Crohn's disease
Conditions
Interventions
subcutaneous gruop:ustekinumab subcutaneous maintenance treatment
intravenous group:ustekinumab intravenous maintenance treatment
Sponsors
Xijing Hospital, Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
No minimum to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with CD were diagnosed as having met the diagnostic criteria of Crohn's disease in the national Consensus on the Diagnosis and Treatment of inflammatory bowel Disease in 2018; 2. Patients with CD whose CDAI > 220 or SES-CD score >= 11; 3. Patients who are able and willing to comply with the study protocol can provide signed and dated written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who may require immediate surgical treatment; 2. Pregnant women or nursing mothers; 3. Patients with severe liver and kidney dysfunction, heart dysfunction or other serious systemic diseases; 4. Any condition that interferes with the completion of the study or interferes with the analysis of the study results, including a history of drug or alcohol abuse, smokers who have never quit smoking, patients with mental illness or poor compliance, with a defined immune system (including HIV infection), hematological or tumor-related illness; 5. Patients who withdraw informed consent; 6. Patients who participated in other clinical trials in the 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate and remission rate;Endoscopic response rate and remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The improvement of IBDQ;The recurrence rate;Incidence of adverse reactions;Difference between first and second line treatment; | — |
Countries
China
Contacts
Public ContactJie Liang
Xijing Hospital, Air Force Military Medical University
Outcome results
None listed