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Recruiting NCT07532213

A Study to Assess Real-world Outcomes for Long-Term Use of Guselkumab

— Observational Inflammatory Bowel Disease Colitis, Ulcerative Crohn Disease

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: Inflammatory Bowel Disease, Colitis, Ulcerative, Crohn Disease. 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
Switzerland
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

Long-Term Use of Guselkumab: Non-interventional Assessment of Real-world Outcomes

Overview

The purpose of this study is to evaluate how long guselkumab remains in participants with moderate to severe crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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 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 confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records
  • 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
  • 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

Switzerland · 1 center
  • Gastroenterologische Praxis und Crohn-Collitis Zentrum Bern — Bern

Identifiers

NCT: NCT07532213 · CNTO1959IBD4008 · CNTO1959IBD4008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗