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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | ulcerative colitis | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 250 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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IRB Contact (For public release) | |
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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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Last follow-up date |
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |