Unique ID issued by UMIN | UMIN000028139 |
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Receipt number | R000032210 |
Scientific Title | Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease |
Date of disclosure of the study information | 2017/07/07 |
Last modified on | 2022/01/31 16:32:01 |
Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease
Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease
Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease
Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease
Japan |
Crohn's disease
Gastroenterology |
Others
NO
This study aimed to evaluate the therapeutic effciency of Ustekinumab for Crohn's disease resistant to conventional treatment
Efficacy
Evaluation of the number of Ustekinumab bound cells in biopsy tissue and blood cells
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Medicine |
Treatment with Ustekinumab
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
50
1st name | Takanari |
Middle name | / |
Last name | Kitazono |
Graduate School of Medical Sciences, Kyushu University
Department of Medicine and Clinical Science
812-8582
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
0926425261
kitazono@intmed2.med.kyushu-u.ac.jp
1st name | Yutaro |
Middle name | / |
Last name | Ihara |
Graduate School of Medical Sciences, Kyushu University
Department of Medicine and Clinical Science
8128582
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University,
0926425261
yihara@intmed2.med.kyushu-u.ac.jp
Graduate School of Medical Sciences, Kyushu University
Graduate School of Medical Sciences, Kyushu University
Self funding
KYUSHU UNIVERSITY Center for Clinical and Translational Research(CCTR)
3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JAPAN
0926425774
ijkseimei@jimu.kyushu-u.ac.jp
NO
2017 | Year | 07 | Month | 07 | Day |
https://www.karger.com/Article/Abstract/518103
Published
https://www.karger.com/Article/Abstract/518103
27
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.
2022 | Year | 01 | Month | 31 | Day |
2021 | Year | 11 | Month | 01 | Day |
The CD patients were limited to active patients with a CDAI150 points or higher, C-reactive protein (CRP) level 0.3 mg/dl or higher, or simple endoscopic score for CD (SES-CD) 3 points or higher.
We prospectively followed patients who underwent induction therapy for active phase CD from June 2017 to March 2020. We collected clinical information, blood samples, and colonic mucosal tissues.
none
The changes in the proportions of T cell subsets after these therapies were analyzed by flow cytometry. Comprehensive gene expression changes in the colonic mucosa were also evaluated.
Completed
2017 | Year | 07 | Month | 04 | Day |
2017 | Year | 07 | Month | 04 | Day |
2017 | Year | 07 | Month | 04 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2017 | Year | 07 | Month | 07 | Day |
2022 | Year | 01 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032210
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