Crohn's disease
Conditions
Interventions
Ustekinumab treatment group:Ustekinumab
Vedolizumab treatment group:Vedolizumab
Sponsors
Shenzhen Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Confirmed diagnosis of Crohn's disease, diagnosis in accordance with the Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Disease (2018-Beijing), and a comprehensive analysis of clinical manifestations, laboratory examination, endoscopy, imaging and pathological histological examination; 2) Adults aged between 18 and 75 years old and with civil behavioural capacity; 3) Patients with Crohn's disease who have not been previously treated with ustekinumab or vedolizumab and plan to switch to treatment with either of these two drugs (based on actual clinical treatment needs); 4) Voluntarily sign the patient informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients treated with two or more biologics in combination; 2) Suffering from any unstable or uncontrolled disease that interferes with the normal course of treatment with ustekinumab (or vedolizumab) for Crohn's disease; 3) Current or recent history of alcohol dependence or illicit drug use within one year prior to enrolment; 4) Suffering from an active psychiatric problem that, in the opinion of the investigator, would interfere with study procedures; 5) Pregnant and lactating women.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| clinical response; | — |
Primary
| Measure | Time frame |
|---|---|
| clinical remission; | — |
Countries
China
Contacts
Public ContactXixiao Yang
Shenzhen Hospital of Southern Medical University
Outcome results
None listed