Systemic lupus erythematosus
Conditions
Interventions
IDEC-C2B8 plus oral prednisolone(tapering) 1000 mg of IDEC-C2B8 on days 1 and 15.Repeated at an interval of 6 months (Days 169 and 183).
Placebo plus oral prednisolone(tapering) 1000 mg of placebo d
Sponsors
Zenyaku Kogyo Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be enrolled in this study: 1)Patients with SLE diagnosed according to the criteria of the American College of Rheumatology (ACR) (revised version, 1997) and with positive antinuclear antibody 2)Patients who develop moderate or severe flares (one or more BILAG category A, or two or more BILAG category B) in spite of 2 weeks or longer therapy with corticosteroids. 3) As for patients receiving immunosuppressant, the immunosuppressant should be limited to only one, and be limited to azathioprine, 6-mercaptopurine (6-MP), mycophenolate mofetil (MMF) or methotrexate (MTX); and the dosage should not be changed within 4 weeks prior to screening. 4)Sixteen to 75 years of age at the time of signing an informed consent form. 5)Patients who agreed to practice an appropriate contraception during the study period and until recovery of CD20 positive cell.
Exclusion criteria
Exclusion criteria: 1.SLE exclusion 1)Unstable patients with thrombocytopenia 2)Proteinuria>1.0g/24hr 3)Retinitis, unfavorably controlled seizure disorder, confusional state, myelitis, stroke syndrome, cerebellar ataxia, or dementia that is associated with SLE 4)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 medical disease in any organ system not related to SLE 4)Require treatments with systemic corticosteroid within one year 5)Active infection 6)Some infection requiring hospitalization, or therapy with intravenous antibiotics within 8 weeks, or therapy with oral antibiotics within 2 weeks 7)Deep-seated infection within one year 8)Serious recurrent or chronic infection 9)History of any malignancy 10)Active alcohol or drug abuse or history of alcohol or drug abuse 11)Major surgery within 4 weeks 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 4)Severe allergic or anaphylactic reactions to acetaminophen and d-chlorpheniramine maleate, and patients have not tolerability or contraindication for steroid therapy with intravenous and oral 5)Treated with <0.75 mg/kg/day of prednisolone for 7 days or more within 4 weeks 6)Treated with new immunosuppressant(s) within 12 weeks; or whom dosage of a immunosuppressant have been changed within 4 weeks 7)Treated with cyclophosphamide, calcineurin inhibitors such as cyclosporine and tacrolimus within 12 weeks 8)Treated with whole blood or blood component transfusion, immune adsorption, hemodialysis within 4 weeks 4.Laboratory exclusion 1)AST, ALT>Nu x 2.5 2)serum creatinine>2.5mg/dL 3)neutrophil<1500/uL 4)Hb<7.0g/dL 5)Thrombocyte<10000/uL 6)Positive HIV, HCV, HBs, Hbc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of overall response rate between IDEC-C2B8 and placebo. | — |
Countries
Japan
Outcome results
None listed