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Not yet recruiting NCT07746765

A Study of Continued Use of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting

— Observational Crohn Disease Colitis, Ulcerative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Crohn Disease, Colitis, Ulcerative. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Real-world Observational Study of Guselkumab Persistence in Patients With Crohn's Disease and Ulcerative Colitis

Overview

The purpose of this study is to find out how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) 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.

Primary outcome measures

  • Time to Guselkumab Discontinuation [Time frame: Up to Week 96]
Secondary outcome measures (12)
  • Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency [Time frame: At Weeks 0 (baseline), 1, 2, 4, 8, 12]
  • Number of Participants with Early Responses to Guselkumab Measured Using Patient Reported Outcome (PRO-2) Components [Time frame: At Weeks 0 (baseline), 1, 2, 4, 8, 12]
  • Number of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI) Score [Time frame: At Weeks 0 (baseline), 12, 48 and 96]
  • Number of Participants Achieving Clinical Response for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS) [Time frame: At Weeks 0 (baseline), 12, 48 and 96]
  • Number of Participants Achieving Clinical Remission for CD as Measured by HBI Score [Time frame: At Weeks 0 (baseline), 12, 48 and 96]
  • Number of Participants Achieving Clinical Remission for UC as Measured by PMS [Time frame: At Weeks 0 (baseline), 12, 48 and 96]
  • Number of Participants Achieving Corticosteroid-Free Clinical Remission for CD [Time frame: At Weeks 0 (baseline), 12, 48 and 96]
  • Number of Participants Achieving Corticosteroid-Free Clinical Remission for UC [Time frame: At Weeks 48 and 96]
  • Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD [Time frame: At Weeks 12, 48 and 96]
  • Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC [Time frame: At Weeks 12, 48 and 96]
  • Characteristics of Participants Receiving Guselkumab Treatment: Age [Time frame: At Baseline]
  • Characteristics of Participants Receiving Guselkumab Treatment: Sex [Time frame: At Baseline]

Eligibility criteria

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
  • Participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records
  • Participant must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements

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 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 informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07746765 · CNTO1959IBD4011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗