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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004427
Receipt No. R000005290
Scientific Title A Prospective Randomized Open Trial to Assess the Efficiency of Infliximab for Crohn's Patients after Intestinal Resection
Date of disclosure of the study information 2010/11/01
Last modified on 2013/04/15

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Basic information
Public title A Prospective Randomized Open Trial to Assess the Efficiency of Infliximab for Crohn's Patients after Intestinal Resection
Acronym Infliximab for Crohn's Disease Patients after Intestinal Resection
Scientific Title A Prospective Randomized Open Trial to Assess the Efficiency of Infliximab for Crohn's Patients after Intestinal Resection
Scientific Title:Acronym Infliximab for Crohn's Disease Patients after Intestinal Resection
Region
Japan

Condition
Condition Crohn's disease
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to evaluate efficacy and safety of infliximab on remission maintenance in Crohn's disease patients who are rejected their active intestinal lesion(s) by surgery treatment performed within a few weeks.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Remission rate at 12 months after the start of protocol treatment
(Full Analysis Set; Discontinuation of protocol treatment is accounted to be non-remission.)
Key secondary outcomes Evaluation of efficiency: Remission ratios at 24 months (and 60 months, maximum) after start of protocol treatment, Ratio of the protocol continuation, Clinical activity in both the CDAI and IOIBD, IBDQ score, CRP value, etc.
Evaluation of safety: Adverse event, Abnormal values in blood test, etc.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Non-infliximab arm:
Conventional medicine is administered, excluding Infliximab, Azathioprine, and 6-Mercaptopurine, to subjects during the study period (for 60 months, maximum).
Interventions/Control_2 Infliximab arm:
Infliximab is administered to subjects during the study period (for 60 months, maximum) together with other conventional medications, such as 5-aminosalicylic acid. Infliximab is administered every 8 weeks to subjects during study period after the start of protocol treatment as a rule. Immunomodulators, such as Azathioprine and 6-Mercaptopurine, are not permitted during the trial.
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
16 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1. A patient who is diagnosed as Crohn's disease (ilititis, colitis, or ileocolitis type).
2. A patient who has the first intestinal resection within 8weeks prior to enroll this trial.
3. A patient who has not been given any immunomodulator(s), such as Azathioprine, 6-Mercaptopurine, within 8 weeks prior to enroll the trial.
4. A patient who has judged not to have other active CD lesion(s) expects the rejected lesion by either just before or during the operation. (judged by a doctor in charge)
5. A patient who is 16 to 64 years old and has written his (her) signature to a document for agreement (If a patient is under 20 years old, a signature of his (her) legal representative is necessary).
Key exclusion criteria 1. A patient who has had hypersensitivity to infliximab.
2. A patient who has had a surgery for anal lesion (without intestinal resection) as a reason to be involved for this trial.
3. A patient who has abscess lesion(s).
4. A patient who has past and/or present episode of tuberoses infection.
5. A patient who is determined as ineligible for a subject in this study by a doctor in charge or others.
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takayuki Matsumoto
Organization Hyogo College of Medicine
Division name Lower GI disease
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo Pref.
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Ken Fukunaga
Organization Hyogo College of Medicine
Division name Lower GI disease
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo Pref.
TEL
Homepage URL
Email

Sponsor
Institute Lower GI disease, Hyogo College of Medicine
Institute
Department

Funding Source
Organization Lower GI disease, Hyogo College of Medicine
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 兵庫医科大学病院

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/22081474
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
2007 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
2012 Year 05 Month 01 Day
Date of closure to data entry
2012 Year 05 Month 01 Day
Date trial data considered complete
Date analysis concluded
2012 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 10 Month 21 Day
Last modified on
2013 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005290

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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