fistulizing Crohn's disease
Conditions
Interventions
Conventional treatment group:Adalimumab, every 2 weeks, 40mg each time, 12 weeks of treatment
Incremental treatment group:Adalimumab, once every 2 weeks, each time 80mg, 12 weeks of treatment
Conventional treatment combination group:Adalimumab, every 2 weeks, 40mg each time, 12 weeks of treatment. Azathioprine, 1.5-4mg/kg/day, course of treatment for 12 weeks
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >= 16 years; 2.Voluntarily sign the informed consent form; 3.Diagnosed with CD according to the criteria of the Inflammatory Bowel Disease Group of the Chinese Society of Gastroenterology; 4.There are one or more fistula drainage tubes, and the fistula exists for more than 3 months; 5.All fistulas are separated and clear and discernible; 6.There are local complications of Crohn's disease, including: abscess and stenosis.
Exclusion criteria
Exclusion criteria: 1.Use of infliximab, cyclophosphamide or tacrolimus within 3 months before enrollment; 2.Women of childbearing age and unwilling to use contraception; 3.Lactating women; 4.Active viral infection; 5.6 months will be intestinal resection; 6.Any other reason, the investigator believes that it is not appropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fistula healing rate and recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Crohn's disease activity index score;Clinical remission rate and recurrence rate, endoscopic remission rate and recurrence rate, fistula healing rate and recurrence rate, wound response rate and healing rate;Clinical remission rate and recurrence rate, endoscopic remission rate and recurrence rate, fistula healing rate and recurrence rate, wound response rate and healing rate;Clinical remission rate and recurrence rate, endoscopic remission rate and recurrence rate, fistula healing rate and recurrence rate, wound response rate and healing rate;Inflammatory bowel disease quality of life analysis scale score; | — |
Countries
China
Contacts
Public ContactZhu Liangru
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed