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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-UMIN000008281
Date of registration: 28/06/2012
Prospective Registration: No
Primary sponsor: Department of Internal Medicien and Rheumatology, Juntendo University School of Medicine
Public title: Dose-escalation study of infliximab or methotrexate based on the disease activity in patients with rheumatoid arthritis treated with infliximab
Scientific title:
Date of first enrolment: 2012/06/01
Target sample size: 30
Recruitment status: Recruiting
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009758
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Naoto Tamura   
Address:  2-1-1 Hongo, Bunkyo-ku, Tokyo Japan
Telephone: 03-3813-3111
Email: tnaoto@juntendo.ac.jp
Affiliation:  Juntendo University Hospital Internal Medicine and Rheumatology
Name: Tamura, Naoto   
Address:  3-1-1 Hongo, Bunkyo-ku, Tokyo Japan
Telephone: 03-3813-3111
Email: tnaoto@juntendo.ac.jp
Affiliation:  Juntendo University Hospital Internal Medicine and Rheumatology
Key inclusion & exclusion criteria
Inclusion criteria: RA patients inadequately responded to MTX therapy
Exclusion criteria: Patients with remmission and low disease acitivuty.
Patients contraindicated or unsuitable to IFX administration, such as active infection.


Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
rheumatoid arthritis
Intervention(s)
Dose-escalation of MTX or IFX
Primary Outcome(s)
Improvement rate of disease acitivity based on DAS28 and SDAI at 54 week
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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