intestinal Beh?et's disease
Conditions
Interventions
One-armed intervention group:adalimumab
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients who are 18 years or older and 70 years or younger; 2. The diagnostic criteria for Behcets bowel disease revised by the Japanese Behcets Disease Research Committee (2003); or the BD diagnostic criteria recommended by the International Research Group for patients with intestinal involvement; 3. Active ulcerative lesions: DAIBD >=40 points, ileal or colon ulcer; 4. Meet the definition of relapsed and refractory Behcet's bowel disease: (1) Receiving intensive treatment: oral or intravenous prednisone 1mg/kg*d or equivalent dose, alone or in combination with colchicine, mesalazine, sulfasalazine, DMARDs (azathioprine, methotrexate) Intestine, mycophenolate mofetil, cyclosporine, tacrolimus, methotrexate, leflunomide) one or more, regular treatment for more than 8 weeks, there are still active intestinal ulcers judged by colonoscopy Patients; or patients who cannot continue intensive treatment due to adverse reactions; (2) Patients who respond to glucocorticoids but relapse after hormone reduction (steroid dependence); (3) There are relative contraindications or intolerances to glucocorticoids.
Exclusion criteria
Exclusion criteria: 1. Combined with diseases similar to BD, such as intestinal tuberculosis, Crohn's disease, ulcerative colitis, infectious colitis or simple ulcer; 2. Acute severe infection: such as sepsis and cellulitis, hepatitis B or C virus infection, viral replication phase, active phase of Mycobacterium tuberculosis infection, human immunodeficiency virus (HIV); 3. Severe comorbidities: including heart failure (>= III NYHA), respiratory failure, renal insufficiency (creatinine clearance = 2 times the upper limit of the normal range); 4. Diagnosis of malignant tumors; 5. Special population: pregnant or breastfeeding patients. People with mental illness or emotional disorder who cannot cooperate; 6. Use B cell depletion therapy within 6 months of enrollment, and use other biological agents within 3 months of enrollment (within 5 half-lives); 7. Those who have been allergic to TNFa inhibitors or have serious adverse reactions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Behcet's Disease Activity Index;Mucosal cure rate;adverse event rate; | — |
Countries
China
Contacts
Public ContactLin Jin; Zhang Bingling
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed