UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004427 |
|---|---|
| Receipt number | 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 09:20:39 |
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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
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
Public contact
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
Sponsor or person
Institute
Lower GI disease, Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005290
