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

Last updated: July 31, 2024
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ileus

Treatment

Ustekinumab

Clinical Study ID

NCT05387031
2022-0276
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of moderate to severe Crohn's disease

  • Obstructive symptoms within the last eight weeks

  • A single or several lumen stricture(s) identified by radiological imaging orendoscopy

  • For strictures identified by CT enterograph defined as a lesion with combination ofa 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 intestinalstrictures with a lumen diameter ≤12 mm or even inability to pass the endoscopeacross the narrowing

Exclusion

Exclusion Criteria:

  • Requirement of urgent surgery or endoscopic intervention within 2 months as judgedby the clinician

  • 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, isolatedintestinal stricture

  • Effective treatments for stricture in the past half a year, such as endoscopicballoon 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 pulmonarytuberculosis-positive chest X-ray or active tuberculosis with strong positivetuberculin skin test, myocardial infarction, heart failure, or demyelinatingneurological disease

  • Currently suffering from a solid tumor, lymphoma, or melanoma and undergoingchemotherapy 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, refractoryvomiting 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 orend-stage disease, expected to be fatal during the course of the study

Study Design

Total Participants: 239
Treatment Group(s): 1
Primary Treatment: Ustekinumab
Phase:
Study Start date:
August 01, 2024
Estimated Completion Date:
August 31, 2027

Study Description

This study intends to select patients with confirmed moderate-to-severe 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.

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.

Connect with a study center

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

    Peking, Beijing
    China

    Active - Recruiting

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

    Chongqing, Chongqing
    China

    Active - Recruiting

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

    Guangzhou, Guangdong
    China

    Active - Recruiting

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

    Huai'an, Jiangsu
    China

    Active - Recruiting

  • Department of Gastroenterology, Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu
    China

    Active - Recruiting

  • Department of Gastroenterology, Affiliated Hospital of Yangzhou University

    Yangzhou, Jiangsu
    China

    Active - Recruiting

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

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

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

    Hangzhou, Zhejiang
    China

    Active - Recruiting

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