NIPH Clinical Trials Search

UMIN ID: C000000378

Registered date:01/04/2006

A combination of methylprednisolone and prednisolone and a combination of Methylprednisolone, prednisolone and mizoribine for systemic lupus erythematosus in children: A randomized controlled trial of efficacy and safety izolibin for (JSRDC04)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedsystematic lupus erythematosus
Date of first enrollment1995/03/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Methylprednisolone+prednisolone Methylprednisolone+prednisolone+mizoribine


Primary OutcomeCumulative flare rate
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum2years-old
Age maximum18years-old
GenderMale and Female
Include criteria
Exclude criteria1.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.

Related Information


public contact
Address 1-3-1 Umezono Kiyose City, Tokyo Japan
Affiliation Japanese Study Group of Renal Disease in Children(JSRDC) Department of Nephrology, Tokyo Metropolitan Children's Hospital
scientific contact
Name Masataka Honda
Address 4-33-13 Daimachi Hachioji City,Tokyo Japan
Affiliation Tokyo Metropolitan Children's Hospital Department of Pediatrics