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

2 novembre 2026 mis à jour par: 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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

200

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: OTHER

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Persistence of Treatment with Guselkumab
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Participants Achieving Clinical Response for Crohn's disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: At Week 0

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

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

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

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Janssen-Cilag, S.A.

Les enquêteurs

  • Directeur d'études: Janssen-Cilag S.A. Clinical Trial, Janssen-Cilag, S.A.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 novembre 2026

Achèvement primaire (Estimé)

30 juin 2029

Achèvement de l'étude (Estimé)

30 octobre 2029

Dates d'inscription aux études

Première soumission

24 septembre 2026

Première soumission répondant aux critères de contrôle qualité

24 septembre 2026

Première publication (Réel)

30 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CNTO1959IBD4010

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

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Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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