NCT07302360Recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 11 Dec 2025
- Start date
- 11 Dec 2025
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Diseases
- Ulcerative colitis
- NCT number
- NCT07302360
What you commit to
- Study type: Observational
- Planned participants: 200
- From 11 Dec 2025 to the primary completion date, 30 Jun 2028
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who will be receiving guselkumab therapy combined with a second advanced therapy
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Changzhou No 2 Peoples Hospital Coordinator of this site? Confirm its status | Changzhou | China | Recruiting |
| The Sixth Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The Second Affiliated Hospital of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Shenzhen Hospital of Southern Medical University Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| The Second Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.