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A Study of Long Term Persistency of Guselkumab in Adult Participants With Inflammatory Bowel Disease (GO-ON)

11. September 2026 aktualisiert von: Janssen Research & Development, LLC

GO-ON: Guselkumab lOngterm Persistency in Adult Patients With inflammatOry Bowel Disease: a Real World, National Non-iNterventional Study

The main purpose of this study is to evaluate treatment persistence of guselkumab (that is how long a person keeps taking their prescribed medicine or continues with their treatment plan without stopping) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

400

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

Inclusion criteria:

  • Must be greater than or equal to (>=) 18 years old
  • 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. Enrolment must take place before or on the day of the first administration (but after treatment decision by physician)
  • Must have a confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or Ulcerative Colitis (UC) recorded in their medical records
  • Participant has received the information note/given his/her oral agreement and has not objected to the collection of their data

Exclusion criteria:

  • Contraindicated to guselkumab per the label
  • 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 a prior history of Stelara (ustekinumab) and biosimilars exposure, may be included
  • History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Guselkumab
Participants with confirmed diagnosis of moderate to severe crohn's disease (CD) or ulcerative colitis (UC) will be enrolled according to the approved local prescribing label and treated with guselkumab according to the local clinical practice. No drug will be provided as part of this study. Only data available from clinical practice will be collected within this study.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Persistence with Guselkumab Treatment
Zeitfenster: Up to Week 96
Time to guselkumab discontinuation will be used to measure the guselkumab persistence in participants and is defined as the time from the first administration of guselkumab to its discontinuation date (defined as the date that the last dose of treatment was administered plus 1 dosing interval).
Up to Week 96

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Merkmale der Teilnehmer, die mit Guselkumab behandelt werden: Alter
Zeitfenster: Zu Studienbeginn
Das Alter der Teilnehmer, die mit Guselkumab behandelt werden, wird berichtet.
Zu Studienbeginn
Merkmale der Teilnehmer, die Guselkumab erhalten: Geschlecht
Zeitfenster: Zu Studienbeginn
Das Geschlecht der Teilnehmer, die mit Guselkumab behandelt werden, wird berichtet.
Zu Studienbeginn
Merkmale von Teilnehmern, die mit Guselkumab behandelt werden: Raucherstatus und Rauchanamnese
Zeitfenster: Zu Studienbeginn
Die Anzahl der Teilnehmer mit aktuellem und ehemaligem Raucherstatus, die eine Guselkumab-Behandlung erhalten, wird berichtet.
Zu Studienbeginn
Merkmale der Teilnehmer, die mit Guselkumab behandelt werden: Körpergröße
Zeitfenster: Zu Studienbeginn
Die Körpergröße der Teilnehmer, die eine Guselkumab-Behandlung erhalten, wird berichtet.
Zu Studienbeginn
Merkmale der Teilnehmer, die Guselkumab erhalten: Gewicht
Zeitfenster: Zu Studienbeginn
Das Gewicht der Teilnehmer, die mit Guselkumab behandelt werden, wird berichtet.
Zu Studienbeginn
Merkmale der mit Guselkumab behandelten Teilnehmer: Krankheitsdauer
Zeitfenster: Zu Studienbeginn
Die Krankheitsdauer der Teilnehmer wird berichtet.
Zu Studienbeginn
Number of Participants Achieving Endoscopic Improvement in Participants with UC as Measured by Mayo Score
Zeitfenster: Up to Week 96
Endoscopic improvement is defined as Mayo score <=1. The Mayo Clinic Score is a composite index with total score ranging from 0 to 12. Higher scores indicate worse disease activity.
Up to Week 96
Number of Participants Achieving Endoscopic Normalization in Participants with UC as Measured by Mayo Score
Zeitfenster: Up to Week 96
Endoscopic normalization is defined as Mayo score =0. The Mayo Clinic Score is a composite index with a total score ranging from 0 to 12. Higher scores indicate worse disease activity.
Up to Week 96
Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency
Zeitfenster: At Weeks 0, 1, 2, 4, 8, 12
Number of participants with early responses to guselkumab measured via bowel urgency will be assessed via participant diaries.
At Weeks 0, 1, 2, 4, 8, 12
Number of Participants with Early Responses to Guselkumab Measured Using Simplified Patient-Reported Outcome (2-item) (PRO-2) Components in Participants with CD
Zeitfenster: At Weeks 0, 1, 2, 4, 8, 12
Number of participants with early responses to guselkumab will be assessed via participant diaries. Measurements captured for CD include stool frequency and abdominal pain (AP).
At Weeks 0, 1, 2, 4, 8, 12
Number of Participants with Early Responses to Guselkumab Measured Using Simplified Patient-Reported Outcome (2-item) (PRO-2) Components in Participants with UC
Zeitfenster: At Weeks 0, 1, 2, 4, 8, 12
Number of participants with early responses to guselkumab will be assessed via participant diaries. Measurements captured for UC include rectal bleeding and stool frequency (SF).
At Weeks 0, 1, 2, 4, 8, 12
Number of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI) Score
Zeitfenster: Up to Week 96
HBI score is used to assess disease severity and treatment effectiveness. The HBI consists of a 5-part questionnaire, assessing general wellbeing, abdominal pain, number of liquid stools per day, abdominal mass and complications. Clinical response for CD is defined as the reduction in HBI by greater than or equal to (>=)3 points from baseline or achieving HBI less than or equal to (<=) 4. Efficacy will be evaluated by line of treatment and subpopulation.
Up to Week 96
Number of Participants Achieving Clinical Remission for CD as Measured by HBI Score
Zeitfenster: Up to Week 96
Clinical remission for CD is defined as a HBI score of <= 4. Efficacy will be evaluated by line of treatment and subpopulation.
Up to Week 96
Number of Participants Achieving Corticosteroid-Free Clinical Response for CD as Measured by HBI Score
Zeitfenster: Up to Week 96
Corticosteroid-free clinical response for CD is defined as the reduction in HBI >=3 points from baseline or achieving HBI <=4 with no use of corticosteroids for at least 30 days. Efficacy will be evaluated by line of treatment and subpopulation.
Up to Week 96
Number of Participants Achieving Corticosteroid-Free Clinical Remission for CD
Zeitfenster: Up to Week 96
Corticosteroid-free clinical remission will be defined as a HBI score of <= 4 and no use of corticosteroids for at least 30 days in participants with CD. Efficacy will be evaluated by line of treatment and subpopulation.
Up to Week 96
Number of Participants Achieving Clinical Response for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)
Zeitfenster: Up to Week 96
Mayo scoring system is used to assess disease severity and treatment effectiveness. The PMS comprises 3 categories: rectal bleeding, SF, and physician assessment. These are rated from 0-3 and are summed to give a total score that ranges from 0-12. Clinical response for UC is defined as the PMS score less than (<) 4 or >= 30 percent (%) reduction from baseline. Efficacy will be evaluated by line of treatment and subpopulation.
Up to Week 96
Number of Participants Achieving Clinical Remission for UC as Measured by PMS
Zeitfenster: Up to Week 96
Clinical remission for UC is defined as the PMS score < 2 and a rectal bleeding subscore of 0. Efficacy will be evaluated by line of treatment and subpopulation.
Up to Week 96
Number of Participants Achieving Corticosteroid-Free Clinical Response for UC as Measured by PMS
Zeitfenster: Up to Week 96
Corticosteroid free clinical response is defined as a PMS score of <4 or >=30% reduction from baseline and no use of corticosteroids for at least 30 days. Efficacy will be evaluated by line of treatment and subpopulation.
Up to Week 96
Number of Participants Achieving Corticosteroid-Free Clinical Remission for UC
Zeitfenster: Up to Week 96
Corticosteroid-free clinical remission will be defined as a PMS score of less than (<)2, no use of corticosteroids for at least 30 days and a rectal bleeding subscore of 0 in participants with UC. Efficacy will be evaluated by line of treatment and subpopulation.
Up to Week 96
Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD
Zeitfenster: Up to Week 96
The CD PRO-2 consists of 2 items: abdominal pain and stool frequency. An AP score <=1 and a mean SF score <=3 and no worsening of AP or SF compared with baseline and no use of corticosteroids for at least 30 days in CD participants will be defined as a corticosteroid-free PRO-2 remission. Efficacy will be evaluated by line of treatment and subpopulation.
Up to Week 96
Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC
Zeitfenster: Up to Week 96
The UC PRO-2 is composed of rectal bleeding and stool frequency. An SF subscore of 0 or 1, where it has not increased from baseline, and a PMS rectal bleeding subscore of 0 with no use of corticosteroids for at least 30 days in UC participants will be defined as a corticosteroid-free PRO-2 remission. Efficacy will be evaluated by line of treatment and subpopulation.
Up to Week 96
Characteristics of Participants Receiving Guselkumab Treatment: Previous Inflammatory Bowel Disease (IBD) Medication Usage
Zeitfenster: At Baseline
The number and type of previous inflammatory bowel disease (IBD) medication used by participant will be reported.
At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity At Index
Zeitfenster: At Baseline
Disease severity per participant at baseline will be assessed.
At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis
Zeitfenster: At Baseline
Participant's age at diagnosis will be reported.
At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Comorbid Diagnoses
Zeitfenster: At Baseline
Number and nature of comorbidities per participant will be reported.
At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: History of UC/CD
Zeitfenster: At Baseline
Number of participants with history of UC/CD will be reported.
At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD-Related Surgeries
Zeitfenster: At Baseline
Number of participants who have undergone previous IBD-related surgeries and the nature of surgeries will be reported.
At Baseline
Number of Participants with Adverse Events (AE)
Zeitfenster: Up to Week 96
An adverse event is any untoward medical occurrence in a participant administered a medicinal product. An adverse event 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 Week 96
Change in C-Reactive Protein (CRP) Levels
Zeitfenster: Up to Week 96
Change in CRP levels since guselkumab initiation will be reported. C-reactive protein is a marker of inflammation that will be measured by physicians following routine clinical practice.
Up to Week 96
Change in Fecal Calprotectin (Fcal) Levels
Zeitfenster: Up to Week 96
Change in Fcal levels since guselkumab initiation will be reported. Fcal is a marker of inflammation that will be measured by physicians following routine clinical practice where higher values indicate greater intestinal inflammation.
Up to Week 96
Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment
Zeitfenster: Up to Week 96
Number of participants with concomitant IBD medications and the type of concomitant medications given during guselkumab treatment will be reported.
Up to Week 96
Health-related Quality of Life As Assessed by Short IBD Questionnaire (SIBDQ) Total Score
Zeitfenster: Up to Week 96
The SIBDQ is a health-related quality of life (HRQoL) tool measuring physical, social, and emotional status in IBD participants. 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.
Up to Week 96
Health-related Quality of life of Participants Receiving Guselkumab Treatment as Assessed by Bowel Urgency
Zeitfenster: Up to Week 96
Health-related Quality of life of participants receiving guselkumab treatment as assessed by bowel urgency will be reported.
Up to Week 96
Health-related Quality of Life of Participants Receiving Guselkumab Treatment as Assessed by PRO-2 Components
Zeitfenster: Up to Week 96
Health-related Quality of life of participants receiving guselkumab treatment as assessed by PRO-2 components will be reported.
Up to Week 96
Functional Assessment Of Chronic Illness (FACIT) Fatigue (FACIT-F) Scale Score
Zeitfenster: Up to Week 96
The FACIT-F scale is a 13-item instrument designed to assess fatigue/tiredness and its impact on daily activities and functioning in chronic diseases. The instrument includes items such as tiredness, weakness, listlessness, lack of energy, and the impact of these feelings on daily functioning over the last 7 days. Scores are numeric and range from 0 to 52 with higher scores indicating less fatigue.
Up to Week 96
Number of CD Participants Achieving Endoscopic Response as Measured by Simple Endoscopy Score-CD (SES-CD)
Zeitfenster: Up to Week 96
Endoscopic response is defined as 50% improvement from baseline in SES-CD total score, or SES-CD total score <= 4. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease. If SES-CD is not available, response is defined as a reduction in ulcer size, number or extend on endoscopy compared to baseline.
Up to Week 96
Number of Participants Achieving Endoscopic Remission in Participants with CD
Zeitfenster: Up to Week 96
Endoscopic remission is defined as SES -CD total score <= 4 with at least 2 points reduction from baseline and no subscore >1 in any individual component . SES-CD score can range from 0 to 56. Higher scores indicating more severe disease. If SES-CD is not available, response is defined as an absence of mucosal ulcers as seen on endoscopy.
Up to Week 96
Number of Participants Achieving Histological Improvement in Participants with UC as Measured by Nancy Score
Zeitfenster: Up to Week 96
Histological improvement defined by a reduction in the Nancy score by at least one point compared to baseline will be reported. The Nancy index is defined by a 5-level classification ranging from grade 0 (absence of significant histological disease activity) to grade 4 (severely active disease).
Up to Week 96
Number of Participants Achieving Histological Remission in Participants with UC as Measured by Nancy Score
Zeitfenster: Up to Week 96
Histological remission defined by a Nancy score of 0 or 1 will be reported. The Nancy index is defined by a 5-level classification ranging from grade 0 (absence of significant histological disease activity) to grade 4 (severely active disease).
Up to Week 96
Number of Participants Achieving Intestinal Utrasound (IUS) Response in Participants with CD as Measured by Bowel Wall Thickness (BWT)
Zeitfenster: At Weeks 24, 48, 72, 96
IUS response is defined as reduction of BWT of >=25% or normalization (<=3 millimeters [mm]) of the most affected segment at Weeks 24, 48, 72, 96 in participants with increased BWT (>3 mm) at baseline.
At Weeks 24, 48, 72, 96
Number of Participants Achieving IUS (Transmural) Remission in Participants with CD as Measured by BWT
Zeitfenster: At Weeks 24, 48, 72, 96
IUS remission is defined as normalization of BWT (<=3 mm) and vascularity (no signal or short signal in color Doppler of the most affected segment) at Weeks 24, 48, 72, 96, in participants with increased BWT (> 3 mm) at baseline
At Weeks 24, 48, 72, 96
Number of Participants Achieving Magnetic Resonance Enterography (MRE) Response in Participants with CD
Zeitfenster: Up to Week 96
MRE response is defined as improvement of bowel wall thickness and contrast enhancement compared to baseline.
Up to Week 96
Number of Participants Achieving MRE Remission in Participants with CD
Zeitfenster: Up to Week 96
MRE remission is defined as bowel wall thickness <=3 mm without segmental mural hyperenhancement.
Up to Week 96
Change from Baseline in Satisfaction with Guselkumab Treatment as per Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score
Zeitfenster: Baseline, Weeks 12, 48, and 96
TSQM-9 is an abbreviated version of the 14-item TSQM, and is a reliable and valid measure to assess treatment satisfaction. t 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. Here, higher scores indicating greater satisfaction for that domain. A positive change from baseline indicates improvement.
Baseline, Weeks 12, 48, and 96
Change from Baseline in Number of UC/CD Emergency Room Visits
Zeitfenster: Baseline, Weeks 12, 48, 96
Change in the number of emergency room visits for treatment of UC/CD will be reported.
Baseline, Weeks 12, 48, 96
Change from Baseline in Number of UC/CD Hospitalizations
Zeitfenster: Baseline, Weeks 12, 48, 96
Change in the number of hospitalizations for treatment of UC/CD will be reported.
Baseline, Weeks 12, 48, 96
Change from Baseline in Number of UC/CD Surgeries
Zeitfenster: Baseline, Weeks 12, 48, 96
Change in the number of surgeries for treatment of UC/CD will be reported.
Baseline, Weeks 12, 48, 96

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Janssen Research & Development, LLC

Ermittler

  • Studienleiter: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

18. September 2026

Primärer Abschluss (Geschätzt)

1. Januar 2030

Studienabschluss (Geschätzt)

19. April 2030

Studienanmeldedaten

Zuerst eingereicht

11. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. September 2026

Zuerst gepostet (Tatsächlich)

16. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CNTO1959IBD4005 (Andere Kennung: Janssen Research & Development, LLC)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

The data sharing policy of Johnson & Johnson Innovative Medicine is available at 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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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