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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: 11 August 2020
Main ID:  JPRN-jRCTs021200013
Date of registration: 31/07/2020
Prospective Registration: No
Primary sponsor: Moroi Rintao
Public title: A comparison between combination therapy of Ustekinumab boosted by Budesonide and monotherapy of Ustekinumab for Crohn's disease.
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. - BUUST
Date of first enrolment: 28/02/2018
Target sample size: 80
Recruitment status: Recruiting
URL:  https://jrct.niph.go.jp/latest-detail/jRCTs021200013
Study type:  Interventional
Study design:  randomized controlled trial, double blind, placebo control, parallel assignment, treatment purpose  
Phase:  3
Countries of recruitment
Japan
Contacts
Name: Rintao    Moroi
Address:  1-1 Seiryo, Aoba-ku, Sendai, Miyagi, Japan 9808574 Miyagi Japan
Telephone: +81-227177171
Email: rinta@med.tohoku.ac.jp
Affiliation:  Tohoku University Hospital
Name: Rintaro    Moroi
Address:  1-1 Seiryo, Aoba-ku, Sendai, Miyagi, Japan 9808574 Miyagi Japan
Telephone: +81-227177171
Email: rinta@med.tohoku.ac.jp
Affiliation:  Tohoku University Hospital
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: >= 18age old
Age maximum: <= 75age old
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's disease
Crohn's disease
D003424
Intervention(s)
Ustekinumab monotherapy 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)
UMIN000030884
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Status: Approval
Approval date: 02/07/2020
Contact:
office@nrs.hosp.tohoku.ac.jp
MHLW Certified Clinical Research Review Board, Tohoku University
+81-22-718-0461
office@nrs.hosp.tohoku.ac.jp
Results
Results available:
Date Posted:
Date Completed:
URL:
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