NCT07093294 Value of IUS in Predicting Vedolizumab Efficacy and Assessing Transmural Healing in Early Crohn's Disease: A Multicenter, Prospective Study
| NCT ID | NCT07093294 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Third Xiangya Hospital of Central South University |
| Condition | Crohn Disease (CD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-06-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07093294 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Crohn Disease (CD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07093294 currently recruiting?
Yes, NCT07093294 is actively recruiting participants. Contact the research team at f3tianli@outlook.com for enrollment information.
Where is the NCT07093294 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT07093294 clinical trial?
NCT07093294 is sponsored by The Third Xiangya Hospital of Central South University. The trial plans to enroll 60 participants.