UMIN-ICDS 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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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