Value of IUS in Predicting Vedolizumab Efficacy and Assessing Transmural Healing in Early Crohn's Disease: A Multicenter, Prospective Study

NCT07093294 | Recruiting

• 1 other identifier: fu3tianli7
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

Crohn Disease (CD); Vedolizumab; Intestinal Ultrasound; Predictor

Outcome Measures

Primary Outcomes (1)

• Bowel wall thickess(BWT)

  BWT is measured by intestinal ultrasound. BWT≤3mm means that CD is in quiescent, \>3mm means CD is active

  follow-up time of about 52 weeks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the Third Xiangya Hospital of Central South University,the First Affiliated Hospital of University of South China,the First People's Hospital of Chenzhou,the First People's Hospital of Changde and the Central Hospital of Shaoyang, early Crohn's Disease patients treated with vedolizumab will be enrolled.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead
• The First Affiliated Hospital of University of South China: collaborator
• The First People's Hospital of Changde City: collaborator
• The Central Hospital of Shaoyang City: collaborator
• First People's Hospital of Chenzhou: collaborator

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Tian Li

CONTACT

0731-13574843423; f3tianli@outlook.com

Yuwei Wu

CONTACT

0731-13308466056; wywer0612@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Li Tian,MD[fu3tianli]

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)