UMIN-CTR Clinical Trial

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
Email	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
Email	rinta@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital, Division of Gastroenterology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035262