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NCT Number: NCT07364734

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

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location status: Recruiting

Location contact

Xiang Gao

CONTACT

[email protected]

+86-020-38663423

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Epidemiological status of Difficult-To-Treat Crohn's Disease

    Time frame: From the beginning of enrollment to three months later

    Calculate the proportion of DTT-CD patients in the total population

  2. Clinical reponse rate

    Time frame: From the begining of enrollment to 1 year.

    Compare the clinical response 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.

  3. Clinical remission rate

    Time frame: From the begining of enrollment to 1 year

    Compare the 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.

  4. Endoscopic outcome

    Time frame: From the begining of enrollment to 1 year

    Compare the endoscopic outcomes of patients with DTT-CD and non DTT-CD during the induction and maintenance periods, including the endoscopic response rate, the endoscopic remission rate, and the mucusal healing rate in the patients using biologics or small molecule drugs.

  5. Ultrasound outcome

    Time frame: From the begining of enrollment to 1 year

    Compare the ultrasound outcomes of patients with DTT-CD and non DTT-CD during the induction and maintenance periods in the patients using biologics or small molecule drugs, including the transmural response rate and the transmural remission rate.

  6. Postoperative recurrence rate

    Time frame: From the begining of enrollment to 1 year

    Compare the postoperative recurrence rates of DTT-CD and non DTT-CD: postoperative recurrence is defined as the recurrence of clinical symptoms, or endoscopic mucosal ulcers, or imaging evidence of intestinal inflammation, etc.

  7. Safety differences

    Time frame: From the begining of enrollment to 1 year

    Compare the safety differences between DTT-CD and non-DTT-CD after one year of biologic therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiang Gao

CONTACT

[email protected]

+86-020-38663423

Sponsors and collaborators

Lead sponsor

Xiang Gao

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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