Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Crohn Disease. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Epidemiological Characteristics and Efficacy Evaluation of Refractory Crohn's Disease: a Multicenter, Prospective and Observational Cohort Study
Overview
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.
Primary outcome measures
- steroid-free remission [Time frame: From the beginning of enrollment to 1 year]
Secondary outcome measures (7)
- Epidemiological status of Difficult-To-Treat Crohn's Disease [Time frame: From the beginning of enrollment to three months later]
- Clinical reponse rate [Time frame: From the begining of enrollment to 1 year.]
- Clinical remission rate [Time frame: From the begining of enrollment to 1 year]
- Endoscopic outcome [Time frame: From the begining of enrollment to 1 year]
- Ultrasound outcome [Time frame: From the begining of enrollment to 1 year]
- Postoperative recurrence rate [Time frame: From the begining of enrollment to 1 year]
- Safety differences [Time frame: From the begining of enrollment to 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT07364734 · 2025-ZSLYEC-556