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Epidemiological Characteristics and Efficacy Evaluation of Refractory Crohn's Disease: a Multicenter, Prospective and Observational Cohort Study

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• The diagnosis of Crohn's disease was confirmed;

• Patients aged 18-65;

• Informed consent was obtained voluntarily.

Locations
Other Locations
China
Sixth Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Xiang Gao
gxiang@mail.sysu.edu.cn
+86-020-38663423
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 1400
Treatments
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
Sponsors
Leads: Xiang Gao

This content was sourced from clinicaltrials.gov

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