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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-UMIN000007432
Date of registration: 02/03/2012
Prospective Registration: Yes
Primary sponsor: Keio University
Public title: Prospective research of infliximab treatment in active RA patients refractry to anti-interleukin six receptor monoclonal antibody.
Scientific title:
Date of first enrolment: 2012/04/01
Target sample size: 100
Recruitment status: Complete: follow-up continuing
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008476
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Tsutomu Takeuchi   
Address:  35 Shinanomachi, Shinjuku-ku, Tokyo JAPAN Japan
Telephone: 03-3353-1211
Email: info@npo-acro.jp
Affiliation:  Keio University School of Medicine Division of Rheumatology
Name: ACRO   
Address:  4F Hoei Fuchu Building, 2-10-3 Kotobukicyo, Fucyu-shi, Toyo, Japan Japan
Telephone: 042-352-7676
Email: info@npo-acro.jp
Affiliation:  NPO Advanced Clinical Research Organization Advanced Clinical Research Organization
Key inclusion & exclusion criteria
Inclusion criteria: Patients with rheumatoid arthritis diagnosed according to the criteria of the American College of Rheumatology (ACR).
Patient treated of TCZ for more than 12 weeks.
SDAI Score more than 3.3 of TCZ treatment the last.
SDAI score 3.3 or more at start of the examination (exceeds 3 weeks from TCZ treatment the last.)
Having received and thoroughly understood an adequate explanation about participation in the study, patients who have personally and voluntarily provided written informed consent.

Exclusion criteria: Patient has received IFX in the past.
During a TCZ washout period, Patient treated of biologics and immunosuppressant which does not have adaptation of preparation or rheumatoid arthritis.
Patient is contraindication of IFX and MTX.


Age minimum: 20years-old
Age maximum: 75years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
rheumatoid arthritis
Intervention(s)
Infliximab and Methotrexate.
Patient is treated with IFX 3mg/kg for 0, 2, or 6 weeks, and henceforth every 8 weeks till 46weeks. Disease activity is assessed every 4weeks (suitable) or every 8 weeks (indispensable), and if SDAI Score 3.3 or more, it will change into of 3mg/kg 4week or 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks. If not remission(SDAI Score 3.3 or more), after change into of 3mg/kg 4week interval medication, it will change into of 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks.
Primary Outcome(s)
The remission rate by SDAI score at 54 weeks.
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
NPO Advanced Clinical Research Organization
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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