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Recruiting NCT07541261

A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia

— Observational 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: 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
Saudi Arabia
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

A Multi-Center, Non-Interventional Study on Effectiveness and Treatment Persistence of Guselkumab in Patients With ULcerative Colitis and Crohn's DiseasE in Real-World Practice in Saudi Arabia

Overview

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 disease, 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 Participant Reported Outcome (PRO-2) Components for Crohn's Disease (CD) [Time frame: Weeks 0, 1, 2, 4, 8, and 12]
  • Number of Participants with Early Responses to Guselkumab Measured Using Participant Reported Outcome (PRO-2) Components for Ulcerative Colitis (UC) [Time frame: Weeks 0, 1, 2, 4, 8, and 12]
  • Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency [Time frame: Weeks 0, 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 Corticosteroid-free remission for UC [Time frame: Weeks 24, 48 and 96]
  • Number of Participants Achieving Corticosteroid-free remission for CD [Time frame: Weeks 24, 48 and 96]
  • Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC [Time frame: Weeks 24, 48 and 96]
  • Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD [Time frame: Weeks 24, 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]
  • Characteristics of Participants Receiving Guselkumab Treatment: Previous Inflammatory Bowel Disease (IBD) Medication Use [Time frame: At Baseline]

Eligibility criteria

Inclusion criteria

  • The participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications described in the current version of the summary of product characteristics (SmPC) approved in Saudi Arabia. The decision to prescribe must solely be made by the treating physician. Enrollment must take place before or at the day of first administration of guselkumab (but after treatment decision by physician) and after obtaining patient consent
  • The participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records
  • The participant must sign a participation agreement/informed consent form (ICF) allowing source data verification

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

Saudi Arabia · 1 center
  • Al Salama Hospital — Jeddah

Identifiers

NCT: NCT07541261 · CNTO1959IBD4009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗