World Health Organization site
Skip Navigation Links

Main
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-UMIN000007786
Date of registration: 19/04/2012
Prospective Registration: Yes
Primary sponsor: Saitama Medical Center. Saitama Medical University
Public title: "Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis "
Scientific title:
Date of first enrolment: 2012/05/01
Target sample size: 40
Recruitment status: Complete: follow-up complete
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009176
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not applicable
Countries of recruitment
Japan
Contacts
Name: Koichi Amano   
Address:  1981 Kamoda, Kawagoe-shi, SAITAMA Japan
Telephone: 0492283859
Email: amanokoi@saitama-med.ac.jp
Affiliation:  Saitama Medical Center. Saitama Medical University Division of Rheumatology and Clinical Immunology
Name: Koichi Amano   
Address:  1981 Kamoda, Kawagoe-shi, SAITAMA Japan
Telephone: 0492283859
Email: amanokoi@saitama-med.ac.jp
Affiliation:  Saitama Medical Center. Saitama Medical University Department of Rheumatology & Clinical Immunology
Key inclusion & exclusion criteria
Inclusion criteria: The patient whom is prescribing TNF inhibitors other than infliximab for the patient, and the disease activity (DAS28(4)-ESR >3.2, SDAI>11, or CDAI>10) more than the degree of middle class is maintaining over 12 or more weeks
Exclusion criteria: "1) The patient who is having infliximab medical treatment already experienced
2) The patient who cannot prescribe a methotrexate tablet for the patient
3) The patient who is experienced in TNF inhibitors as for more than 2 agent
4) In addition, the patient who judged that a research doctor was unsuitable "


Age minimum: 20years-old
Age maximum: 75years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
infliximab plus methotrexate
Primary Outcome(s)
the remission rate of 1-2years after(DAS28(4)-CRP<2.3 or DAS28(4)-ESR<2.6 or SDAI<3.3 or CDAI<2.8)
Secondary Outcome(s)
the low disease activity maintenance rate of 1-2 years after (DAS28(4)-ESR<3.2 or SDAI<11 or CDAI<10
the low disease activity maintenance rate of 1-2 years after (DAS28(4)-ESR<3.2 or SDAI<11 or CDAI<10
Secondary ID(s)
Source(s) of Monetary Support
Saitama Medical Center, Saitama Medical Universitity
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history