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Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Summary
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.
Official title: Efficacy of Ustekinumab-based Integrated Medicine Therapy in Patients With Symptomatic Stricturing Crohn's Disease: a Multicenter, Prospective, Observational Cohort Study
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
OBSERVATIONAL
Enrollment
239
Start Date
2024-08-01
Completion Date
2028-08-01
Last Updated
2026-02-27
Healthy Volunteers
No
Interventions
Ustekinumab
The initial intravenous (IV) infusion with ustekinumab at baseline was weight-adjusted (260 mg ≤55 kg, 390 mg between 55 and 85 kg, 520 mg ≥85 kg). According to the label, the first subcutaneous (SC) 90 mg induction dose was administered at week 8 followed by a maintenance dose of 90 mg SC every 8 or 12 weeks, at the discretion of the physician. 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.
Locations (8)
Department of Gastroenterology, Seventh Medical Center of PLA Army General Hospital
Beijing, Beijing Municipality, China
Department of Gastroenterology, Chongqing Renji Hospital, University of Chinese Academy of Sciences
Chongqing, Chongqing Municipality, China
Department of Gastroenterology, Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Department of Gastroenterology, Huai'an First People's Hospital
Huai'an, Jiangsu, China
Department of Gastroenterology, Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Department of Gastroenterology, Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, China
Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China