhadovaný)

30. ledna 2029

Dokončení studie (Odhadovaný)

15. března 2029

Termíny zápisu do studia

První předloženo

29. července 2026

První předloženo, které splnilo kritéria kontroly kvality

4. srpna 2026

První zveřejněno (Aktuální)

5. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CNTO1959PSO4038 (Jiný identifikátor: Janssen Research & Development, LLC)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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

Informace o lécích a zařízeních, studijní dokumenty

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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