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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008486
Receipt No. R000009968
Scientific Title Multicenter prospective cohort study of remission induction and maintainance effects of anti-TNFagents for Crohn's jejunoileitis.
Date of disclosure of the study information 2012/07/20
Last modified on 2014/10/19

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Basic information
Public title Multicenter prospective cohort study of remission induction and maintainance effects of anti-TNFagents for Crohn's jejunoileitis.
Acronym Effects of Anti-TNFagents for Crohn's jejunoileitis.
Scientific Title Multicenter prospective cohort study of remission induction and maintainance effects of anti-TNFagents for Crohn's jejunoileitis.
Scientific Title:Acronym Effects of Anti-TNFagents for Crohn's jejunoileitis.
Region
Japan

Condition
Condition Suspected and documented Cron's jejunoileitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 There have been few reports regarding drug effects for Crohn's jejunoileitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes of enteroscopic findings
Key secondary outcomes CDAI, IOIBD, CRP, Adverse events of anti-TNF agents and patency capsule endoscopy, etc.

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Infliximab
Interventions/Control_2 Adalimumab
Interventions/Control_3 Immunomodulator
Interventions/Control_4 Diet therapy
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
10 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with susupected or documented Crohn's jejunoileitis
Key exclusion criteria Contraindications of anti-TNF agents
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidemi Goto
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65 Tsuruma-cho, Showa-ku, Nagoya
TEL 052-744-2172
Email hgoto@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Ohmiya
Organization Fujita Health University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL 0562-93-9240
Homepage URL
Email nohmiya@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization None
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 豊橋市民病院(愛知県)、名古屋医療センター(愛知県)、江南厚生病院(愛知県)、刈谷豊田総合病院(愛知県)、小牧市民病院(愛知県)、一宮市民病院(愛知県)、岡崎市民病院(愛知県)、海南病院(愛知県)、上飯田第一病院(愛知県)、公立陶生病院(愛知県)、トヨタ記念病院(愛知県)、豊田厚生病院(愛知県)、半田市立半田病院(愛知県)、ブラザー記念病院(愛知県)、八千代病院(愛知県)、山下病院(愛知県)、

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 20 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 Enrolling by invitation
Date of protocol fixation
2012 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 25 Day
Last follow-up date
2015 Year 09 Month 30 Day
Date of closure to data entry
2015 Year 10 Month 01 Day
Date trial data considered complete
2015 Year 10 Month 10 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 07 Month 20 Day
Last modified on
2014 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009968

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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