Epidemiological Characteristics and Efficacy Evaluation of Refractory Crohn's Disease: a Multicenter, Prospective and Observational Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,400
- Locations
- 1
- Primary Endpoint
- steroid-free remission
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Total study population
The total study population included all CD patients who visited the Sixth Affiliated Hospital of Sun Yat sen University during the specified time period (November 2025 to January 2026), including newly diagnosed and previously diagnosed patients
Outcomes
Primary Outcomes
steroid-free remission
Time Frame: From the beginning of enrollment to 1 year
Compare the steroid-free clinical remission rates of patients with DTT-CD and non DTT-CD during the induction and maintenance periods in the patients using biologics or small molecule drugs. "Steroid-free" refers to patients who do not receive concomitant steroid medication.
Secondary Outcomes
- Epidemiological status of Difficult-To-Treat Crohn's Disease(From the beginning of enrollment to three months later)
- Clinical reponse rate(From the begining of enrollment to 1 year.)
- Clinical remission rate(From the begining of enrollment to 1 year)
- Endoscopic outcome(From the begining of enrollment to 1 year)
- Ultrasound outcome(From the begining of enrollment to 1 year)
- Postoperative recurrence rate(From the begining of enrollment to 1 year)
- Safety differences(From the begining of enrollment to 1 year)
Investigators
Xiang Gao
Director of Gastroenterology
Sixth Affiliated Hospital, Sun Yat-sen University