A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis (GENIUS)

Janssen (J&J Innovative Medicine)

Status: Not yet enrolling

Conditions: Colitis, Ulcerative

Study type: Observational

Funder types: Industry

Identifiers

NCT07302360

CNTO1959UCO4003 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the measurable changes in health, function, or quality of life (clinical outcomes) after receiving guselkumab in real-world clinical practice amongst Chinese participants with ulcerative colitis (UC; a long-term disease of the large intestine in which the lining of the colon [part of large intestine] becomes inflamed and develops tiny open ulcers), who have not received biologic therapy (a medicine made from living organisms or their components) previously.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a confirmed diagnosis of moderately to severely active UC, defined as: a) baseline modified Mayo score of 4 to 9; b) screening endoscopy with Mayo endoscopic subscore (MES) greater than or equal to (>=) 2; c) Mayo rectal bleeding subscore (RBS) >= 1 at baseline
• Eligible for advanced treatment and initiate guselkumab therapy per participating physician decision in accordance with product package insert
• Have no prior exposure to advanced therapies (bio-naive), such as tumor necrosis factor (TNF)-alpha antagonists, anti-integrin agents, anti-interleukin (IL) agents, sphingosine-1-phosphate receptor modulators, janus kinase (JAK) inhibitors or their corresponding generics and biosimilars, per participating physician assessment
• Participant (and/or their legally-acceptable representative where applicable) must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements

Exclusion criteria

• Acute severe UC or infectious colitis or other conditions when patients is likely to require a colectomy
• Contraindicated to guselkumab per the label
• Currently enrolled in or plan to participate in any other clinical trials from signing informed consent to the final dose administration of guselkumab
• Participants who will be receiving guselkumab therapy combined with a second advanced therapy
• Participants with a history of colectomy and/or pouch

Trial design

200 participants in 1 patient group

Guselkumab: Moderate to Severe Ulcerative Colitis (UC)

Description:

Participants with confirmed diagnosis of moderate-to-severe UC 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 and observed.