Unique ID issued by UMIN | C000000159 |
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Receipt number | R000000017 |
Scientific Title | Mizolibin for systemic lupus erythematosus in children(JSRDC10) |
Date of disclosure of the study information | 2006/04/01 |
Last modified on | 2011/07/11 17:47:08 |
Mizolibin for systemic lupus erythematosus in children(JSRDC10)
Mizolibin for systemic lupus erythematosus in children(JSRDC10)
Mizolibin for systemic lupus erythematosus in children(JSRDC10)
Mizolibin for systemic lupus erythematosus in children(JSRDC10)
Japan |
systematic lupus erythematosus
Clinical immunology | Pediatrics |
Others
NO
We investigate efficacy and safety of a combination of mizoribine and prednisolone for systematic lupus erythematosus in children, comparing with prednisolone.
Safety,Efficacy
flare proportion
Interventional
Single arm
Non-randomized
Open -but assessor(s) are blinded
Historical
1
Treatment
Medicine |
Methylprednisolone+mizoribine+prednisolone
2 | years-old | <= |
18 | years-old | >= |
Male and Female
1.Diagnoses of systematic lupus erythematosus based on guidline defined by children collagen disease study group in Health and Welfare Ministry.
2.Aged two years to 18 years.
3.Written informed consent from the patients' parents or legal guardians.
1.Chronic rheumatoid arthritis, diffuse scleroderma or dermatomyositis.
2.History of immunosuppressive drugs administration.
3.Medical history of allergy or hypersensitivity reactions to mizoribine.
4.Poorly controlled hypertension.
5.Active infectious disease.
6.Severe liver disfunction.
7.Pregnancy.
8.Judged inappropriate for this study by the physicians.
30
1st name | |
Middle name | |
Last name | Masataka Honda |
Tokyo Metropolitan Children's Medical Center
Department of Pediatric nephrology
2-8-29 Musashinodai, Fuchu-shi, TOKYO, JAPAN
1st name | |
Middle name | |
Last name |
Japanese Study Group of Renal Disease in Children(JSRDC)
Tokyo Metropolitan Children's Medical Center
2-8-29 Musashinodai, Fuchu-shi, TOKYO, JAPAN
Japanese Study Group of Renal Disease in Children(JSRDC)
The Kidney Foundation,Japan
Non profit foundation
NO
2006 | Year | 04 | Month | 01 | Day |
Unpublished
Terminated
2006 | Year | 03 | Month | 01 | Day |
2006 | Year | 03 | Month | 01 | Day |
2010 | Year | 08 | Month | 01 | Day |
2005 | Year | 09 | Month | 11 | Day |
2011 | Year | 07 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000017
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