Evaluating Ustekinumab for Treating Stricturing Crohn's Disease

Efficacy of Ustekinumab-based Integrated Medicine Therapy in Patients With Symptomatic Stricturing Crohn's Disease: a Multicenter, Prospective, Observational Cohort Study

This study is testing if ustekinumab can help people with moderate-to-severe Crohn's disease who have blockages in their intestines feel better over a two-year period.

Quick facts

• Study type: Observational
• Enrollment: 239 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: ustekinumab, chemotherapy, radiation
• Locations: 8 sites (Beijing, Beijing Municipality and 7 other locations)
• Trial ID: NCT05387031 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the efficacy of ustekinumab therapy in patients with moderate-to-severe Crohn's disease who exhibit obstructive symptoms due to intestinal strictures. Patients will be selected based on confirmed stenosis identified through radiography or endoscopy, and their treatment will be monitored over a period of up to 104 weeks. Comprehensive data, including medical history, laboratory tests, and symptom assessments, will be collected at various follow-up points to evaluate treatment outcomes. The primary endpoint is the success of ustekinumab treatment at week 52, with a focus on disease activity and symptom relief.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with moderate-to-severe Crohn's disease who have experienced obstructive symptoms and have identifiable intestinal strictures.

Not a fit: Patients requiring urgent surgical intervention or those with complications such as perforation or active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective treatment option for patients suffering from stricturing Crohn's disease, potentially improving their quality of life.

How similar studies have performed: Previous studies have shown promising results with ustekinumab in treating Crohn's disease, indicating that this approach has potential based on existing evidence.

Eligibility criteria

Inclusion Criteria:

* Clinical diagnosis of moderate to severe Crohn's disease
* Obstructive symptoms within the last eight weeks
* A single or several lumen stricture(s) identified by radiological imaging or endoscopy
* For strictures identified by CT enterograph defined as a lesion with combination of a reduction of luminal narrowing \>50%, an increase in bowel wall thickness \>25% relative to non-affected bowel and pre-stricture dilation \>3.0 cm
* For strictures identified during endoscopic procedure defined by intestinal strictures with a lumen diameter ≤12 mm or even inability to pass the endoscope across the narrowing

Exclusion Criteria:

* Requirement of urgent surgery or endoscopic intervention within 2 months as judged by the clinician
* Symptoms or signs of perforation such as active perianal sepsis, abdominal abscess, intestinal fistula, and abdominal adhesions
* Intestinal obstruction caused by surgery, intra-abdominal abscess, isolated intestinal stricture
* Effective treatments for stricture in the past half a year, such as endoscopic balloon dilatation, intestinal stricture plasty, surgery/manual anal dilatation, etc.
* Unable to eat after using enteral nutrition for more than 2 months
* History of ustekinumab (UST) or other IL-23 antagonists use in the past 12 months
* CT enterograph contraindications, such as allergy to contrast media
* Relative contraindications of biological agents, such as pulmonary tuberculosis-positive chest X-ray or active tuberculosis with strong positive tuberculin skin test, myocardial infarction, heart failure, or demyelinating neurological disease
* Currently suffering from a solid tumor, lymphoma, or melanoma and undergoing chemotherapy or radiation therapy
* Combination of intestinal dysplasia (eg, diagnosed with short bowel syndrome), colostomy, or colorectal tumors
* Combination of active gastrointestinal bleeding, shock, severe diarrhea, refractory vomiting and severe malabsorption syndrome
* Combination of severe liver and kidney dysfunction
* Coexistence of bacterial or viral active infection
* Pregnant or breastfeeding
* Severe hemodynamics, unstable vital signs or presence of rapidly progressive or end-stage disease, expected to be fatal during the course of the study

Where this trial is running

Beijing, Beijing Municipality and 7 other locations

• Department of Gastroenterology, Seventh Medical Center of PLA Army General Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Department of Gastroenterology, Chongqing Renji Hospital, University of Chinese Academy of Sciences — Chongqing, Chongqing Municipality, China (Recruiting)
• Department of Gastroenterology, Sixth Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)
• Department of Gastroenterology, Huai'an First People's Hospital — Huai'an, Jiangsu, China (Recruiting)
• Department of Gastroenterology, Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• Department of Gastroenterology, Affiliated Hospital of Yangzhou University — Yangzhou, Jiangsu, China (Recruiting)
• Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Jingwen Liu, MD. — Center of IBD, the Second Affiliated Hospital, Zhejiang University School of Medicine
• Study coordinator: Yan Chen, MD.

Conditions Crohn Disease; Stricture; Bowel; Intestinal Stricture; intestinal stricture; Ustekinumab; integrated medicine therapy; cohort study