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

Recruitingn/aAges 18 Years - 80 YearsAllThe Third Xiangya Hospital of Central South Unive…
NCT07034664 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Crohn's disease (CD) is a chronic non-specific intestinal inflammatory disease with incompletely clarified etiology, which can involve multiple organs and systems , and is prone to severe complications such as intestinal obstruction, perforation, and fistula.Currently, the main therapeutic drugs for CD include aminosalicylates, glucocorticoids, immunosuppressants, biological agents, etc. With the development of medical technology, biological agents have begun to be applied to moderate-to-severe Crohn's disease, providing new treatment options for patients with moderate-to-severe Crohn's disease. Guselkumab is a selective inhibitor of the interleukin-23 (IL-23) p19 subunit.The GALAXI2 and GALAXI3 studies demonstrated that guselkumab can better achieve the therapeutic goal of mucosal healing. The clinical remission rates of guselkumab at week 12 were 47.1% and 47.1%, respectively, and the

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📋 Eligibility rules (as published)
Inclusion Criteria: Age ≥ 18 years and ≤ 80 years; * Patients with newly diagnosed or relapsed moderate to severe Crohn's disease; * Guselkumab 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 Guselkumab: allergy, active tuberculosis or other active infections, and comorbidities such as severe liver dysfunction; * Patients with a history of extensive colectomy or recent proposed colectomy, history of colonic mucosal dysplasia; * Hypersensitivity to the components of SonoVue contrast media.
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What it tests

  • Not listed
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Where

1 site
The Third Xiangya Hospital of Central South University
Changsha, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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