A Study of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis

NCT07606339 | Not Yet Recruiting

• 1 other identifier: CNTO1959IBD4013
• Study Type: observational
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.

Conditions

Crohn Disease; Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• Persistence with Guselkumab Treatment

  Persistence with guselkumab treatment is defined as time at which the next infusion should have taken place for a participant after their last scheduled infusion. It will be used to measure the guselkumab persistence in participants.

  Up to Week 96

Secondary Outcomes (50)

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

  At Weeks 0 (baseline) 1, 2, 4, 8 and 12

• Number of Participants with Early Responses to Guselkumab Measured Using Patient Reported Outcome (PRO-2) Components

  At Weeks 0 (baseline), 1, 2, 4, 8 and 12

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

  At Weeks 12, 48 and 96

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

  At Weeks 12, 48 and 96

• Number of Participants Achieving Clinical Remission for CD as Measured by HBI Score

  At Weeks 12, 48 and 96

Study Arms (1)

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

Participants with confirmed diagnosis of moderate to severe crohn's disease (CD) or ulcerative colitis (UC) treated with guselkumab in routine clinical practice will be enrolled. No drug will be provided as a part of this study. Only data available from clinical practice and medical records 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 receiving guselkumab in routine clinical practice.

You may qualify if:

• 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
• 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

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-Cilag Pharma GmbH: lead

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Janssen-Cilag Pharma GmbH Clinical Trial

  Janssen-Cilag Pharma GmbH

  STUDY DIRECTOR

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: May 19, 2026
• First Posted: May 26, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 15, 2029
• Study Completion (Estimated): June 15, 2029
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share