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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-UMIN000012790
Date of registration: 01/02/2014
Prospective Registration: Yes
Primary sponsor: Saitama Medical center
Public title: Prospective Pilot study of Infliximab Dose-intensification determined by Capsule Endoscopic Evaluation of Small Intestinal Involvements in Patients with Crohn's Disease
Scientific title:
Date of first enrolment: 2014/02/01
Target sample size: 20
Recruitment status: Complete: follow-up complete
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014942
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Shingo Kato   
Address:  1981 Kamoda, Kawagoe, Saitama Japan
Telephone: 049-228-3564
Email: skato@saitama-med.ac.jp
Affiliation:  Saitama Medical center Department of gastroenterology and Hepatology
Name: Shingo Kato   
Address:  981 Kamoda, Kawagoe, Saitama Japan
Telephone: 049-228-3564
Email: skato@saitama-med.ac.jp
Affiliation:  Saitama Medical center Department of gastroenterology and Hepatology
Key inclusion & exclusion criteria
Inclusion criteria: 6 months steroid free CD patients with CDAI which was no more than 150
Exclusion criteria: patients with contraindication of infliximab
patients with pregnancy and lactation
patients without informed consent
patients under and after treatment of malignancy


Age minimum: 20years-old
Age maximum: 65years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)
dose intensification of 10mg/kg infliximab with additional treatment with thiopurines in case of aggravation at 6 months
Primary Outcome(s)
mucosal healing rates at 6 months
Secondary Outcome(s)
mucosal healing rates at 12 months
improvement of mucosal regions at 6 and 12 months
serum CRP titer at 6 and 12 months
stool calprotectin titer at 6 and 12 months
stool PTX3 titer at 6 and 12 months
safety
Secondary ID(s)
Source(s) of Monetary Support
Saitama Medical center
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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