A Study to Assess Real-world Outcomes for Long-Term Use of Guselkumab

NCT07532213 | Not Yet Recruiting

• 1 other identifier: CNTO1959IBD4008
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate how long guselkumab remains 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

Inflammatory Bowel Disease; Colitis, Ulcerative; Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Time to Guselkumab Persistence

  Persistence with guselkumab will be measured through time to discontinuation (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 (57)

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

  Baseline (at Week 0), Weeks 1, 2, 4, 8 and 12

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

  Baseline (at Week 0), Weeks 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

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

  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 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 standard clinical practice and medical records will be collected.

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:

• 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 (but after treatment decision by physician)
• Must have 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 A.G., Switzerland: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic 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 8, 2026
• First Posted: April 15, 2026
• Study Start: April 23, 2026
• Primary Completion (Estimated): April 10, 2029
• Study Completion (Estimated): April 10, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share