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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.
Register: JPRN
Last refreshed on: 2 April 2019
Main ID:  JPRN-UMIN000030884
Date of registration: 20/02/2018
Prospective Registration: Yes
Primary sponsor: Tohoku University Hospital, Division of Gastroenterology
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.
Scientific title:
Date of first enrolment: 2018/02/27
Target sample size: 80
Recruitment status: Recruiting
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035262
Study type:  Interventional
Study design:  Parallel Randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Rintaro Moroi   
Address:  1-1 Seiryo, Aoba, Sendai, Miyagi 980-8574, Japan Japan
Telephone: 022-717-7171
Email: rinta@med.tohoku.ac.jp
Affiliation:  Tohoku University Hospital Division of Gastroenterology
Key inclusion & exclusion criteria
Inclusion criteria: Japanese Crohn's disease

From moderate to severe activity
(CDAI > 220)

Performance Status:0-2

Outpatient (Around 1 week admission is permitted).

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
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)
Ustekinumab monotherapy for 32 weeks.
Combination of Budesonide and Ustekinumab for 32 weeks.
Primary Outcome(s)
The remission rate at 8 weeks.
Secondary Outcome(s)
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.
Secondary ID(s)
Source(s) of Monetary Support
None
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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