UMIN-CTR Clinical Trial

Basic information
Public title	Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease
Acronym	Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease
Scientific Title	Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease
Scientific Title:Acronym	Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease
Region	Japan

Condition
Condition	Crohn's disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to evaluate the therapeutic effciency of Ustekinumab for Crohn's disease resistant to conventional treatment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the number of Ustekinumab bound cells in biopsy tissue and blood cells
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Treatment with Ustekinumab
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Takanari Middle name / Last name Kitazono
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Medicine and Clinical Science
Zip code	812-8582
Address	Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL	0926425261
Email	kitazono@intmed2.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Yutaro Middle name / Last name Ihara
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Medicine and Clinical Science
Zip code	8128582
Address	Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University,
TEL	0926425261
Homepage URL
Email	yihara@intmed2.med.kyushu-u.ac.jp

Sponsor
Institute	Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	Graduate School of Medical Sciences, Kyushu University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	KYUSHU UNIVERSITY Center for Clinical and Translational Research(CCTR)
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JAPAN
Tel	0926425774
Email	ijkseimei@jimu.kyushu-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 07 Day

Related information
URL releasing protocol	https://www.karger.com/Article/Abstract/518103
Publication of results	Published

Result
URL related to results and publications	https://www.karger.com/Article/Abstract/518103
Number of participants that the trial has enrolled	27
Results	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.
Results date posted	2022 Year 01 Month 31 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 11 Month 01 Day
Baseline Characteristics	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.
Participant flow	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.
Adverse events	none
Outcome measures	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.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 04 Day
Date of IRB	2017 Year 07 Month 04 Day
Anticipated trial start date	2017 Year 07 Month 04 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 07 Day
Last modified on	2022 Year 01 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032210