Measuring how common and how treatment-resistant difficult-to-treat Crohn's disease is in China.
Epidemiological Characteristics and Efficacy Evaluation of Refractory Crohn's Disease: a Multicenter, Prospective and Observational Cohort Study
This project will measure how common difficult-to-treat Crohn's disease is in adults in China and see how their treatment responses and prognosis compare to other Crohn's patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1400 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07364734 on ClinicalTrials.gov |
What this trial studies
This is an observational, hospital-based study that uses the IOIBD 2023 definition to identify adults with difficult-to-treat Crohn's disease (DTT-CD) and collects demographic, clinical, treatment history, surgical history, and outcome data. Investigators will estimate the prevalence of DTT-CD among eligible Crohn's patients at the recruiting center and compare rates of treatment failure, recurrence, surgeries, and complex anal fistula between DTT-CD and non-DTT-CD groups. Key exclusions include unclear diagnoses, seriously missing baseline data, current enrollment in experimental drug trials, contraindications to biologics or small molecules, short bowel syndrome, and ostomy. Standard epidemiological analyses and group comparisons will be used to describe differences in efficacy and prognosis.
Who should consider this trial
Good fit: Adults aged 18–65 with a confirmed diagnosis of Crohn's disease who can give informed consent and have adequate baseline clinical data are eligible.
Not a fit: Patients with unclear Crohn's diagnoses, severely missing baseline data, current participation in experimental drug trials, short bowel syndrome, or an ostomy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the project could clarify how common DTT-CD is in China and help clinicians prioritize monitoring and treatment strategies for higher-risk patients.
How similar studies have performed: International epidemiological work has reported DTT-CD in about 24.8% of Crohn's patients and some retrospective analyses have noted differing patterns, but prospective or large-scale Chinese data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The diagnosis of Crohn's disease was confirmed; * Patients aged 18-65; * Informed consent was obtained voluntarily. Exclusion Criteria: * 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.
Where this trial is running
Guangzhou, Guangdong
- Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Xiang Gao
- Email: gxiang@mail.sysu.edu.cn
- Phone: +86-020-38663423
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.