Unique ID issued by UMIN | UMIN000015495 |
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Receipt number | R000018004 |
Scientific Title | Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka) |
Date of disclosure of the study information | 2014/10/22 |
Last modified on | 2019/05/01 16:38:17 |
Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)
Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)
Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)
Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)
Japan |
Systemic sclerosis
Medicine in general | Clinical immunology |
Others
NO
To explore the effect of tocilizumab on skin sclerosis in patients with systemic sclerosis
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Sum of skin scores from 17 sites of the body (modified Rodnan total skin score)
Skin hardness, elasticity, and viscosity evaluate by Vesmter
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Administrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies
20 | years-old | <= |
80 | years-old | > |
Male and Female
1)Patients with systemic sclerosis with sever skin sclerosis
2)Over 6 modified Rodnan total skin score with skin sclerosis on fingers, dorsal hands, forearms, and upper arms; change of total skin score is within 20% during the screening period (two months)
3)No malignancy
4)From 20 years old to 80 years old
5)Agreement to contraception during the study period
6)Patients who are able to give consent in writing after reading the explanatory text
1)Patients who are administered the other biologics
2)Patients who have history of anaphylactic reactions to this drug
3)Patients who have HBV or who are under the septic condition
4)significant liver damage
5)significant renal damage
6)possibility of tuberculosis
7)pregnancy
8)breast-feeding
9)participating in other clinical trial within three months before the beginni
ng of this trial
10)judged inappropriate for this study by the physicians
5
1st name | |
Middle name | |
Last name | Yoshihito Shima |
Osaka University Graduate School of Medicine
Dept. of Respiratory medicine, Allergy and Rheumatic diseases
2-2 Yamada-oka, Suita, 565-0871 Japan
06-6879-3833
ryanjin@imed3.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Yoshihito Shima |
Osaka University
Allergy and Rheumatic Diseases
2-2 Yamada-Oka, Suita, 565-0871 Japan
06-6879-3833
ryanjin@imed3.med.osaka-u.ac.jp
Osaka University
Self funding
Self funding
NO
大阪大学医学部附属病院
2014 | Year | 10 | Month | 22 | Day |
Unpublished
Terminated
2014 | Year | 03 | Month | 03 | Day |
2014 | Year | 03 | Month | 03 | Day |
2014 | Year | 04 | Month | 01 | Day |
2017 | Year | 03 | Month | 31 | Day |
2017 | Year | 03 | Month | 31 | Day |
2014 | Year | 10 | Month | 21 | Day |
2019 | Year | 05 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018004
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Research case data | |
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