NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000002340

Registered date:20/08/2009

Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedRheumatoid Arthritis
Date of first enrollment2009/08/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
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

Outcome(s)

Primary OutcomeDAS28, EULAR responsiveness
Secondary OutcomemHAQ, The number and dosages of concomitant medication

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaPatients whose DAS28-ESR are below 3.2 (DAS28-CRP>2.7) after low-dose infliximab (3mg/Kg) therapy at least 5 times

Related Information

Contact

public contact
Name Tatsuya Koike
Address Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan Japan
Telephone 06-6645-3984
E-mail tatsuya@med.osaka-cu.ac.jp
Affiliation Osaka City University Medical School Rheumatosurgery
scientific contact
Name Tatsuya Koike
Address Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan Japan
Telephone 06-6645-3984
E-mail
Affiliation Osaka City University Medical School Rheumatosurgery