Evaluating Ustekinumab for Treating Stricturing Crohn's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Jingwen Liu, MD. — Center of IBD, the Second Affiliated Hospital, Zhejiang University School of Medicine
• Study coordinator: Yan Chen, MD.
• Email: chenyan72_72@zju.edu.cn
• Phone: +86-571-87783777

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Guselkumab vs Ustekinumab for stricturing Crohn's disease

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• Guselkumab for Chinese patients with Crohn's disease who stopped responding to ustekinumab

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• Using a special balloon to treat recurring benign bowel strictures

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.