Crohn Disease
Conditions
Keywords
Difficult-To-Treat Crohn's Disease, Epidemiological Characteristics, Efficacy Evaluation
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.
Interventions
None listed
Sponsors
Xiang Gao
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| steroid-free remission | 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
| Measure | Time frame | Description |
|---|---|---|
| Epidemiological status of Difficult-To-Treat Crohn's Disease | From the beginning of enrollment to three months later | Calculate the proportion of DTT-CD patients in the total population |
| Clinical reponse rate | 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. |
| Clinical remission rate | 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. |
| Endoscopic outcome | 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. |
| Ultrasound outcome | 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. |
| Postoperative recurrence rate | 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. |
| Safety differences | 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. |
Countries
China
Contacts
CONTACTXiang Gao
Outcome results
None listed