Unique ID issued by UMIN | UMIN000011520 |
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Receipt number | R000013474 |
Scientific Title | Keep persistent efficacy by Abstaining from biological treatment after Numerical SDAI remission with AdalImumab (KANSAI study) |
Date of disclosure of the study information | 2013/08/19 |
Last modified on | 2013/08/19 16:43:15 |
Keep persistent efficacy by Abstaining from biological treatment after Numerical SDAI remission with AdalImumab (KANSAI study)
Keep persistent efficacy by Abstaining from biological treatment after Numerical SDAI remission with AdalImumab (KANSAI study)
Keep persistent efficacy by Abstaining from biological treatment after Numerical SDAI remission with AdalImumab (KANSAI study)
Keep persistent efficacy by Abstaining from biological treatment after Numerical SDAI remission with AdalImumab (KANSAI study)
Japan |
rheumatoid arthritis
Medicine in general | Clinical immunology | Orthopedics |
Others
NO
Assess the duration of maintaining low disease activity (LDA) in the rheumatoid arthritis (RA) patients who discontinued adalimumab treatment following achievement of LDA, and make this insight contribute on development of novel treatment option for RA in Japan.
Efficacy
Confirmatory
Pragmatic
Not applicable
Proportion of patients with biologic free remission at week 52
1. Period until bio-free of tapering and stopping arm
2. Proportion of patients with bio-free and the maintain rate
3. Disease activity(DAS,SDAI), mTSS, HAQ at week 26, 52 and 104(after ADA free at week 0, 26, 52 and 104)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
NO
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
After achieve remission and maintain,
ADA is step down and step out over the 104 weeks (arm A)
After achieve remission and maintain,
Maintenance of previous does with ADA treatment over the 52 weeks, and ADA is step down and step out over the 104 weeks (arm B)
Not applicable |
Not applicable |
Male and Female
Patient of RA with Adalimumab treatment that maintain remission (SDAI<=3.3) of twice over the 24 weeks
Patient who using other biologic DMARDs and investigational product.
Patient who treating with LCAP.
80
1st name | |
Middle name | |
Last name | Yutaka Kawahito |
Kyoto Prefectural University of Medicine
Inflammation and Immunology
Kajii-cyo Kawaramachji-Hirokoji Kamigyo-ku Kyoto 602-8566 Japan
075-251-5505
1st name | |
Middle name | |
Last name | Aihiro Yamamoto |
Kyoto Prefectural University of Medicine
Inflammation and Immunology
075-251-5505
KANSAI RA investigator
None
Self funding
NO
大阪リハビリテーション病院
大阪南医療センター
近畿大学医学部堺病院
大阪市立大学医学部附属病院
兵庫医科大学
大阪大学医学部附属病院
神戸大学医学部附属病院
天理よろづ相談所病院
京都大学医学部附属病院
医療法人行岡医学研究会 行岡病院
神戸・甲南山手クリニック
2013 | Year | 08 | Month | 19 | Day |
Unpublished
Enrolling by invitation
2013 | Year | 06 | Month | 07 | Day |
2013 | Year | 06 | Month | 07 | Day |
2013 | Year | 08 | Month | 19 | Day |
2013 | Year | 08 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013474
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