Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT07177118
Eligibility Criteria:
Inclusion Criteria:
\- Here's the translation of the provided criteria into English:
1. Age between 18 and 80 years old, with no gender restrictions.
2. Voluntarily sign an informed consent form.
3. Diagnosed with fibrostenosing Crohn's disease by endoscopy and histology, and meet the following criteria:
* Presence of symptoms indicating fibrostenosis, such as cramping, dietary restrictions or changes, postprandial vomiting, and abdominal pain;
* Endoscopic or radiological confirmation of new fibrotic stenosis (not caused by previous dilation/stenting);
* The length of stenosis is less than 10 cm, and there are no more than 2 stenoses in a single intestinal segment;
4. Clinical manifestations of intestinal obstruction or sub-obstruction.
5. Insufficient efficacy, intolerance, or contraindications to conventional or biological agents (azathioprine, 6-mercaptopurine, methotrexate, TNF-α inhibitors, etc.).
6. Plan to receive treatment with risankizumab or ustekinumab for the first time.
7. Have not previously used risankizumab or ustekinumab; if other biological agents have been used, they have been discontinued for at least the specified washout period (TNF-α inhibitors ≥8 weeks).
Exclusion Criteria:
* Here is the translation of the exclusion criteria into English:
1. Age less than 18 or greater than 80 years old.
2. Refusal or inability to sign the informed consent form.
3. Absence of symptoms of fibrostenotic Crohn's disease, such as cramping, dietary restrictions or changes, postprandial vomiting, and abdominal pain.
4. Prior stenting and/or dilation treatment for stenosis (within less than 1 year).
5. Pregnancy, lactation, or planning to conceive.
6. Inaccessible endoscopy or presence of clinical conditions incompatible with endoscopy.
7. Presence of abscesses, fistulas, or active complex strictures (not limited to the strictured segment).
8. Stenosis length of 10 cm or greater, or more than 2 strictures in a single intestinal segment.
9. Severe coagulation dysfunction (platelet count \< 50,000; INR \> 1.5).
10. Presence of end-stage organ failure, positive for Human Immunodeficiency Virus, uncontrolled infections, or a history of malignant tumors within the past 5 years.
11. Having received or started treatment with risankizumab or ustekinumab.
12. Investigator determines other conditions that make participation in this clinical study unsuitable.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07177118
Study Brief:
Protocol Section:
NCT07177118