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
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