IUS Predicts Upadacitinib Efficacy in Patients With Moderate to Severe Crohn's Disease：a Prospective Study

NCT06573944 | Unknown

• 1 other identifier: fu3tianli3
• Study Type: observational
• Target: 34
• 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, and can present with serious complications such as intestinal obstruction, perforation, abdominal abscesses, and fistulae. 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. Upadacitinib is a novel oral small molecule agent that is a highly selective JAK-1 inhibitor. A large real-world study showed that in refractory moderate-to-severe CD, upadacitinib showed a clinical response rate of 76.5% and a clinical remission rate of 70.6% at 8 weeks of treatment. Intestinal ultrasound (IUS) 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. There are no validated indicators to predict the efficacy of upatinib 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 of upatinib therapy. Therefore, we propose for the first time that intestinal ultrasound be used as a method to predict the response to upadacitinib in CD patients, with the aim of providing evidence to guide the development of individualized treatment plans.

Conditions

Crohn's Disease; Upadacitinib; Intestinal Ultrasound; Predictors

Outcome Measures

Primary Outcomes (1)

• Bowel wall thickness (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 54 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, patients with newly diagnosed or relapsed moderate to severe Crohn's disease treated with upadacitinib will be enrolled.

You may qualify if:

• Age ≥ 18 years and ≤ 80 years;
• Patients with newly diagnosed or relapsed moderate to severe Crohn's disease
• Upadacitinib therapy is proposed to be applied within 1 month after baseline endoscopy and intestinal ultrasound,;
• No history of abdominal surgery;
• Clearly understand, voluntarily participate in the study, and sign an informed consent form.

You may not qualify if:

• Contraindications to upadacitinib: 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

Study Sites (1)

The Third Xiangya Hospital of Central South University

Hunan, 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

Li Tian

CONTACT

0731-13574843423; f3tianli@outlook.com

Yuanyuan Huang

CONTACT

0731-18874383889; 18874383889@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: August 24, 2024
• First Posted: August 27, 2024
• Study Start: January 16, 2024
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)