NCT05387031 Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease
| NCT ID | NCT05387031 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Crohn Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 239 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 239 participants in total. It began in 2024-08-01 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 * For strictures identified during endoscopic procedure defined by intestinal strictures with a lumen diameter ≤12 mm or even inability to pass the endoscope across the narrowing Exclusion Criteria: * 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. * Unable to eat after using enteral nutrition for more than 2 months * History of ustekinumab (UST) or other IL-23 antagonists use in the past 12 months * CT enterograph contraindications, such as allergy to contrast media * Relative contraindications of biological agents, such as pulmonary tuberculosis-positive chest X-ray or active tuberculosis with strong positive tuberculin skin test, myocardial infarction, heart failure, or demyelinating neurological disease * Currently suffering from a solid tumor, lymphoma, or melanoma and undergoing chemotherapy or radiation therapy * Combination of intestinal dysplasia (eg, diagnosed with short bowel syndrome), colostomy, or colorectal tumors * Combination of active gastrointestinal bleeding, shock, severe diarrhea, refractory vomiting and severe malabsorption syndrome * Combination of severe liver and kidney dysfunction * Coexistence of bacterial or viral active infection * Pregnant or breastfeeding * Severe hemodynamics, unstable vital signs or presence of rapidly progressive or end-stage disease, expected to be fatal during the course of the study
Contact & Investigator
Yan Chen, MD.
STUDY CHAIR
Center of IBD, the Second Affiliated Hospital, Zhejiang University School of Medicine
Frequently Asked Questions
Who can join the NCT05387031 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05387031 currently recruiting?
Yes, NCT05387031 is actively recruiting participants. Contact the research team at chenyan72_72@zju.edu.cn for enrollment information.
Where is the NCT05387031 trial being conducted?
This trial is being conducted at Beijing, China, Chongqing, China, Guangzhou, China, Huai'an, China and 4 additional locations.
Who is sponsoring the NCT05387031 clinical trial?
NCT05387031 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The principal investigator is Yan Chen, MD. at Center of IBD, the Second Affiliated Hospital, Zhejiang University School of Medicine. The trial plans to enroll 239 participants.