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

2026. augusztus 27. frissítette: 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.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

100

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Magyarország
      • Budapest, Magyarország, 1088
        • Toborzás
        • Semmelweis University

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Kohorszok és beavatkozások

Csoport / Kohorsz
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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Percentage of Participants Achieving Absolute Psoriasis Area Severity Index (aPASI) <=3 at Week 20 Following Switch from Ustekinumab to Guselkumab
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Percentage of Participants Achieving aPASI <= 3 at Weeks 4, 12, 36 and 52
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: At Baseline
Participant's age at the time of starting guselkumab treatment will be reported.
At Baseline
Demographic Characteristics: Sex
Időkeret: At Baseline
Sex (male, female) of participants at the time of starting guselkumab treatment will be reported.
At Baseline
Demographic Characteristics: Weight
Időkeret: At Baseline
Weight of participants at the time of starting guselkumab treatment will be reported.
At Baseline
Demographic Characteristics: Height
Időkeret: At Baseline
Height of participants at the time of starting guselkumab treatment will be reported.
At Baseline
Clinical Characteristics: Time Since Psoriasis Diagnosis
Időkeret: At Baseline
Time since psoriasis diagnosis (years), in participants starting guselkumab treatment will be reported.
At Baseline
Clinical Characteristics: Time Since First Symptoms
Időkeret: At Baseline
Time since first symptoms (years), in participants starting guselkumab treatment will be reported.
At Baseline
Clinical Characteristics: Severity of Psoriasis
Időkeret: At Baseline
Severity of psoriasis (mild, moderate, severe) in participants starting guselkumab treatment will be reported.
At Baseline
Clinical Characteristics: Affected Areas
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: At Baseline
Specific psoriatic comorbidities at baseline will be reported.
At Baseline
Number of Participants with Adverse Events (AE)
Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Janssen-Cilag Kft.

Nyomozók

  • Tanulmányi igazgató: Janssen-Cilag Kft. Clinical Trial, Janssen-Cilag Kft.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. szeptember 15.

Elsődleges befejezés (Becsült)

2029. január 30.

A tanulmány befejezése (Becsült)

2029. március 15.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. július 29.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 4.

Első közzététel (Tényleges)

2026. augusztus 5.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. augusztus 28.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 27.

Utolsó ellenőrzés

2026. augusztus 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • CNTO1959PSO4038 (Egyéb azonosító: Janssen Research & Development, LLC)

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

IGEN

IPD terv leírása

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

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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