Ultrasound scans to predict vedolizumab response in early Crohn's disease
Tests whether intestinal ultrasound predicts vedolizumab response in adults with early Crohn's disease.
Key facts
- Who runs it
- The Third Xiangya Hospital of Central South University
- Where
- Changsha, ChinaSee the site
- Trial code
- Registry title
- Value of IUS in Predicting Vedolizumab Efficacy and Assessing Transmural Healing in Early Crohn's Disease: A Multicenter, Prospective Study
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 1 Jun 2025
- Expected to end
- 30 Sept 2027
- Type of study
- Observational
- Record updated
- 30 July 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with early Crohn's disease who plan to start vedolizumab. It uses bowel ultrasound to see how well the treatment works.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Early Crohn's disease: disease for 18 months or less, without complications such as fistulas or strictures.
- Earlier treatment
- No earlier biologic or advanced therapy. Vedolizumab is planned within 1 month after the first endoscopy and bowel ultrasound. No earlier bowel surgery.
Main reasons for not taking part
- Contraindications to vedolizumab, such as allergy, active tuberculosis or other active infection
- Moderate-to-severe heart failure (NYHA grade III/IV)
- Nerve demyelinating lesions
- Live vaccine in the last 3 months
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Age ≥ 18 years and ≤ 80 years
- Early CD patients (disease duration ≤18 months, biologic-naïve and treatment-naïve for advanced therapies, without complications such as fistulas or strictures)
- Vedolizumab therapy is proposed to be applied within 1 month after baseline endoscopy and intestinal ultrasound,
- No history of intestinal surgery
- Clearly understand, voluntarily participate in the study, and sign an informed consent form
Who cannot take part
- Contraindications to vedolizumab: allergy, active tuberculosis or other active infections, moderate-to-severe heart failure (NYHA grade III/ IV), demyelinating lesions of the nervous system, live vaccination within the last 3 months, pregnancy and lactation
- Patients with a history of extensive colectomy or recent proposed colectomy, history of colonic mucosal dysplasia
- Hypersensitivity to the components of SonoVue contrast media
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in China
- The Third Xiangya Hospital of Central South UniversityChangsha, ChinaContact: Tian LiTaking people
About the trial
What the trial wants to find out
Crohn's disease(CD) is a chronic nonspecific inflammatory disease of the intestinal tract whose etiology is not yet fully understood,characterized by transmural inflammation , can present with serious complications such as intestinal obstruction, perforation, abdominal abscesses, and fistulae. In recent years, the incidence of CD has increased rapidly, causing a heavy social and economic burden. Currently, the main therapeutic drugs for CD include aminosalicylic acid preparations, glucocorticoids, immunosuppressants, and biological agents. With the development of medical technology, small molecule preparations have begun to be applied to moderate-to-severe Crohn's disease, providing new treatment options for patients with Crohn's disease.
Read full original descriptionShow less
Vedolizumab, a humanized monoclonal antibody.the GEMINI study demonstrated its superior efficacy over placebo in inducing and maintaining clinical remission. And the VERSIFY study confirmed its advantage in achieving mucosal healing, with a transmural healing rate of 29.1% at week 52.
Intestinal ultrasound is a noninvasive, reproducible, convenient, and inexpensive test that can greatly increase the frequency of assessing treatment response and speed up the clinical decision-making process.The 2019 ECCO-ESGAR guidelines recommend intestinal ultrasound for disease monitoring in patients with CD. Multiple studies have shown that most ultrasound markers normalize within 12 weeks of treatment initiation, and in particular, normalization of bowel wall thickness is highly correlated with clinical response at 12 weeks. There are no validated indicators to predict the efficacy of upadacitinib treatment in patients with moderate-to-severe CD in the currently available studies.
Currently, there are no national or international studies in which intestinal ultrasound predicts the efficacy and assesses the transmural healing of vedolizumab therapy. Therefore, we propose for the first time that intestinal ultrasound be used as a method to predict the response to vedolizumab in early CD patients, with the aim of providing evidence to guide the development of individualized treatment plans.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Value of Intestinal Ultrasound in Predicting Vedolizumab Response and Assessing Transmural Healing in Early Crohn's Disease: A Multicenter, Prospective Study
- Plain-language title
- Ultrasound scans to predict vedolizumab response in early Crohn's diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07093294, who can take part
- Record updated
- 30 July 2025