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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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

Qualifiers

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 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

Disqualifiers

Requirement of urgent surgery or endoscopic intervention within 2 months as judged by 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, 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.

Trial design

Treatments tested in this trial

  • Ustekinumab

Treatment groups

239 Participants
are divided into 1 treatment group

Sponsors and collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Collaborator

Second Affiliated Hospital of Soochow University

Collaborator

Chongqing Renji Hospital, University of Chinese Academy of Sciences

Collaborator

The First Affiliated Hospital of Zhejiang Chinese Medical University

Collaborator

Seventh Medical Center of PLA Army General Hospital

Collaborator

First People's Hospital of Hangzhou

Collaborator

Yangzhou University

Collaborator

Xian-Janssen Pharmaceutical Ltd.

Collaborator