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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-UMIN000021492
Date of registration: 20/03/2016
Prospective Registration: No
Primary sponsor: Inoue Hospital
Public title: To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients.
Scientific title:
Date of first enrolment: 2016/03/01
Target sample size: 40
Recruitment status: Complete: follow-up complete
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Name: Makoto Inoue   
Address:  55 Tohrimachi,Takasaki city, Gunma 370-0053,Japan Japan
Telephone: 027-322-3660
Affiliation:  Inoue Hospital Dpepartment of Rheumatology
Key inclusion & exclusion criteria
Inclusion criteria: rheumatoid arthritis treated infliximab
Exclusion criteria: 1.Patients who corresponds to a contraindication of infliximab of infliximab biosimilar 1

2.Patients their doctors find not appropriate for this study

Age minimum: 18years-old
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Rheumatoid arthritis
switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients.
Primary Outcome(s)
Change in safety and efficacy before and after switch prescripution.
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Inoue Hospital
Secondary Sponsor(s)
Ethics review
Approval date:
Results available:
Date Posted:
Date Completed:
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