Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease
- Conditions
- Crohn's disease
- Registration Number
- JPRN-UMIN000028139
- Lead Sponsor
- Graduate School of Medical Sciences, Kyushu University
- Brief Summary
The frequency of T helper 17 (Th17) cells was significantly decreased in the peripheral blood of patients with active CD after UST therapy, but not in the anti-TNF therapy. In addition, the changes in gene expression before and after UST and anti-TNF therapy were clearly different. From the above results, it was shown that the suppression of Th17 differentiation by UST therapy is associated with the anti-inflammatory effect on CD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 27
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the number of Ustekinumab bound cells in biopsy tissue and blood cells
- Secondary Outcome Measures
Name Time Method 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