Recruiting NCT07242248
A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)
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's 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
- United Kingdom
- 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 Observation of Guselkumab Treatment in Patients With Ulcerative Colitis and Crohn's Disease - a Study of Treatment Outcomes in the UK
Overview
The purpose of this study is to evaluate the clinical effectiveness (how well the treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are the outcomes of treatment (clinical outcomes) in adult participants with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD) under real-world settings. CD and UC are the main type of Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.
Primary outcome measures
- Number of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI) [Time frame: Up to Week 96]
- Number of Participants Achieving Clinical Remission for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS) [Time frame: Up to Week 96]
- Number of Participants Achieving Clinical Response for CD as Measured by HBI [Time frame: Up to Week 96]
- Number of Participants Achieving Clinical Response for UC as Measured by PMS [Time frame: Up to Week 96]
- Number of Participants Achieving Corticosteroid-free Remission for CD as Measured by HBI [Time frame: Up to Week 96]
- Number of Participants Achieving Corticosteroid-free Remission for UC as Measured by PMS [Time frame: Up to Week 96]
- Number of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI [Time frame: Up to Week 96]
- Number of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS [Time frame: Up to Week 96]
- Number of Participants Achieving Patient-Reported Outcome (PRO)-2 Corticosteroid-Free Remission for CD as Measured by HBI [Time frame: Up to Week 96]
- Number of Participants Achieving PRO-2 Corticosteroid-Free Remission for UC as Measured by PMS [Time frame: Up to Week 96]
Secondary outcome measures (12)
- Number of Participants with Early Responses to Guselkumab Measured Using PRO-2 Components for UC [Time frame: Baseline (at Week 0), Weeks 1, 2, 4, 8, 12]
- Number of Participants with Early Responses to Guselkumab Measured Using PRO-2 Components for CD [Time frame: Baseline (at Week 0), Weeks 1, 2, 4, 8, 12]
- Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency [Time frame: Baseline (at Week 0), Weeks 1, 2, 4, 8, 12]
- Time to Guselkumab Persistence [Time frame: Up to Week 96]
- Characteristics of Participants Receiving Guselkumab Treatment: Age [Time frame: At Baseline]
- Characteristics of Participants Receiving Guselkumab Treatment: Sex [Time frame: At Baseline]
- Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD Medication Use, Smoking Status and History, History of UC and History of CD [Time frame: At Baseline]
- Characteristics of Participants Receiving Guselkumab Treatment: Height [Time frame: At Baseline]
- Characteristics of Participants Receiving Guselkumab Treatment: Weight [Time frame: At Baseline]
- Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity [Time frame: At Baseline]
- Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis [Time frame: At Baseline]
- Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration [Time frame: At Baseline]
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 the drug. Decision to prescribe must solely be made by the treating physician in line with the Trust's/ Health Board's treatment guidance. Enrolment must take place before or at the day of 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
- Must sign a 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
- Has a 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
United Kingdom · 1 center
- London North West University Healthcare NHS Trust — Harrow
Identifiers
NCT: NCT07242248 · CNTO1959IBD4006 · CNTO1959IBD4006