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

NCT07364734 | Recruiting DMC

• 1 other identifier: 2025-ZSLYEC-556
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• steroid-free remission

  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.

  From the beginning of enrollment to 1 year

Secondary Outcomes (7)

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Crohn's disease who visited tertiary hospitals, including those newly diagnosed and those previously diagnosed.

You may qualify if:

• The diagnosis of Crohn's disease was confirmed;
• Patients aged 18-65;
• Informed consent was obtained voluntarily.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiang Gao: lead

Study Sites (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Xiang Gao

CONTACT

+86-020-38663423; gxiang@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Gastroenterology

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 23, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

CN (1)