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

2. november 2026 oppdatert av: 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).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Studietype

Observasjonsmessig

Registrering (Antatt)

200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Study Contact
Telefonnummer: 844-434-4210
E-post: Participate-In-This-Study1@its.jnj.com

Studiesteder

Spania
- - Santiago de Compostela, Spania, 15706
    - Hosp. Clinico Univ. de Santiago

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: COHORT
Tidsperspektiver: OTHER

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Persistence of Treatment with Guselkumab Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Number of Participants Achieving Clinical Response for Crohn's disease (CD) as Measured by Harvey-Bradshaw Index (HBI) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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 Tidsramme: 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 Tidsramme: At Week 0	Age of participants receiving guselkumab treatment will be reported.	At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Sex Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: At Week 0	Height of participants receiving guselkumab treatment will be reported.	At Week 0
Characteristics of Participants Receiving Guselkumab Treatment: Weight Tidsramme: 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 Tidsramme: 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 Tidsramme: Up To 96 weeks	Disease severity of participants will be reported.	Up To 96 weeks
Characteristics of Participants Receiving Guselkumab Treatment: Age At Diagnosis Tidsramme: 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 Tidsramme: At Week 0	Participants disease duration at study initiation will be reported.	At Week 0
Number of Participants with Comorbid Diagnoses Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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) Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Janssen-Cilag, S.A.

Etterforskere

Studieleder: Janssen-Cilag S.A. Clinical Trial, Janssen-Cilag, S.A.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. november 2026

Primær fullføring (Antatt)

30. juni 2029

Studiet fullført (Antatt)

30. oktober 2029

Datoer for studieregistrering

Først innsendt

24. september 2026

Først innsendt som oppfylte QC-kriteriene

24. september 2026

Først lagt ut (Faktiske)

30. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

CNTO1959IBD4010

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

IPD-planbeskrivelse

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.

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