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

Guselkumab Real-world Effectiveness Among Bio-NaÏve Patients With Moderate-to-severe Ulcerative Colitis in China: A Multicenter, Non-interventional, Prospective Study

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.

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