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

NCT07541261 | Not Yet Recruiting

• 1 other identifier: CNTO1959IBD4009
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Colitis; Ulcerative; Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Time to Guselkumab Discontinuation

  Time to guselkumab discontinuation is defined as time at which the next infusion should have taken place for a participant after their last scheduled infusion.

  Up to Week 96

Secondary Outcomes (36)

• Number of Participants with Early Responses to Guselkumab Measured Using Participant Reported Outcome (PRO-2) Components for Crohn's Disease (CD)

  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)

  Weeks 0, 1, 2, 4, 8, and 12

• Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency

  Weeks 0, 1, 2, 4, 8, and 12

• Number of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI)

  Weeks 12, 48 and 96

• Number of Participants Achieving Clinical Response for UC as Measured by Partial Mayo Score (PMS)

  Weeks 12, 48 and 96

Study Arms (1)

Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD): Guselkumab

Participants with confirmed diagnosis of moderate-to-severe UC or CD treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available from clinical practice, through routine therapeutic procedures and evaluation assessments will be collected within this study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include participants with confirmed diagnosis of moderate-to-severe crohn's disease (CD) or ulcerative colitis (UC) disease.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

MeSH Terms

Conditions

Colitis; Ulcer; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammatory Bowel Diseases

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: April 17, 2026
• Primary Completion (Estimated): January 2, 2029
• Study Completion (Estimated): January 2, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share