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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002604
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Clinical Research Group of inflammatory bowel disease in Japan
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003157

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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