RecruitingNCT05387031

Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease

Efficacy of Ustekinumab-based Integrated Medicine Therapy in Patients With Symptomatic Stricturing Crohn's Disease: a Multicenter, Prospective, Observational Cohort Study


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

239 participants

Start Date

Aug 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This study intends to select patients with confirmed moderate-to-severe Crohn's disease (CD) and obstructive symptoms of intestinal stenosis, who have clear evidence of lumen stenosis caused by the disease itself through radiography or endoscopy. After the informed consent of the patients, comprehensive drug therapy with ustekinumab as the mainstay was performed. The basic information and medical history of the patients were collected, and the treatment process of the patients was followed up and recorded, and the drug regimen was adjusted according to the physician's experience and judgment. At different follow-up time points, blood, feces, tissue and other specimens of patients were collected according to the situation, and gastrointestinal endoscopy, imaging examination, laboratory index examination, self-assessment of subjects' symptoms, and nutritional risk screening were performed on the patients. This study evaluated the CD disease activity, obstructive symptoms, and radiographic or endoscopic remission in patients at different follow-up time points, and comprehensively evaluated the efficacy of ustekinumab in relieving stenotic CD and its related factors.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether the biologic drug ustekinumab — which works by reducing specific immune signals that drive gut inflammation — can shrink the narrowings (strictures) that form in the intestine in people with Crohn's disease and relieve the painful, obstructive symptoms these strictures cause. **You may be eligible if...** - You have been diagnosed with moderate to severe Crohn's disease - You have had obstructive bowel symptoms (cramping, bloating, or vomiting after eating) within the past 8 weeks - Imaging has confirmed one or more narrowed areas (strictures) in your intestine that are not purely scar tissue **You may NOT be eligible if...** - You need urgent surgery or an endoscopic procedure to open the narrowing within 2 months - You have signs of bowel perforation, abscess, or severe perianal infection - You have previously not responded to ustekinumab - You are pregnant or breastfeeding - You have active tuberculosis or a serious ongoing infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUstekinumab

The initial intravenous (IV) infusion with ustekinumab at baseline was weight-adjusted (260 mg ≤55 kg, 390 mg between 55 and 85 kg, 520 mg ≥85 kg). According to the label, the first subcutaneous (SC) 90 mg induction dose was administered at week 8 followed by a maintenance dose of 90 mg SC every 8 or 12 weeks, at the discretion of the physician. This study evaluated the CD disease activity, obstructive symptoms, and radiographic or endoscopic remission in patients at different follow-up time points, and comprehensively evaluated the efficacy of ustekinumab in relieving stenotic CD and its related factors.


Locations(8)

Department of Gastroenterology, Seventh Medical Center of PLA Army General Hospital

Beijing, Beijing Municipality, China

Department of Gastroenterology, Chongqing Renji Hospital, University of Chinese Academy of Sciences

Chongqing, Chongqing Municipality, China

Department of Gastroenterology, Sixth Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Department of Gastroenterology, Huai'an First People's Hospital

Huai'an, Jiangsu, China

Department of Gastroenterology, Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Department of Gastroenterology, Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

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NCT05387031


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