A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia (EAGLE)

Janssen (J&J Innovative Medicine)

Status: Not yet enrolling

Conditions: Ulcerative; Colitis; Crohn Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT07541261

CNTO1959IBD4009 (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate treatment persistence of guselkumab (that is how long a person keeps taking their prescribed medicine or continues with their treatment plan without stopping) 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications described in the current version of the summary of product characteristics (SmPC) approved in Saudi Arabia. The decision to prescribe must solely be made by the treating physician. Enrollment must take place before or at the day of first administration of guselkumab (but after treatment decision by physician) and after obtaining patient consent
• The participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records
• The participant must sign a participation agreement/informed consent form (ICF) allowing source data verification

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

100 participants in 1 patient group

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

Description:

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 clinical practice, through routine therapeutic procedures and evaluation assessments will be collected within this study.