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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030884
Receipt No. 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

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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
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/ctr_e/ctr_view.cgi?recptno=R000035262

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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