Crohn'
Conditions
Interventions
Treatment with Ustekinumab
Sponsors
Graduate School of Medical Sciences, Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with moderate to severe active phase Crohn's disease who are resistant to conventional treatment, or patients requiring the introduction of Ustekinumab after Crohn's disease surgery. 2) Patients who aged 20 years or older. 3) Patients who wanted treatment by Ustekinumab, and obtained written consent.
Exclusion criteria
Exclusion criteria: 1) Patients with serious infection. 2) Patients with active tuberculosis. 3) Patients whose dosage of steroids is not stable (patients over 30 mg / day) 4) Patients with severe heart disease, liver disease, kidney disease. 5) Patients with marked blood coagulation disorders and thrombocytopenia. 6) Antithrombotic drugs Patients who are taking internal medicine and patients under anticoagulation therapy. 7) Pregnant women or patients who may be pregnant, breast-feeding patients. 8) Patients who are judged to be difficult to participate in the examination due to psychosis or psychiatric symptoms. 9) Patients with short bowel syndrome. 10) Patients who are judged inappropriate by the attending physician, such as a decline in compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the number of Ustekinumab bound cells in biopsy tissue and blood cells | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission induction rate, drug efficacy rate, remission maintenance rate and duration, endoscopic improvement rate, side effect occurrence rate, biomarker such as CRP, changes in intestinal flora before and after administration of Ustekinumab, various inflammatory properties in blood and tissues Changes in cytokines | — |
Countries
Japan
Contacts
Public ContactYutaro Ihara
Graduate School of Medical Sciences, Kyushu University Department of Medicine and Clinical Science
Outcome results
None listed