A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)

Официальное название

Real World Observation of Guselkumab Treatment in Patients With Ulcerative Colitis and Crohn's Disease - a Study of Treatment Outcomes in the UK

Обзор

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.

Первичные конечные точки

• Number of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI) [Срок оценки: Up to Week 96]
• Number of Participants Achieving Clinical Remission for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS) [Срок оценки: Up to Week 96]
• Number of Participants Achieving Clinical Response for CD as Measured by HBI [Срок оценки: Up to Week 96]
• Number of Participants Achieving Clinical Response for UC as Measured by PMS [Срок оценки: Up to Week 96]
• Number of Participants Achieving Corticosteroid-free Remission for CD as Measured by HBI [Срок оценки: Up to Week 96]
• Number of Participants Achieving Corticosteroid-free Remission for UC as Measured by PMS [Срок оценки: Up to Week 96]
• Number of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI [Срок оценки: Up to Week 96]
• Number of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS [Срок оценки: Up to Week 96]
• Number of Participants Achieving Patient-Reported Outcome (PRO)-2 Corticosteroid-Free Remission for CD as Measured by HBI [Срок оценки: Up to Week 96]
• Number of Participants Achieving PRO-2 Corticosteroid-Free Remission for UC as Measured by PMS [Срок оценки: Up to Week 96]

Вторичные конечные точки (12)

• Number of Participants with Early Responses to Guselkumab Measured Using PRO-2 Components for UC [Срок оценки: 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 [Срок оценки: Baseline (at Week 0), Weeks 1, 2, 4, 8, 12]
• Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency [Срок оценки: Baseline (at Week 0), Weeks 1, 2, 4, 8, 12]
• Time to Guselkumab Persistence [Срок оценки: Up to Week 96]
• Characteristics of Participants Receiving Guselkumab Treatment: Age [Срок оценки: At Baseline]
• Characteristics of Participants Receiving Guselkumab Treatment: Sex [Срок оценки: At Baseline]
• Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD Medication Use, Smoking Status and History, History of UC and History of CD [Срок оценки: At Baseline]
• Characteristics of Participants Receiving Guselkumab Treatment: Height [Срок оценки: At Baseline]
• Characteristics of Participants Receiving Guselkumab Treatment: Weight [Срок оценки: At Baseline]
• Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity [Срок оценки: At Baseline]
• Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis [Срок оценки: At Baseline]
• Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration [Срок оценки: At Baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 1 центр

• London North West University Healthcare NHS Trust — Harrow

Идентификаторы

NCT: NCT07242248 · CNTO1959IBD4006 · CNTO1959IBD4006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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