UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002604 |
|---|---|
| Receipt number | R000003157 |
| Scientific Title | Combined therapy of infliximab with surgery in maintenance of remission in Crohn's disease |
| Date of disclosure of the study information | 2009/11/01 |
| Last modified on | 2014/04/09 18:24:11 |
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Basic information
Public title
Combined therapy of infliximab with surgery in maintenance of remission in Crohn's disease
Acronym
Combined therapy of infliximab with surgery in Crohn's disease
Scientific Title
Combined therapy of infliximab with surgery in maintenance of remission in Crohn's disease
Scientific Title:Acronym
Combined therapy of infliximab with surgery in Crohn's disease
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study is a prospective randomized study to investigate therapeutic effects of the combined therapy of infliximab with surgery in Crohn's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Presense or absense of endoscopic recurrence at the anastomotic site after 24 months.
Key secondary outcomes
Endoscopic grade evaluated with Rutgeerts's grading scale after 24 months.
Crohn's disease activity index point after 24 months.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients are randomly divided into two groups, groups treated with or without infliximab by staffs of Keio Clinical Research Center at 2 to 4 weeks after surgery.
Patients receive infliximab 5 mg/kg at 0, 2, 6 weeks, followed by every 8 weeks for 2 years. Alternatively, patients continue to receive infliximab with intervals of 8 weeks if they received infliximab within 8 weeks from the time point 0.
Interventions/Control_2
Patients without infliximab receive maintenance therapy without immunomodulators.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients are enrolled within 4 weeks of resection of macroscopically diseased bowel with anastomosis between normal ileum and colon (ileocolonic anastomosis) or colon and colon (colocolonic anastomosis). Any type of anastomosis is permitted. Surgeons are required to confirm that no macroscopic lesion is left in the remnant intestine except for the strictureplasty sites. Number of strictureplasty must be less than three and the type of plasty is restricted to Heineke-Mickulicz type.
Key exclusion criteria
Exclusion criteria include 1) 3 or more surgeries in the past, 2) presence of the stoma, 3) multiple anastomosis, 4) 4 or more strictureplasties, or 5) other types of strictureplasty excepting Heineke-Mickulicz type. A patient is also excluded when doctors in charge of the patient consider that exclusion of the patient is preferable.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sasaki Iwao |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Biological Regulation, Department of Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haneda Sho |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Surgery, Division of Biological Regulation
Zip code
Address
TEL
022-717-7205
Homepage URL
Sponsor or person
Institute
Clinical Research Group of inflammatory bowel disease in Japan
Institute
Department
Personal name
Funding Source
Organization
nothing particular
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
関西医科大学（大阪府）、関西医科大学付属枚方病院（大阪府）、京都大学病院（京都府）、慶応大学病院（東京都）、岩手医科大学病院（岩手県）、札幌厚生病院（北海道）、北里大学病院（神奈川県）、広島大学病院（広島県）、大腸肛門病センター家田病院（愛知県）、東京女子医科大学病院（東京都）、金沢大学病院（石川県）、四日市社会保険病院（三重県）、医療法人健生会土庫病院（奈良県）、鹿児島大学病院（鹿児島県）、京都府立医科大学病院（京都府）、神戸大学病院（兵庫県）、東北大学病院（宮城県）、富山県立中央病院（富山県）、福岡大学筑紫病院（福岡県）、弘前大学病院（青森県）、名古屋大学病院（愛知県）、横浜市立大学附属市民総合医療センター（神奈川県）、杏林大学病院（東京都）、北野病院（大阪府）、帝京大学病院（東京）、東邦大学医療センター佐倉病院（千葉）、兵庫医科大学病院（兵庫）、東北労災病院（宮城県）、横浜市民病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2009 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 08 | Day |
Last modified on
| 2014 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003157
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
