Ustekinumab Use in Adults With Narrowed Bowel From Crohn's Disease

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 65 with moderate to severe Crohn's disease and a narrowing of the bowel that causes blockage symptoms. Everyone receives ustekinumab-based treatment.

Age

18 to 65 years

Sex

All sexes

Disease stage

Moderate to severe Crohn's disease with blockage symptoms in the last 8 weeks. One or more bowel narrowings are seen on imaging or endoscopy.

Earlier treatment

People cannot join if they used ustekinumab or other IL-23 blockers in the past 12 months. They also cannot join if they had treatment for the narrowing in the past half a year, such as balloon widening or surgery.

Biomarker or test result

On CT enterography, the narrowing means over 50% less bowel opening, over 25% thicker bowel wall and widening before the narrowing of over 3.0 cm (1.2 in). At endoscopy, it means an opening of 12 mm or less, or the scope cannot pass.

Main reasons for not taking part

• Need for urgent surgery or endoscopic treatment within 2 months
• Signs of perforation, such as abscess, fistula or perianal infection
• Active bacterial or viral infection, or active tuberculosis
• Current solid tumour, lymphoma or melanoma under chemotherapy or radiation
• Pregnant or breastfeeding

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 65 years old?YesNo

What the trial wants to find out

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.

The group in the trial

• patients with symptomatic stricturing Crohn's disease

  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.

  Treatment: Ustekinumab