Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease

Sponsor
Xiang Gao
Study ID
NCT07364734
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jan 23, 2026
Start date
Nov 1, 2025
Status verified
Jan 2026
Primary completion
Nov 1, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
1,400 participants (estimated)

Arms

  • Arm: 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

Primary Outcome Measure

steroid-free remission [ Time Frame: From the beginning of enrollment to 1 year ]

Central Contacts

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