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A Real-World Study of Guselkumab Persistence and Effectiveness in Participants With Crohn's Disease or Ulcerative Colitis (GALILEO)

2 listopada 2026 zaktualizowane przez: Janssen-Cilag, S.A.

Guselkumab: A Real Life Non-Interventional, Persistence and Effectiveness Study in Patients With Crohn's Disease or Ulcerative Colitis

The purpose of this study is to evaluate how long participants with moderate-to-severe Crohn's Disease (CD) and Ulcerative Colitis (UC) continue treatment with guselkumab in a real-world setting. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

200

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Hiszpania
      • Santiago de Compostela, Hiszpania, 15706
        • Hosp. Clinico Univ. de Santiago

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

The study population will include participants with confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or Ulcerative colitis (UC) disease.

Opis

Inclusion criteria:

  • Participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of the drug. Decision to prescribe must solely be made by the treating physician. Participant must have been at least 8 weeks under guselkumab treatment before being included in the study, regardless if they are still on guselkumab treatment or not
  • Participant must have a confirmed diagnosis of moderate-to-severe or Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records: Harvey-Bradshaw Index (HBI) greater than (>)4 for CD and Partial Mayo Score (pMS)>2 for UC
  • Participant [and/or their legally-acceptable representative where applicable] must sign a participation agreement/informed consent form (ICF) allowing source data verification in accordance with local requirements

Exclusion criteria:

  • Contraindicated to guselkumab per the label
  • It is currently enrolled in an interventional clinical study
  • Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya® (guselkumab), Skyrizi® (risankizumab) and Omvoh® (mirikizumab). As an exception, participants with history of ustekinumab exposure, may be included
  • History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)
  • Is unable to provide the ICF

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: COHORT
  • Perspektywy czasowe: OTHER

Kohorty i interwencje

Grupa / Kohorta
Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)

Participants with confirmed diagnosis of moderate-to-severe UC or CD receiving guselkumab according to clinical practice will be enrolled. Only data available within clinical routine as standard of care will be documented for this study.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Persistence of Treatment with Guselkumab
Ramy czasowe: Up to 96 weeks

Persistence of treatment with guselkumab will be measured through time to guselkumab discontinuation defined as the time at which the next infusion should have taken place for a participant after their last scheduled infusion.
Up to 96 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants Achieving Clinical Response for Crohn's disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
Ramy czasowe: Up to 96 weeks

Participants reporting effectiveness with treatment of guselkumab will be measured through the HBI for CD. Clinical response for CD is defined as the HBI score less than or equal to (<=) 4 or a decrease in HBI by greater than or equal to (>=) 3 from baseline. The HBI consists of a 5-part questionnaire, assessing general wellbeing, abdominal pain (AP), number of liquid stools per day, abdominal mass and complications.
Up to 96 weeks
Number of Participants Achieving Clinical Response for CD as Measured by Patient Reported Outcome (PRO-2)
Ramy czasowe: Up to 96 weeks

Number of participants with clinical response to guselkumab will be assessed using PRO-2, including stool frequency and abdominal pain in CD participants through the patient's electronic (e)-diary.
Up to 96 weeks
Number of Participants Achieving Clinical Response for Ulcerative colitis (UC) as Measured by Partial Mayo Score (PMS)
Ramy czasowe: Up to 96 weeks

Participants reporting effectiveness with treatment of guselkumab will be measured through the PMS for UC. Clinical response for UC is defined as the PMS score < 4 or >= 30 percent (%) reduction from baseline. PMS comprises 3 categories: rectal bleeding, stool frequency, and physician assessment.
Up to 96 weeks
Number of Participants Achieving Clinical Response for UC as Measured by PRO-2
Ramy czasowe: Up to 96 weeks

Number of participants achieving clinical response to guselkumab will be assessed using PRO-2, including stool frequency and rectal bleeding in UC participants through the patient's e-diary.
Up to 96 weeks
Characteristics of Participants Receiving Guselkumab Treatment: Age
Ramy czasowe: At Week 0

Age of participants receiving guselkumab treatment will be reported.
At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Sex
Ramy czasowe: At Week 0

Sex of participants receiving guselkumab treatment will be reported.
At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Previous Inflammatory Bowel Disease (IBD) Medication Use
Ramy czasowe: At Week 0

Participants with previous IBD medication use will be reported.
At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Smoking Status and History
Ramy czasowe: At Week 0

Smoking status and history of participants receiving guselkumab treatment will be reported.
At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Height
Ramy czasowe: At Week 0

Height of participants receiving guselkumab treatment will be reported.
At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Weight
Ramy czasowe: At Weeks 0, 4, 12, 48 and 96

Weight of participants receiving guselkumab treatment will be reported.
At Weeks 0, 4, 12, 48 and 96
Characteristics of Participants Receiving Guselkumab Treatment: Disease Status
Ramy czasowe: Up to 96 weeks

Disease status of participants receiving guselkumab treatment will be reported.
Up to 96 weeks
Characteristics of Participants Receiving Guselkumab Treatment: Severity at Index
Ramy czasowe: Up To 96 weeks

Disease severity of participants will be reported.
Up To 96 weeks
Characteristics of Participants Receiving Guselkumab Treatment: Age At Diagnosis
Ramy czasowe: At Week 0

Age at diagnosis of participants receiving guselkumab treatment will be reported.
At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration
Ramy czasowe: At Week 0

Participants disease duration at study initiation will be reported.
At Week 0
Number of Participants with Comorbid Diagnoses
Ramy czasowe: Up to 96 weeks

Participants with comorbid diagnoses will be reported.
Up to 96 weeks
Number of Participants with History of UC/CD Previous IBD Related Therapy Use and Surgeries
Ramy czasowe: At Week 0

Participants with history of UC/CD and previous IBD-related therapy use and surgeries will be reported.
At Week 0
Number of Participants Receiving Concomitant IBD Medications
Ramy czasowe: Up to 96 weeks

Participants receiving concomitant IBD medications for UC and CD will be reported.
Up to 96 weeks
Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scale Score
Ramy czasowe: Baseline (Week 0) up to 96 weeks

The SIBDQ is a 10-item survey measuring HRQoL over the last 2 weeks (frequency of bowel movement, abdominal cramps, fatigue, lack of energy, worry of surgery, fear of no toilet, ability to relax, irritable, impact on leisure, impact on intimacy). The total score ranges from 10 to 70, where high score indicates better QoL.
Baseline (Week 0) up to 96 weeks
Change from Baseline in Satisfaction with Guselkumab Treatment Using Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scale Score
Ramy czasowe: Baseline (Week 0) up to 96 weeks

The TSQM-9 is an abbreviated version of the 14-item TSQM, and is a reliable and valid measure to assess treatment satisfaction in naturalistic study designs, in which there is potential that the administration of the side effects domain of the TSQM would interfere with routine clinical care. It consists of 9 items distributed in the domains: side effects, effectiveness, convenience, and global satisfaction, with scores at each domain ranging from 0 to 100, with higher score indicating higher treatment satisfaction.
Baseline (Week 0) up to 96 weeks
Change in Number of UC/CD Emergency Room Visits
Ramy czasowe: Baseline (Week 0) up to 96 weeks

Change in the number of emergency room visits for treatment of UC/CD will be reported.
Baseline (Week 0) up to 96 weeks
Change in Number of UC/CD-Hospitalizations
Ramy czasowe: Baseline (Week 0) up to 96 weeks

Change in the number of hospitalizations for treatment of UC/CD will be reported.
Baseline (Week 0) up to 96 weeks
Change in Number of UC/CD Surgeries
Ramy czasowe: Baseline (Week 0) up to 96 weeks

Change in the number of surgeries for treatment of UC/CD will be reported.
Baseline (Week 0) up to 96 weeks
Change in C-Reactive Protein (CRP) Levels
Ramy czasowe: At Weeks 0, 4, 12, 48 and 96

Change in CRP levels since guselkumab initiation will be reported. CRP is a marker of inflammation that will be measured by physicians following routine clinical practice.
At Weeks 0, 4, 12, 48 and 96
Change in Fecal Calprotectin (Fcal) Levels
Ramy czasowe: At Weeks 0, 4, 12, 48 and 96

Change in Fcal levels since guselkumab initiation will be reported. The Fcal is a marker of inflammation that will be measured by physicians following routine clinical practice.
At Weeks 0, 4, 12, 48 and 96
Number of Participants with Adverse events (AEs)
Ramy czasowe: Up to 96 weeks

An adverse event is any untoward medical occurrence in a participant administered a medicinal product. An AE does not necessarily have a causal relationship with the treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal finding or lack of expected pharmacological action), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Up to 96 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Janssen-Cilag, S.A.

Śledczy

  • Dyrektor Studium: Janssen-Cilag S.A. Clinical Trial, Janssen-Cilag, S.A.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 listopada 2026

Zakończenie podstawowe (Szacowany)

30 czerwca 2029

Ukończenie studiów (Szacowany)

30 października 2029

Daty rejestracji na studia

Pierwszy przesłany

24 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

24 września 2026

Pierwszy wysłany (Rzeczywisty)

30 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CNTO1959IBD4010

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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