A Real-World Study of Guselkumab Persistence and Effectiveness in Participants With Crohn's Disease or Ulcerative Colitis

NCT07848737 | Not Yet Recruiting

• 1 other identifier: CNTO1959IBD4010
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate how long participants with moderate-to-severe Crohn's Disease (CD) and Ulcerative Colitis (UC) continue treatment with guselkumab in a real-world setting. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).

Conditions

Colitis, Ulcerative; Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Persistence of Treatment with Guselkumab

  Persistence of treatment with guselkumab will be measured through time to guselkumab discontinuation defined as the time at which the next infusion should have taken place for a participant after their last scheduled infusion.

  Up to 96 weeks

Secondary Outcomes (25)

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

  Up to 96 weeks

• Number of Participants Achieving Clinical Response for CD as Measured by Patient Reported Outcome (PRO-2)

  Up to 96 weeks

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

  Up to 96 weeks

• Number of Participants Achieving Clinical Response for UC as Measured by PRO-2

  Up to 96 weeks

• Characteristics of Participants Receiving Guselkumab Treatment: Age

  At Week 0

Study Arms (1)

Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)

Participants with confirmed diagnosis of moderate-to-severe UC or CD receiving guselkumab according to clinical practice will be enrolled. Only data available within clinical routine as standard of care will be documented for 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:

• Participant 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. Participant must have been at least 8 weeks under guselkumab treatment before being included in the study, regardless if they are still on guselkumab treatment or not
• Participant must have a confirmed diagnosis of moderate-to-severe or Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records: Harvey-Bradshaw Index (HBI) greater than (\>)4 for CD and Partial Mayo Score (pMS)\>2 for UC
• Participant \[and/or their legally-acceptable representative where applicable\] 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
• It 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 the ICF

Sponsors & Collaborators

• Janssen-Cilag, S.A.: lead

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Janssen-Cilag S.A. Clinical Trial

  Janssen-Cilag, S.A.

  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: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): October 30, 2029
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share