An observational study in Crohn Disease, Stricture; Bowel and Intestinal Stricture, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 8 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational
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.
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.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 239 is above the median of 185 across 645 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
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Participants were adult CD patients treated with their first UST therapy for symptomatic strictures (confirmed on endoscopy or imaging) from centers of IBD at 8 hospitals all over China. This study does not involve the use of vulnerable groups.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: 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.
Also known as: Stelara
Number of participants with treatment success at week 52
The primary endpoint was the success at week 52, defined as ustekinumab continuation with all the following criteria: (1) no use of a prohibited treatment (corticosteroids after the eight week following inclusion, parenteral nutrition, other biological agents); (2) no endoscopic dilation; (3) no bowel surgery for resection of small bowel stricture; (4) no severe adverse events leading to ustekinumab withdrawal and (5) no study withdrawal whatever the reason. Clinical improvement was measured by symptoms and clinical remission (Crohn's Disease Activity Index \<150), steroid-free symptom improvement (obstructive symptom score) following initial steroid tapering, Crohn's Disease Obstructive Score (improvement of ≥1 point), treatment failure (defined as bowel obstruction requiring surgery, endoscopic balloon dilation, or persisting symptoms necessitating change in treatment), the need for surgery.
Time frame: up to 52 weeks
Number of participants with improvement in stricture inflammation and morphology on imaging
CT and MRI stricture improvement was defined as resolution of prestenotic dilatation (small bowel diameter \<3.0 cm); stricture resolution (normal bowel wall thickness and luminal diameter with absence of prestenotic dilation; and reduced stricture length by ≥1 mm). Intestinal ultrasound stricture improvement included normalisation of prestenotic dilation (\<3.0 cm) or reduction in prestenotic dilation (≥50%). Endoscopic stricture improvement included increased luminal diameter; the ability to pass a standard paediatric colonoscope (11.5 mm diameter); and improved stricture ulceration score using SES-CD or DBE-CD.
Time frame: at week 8, 24, 52 and 104
Number of participants with improvement in general health
General health improvement was measured by patient reported outcomes of Inflammatory Bowel Disease (IBD) Quality of Life Questionnaire. The minimum and maximum values are 32 and 224 points respectively, and higher scores mean a better outcome.
Time frame: at week 8, 24, 52 and 104
Number of Participants with surgery
Number of Participants with surgery during follow-up included patients undergoing any surgery for endoscopic dilatation and stricture resection.
Time frame: at week 8, 24, 52 and 104
Number of participants with treatment success at week 104
Success at week 104 was defined in the same way as in week 52.
Time frame: at week 104
Degree of HBI reduction (Clinical response)
Clinical response was defined as HBI reduce at least three points
Time frame: at week 8, 24, 52 and 104
Reduction in CRP and FC levels (Biochemical ease)
Fecal calprotectin (FC) level ≤ 200 μg/g and/or CRP≤5 mg/L, or decrease ≥ 50%, compared to the baseline significant.
Time frame: at week 8, 24, 52 and 104
UST drug concentration
Measurements of UST drug concentration and antibody concentration, and their relationship with improvement of inflammation or imaging (CT enterography, bowel ultrasound, and endoscopy).
Time frame: at week 8, 24, 52 and 104
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Safety outcomes included the number of drug-related adverse events, infections, and disease-related hospitalizations per 100 patients per year. Adverse events were categorized as: possibly related, probably related, and not related to UST. Infections were classified as: 1) mild: infections that did not require medication; 2) moderate: infection treated with oral antibiotics or antiviral drugs; (3) Severe: infection requiring hospitalization or treatment with intravenous antibiotics or antiviral drugs.
Time frame: at week 8, 24, 52 and 104
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Second Affiliated Hospital, School of Medicine, Zhejiang University →