Crohn
Conditions
Interventions
UPA group:UPA
UPA+UST group:UPA+UST
Sponsors
Northern Jiangsu People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with CD, with a disease course of 3 months or more 2.Age: 18-75 years 3.Moderate to severe active CD, Crohn's Disease Activity Index (CDAI) between 220 and 450 4.Simplified endoscopic score (SES-CD) >=6 (for isolated ileal lesions, >=4) 5.Average of 4 or more watery/loose stools per day, or daily abdominal pain score >=2 (on a 0-3 scale) 6.Inadequate response, loss of response, or intolerance to at least one biologic therapy 7.Blood tests: hemoglobin >=8 g/dL, neutrophils >=1.5x10^9/L, platelets >=100x10^9/L.
Exclusion criteria
Exclusion criteria: 1. Presence of active tuberculosis, HIV infection, uncontrolled opportunistic infections (e.g., hepatitis B, CMV enteritis), or risk of infection requiring intravenous antibiotic treatment; 2.History of venous thromboembolism, myocardial infarction, or stroke within the past 6 months; 3.History of solid tumor or hematological malignancy within the past 5 years; 4.Comorbidity with other intestinal diseases; 5.Abnormal liver or kidney function; 6.Pregnant or lactating women; 7.Use of systemic immunosuppressants within 4 weeks, receipt of biologic agent treatment within 8 weeks, or a history of JAK inhibitor use;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response and remission rate, endoscopic response and remission rate , biochemistry remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactJie Chen
Northern Jiangsu People's Hospital
Outcome results
None listed