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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-UMIN000002340
Date of registration: 20/08/2009
Prospective Registration: No
Primary sponsor: Department of Rheumatosurgery, Osaka City University Medical School
Public title: Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET)
Scientific title:
Date of first enrolment: 2009/08/01
Target sample size: 60
Recruitment status: Complete: follow-up complete
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002863
Study type:  Interventional
Study design:  Parallel Randomized  
Phase:  Phase IV
Countries of recruitment
Japan
Contacts
Name: Tatsuya Koike   
Address:  Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan Japan
Telephone: 06-6645-3984
Email:
Affiliation:  Osaka City University Medical School Rheumatosurgery
Name: Tatsuya Koike   
Address:  Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan Japan
Telephone: 06-6645-3984
Email: tatsuya@med.osaka-cu.ac.jp
Affiliation:  Osaka City University Medical School Rheumatosurgery
Key inclusion & exclusion criteria
Inclusion criteria: Patients whose DAS28-ESR are over 3.2 (DAS28-CRP>2.7) after low-dose infliximab (3mg/Kg) therapy at least 5 times
Exclusion criteria: Patients whose DAS28-ESR are below 3.2 (DAS28-CRP>2.7) after low-dose infliximab (3mg/Kg) therapy at least 5 times

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Treatment with higher dosages of infliximab (3-10 mg/Kg)
Every 2 months
Follow-up to 54 weeks
Treatment with one of other biologics (etanercept, adalimumab, tocilizumab) in standard protocol
Follow-up to 54 weeks
Primary Outcome(s)
DAS28, EULAR responsiveness
Secondary Outcome(s)
mHAQ, The number and dosages of concomitant medication
Secondary ID(s)
Source(s) of Monetary Support
Department of Rheumatosurgery, Osaka City University Medical School
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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