UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012092
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kobataku@insti.kitasato-u.ac.jp

Sponsor
Institute Center for Clinical Research, Keio University School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013980

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.