Systemic lupus erythematosus
Conditions
Interventions
1000 mg of rituximab on days 1, 15, 169 and 183
Sponsors
Zenyaku Kogyo Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with SLE diagnosed according to the American College of Rheumatology (ACR) criteria (revised version, 1997) and with positive antinuclear antibody 2)Patients who developed flares in spite of 2 weeks or longer therapy with high-dose corticosteroids 3)Age 16-75 years at the time of signing an informed consent form 5)Patients who agreed to practice an appropriate contraception during the study period, etc
Exclusion criteria
Exclusion criteria: 1.SLE exclusion 1)APS complication 2.General health exclusion 1)Pregnant women or lactating mothers 2)History of severe allergic or anaphylactic reactions to humanized antibodies, murine antibodies or murine-derived products 3)Uncontrolled disease in any organ system not related to SLE 4)Require treatments with systemic corticosteroid within one year, etc 3.Medication exclusion 1)Treated with any B-cell targeted therapy 2)Received other investigational drug within 6 months, or participating another clinical investigation 3)Received a vaccine within 4 weeks, etc 4.Laboratory exclusion 1)AST, ALT>Nu x 2.5 2)serum creatinine>8.0mg/dL 3)neutrophil<1500/uL 4)Hb<7.0g/dL 5)thrombocyte<10,000/uL 6)Positive HIV, HCV, HBs, HBc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy evaluation | — |
Countries
Japan
Outcome results
None listed