NCT07364734Recruiting
Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease
Epidemiological Characteristics and Efficacy Evaluation of Refractory Crohn's Disease: a Multicenter, Prospective and Observational Cohort Study
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1400 (estimated)
- First submitted
- 16 Jan 2026
- Start date
- 1 Nov 2025
- Primary completion date
- 1 Nov 2027
- Lead sponsor
- Xiang Gao
- Diseases
- Crohn's disease
- NCT number
- NCT07364734
What you commit to
- Study type: Observational
- Planned participants: 1400
- From 1 Nov 2025 to the primary completion date, 1 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients currently enrolled in clinical trials or receiving experimental drugs;
Other illness
- Other contraindications to biologics or small molecule drugs (including active infection, pregnancy, etc.);
- Patients with short bowel syndrome;
Other
- The diagnosis of CD was unclear;
- The clinical baseline data were missing seriously;
- Patients with a small bowel or colostomy.
Who the study is looking for
- The diagnosis of Crohn's disease was confirmed;
- Patients aged 18-65;
- Informed consent was obtained voluntarily.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.