An observational study in CD - Crohn's Disease, Stricture; Bowel and IBD - Inflammatory Bowel Disease, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-02.
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 Guselkumab or 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.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 100 is below 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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Patients who will initially receive Guselkumab or Ustekinumab for the treatment of stricturing Crohn's disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Evidence of definite luminal strictures caused by the disease itself confirmed by radiographic imaging or endoscopic examination, i.e., meeting any of the following criteria:
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.
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.
Guselkumab standard usage and optimized usage for the treatment of patients with symptomatic stricturing Crohn's disease
Drug: Guselkumab (GUS)
Ustekinumab standard usage and optimized usage for the treatment of patients with symptomatic stricturing Crohn's disease
Drug: Ustekinumab (UST)
① Induction phase (Weeks 1-12): GUS 200 mg intravenously (IV) every 4 weeks for 3 doses, followed by a maintenance phase with GUS 100 mg subcutaneously (SC) every 8 weeks (for patients with all indicators within the normal range). ② Maintenance phase: Dosing adjustments shall be optimized based on the clinician's experience: If any disease activity occurs during the maintenance phase (e.g., suboptimal levels of CRP or FCP), administer GUS 200 mg SC every 4 weeks, or GUS 100 mg SC every 8 weeks plus enteral nutrition accounting for no more than 50% of the total daily energy intake. In case of persistent disease activity, administer intensive intravenous infusion of GUS 200 mg for 3 doses based on patient needs and shared decision-making.
① Induction phase (Weeks 1-8): UST 6 mg/kg intravenously (IV) for 1 dose, followed by UST 90 mg subcutaneously (SC) every 8 weeks. A maintenance dose of 90 mg SC shall be administered every 8 or 12 weeks thereafter on a case-by-case basis. ② Experience-based dosing optimization and adjustment: If C-reactive protein (CRP) or fecal calprotectin (FCP) levels are suboptimal, two treatment approaches shall be adopted based on patient needs and shared decision-making: intravenous intensification therapy (predominantly 2 to 3 IV doses, i.e., 260 mg or 390 mg, with a follow-up visit at 8 weeks); or 90 mg SC with a shortened administration interval (with a follow-up visit at 4 to 6 weeks). ③ The duration of Exclusive Enteral Nutrition (EEN) use shall not exceed 2 weeks. If enteral nutrition support is required beyond 2 weeks, switch to Partial Enteral Nutrition (PEN), which shall account for less than 50% of the patient's total energy requirement.
Continuation of ustekinumab
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 anti-TNFs); (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.
Time frame: up to 52 weeks
CT stricture improvement
CT 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%).
Time frame: at Week 0 and 52
General health improvement
General health improvement was measured by patient reported outcomes through health-related quality of life (Inflammatory Bowel Disease (IBD) Quality of Life Questionnaire).
Time frame: at Week 0, 8, 24 and 52
Number of Participants with surgery
Surgical rates during follow-up included the proportion of patients undergoing any surgery for endoscopic dilatation and stricture resection.
Time frame: up to 52 weeks
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Second Affiliated Hospital, School of Medicine, Zhejiang University →