UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008486 |
|---|---|
| Receipt number | 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 | 2023/10/08 22:32:36 |
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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
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
nohmiya@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2012 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 12 | Day |
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
| 2023 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009968
