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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-UMIN000016844
Date of registration: 20/03/2015
Prospective Registration: No
Primary sponsor: Takarazuka city hospital
Public title: The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF Inhibitors
Scientific title:
Date of first enrolment: 2014/02/07
Target sample size: 80
Recruitment status: Recruiting
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019556
Study type:  Interventional
Study design:  Parallel Randomized  
Phase:  Not applicable
Countries of recruitment
Japan
Contacts
Name: Takafumi Hagiwara   
Address:  Kohama4-5-1, Takarazuka city Japan
Telephone: 0797-87-1161
Email: college@katzenauge.sakura.ne.jp
Affiliation:  Takarazuka city hospital Rheumatology
Name: Taskafumi Hagiwara   
Address:  Kohama4-5-1, Takarazuka city Japan
Telephone: 0797-87-1161
Email: college@katzenauge.sakura.ne.jp
Affiliation:  Takarazuka city hospital Rheumatology
Key inclusion & exclusion criteria
Inclusion criteria: Rheumatoid arthritis patients(RA) diagnosed by ACR/EULAR 2013 RA classfication criteria, and they are patients of biologics naive and inadequate response by methotrexate (MTX) therapy.
Exclusion criteria: other csDMARDs without MTX user

Age minimum: 20years-old
Age maximum: 90years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Rheumatoid arthritis
Intervention(s)
infliximab: standard strategy
infliximab: aggressive strategy
golimumab: standard strategy
golimumab: aggressive strategy
Primary Outcome(s)
Clinical remission induction rates
Secondary Outcome(s)
DAS28(ESR&CRP) SDAI CDAI
HAQDI
modified total sharp score
Secondary ID(s)
Source(s) of Monetary Support
Takarazuka city hospital
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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