Actively Recruiting
Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-02-27
239
Participants Needed
8
Research Sites
208 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
S
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study intends to select patients with confirmed moderate-to-severe Crohn's disease (CD) and obstructive symptoms of intestinal stenosis, who have clear evidence of lumen stenosis caused by the disease itself through radiography or endoscopy. After the informed consent of the patients, comprehensive drug therapy with ustekinumab as the mainstay was performed. The basic information and medical history of the patients were collected, and the treatment process of the patients was followed up and recorded, and the drug regimen was adjusted according to the physician's experience and judgment. At different follow-up time points, blood, feces, tissue and other specimens of patients were collected according to the situation, and gastrointestinal endoscopy, imaging examination, laboratory index examination, self-assessment of subjects' symptoms, and nutritional risk screening were performed on the patients. This study evaluated the CD disease activity, obstructive symptoms, and radiographic or endoscopic remission in patients at different follow-up time points, and comprehensively evaluated the efficacy of ustekinumab in relieving stenotic CD and its related factors.
CONDITIONS
Official Title
Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of moderate to severe Crohn's disease
- Obstructive symptoms within the last eight weeks
- Presence of one or more intestinal strictures confirmed by radiological imaging or endoscopy
- Strictures on CT enterography showing more than 50% narrowing, over 25% bowel wall thickening, and pre-stricture dilation over 3.0 cm
- Endoscopic strictures with lumen diameter 12 mm or less or inability to pass the endoscope through the narrowing
You will not qualify if you...
- Need for urgent surgery or endoscopic intervention within two months
- Signs of perforation such as active perianal sepsis, abdominal abscess, intestinal fistula, or abdominal adhesions
- Intestinal obstruction caused by surgery, abscess, or isolated stricture
- Treatment for strictures in the past six months including balloon dilation, surgery, or manual anal dilation
- Inability to eat after more than two months of enteral nutrition
- Use of ustekinumab or IL-23 antagonists in the past 12 months
- Allergies to contrast media preventing CT enterography
- Contraindications for biological agents, including tuberculosis, heart conditions, or neurological diseases
- Current solid tumor, lymphoma, or melanoma under chemotherapy or radiation
- Presence of intestinal dysplasia, colostomy, or colorectal tumors
- Active gastrointestinal bleeding, shock, severe diarrhea, vomiting, or malabsorption syndrome
- Severe liver or kidney dysfunction
- Active bacterial or viral infections
- Pregnancy or breastfeeding
- Severe unstable health conditions or rapidly progressive or end-stage disease expected to be fatal during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Department of Gastroenterology, Seventh Medical Center of PLA Army General Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
Department of Gastroenterology, Chongqing Renji Hospital, University of Chinese Academy of Sciences
Chongqing, Chongqing Municipality, China
Actively Recruiting
3
Department of Gastroenterology, Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Actively Recruiting
4
Department of Gastroenterology, Huai'an First People's Hospital
Huai'an, Jiangsu, China
Actively Recruiting
5
Department of Gastroenterology, Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
6
Department of Gastroenterology, Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, China
Actively Recruiting
7
Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
8
Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Yan Chen, MD.
CONTACT
J
Jingwen Liu, MD.
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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