Unique ID issued by UMIN | UMIN000007019 |
---|---|
Receipt number | R000008277 |
Scientific Title | Efficacy and safety of tocilizumab mono-therapy in patients with adult-onset Still's disease |
Date of disclosure of the study information | 2012/02/01 |
Last modified on | 2018/08/09 14:21:04 |
Efficacy and safety of tocilizumab mono-therapy in patients with adult-onset Still's disease
Treatment of AOSD by tocilizumab mono-therapy
Efficacy and safety of tocilizumab mono-therapy in patients with adult-onset Still's disease
Treatment of AOSD by tocilizumab mono-therapy
Japan |
Rheumatoid arthritis
Clinical immunology |
Others
NO
To evaluate the efficacy and safety of tocilizumab monotherapy for AOSD
Safety,Efficacy
Confirmatory
Pragmatic
Improvement of major clinical signs and symptoms at week 12 and 28 (fever, arthritis,skin eruption, leukocytosis, serum ferritin)
Improvement of major clinical signs,treatment survival rate,patient's global assessment(by VAS),relapse rate and adverse events at week 52 and 104
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
tocilizumab monotherapy
16 | years-old | <= |
70 | years-old | > |
Male and Female
AOSD patients who fulfilled the AOSD classification criteria by Yamaguchi in 1992
1) patients who are prohibited to use tocilizumab by the JCR guideline for proper tocilizumab use
2) patients who are thought to be inappropriate for the treatment with tocilizumab by their attending doctor
40
1st name | |
Middle name | |
Last name | Koichi Amano |
Saitama Medical Center,
Saitama Medical University
Department of Rheumatology and Clinical Immunology
1981 Kamoda Kawagoe, Saitama 350-8550
049-228-3859
amanokoi@saitama-med.ac.jp
1st name | |
Middle name | |
Last name | Ryota Sakai |
Saitama Medical Center, Saitama Medical Universitity
Department of Rheumatology & Clinical Immunology
1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
0492283574
r_sakai@saitama-med.ac.jp
Department of Rheumatology & Clinical Immunology,Saitama Medical Center, Saitama Medical Universitity
Saitama Medical Center, Saitama Medical Universitity
Self funding
NO
2012 | Year | 02 | Month | 01 | Day |
Partially published
Completed
2012 | Year | 02 | Month | 01 | Day |
2012 | Year | 02 | Month | 01 | Day |
2018 | Year | 03 | Month | 01 | Day |
2018 | Year | 03 | Month | 01 | Day |
2018 | Year | 06 | Month | 01 | Day |
2018 | Year | 12 | Month | 01 | Day |
2012 | Year | 01 | Month | 05 | Day |
2018 | Year | 08 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008277
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |