Crohn's disease
Conditions
Interventions
VDZ monotherapy group:None
Combined treatment with VDZ and other medications group:None
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. IBD patients diagnosed based on clinical, imaging, endoscopic, and postoperative pathological examinations are included in the study, all meeting the diagnostic criteria of the "Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease" (2023, Guangzhou); 2. Age >= 18 years, diagnosed with moderate to severe CD (CDAI >= 220 or endoscopy suggesting active lesions with SES-CD score of 7 or above); 3. Regardless of whether they have received monotherapy, they must satisfy the criteria for receiving VDZ in combination with other biological agents (such as anti-TNF, ustekinumab) or upadacitinib treatment for >= 12 weeks.
Exclusion criteria
Exclusion criteria: 1.Complicated with severe dysfunction of vital organs (heart, liver, kidney, etc.). 2. Patients with other severe diseases unrelated to IBD that significantly affect outcome assessment, including malignant tumors, severe infections, pregnancy, or those who initiated dual biologic therapy for indications other than Crohn's disease (e.g., rheumatic or dermatological diseases). 3.Poor treatment compliance, failure to complete therapy or follow-up as per protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Crohn's Disease Activity Index;Patient-Reported Outcomes-2;CDEIS/SES – CD; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of Medication Safety and Tolerability;Inflammatory Bowel Disease Questionnaire; | — |
Countries
China
Contacts
Public ContactSun Xiaomin
Shanghai Tenth People's Hospital
Outcome results
None listed