About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
The diagnosis of Crohn's disease was confirmed;
Patients aged 18-65;
Informed consent was obtained voluntarily.
Disqualifiers
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.);
Trial population
Patients with Crohn's disease who visited tertiary hospitals, including those newly diagnosed and those previously diagnosed.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Epidemiological status of Difficult-To-Treat Crohn's Disease
Calculate the proportion of DTT-CD patients in the total population
Clinical reponse rate
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.
Clinical remission rate
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.
Endoscopic outcome
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.
Sponsors and contacts
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Xiang Gao
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor institution