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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-UMIN000000512
Date of registration: 03/11/2006
Prospective Registration: No
Primary sponsor: Rheumatosurgery, Osaka City University Medical School
Public title: Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate
Scientific title:
Date of first enrolment: 2006/10/01
Target sample size: 30
Recruitment status: Complete: follow-up complete
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000620
Study type:  Interventional
Study design:  Factorial Non-randomized  
Phase:  Not applicable
Countries of recruitment
Japan
Contacts
Name: Yuko Sugioka   
Address:  Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan Japan
Telephone: 06-6645-3851
Email: tatsuya@med.osaka-cu.ac.jp
Affiliation:  Osaka City University Medical School Orthopaedic Surgery
Name: tatsuya Koike   
Address:  Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan Japan
Telephone: 06-6645-3851
Email:
Affiliation:  Osaka City University Medical School Rheumatosurgery
Key inclusion & exclusion criteria
Inclusion criteria: Rheumatoid arthritis patients who have been treated with methotrexate and infliximab for over 22 weeks
Exclusion criteria: Dose of predonisone is over 5mg/day, patients who cannot receive tacrolimus

Age minimum: Not applicable
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
If the score of DAS28 is under 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, doses of methotrexate will reduced to 2mg/w. When the score of DAS28 increses, tacrolimus will be administered instead of methotrexate. Period of observation is 32 weeks.
If the score of DAS28 is over 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, tacrolimus will be administered. Period of observation is 32 weeks.
Primary Outcome(s)
DAS28
Secondary Outcome(s)
ACR definition of improvement, CRP, Adverse events
Secondary ID(s)
Source(s) of Monetary Support
Tanabe Seiyaku Co. Ltd.
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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