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

ConditionCrohn Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorXiang Gao

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,400 Participants
are grouped into 1 trial group
Group A: Total study population

Trial outcomes

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.

Time frame
From the beginning of enrollment to 1 year

Secondary outcomes

1

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

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

Time frame
From the beginning of enrollment to three months later
2

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.

Time frame
From the begining of enrollment to 1 year.
3

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.

Time frame
From the begining of enrollment to 1 year
4

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.

Time frame
From the begining of enrollment to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiang Gao

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Sponsor institution