Crohn'sRecruiting
Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease
Observational · No treatment assigned · 8 sites · Second Affiliated Hospital, Zhejiang University, School of Medicine
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease, Stricture; Bowel and Intestinal Stricture. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 2 more requirement(s). There are also 15 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 239 participants are expected to take part.
- Start date: 2024-08-01.
- Main results expected around 2027-08-01 (estimate from the record).
- 8 study sites listed (8 marked recruiting) in China.
Main thing being measured
- Number of participants with treatment success at week 52 (up to 52 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease; Stricture; Bowel; Intestinal Stricture |
| Lead sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Collaborators | Sixth Affiliated Hospital, Sun Yat-sen University; Second Affiliated Hospital of Soochow University; Chongqing Renji Hospital, University of Chinese Academy of Sciences; The First Affiliated Hospital of Zhejiang Chinese Medical University; Seventh Medical Center of PLA Army General Hospital; First People's Hospital of Hangzhou; Yangzhou University; Xian-Janssen Pharmaceutical Ltd. |
| Enrollment | 239 (estimated) |
| Start date | 2024-08-01 |
| Primary completion (est.) | 2027-08-01 |
| First posted | 2022-05-24 |
| Last updated | 2026-02-27 |
| Official title | Efficacy of Ustekinumab-based Integrated Medicine Therapy in Patients With Symptomatic Stricturing Crohn's Disease: a Multicenter, Prospective, Observational Cohort Study |
| ClinicalTrials.gov ID | NCT05387031 |
Interventions
- Ustekinumab (Drug)
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, obstru…
Full eligibility criteria (from the record)
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
Locations (8)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.