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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000030884 |
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Date of registration:
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20/02/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A comparison of remission rate at 8 weeks between combination therapy of Ustekinumab and Budesonide and monotherapy of Ustekinumab in moderate to severe Japanese Crohn's disease; A phase III, single-center, double blind, randomized control trial.
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Scientific title:
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A comparison of remission rate at 8 weeks between combination therapy of Ustekinumab and Budesonide and monotherapy of Ustekinumab in moderate to severe Japanese Crohn's disease; A phase III, single-center, double blind, randomized control trial. - A comparison between combination therapy of Ustekinumab boosted by Budesonide and monotherapy of Ustekinumab for Crohn's disease. (BUUST study) |
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Date of first enrolment:
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2018/02/27 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035262 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Rintaro
Moroi |
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Address:
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1-1 Seiryo, Aoba, Sendai, Miyagi 980-8574, Japan
9808574
Japan |
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Telephone:
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022-717-7171 |
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Email:
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rinta@med.tohoku.ac.jp |
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Affiliation:
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Tohoku University Hospital Division of Gastroenterology |
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Name:
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Rintaro
Moroi |
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Address:
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1-1 Seiryo, Aoba, Sendai, Miyagi 980-8574, Japan
Japan |
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Telephone:
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022-717-7171 |
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Email:
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rinta@med.tohoku.ac.jp |
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Affiliation:
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Tohoku University Hospital Division of Gastroenterology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: With stoma. With surgical lesion such as stenosis or abscess. Inpatient with intravenous hyperalimentation. History of allergy for Ustekinumab or Budesonide. Woman with pregnancy, possibility of pregnancy. Woman who is within 28 days after postpartum, or gives the breast to a child. With psychiatric disorder Within 5 years after diagnosis or treatment of malignant tumor. Patient who has active infection.
Age minimum:
18years-old
Age maximum:
75years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Crohn's disease
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Intervention(s)
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Ustekinumab monotherapy for 32 weeks.
Combination of Budesonide and Ustekinumab for 32 weeks.
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Primary Outcome(s)
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The remission rate at 8 weeks.
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Secondary Outcome(s)
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The maintaining remission rate at 32 weeks after the start of treatment. The responder rate at 8 and 32 weeks after the start of treatment. The score of C reactive protein and albumin at 8 and 32 weeks after the start of treatment. The rate of mucosal healing at 8 and 32 weeks after the start of treatment. The rate of side effects. The relationship between clinical factors at baseline and clinical effects of Ustekinumab and Budesonide. The concentration of cytokine(i.e.TL1A, IL12) and anti Ustekinumab antibody.
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Source(s) of Monetary Support
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None
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Ethics review
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Status: YES
Approval date: 07/02/2018
Contact:
rinri-2@proj.med.tohoku.ac.jp
Tohoku University Hospital, Institutional Review Board
022-718-4105
rinri-2@proj.med.tohoku.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/04/2020 |
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URL:
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