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

Launched by THE THIRD XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Aug 24, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a non-invasive test called intestinal ultrasound (IUS) can help predict how well a new medication, upadacitinib, will work in patients with moderate to severe Crohn's disease. Crohn's disease is a long-lasting condition that causes inflammation in the digestive tract, leading to various complications. Upadacitinib is a new oral medication that has shown promising results in treating this condition. The goal of the study is to see if IUS can help doctors decide on the best treatment approach for each patient based on their individual response to upadacitinib.

To participate in this trial, you must be between 18 and 80 years old and have either newly diagnosed or returning moderate to severe Crohn's disease. You should also be willing to start treatment with upadacitinib within a month after undergoing an initial examination that includes an endoscopy and an intestinal ultrasound. Participants can expect to have regular check-ups to monitor their health and response to treatment. It's important to note that individuals with certain health issues or previous surgeries related to Crohn's disease may not be eligible for the study. By participating, you could contribute to finding better ways to manage Crohn's disease for yourself and others.

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Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.