Crohn's disease
Conditions
Interventions
Test group:Expected treatment regimen of adalimumab stem: Week 0, 160 mg
Week 2, 80 mg
followed by 40 mg every 2 weeks. The course of treatment was 24 weeks.
Sponsors
Tangdu Hospital, Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Age = 16 years; 2) Patients diagnosed with CD based on clinical manifestations and relevant examinations (endoscopic findings and pathological results) consistent with the consensus opinion on the diagnosis and treatment of inflammatory bowel disease; 3) Crohn's Disease Activity Index (CDAI) score between 220 and 450 at baseline; 4) Subject is able and willing to provide written informed consent and comply with the requirements of this study protocol. 5) No immunosuppressants or biologics were used prior to enrollment. 6) 5-aminosalicylic acid was not used before enrollment. 7) No hormone drugs were used before enrollment.
Exclusion criteria
Exclusion criteria: 1) Pregnant and lactating women; 2) Patients who are in the period of systemic acute and chronic infection, or have a previous history of active tuberculosis and hepatitis; 3) Subjects with malignant tumors; 4) Patients with severe heart, liver, kidney and other organs and systemic diseases; 5) Have other conditions that, in the opinion of the investigator, make the use of the trial drug inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Remission;Clinical Response;Adalimumab trough concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events;IBD-Q;CDAI; | — |
Countries
China
Contacts
Public ContactWang Xin
Tangdu Hospital, Fourth Military Medical University
Outcome results
None listed