Efficacy and safety of rituximab for patients with severe rheumatic disease

Efficacy and safety of rituximab for patients with severe rheumatic disease - Efficacy and safety of rituximab for patients with severe rheumatic disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018376

Enrollment

Registered

2015-07-22

Start date

2015-07-22

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

Childhood-onset severe rheumatic disease (systemic lupus erhythematosus, dermatomyositis, poly myositis, systemic sclerosis , mixed connective tissue disease, Sjogren&#39

Interventions

1) Induction Therapy rituximab 375mg/m2 (max500mg) 1-4 times/1-2 weeks 2) Maintenance Therapy rituximab 375mg/m2 (max500mg) 1 times/6-12 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnose at Childhood(1 to 16years old), registance against standerd treatment or steroid-dependent 2. No experience of rituximab treatment 3. Patients gave written informed consent

Exclusion criteria

Exclusion criteria: 1. Pulmonary tuberculosis, active bacterial infection or deep mycotic infection 2. Infection of HIV, HCV or HBV 3. Administraion of live vaccine within 4 weeks 4. Interstatial lung disease 5. Cardiac dysfunction 6. Pregnant subjects or subjects who do not agree with contraception during the study period

Design outcomes

Primary

Measure	Time frame
inhibition of disease activity	—

Secondary

Measure	Time frame
improvement of physician's VAS, patient's VAS, biomarkers of disease activity and dose of corticosteroids	—

Countries

Japan

Contacts

Public ContactKenichi Nishimura

Yokohama City University Hospital Pediatrics

ken_1_0306@hotmail.com045-787-2800

Outcome results

None listed

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