Actively Recruiting
A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis
Led by Xian-Janssen Pharmaceutical Ltd. · Updated on 2026-05-08
200
Participants Needed
9
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of moderately to severely active ulcerative colitis with a baseline modified Mayo score of 4 to 9
- Screening endoscopy showing Mayo endoscopic subscore of 2 or higher
- Mayo rectal bleeding subscore of 1 or higher at baseline
- Eligible for advanced treatment and starting guselkumab therapy as decided by their doctor
- No prior use of advanced therapies such as TNF-alpha antagonists, anti-integrin agents, anti-IL agents, S1P receptor modulators, JAK inhibitors, or their generics/biosimilars
- Signed informed consent form allowing data verification according to local rules
You will not qualify if you...
- Having acute severe ulcerative colitis, infectious colitis, or other conditions likely requiring colectomy
- Contraindicated for guselkumab according to product label
- Currently enrolled in or planning to participate in another clinical trial from consent signing until final guselkumab dose
- Receiving guselkumab combined with a second advanced therapy
- History of colectomy or pouch surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Peking Union Medical College Hospital
Beijing, China, 100006
Actively Recruiting
2
Peking University People's Hospital
Beijing, China, 100044
Actively Recruiting
3
Changzhou No 2 Peoples Hospital
Changzhou, China, 213003
Actively Recruiting
4
The First Affiliated Hospital Sun Yat-Sen University
Guangzhou, China, 510080
Actively Recruiting
5
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
Actively Recruiting
6
The Second Affiliated Hospital of Zhejiang University
Hangzhou, China, 310009
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7
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, China, 223800
Actively Recruiting
8
The Second Hospital of Hebei Medical University
Shijiazhuang, China, 050000
Actively Recruiting
9
Tianjin Medical University General Hospital
Tianjin, China, 300052
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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