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)

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) - A combination of methylprednisolone and prednisolone and a combination of methylprednisolone, prednisolone and mizoribine: A randomized controlled trial (JSRDC04)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000378

Enrollment

Registered

2006-04-01

Start date

1995-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

systematic lupus erythematosus

Interventions

Methylprednisolone+prednisolone Methylprednisolone+prednisolone+mizoribine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.First 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Cumulative flare rate	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026