UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030884 |
|---|---|
| Receipt number | R000035262 |
| Scientific Title | 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. |
| Date of disclosure of the study information | 2018/02/20 |
| Last modified on | 2019/07/23 11:08:29 |
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Basic information
Public title
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.
Acronym
A comparison between combination therapy of Ustekinumab boosted by Budesonide and monotherapy of Ustekinumab for Crohn's disease. (BUUST study)
Scientific Title
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.
Scientific Title:Acronym
A comparison between combination therapy of Ustekinumab boosted by Budesonide and monotherapy of Ustekinumab for Crohn's disease. (BUUST study)
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of combination therapy of Ustekinumab and Budesonide compared to monotherapy of Ustekinumab for Japanese Crohn's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The remission rate at 8 weeks.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ustekinumab monotherapy for 32 weeks.
Interventions/Control_2
Combination of Budesonide and Ustekinumab for 32 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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Japanese Crohn's disease
From moderate to severe activity
(CDAI > 220)
Performance Status:0-2
Outpatient (Around 1 week admission is permitted).
Key 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.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Rintaro |
| Middle name | |
| Last name | Moroi |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
9808574
Address
1-1 Seiryo, Aoba, Sendai, Miyagi 980-8574, Japan
TEL
022-717-7171
rinta@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Rintaro |
| Middle name | |
| Last name | Moroi |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
9808574
Address
1-1 Seiryo, Aoba, Sendai, Miyagi 980-8574, Japan
TEL
022-717-7171
Homepage URL
rinta@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital, Division of Gastroenterology
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
Tohoku University Hospital, Institutional Review Board
Address
1-1 Seiryo, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-718-4105
rinri-2@proj.med.tohoku.ac.jp
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
| 2018 | Year | 02 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 18 | Day |
Last modified on
| 2019 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035262
