Magnifying endoscopy trial to evaluate the effects of adalimumab on mucosal healing in Crohn's disease with special reference to Peyer's patches
Not Applicable
- Conditions
- Crohn's disease
- Registration Number
- JPRN-UMIN000016014
- Lead Sponsor
- agasaki University Hospital
- Brief Summary
none
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 1
Inclusion Criteria
Not provided
Exclusion Criteria
severe infection active tuberculosis demyelinating disease congestive heart failure enteral nutrition with more than 1200 kcal primary failure with infliximab administration of investigational new drug within 24 weeks unsettled treatment with antibiotics, azathioprine, mercaptoprine, methotrexate within 28 days and with steroids within 14 days treatment with prednisolone at more than 40 mg dose, cyclosporine, tacrolimus, alkylating agaents leukocytoapheresis within 8 weeks aritifical anus and ileoanal pouch severe stricture, fistula and abcess total parenteral or entral nutrition exclusion by responsible persons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients who achieved endoscopic remission The percentage of patients who achieved CE remission at week 52 will be calculated for subgroups of patients who achieved ME remission and CE remission at week 12.
- Secondary Outcome Measures
Name Time Method Percentages of patients who achieved ME remission at weeks 12 and 52 Percentages of patients who achieved CE remission at weeks 12 and 52 Percentages of patients who achieved ME remission and a CDAI score of <150 at weeks 12 and 52 Endoscopic assessment of colonic segments other than terminal ileum (SES-CD) at weeks 12 and 52 Rates of all-cause hospitalization and CD-related hospitalization by week 52 in patients who achieved ME remission and those who achieved CE remission only. Correlations between clinical remission (CDAI/HBI), inflammatory response (CRP, etc.) and ME remission (normalization of PP structure).