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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-UMIN000027465
Date of registration: 24/05/2017
Prospective Registration: Yes
Primary sponsor: University of Toyama
Public title: Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis
Scientific title: Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis - Efficacy and safety of IFX-BS in UC patients
Date of first enrolment: 2017/05/29
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=R000031466
Study type:  Interventional
Study design:  Parallel Randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name:     Sohachi Nanjo
Address:  Sugitani 2630, Toyama City, Toyama Prefecture, Japan Japan
Telephone: 076-434-7301
Email: snanjo@med.u-toyama.ac.jp
Affiliation:  University of Toyama Department of Gastroenterology and Hematology, Graduate School of Medicine and Pharmaceutical Scienc
Name:     Sohachi Nanjo
Address:  Sugitani 2630, Toyama City, Toyama Prefecture, Japan Japan
Telephone: 076-434-7301
Email: snanjo@med.u-toyama.ac.jp
Affiliation:  University of Toyama Department of Gastroenterology and Hematology, Graduate School of Medicine and Pharmaceutical Sciences
Key inclusion & exclusion criteria
Inclusion criteria:
Exclusion criteria: 1) Patients younger than 20 years old
2) Patients keeping in the clinical remission state for more than 10 years


Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
ulcerative colitis
Intervention(s)
Infliximab (5mg/kg, every 8 weeks, for 12 months)
Biosimilar Infliximab (5mg/kg, every 8 weeks, for 12 months)
Primary Outcome(s)
The remission rate and the adverse events 24 and 48 weeks after the switch from infliximab to its biosimilar
Secondary Outcome(s)
The value of partial Mayo's score
The value of serum CRP
The value of serum albumin
The value of hemoglobin
The increase of Infliximab or biosimilar Infliximab
Secondary ID(s)
Source(s) of Monetary Support
plural commercial corporations
Secondary Sponsor(s)
Ethics review
Status: YES
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed: 31/12/2018
URL:
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