Actively Recruiting
Guselkumab Real-world Effectiveness in Bio-Naive Chinese Adults With Moderate-to-Severe Ulcerative Colitis: A Multicenter Observational Study
Led by Xian-Janssen Pharmaceutical Ltd. · Updated on 2026-06-05
200
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of guselkumab in Chinese adults with moderate-to-severe ulcerative colitis (UC) who have not previously received biologic therapy. The study aims to observe changes in health, function, and quality of life in real-world clinical practice for this long-term inflammatory condition of the colon. Participants with confirmed moderate-to-severe UC will receive guselkumab treatment as part of their usual care, with no study drug provided by the trial. The study will collect and observe data from standard clinical practice and medical records without altering treatment. The main evaluation point is the percentage of participants achieving clinical response at week 12, with additional assessments at weeks 2, 24, and 48. During the study, participants' clinical responses, symptom improvements, remission rates, and inflammatory markers will be monitored through medical records and routine care visits. Outcomes include changes in stool frequency, rectal bleeding, endoscopic healing, and quality of life questionnaires. The study will track treatment continuation, dosing schedules, and any switches or discontinuations up to 48 weeks, providing insight into guselkumab's real-world effectiveness and safety.
CONDITIONS
Brief 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 moderate-to-severe 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 as decided by their physician
- No prior use of advanced therapies such as TNF-alpha antagonists, anti-integrin agents, anti-IL agents, sphingosine-1-phosphate receptor modulators, JAK inhibitors, or related biosimilars
- Signed informed consent form allowing data verification according to local rules
You will not qualify if you...
- Acute severe UC, infectious colitis, or other conditions likely requiring colectomy
- Contraindications to guselkumab as per product label
- Currently enrolled or planning to enroll in other clinical trials from consent to final guselkumab dose
- Receiving guselkumab combined with another advanced therapy
- History of colectomy or pouch surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants who undergo routine care are observed to collect data on their treatment with guselkumab as part of standard clinical practice.
Visits aligned with routine clinical practice up to Week 48
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
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3
Changzhou No 2 Peoples Hospital
Changzhou, China, 213003
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4
The First Affiliated Hospital Sun Yat-Sen University
Guangzhou, China, 510080
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5
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
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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
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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