A Study of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis (G-FORCE)

Janssen-Cilag Pharma GmbH

Status: Begins enrollment this month

Conditions: Colitis, Ulcerative; Crohn Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT07606339

CNTO1959IBD4013

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

35 participants in 1 patient group

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

Description:

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.