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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028139
Receipt No. 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 2017/07/07

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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
Middle name
Last name Takanari Kitazono
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Medicine and Clinical Science
Zip code
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
Middle name
Last name Yutaro Ihara
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Medicine and Clinical Science
Zip code
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
Address
Tel
Email

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

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

Other
Other related information

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


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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