Unique ID issued by UMIN | UMIN000003880 |
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Receipt number | R000004668 |
Scientific Title | Keeping cartilagious quality by adalimumab in patient with rheumatoid arthritis in Kansai area |
Date of disclosure of the study information | 2010/07/07 |
Last modified on | 2012/11/28 21:28:23 |
Keeping cartilagious quality by adalimumab in patient with rheumatoid arthritis in Kansai area
KABUKI study
Keeping cartilagious quality by adalimumab in patient with rheumatoid arthritis in Kansai area
KABUKI study
Japan |
Rheumatoid arthritis
Clinical immunology | Orthopedics |
Others
NO
To determine joint destruction in echo, X-rays,and biochemical study when patients with rheumatoid arthritis were given adalimumab. 24 weeks later, we divide the group of low disease activity into a group maintaining dosage interval and the group to extend by randomization. Also we conduct a change to other biological products or antirheumatic drug addition by randomization if subjects do not enter the low disease activity group. We evaluate those four groups at 48 weeks later.
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
Disease activity score 28 (DAS28), modified Health Assessment Questionnaire (mHAQ), Cartilage Oligometric Matrix Protein (COMP), Sharp score, Echo score
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
4
Treatment
Medicine |
DAS28>3.2 at 24 weeks
Switching to another biologics
DAS28>3.2 at 24 weeks
Dose up of MTX or addition of other DMARDs
DAS28<=3.2 at 24 weeks
40 mg of Adalimumab every two week
DAS28<=3.2 at 24 weeks
40 mg of Adalimumab every four week
20 | years-old | <= |
Not applicable |
Male and Female
Rheumatoid arthritis patients who receive adalimumab under an adaptation of biologics
A malignant tumor, a lymphoma, active tuberculosis, demyelinating disease, congestive heart failure
100
1st name | |
Middle name | |
Last name | Tatsuya Koike |
Osaka City University Medical School
Rheumatosurgery
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
06-6645-3984
1st name | |
Middle name | |
Last name | Tatsuya Koike |
Osaka City University Medical School
Rheumatosurgery
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
06-6645-3984
tatsuya@med.osaka-cu.ac.jp
Osaka City University Medical School
None
Self funding
Higashi Sumiyoshi Morimoto Hospital, Yodogawa Christian Hospital, Kitade Hospital, Shirahama Hamayu Hospital
NO
東住吉森本病院(大阪府)、淀川キリスト教病院(大阪府)、北出病院(和歌山県)、白浜はまゆう病院(和歌山県)、公立山城病院(京都府)
2010 | Year | 07 | Month | 07 | Day |
Unpublished
Open public recruiting
2009 | Year | 10 | Month | 30 | Day |
2010 | Year | 07 | Month | 01 | Day |
2014 | Year | 12 | Month | 31 | Day |
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 05 | Month | 31 | Day |
2015 | Year | 12 | Month | 31 | Day |
2010 | Year | 07 | Month | 06 | Day |
2012 | Year | 11 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004668
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