Crohn’s disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Age range is 18 to 70 years old. (2) Adopting a continuous UST intravenous infusion treatment plan: the first dose is sufficient UST (6mg/kg) for intravenous induction therapy, followed by intravenous injection of the same dose of UST every 8 weeks for maintenance treatment. (3) Prior to UST treatment, pelvic magnetic resonance imaging (MRI) was performed to evaluate perianal lesions using a 1.5T system consisting of coronal, sagittal, and axial T1, T2 weighted turbo spin echo sequences, as well as axial T2 weighted sequences with fat suppression. (4) No obvious luminal inflammation was found after evaluation by digestive endoscopy (colonoscopy, enteroscopy, gastroscopy), computed tomography enterography (CTE) or magnetic resonance enterography (MRE), intestinal ultrasound (IUS), etc.
Exclusion criteria
Exclusion criteria: (1) Previously treated with infliximab, adalimumab, vedolizumab, or upatinib (small molecule drugs), etc. (2) Take oral corticosteroids, immunosuppressants, or undergo intestinal surgery within 3 months or 24 weeks prior to receiving UST treatment. (3) Significant luminal inflammation was found through digestive endoscopy, CTE or MRE, IUS and other examinations. (4) Combined with cardiovascular and cerebrovascular diseases, severe liver and kidney dysfunction, active tuberculosis, and malignant tumors. (5) Combined with autoimmune diseases such as Sjogren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, Graves' disease, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fistula clinical response rate;fistula clinical remission rate;fistula radiologic response rate; | — |
Countries
China
Contacts
Second Affiliated Hospital of Wenzhou Medical University