UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013716 |
|---|---|
| Receipt number | R000016013 |
| Scientific Title | A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis |
| Date of disclosure of the study information | 2014/04/15 |
| Last modified on | 2015/03/06 15:57:44 |
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Basic information
Public title
A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis
Acronym
A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis
Scientific Title
A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis
Scientific Title:Acronym
A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aims to evaluate the efficacy of infliximab for tacrolimus- resistant active ulcerative colitis by comparing the switching method of administration
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
rate of mucosal healing
Key secondary outcomes
remission rate
improvement rate
steroid-sparing effect
safety
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
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After administrating tacrolimus and infliximab for 6 weeks,tacrolimus is tapered to 0mg.
Interventions/Control_2
Infliximab monotherapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have been diagnosed with ulcerative colitis based on the diagnostic criteria of the Japanese Ministry of Health, Labour and Welfare.
Tacrolimus-resistance
16 years of age and older at the time of registration.
Patients who have been signed informed consent document before entering this study.
Key exclusion criteria
Patients applied to the medically contraindicated of infliximab
Patients during pregnancy
Patients are taking concomitant any other biological therapies or cyclosporine
Patients are determined to be inappropriate for administration of infliximab by doctors
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Reiko Kunisaki |
Organization
Yokohama City University Medical Center
Division name
IBD Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
kunisakireiko@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reiko Kunisaki |
Organization
Yokohama City University Medical Center
Division name
IBD Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
kunisakireiko@gmail.com
Sponsor or person
Institute
Yokohama City University Medical Center
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
横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 15 | 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
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 15 | Day |
Last modified on
| 2015 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016013
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
