A Study to Assess Guselkumab in Participants With Moderate-to-Severe Inflammatory Bowel Disease in Real Life Italian Setting

NCT07851207 | Not Yet Recruiting

• 1 other identifier: CNTO1959IBD4015
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) receiving guselkumab in a real-world setting, and to evaluate treatment persistence (continuation) and clinical effectiveness (how well it works) in the overall population and in predefined participant subgroups. The study will also assess patient-reported outcomes, including fatigue (low energy), health-related quality of life (HRQoL), and treatment satisfaction. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Persistence of Treatment with Guselkumab

  Persistence of treatment with guselkumab will be defined as the time elapsed from the date of the first administration of guselkumab to its discontinuation date. The discontinuation date will be defined as the date that the next administration of guselkumab should have taken place for a paticipant after the last dose of treatment was administered.

  Up to Week 96

Secondary Outcomes (44)

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

  Up to Week 12

• Percentage of Participants with Early Responses to Guselkumab Measured Using PRO-2 for Ulcerative Colitis (UC)

  Up to Week 12

• Percentage of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency (BU)

  Up to Week 12

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

  Up to Week 96

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

  Up to Week 96

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 treated with guselkumab as per standard clinical practice, according to the summary of product characteristics (SmPC) and local guidelines will be enrolled. Only data available from clinical routine will be collected in 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 have a confirmed diagnosis of moderate-to-severe CD or UC recorded in the medical records
• The participant must be eligible for biologic treatment and scheduled to initiate treatment with guselkumab for CD or UC management as per physician decision under routine clinical practice conditions, and according to the summary of product characteristics (SmPC) of the drug
• The participant has provided signed informed consent

You may not qualify if:

• The participant is currently enrolled in an interventional clinical study
• The participant has been previously exposed to interleukin (IL)-23 inhibitors, including guselkumab (Tremfya), risankizumab (Skyrizi) or mirikizumab (Omvoh). As an exception, participants who had previously received ustekinumab may be included
• The participant has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy, including biologics and/or small molecules
• The participant is unable to provide the informed consent form (ICF) and/or unable to complete the questionnaires/scales and patient's diary to address the study objectives

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Janssen Cilag SpA Clinical Trial

  Janssen Cilag SpA

  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: September 25, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share