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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-UMIN000005761
Date of registration: 13/06/2011
Prospective Registration: No
Primary sponsor: Kenji Watanabe
Public title: The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to Infliximab
Scientific title:
Date of first enrolment: 2010/10/27
Target sample size: 50
Recruitment status: Complete: follow-up complete
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006811
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name:    
Address:  Japan
Telephone:
Email: nkamata@med.osaka-cu.ac.jp
Affiliation:  Osaka City University Gradatescool of Medicine Gastroenterology
Name: Kenji Watanabe   
Address:  1-4-3, Asahi-machi, Abeno-ku, Osaka Japan
Telephone:
Email:
Affiliation:  Osaka City University Gradatescool of Medicine Gastroenterology
Key inclusion & exclusion criteria
Inclusion criteria: Crohn's Disease patient as following 1)or 2)
1)the patient who treated with IFX infusion of interval every 4-6 weeks.
2)the patient who could not keep to treat with IFX due to side effect or ineffectiveness.

Exclusion criteria: 1)The patient of contraindication for adalimumab as following
a.serious infections
b.active tuberculosis
c.hypersensitivity
d.neurologic reactions (peripheral demyelinating disease)
e.congestive heart failure
2)The case which is hard to get the patient's consent
3)The patient who was judged for unsuitable by responsibility doctor


Age minimum: Not applicable
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Crohn's Disease patient as following 1)or 2) 1)the patient who treated with IFX infusion of interval every 4-6 weeks. 2)the patient who could not keep to treat with IFX due to side effect or ineffectiveness.
Intervention(s)
Adalimumab (HUMIRA 40mg for SC Injection)

Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29.
Primary Outcome(s)
CDAI score in the 28th week (the rate of remission, CR70, CR100), SF-36, IBDQ
Secondary Outcome(s)
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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