Crohn's disease
Conditions
Interventions
IFX5mg/kg Group:5 mg/kg at Weeks 0,2 and 6, followed 5mg /kg every 8 weeks
IFX10mg/kg Group:10 mg/kg at Weeks 0,2 and 6, followed 5mg /kg every 8 weeks
Anjianning Group:160mg at Week 0,80mg at Week2, followed 40mg every 2 weeks
Humira group:160mg at Week 0,80mg at Week2, followed 40mg every 2 weeks
Sponsors
The Affiliated Hospital of Nanjing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with Crohn's disease confirmed by physical examination or MRI examination with perianal lesions (mainly anal fistula) and treated with anti TNF - a monoclonal antibody. Crohn's disease lacks the gold standard of diagnosis. It is mainly combined with clinical, laboratory, imaging, endoscopic and histopathological findings to make a comprehensive analysis, and make a diagnosis on the basis of excluding infectious and other non infectious colitis. 2. Subjects aged from 18 to 65, regardless of gender; 3. The subjects with clear consciousness had no mental system disease and normal cognitive personality; 4. Subjects meeting the indications of anti TNF - a McAb use; 5. The subjects who knew the content of the study voluntarily participated in the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with previous gastrointestinal diseases other than Crohn's disease, such as intestinal tuberculosis, Behcet's disease, primary intestinal malignant lymphoma, colorectal cancer, etc; 2. Patients who refused to participate in the study; 3. Patients with contraindications for the use of anti TNF - a monoclonal antibody; 4. Patients with poor compliance; 5. Patients with serious diseases of heart, liver, kidney and other important organs; 6. Patients with tumors, infectious diseases, immune diseases, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CDAI;PDAI;blood concentration;antibody; | — |
Countries
China
Contacts
Public ContactBolin Yang
Affiliated Hospital of Nanjing University of traditional Chinese Medicine
Outcome results
None listed