Actively Recruiting
A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-03-23
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of guselkumab in adults aged 18 to 75 years with moderate to severe Crohn's disease who have previously not responded to or could not tolerate ustekinumab treatment. The study focuses on patients with a diagnosis of Crohn's disease for at least 3 months and seeks to address the limited data available for guselkumab use in this specific group. It is a prospective, single-center observational study that plans to enroll about 60 participants. Participants will receive guselkumab following a defined induction and maintenance treatment regimen, with the entire observation lasting 52 weeks. The study will monitor the patients without altering their usual care, focusing on the real-world effects of guselkumab after prior ustekinumab therapy. No placebo or comparator drugs are involved, as this is an observational study. During the study, participants will attend scheduled visits for clinical assessments, including measurement of disease activity scores and quality of life evaluations. Researchers will track clinical remission rates at Week 52, along with other measures such as clinical response, endoscopic improvement, biomarker normalization, and safety. The study includes close safety monitoring and quality of life questionnaires to understand the treatment impact comprehensively.
CONDITIONS
Brief Title
A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years
- Diagnosis of Crohn's disease for at least 3 months
- Moderate to severe disease activity (CDAI 220-450)
- Previous treatment with at least one standard dose of ustekinumab with documented primary non-response, secondary loss of response, or intolerance leading to discontinuation
- Willing and able to comply with all study visits and procedures
You will not qualify if you...
- Previous exposure to any anti-IL-23p19 therapy including guselkumab
- Active intestinal infection, unremoved stenotic lesions with obstructive symptoms, short bowel syndrome, stoma, or recent abdominal abscess within 8 weeks
- History of malignancy except certain skin cancers
- Active tuberculosis or severe opportunistic infection
- Pregnancy, lactation, or planned pregnancy during the study period
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 - 52 weeks
Participants who undergo routine care are observed to evaluate the effectiveness and safety of guselkumab in Crohn's disease patients previously treated with ustekinumab.
Regular visits as per routine clinical care up to Week 52
Trial Site Locations
Total: 1 location
1
Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
S
Shurong Hu, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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