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

maanantai 2. marraskuuta 2026 päivittänyt: 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).

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Arvioitu)

200

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

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

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Havaintomallit: COHORT
  • Aikanäkymät: OTHER

Kohortit ja interventiot

Ryhmä/Kohortti
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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Persistence of Treatment with Guselkumab
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Participants Achieving Clinical Response for Crohn's disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: At Week 0

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

Height of participants receiving guselkumab treatment will be reported.
At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Weight
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Up To 96 weeks

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

Participants disease duration at study initiation will be reported.
At Week 0
Number of Participants with Comorbid Diagnoses
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Janssen-Cilag, S.A.

Tutkijat

  • Opintojohtaja: Janssen-Cilag S.A. Clinical Trial, Janssen-Cilag, S.A.

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Arvioitu)

Sunnuntai 15. marraskuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Lauantai 30. kesäkuuta 2029

Opintojen valmistuminen (Arvioitu)

Tiistai 30. lokakuuta 2029

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 24. syyskuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 24. syyskuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Keskiviikko 30. syyskuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Tiistai 3. marraskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 2. marraskuuta 2026

Viimeksi vahvistettu

Sunnuntai 1. marraskuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • CNTO1959IBD4010

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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.

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

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