Crohn's disease
Conditions
Interventions
UST group:UST was administered via intravenous injection at a dose of 6mg/kg at week 0, 6mg/kg at week 6, (90mg subcutaneous injection) at week 14w, 22w(90mg subcutaneous injection) (reassessment),
VDZ group:VDZ intervention therapy was administered, with 0w (injection of 300mg intravenously), 2w (injection of 300mg intravenously), 6w (injection of 300mg intravenously), 14w (injection of 300mg i
Sponsors
shanghai tenth people' s hospital of tongji university
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: Target population: patients with Crohn's Disease Inclusion criteria: 1. Diagnosis of Crohn's Disease for at least 3 months; 2. No biological agents have been used in the past; 3. Age: 18-80 years old; 4. Active patients: CDAI>=150 , SES-CD>=4 ; 5. no response to traditional treatment, intolerant or dependent on glucocorticoids ; 6. patients on oral glucocorticoids could be enrolled but should on a stable dose (prednisone equivalent =40 mg/day or budesonide =9 mg/day) for at least 3 weeks prior to randomization. 7. Athathioprine, thiopurine, methotrexate, or intravenous corticosteroids must be discontinued at least 3 weeks prior to randomization, and other immunosuppressants (e.g., Janus kinase inhibitors, Thioguanine and cyclosporine) must be discontinued at least 4 weeks prior to randomization.
Exclusion criteria
Exclusion criteria: 1. Intestinal perforation, abdominal abscess; 2. Recent (within three months) surgery patients (intestinal surgery); 3. Severe infection, tumor, autoimmune disease; 4. Pregnant women; 5. Enterectomy was performed within 6 months of randomization, intra-abdominal surgery within 3 months of randomization, or hospitalization for intestinal obstruction; 6. Total parenteral nutrition was given within 3 weeks of randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Crohn's disease activity index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Crohn's disease activity index;simple endoscopic score for Crohn's disease; | — |
Countries
China
Contacts
Public ContactChangqin Liu
shanghai tenth people' s hospital of tongji university
Outcome results
None listed