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.
Not Applicable
Recruiting
- Conditions
- Crohn's disease
- Registration Number
- JPRN-UMIN000030884
- Lead Sponsor
- Tohoku University Hospital, Division of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The remission rate at 8 weeks.
- Secondary Outcome Measures
Name Time Method 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.