Observes guselkumab use in Chinese adults with ulcerative colitis
Studies how guselkumab works in real-world care for ulcerative colitis patients new to biologics.
Plain-language title generated from the registry record
Registry title: A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis
Key facts
- Where
- Beijing, Changzhou, Guangzhou, Hangzhou, Nanjing, Shenzhen, Shijiazhuang, and Tianjin, ChinaSee the 11 sites
Where in China
- Peking Union Medical College HospitalBeijing, ChinaTaking people
- Peking University People's HospitalBeijing, ChinaTaking people
- Changzhou No 2 Peoples HospitalChangzhou, ChinaTaking people
- The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaTaking people
- The Sixth Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, ChinaTaking people
- Sir Run Run Shaw Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
- The Second Affiliated Hospital of Zhejiang UniversityHangzhou, ChinaTaking people
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing, ChinaTaking people
- Shenzhen Hospital of Southern Medical UniversityShenzhen, ChinaTaking people
- The Second Hospital of Hebei Medical UniversityShijiazhuang, ChinaTaking people
- Tianjin Medical University General HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xian-Janssen Pharmaceutical Ltd.
- Trial code
- NCT07302360
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
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: 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: Participants who will be receiving guselkumab therapy combined with a second advanced therapy; Acute severe UC or infectious colitis or other conditions when patients is likely to require a colectomy; Participants with a history of colectomy and/or pouch; 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.