Crohn's disease
Conditions
Interventions
The control group:None
Treatment group:none
Sponsors
Shanghai 10th People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.Patients with IBD diagnosed by clinical, imaging, endoscopic, and postoperative pathological examinations, all meeting the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023·Guangzhou) . 2.Aged >=18 years, diagnosed with moderate-to-severe CD (CDAI >=220 or endoscopic active lesions with SES-CD score >=7). 3.Regardless of prior monotherapy, patients who have received VDZ combined with other biologics (e.g., anti-TNF, ustekinumab) or upadacitinib 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 |
|---|---|
| Simple Endoscopic Score for Crohn's Disease;Crohn's Disease Endoscopic Index of Severity;Crohn's Disease Activity Index;Patient-Reported Outcomes-2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of Medication Safety and Tolerability;Inflammatory Bowel Disease Questionnaire; | — |
Countries
China
Contacts
Public ContactSun Xiaomin
Tongji University Tenth People's Hospital: Shanghai Tenth People's Hospital
Outcome results
None listed