Actively Recruiting
Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease
Led by Xiang Gao · Updated on 2026-01-23
1400
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Difficult to treat Crohn's disease (DTT-CD) was defined by the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) in 2023, which refers to CD patients with poor response to drug treatment and poor prognosis. Foreign epidemiological studies have shown that DTT-CD accounts for 24.8% of all CD patients, and most of them are patients with advanced treatment failure according to more than two different mechanisms. Our previous retrospective data suggested that compared with foreign DTT-CD patients, there was no significant difference in the proportion of patients with advanced treatment failure due to more than two different mechanisms, but the proportion of patients with recurrence after two intestinal resection and complex anal fistula was increased. Therefore, this project aims to determine the current prevalence and epidemiological status of DTT-CD in China; To clarify the difference in efficacy and prognosis between DTT-CD patients and non DTT-CD patients using advanced treatment (including biological agents and small molecule drugs); Objective to evaluate the incidence and risk factors of non DTT-CD patients progressing to DTT-CD within 1 year. To further verify whether the domestic DTT-CD population is significantly different from the foreign population, and provide theoretical support for the selection of subsequent treatment options.
CONDITIONS
Official Title
Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The diagnosis of Crohn's disease was confirmed;
- Patients aged 18-65;
- Informed consent was obtained voluntarily.
You will not qualify if you...
- The diagnosis of CD was unclear;
- The clinical baseline data were missing seriously;
- Patients currently enrolled in clinical trials or receiving experimental drugs;
- Other contraindications to biologics or small molecule drugs (including active infection, pregnancy, etc.);
- Patients with short bowel syndrome;
- Patients with a small bowel or colostomy.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
Research Team
X
Xiang Gao
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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