UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012092 |
|---|---|
| Receipt number | R000013980 |
| Scientific Title | Further maintenance of remission for a year after infliximab withdrawal in ulcerative colitis treatment: a multicenter, controlled trial in Japan |
| Date of disclosure of the study information | 2013/12/01 |
| Last modified on | 2019/04/22 15:07:59 |
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Basic information
Public title
Further maintenance of remission for a year after infliximab withdrawal in ulcerative colitis treatment: a multicenter, controlled trial in Japan
Acronym
HAYABUSA study
Scientific Title
Further maintenance of remission for a year after infliximab withdrawal in ulcerative colitis treatment: a multicenter, controlled trial in Japan
Scientific Title:Acronym
HAYABUSA study
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the feasibility of stopping infliximab and the profile of the patients who could stop IFX by comparing the remission rate between patients who stop and continue IFX after 48 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
remission rate after 48 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
stop every-8-week administration of IFX
Interventions/Control_2
continue administration of IFX every 8 weeks
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are diagnosed as UC based on the diagnostic criteria of Reserch Group of Intractable Inflammatory Bowel Disease (2011).
2) Patients on 5mg/kg of IFX every 8 weeks after induction at week 0, 2, 6 week.
3) Patients who are assessed their clinical activity by Clinical Activity Index (CAI) after 14th week of IFX.
4) Patients whose disease activity is 4 or lower by CAI.
5) Patients who received full-explanation and completely understood the study. Informed consent by the document is required.
Key exclusion criteria
1) Patients who are maintained remission for longer than 16 weeks.
2) Patients who have relapsed after once induced remission but before registered to the study.
3) Females who are pregnant, breast-feeding, or cannot exclude the possibility of pregnancy.
4) Patients who have a history of severe infusion reaction.
5) Patients who are considered ineligible for this study by the principal investigator or collaborative doctors.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshifumi Hibi |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
Address
5-9-1 Shirokane, Minato-ku, Tokyo
TEL
03-3444-6161
thibi@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taku Kobayashi |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
Address
5-9-1 Shirokane, Minato-ku, Tokyo
TEL
03-3444-6161
Homepage URL
kobataku@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Center for Clinical Research, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tanabe-Mitsubishi Pharmaceutical Company
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | 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
| 2013 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2014 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 02 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 21 | Day |
Last modified on
| 2019 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013980
| 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 |
