Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease
NCT ID: NCT05387031
Last Updated: 2024-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
239 participants
OBSERVATIONAL
2024-08-31
2027-08-31
Brief Summary
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Detailed Description
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The investigators conduct follow-up and disease assessment at weeks 0, 12, 24, 52, and 104, respectively. The investigators define the primary endpoint of the study as the treatment success of ustekinumab at week 52, and investigate the efficacy of ustekinumab by site of stricture and assessed possible clinical, biochemical, and radiological predictors of treatment response at weeks 12, 24, 52, and 104. This clinical study provides evidence for the efficacy of ustekinumab-based comprehensive drugs in the treatment of stenotic Crohn's disease, provides biological information resources for future treatment options for patients with stenotic CD, and can also be used for disease diagnosis and treatment. In this group of people, the investigators tend to further analyze and find the influencing factors related to the development of stenotic CD disease and drug response, in order to provide corresponding support for clinical activities in the early stage of the disease or during the treatment process, and to improve the effectiveness and accuracy of individualized treatment for patients.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients with symptomatic stricturing Crohn's disease
The decision to start ustekinumab was at the discretion of the treating physician. 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.
Ustekinumab
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.
Interventions
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Ustekinumab
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Obstructive symptoms within the last eight weeks
* A single or several lumen stricture(s) identified by radiological imaging or endoscopy
* For strictures identified by CT enterograph defined as a lesion with combination of a reduction of luminal narrowing \>50%, an increase in bowel wall thickness \>25% relative to non-affected bowel and pre-stricture dilation \>3.0 cm
* For strictures identified during endoscopic procedure defined by intestinal strictures with a lumen diameter ≤12 mm or even inability to pass the endoscope across the narrowing
Exclusion Criteria
* Symptoms or signs of perforation such as active perianal sepsis, abdominal abscess, intestinal fistula, and abdominal adhesions
* Intestinal obstruction caused by surgery, intra-abdominal abscess, isolated intestinal stricture
* Effective treatments for stricture in the past half a year, such as endoscopic balloon dilatation, intestinal stricture plasty, surgery/manual anal dilatation, etc.
* Unable to eat after using enteral nutrition for more than 2 months
* History of ustekinumab (UST) or other IL-23 antagonists use in the past 12 months
* CT enterograph contraindications, such as allergy to contrast media
* Relative contraindications of biological agents, such as pulmonary tuberculosis-positive chest X-ray or active tuberculosis with strong positive tuberculin skin test, myocardial infarction, heart failure, or demyelinating neurological disease
* Currently suffering from a solid tumor, lymphoma, or melanoma and undergoing chemotherapy or radiation therapy
* Combination of intestinal dysplasia (eg, diagnosed with short bowel syndrome), colostomy, or colorectal tumors
* Combination of active gastrointestinal bleeding, shock, severe diarrhea, refractory vomiting and severe malabsorption syndrome
* Combination of severe liver and kidney dysfunction
* Coexistence of bacterial or viral active infection
* Pregnant or breastfeeding
* Severe hemodynamics, unstable vital signs or presence of rapidly progressive or end-stage disease, expected to be fatal during the course of the study
18 Years
65 Years
ALL
No
Sponsors
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Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Second Affiliated Hospital of Soochow University
OTHER
Chongqing Renji Hospital, University of Chinese Academy of Sciences
OTHER_GOV
The First Affiliated Hospital of Zhejiang Chinese Medical University
OTHER
Seventh Medical Center of PLA Army General Hospital
OTHER
First People's Hospital of Hangzhou
OTHER
Yangzhou University
OTHER
Xian-Janssen Pharmaceutical Ltd.
INDUSTRY
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Yan Chen, MD.
Role: STUDY_CHAIR
Center of IBD, the Second Affiliated Hospital, Zhejiang University School of Medicine
Jingwen Liu, MD.
Role: PRINCIPAL_INVESTIGATOR
Center of IBD, the Second Affiliated Hospital, Zhejiang University School of Medicine
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-0276
Identifier Type: -
Identifier Source: org_study_id
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