A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus Erythematosus

UMIN ID: UMIN000000639

Registered date:16/03/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Systemic lupus erythematosus
• Date of first enrollment: 2007/03/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 day 1 and 15.Repeated at an interval of 6 months (Days 169 and 183).

Outcome(s)

• Primary Outcome: Comparison of overall response rate between IDEC-C2B8 and placebo.

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Zenyaku Kogyo Co., Ltd.
• Source(s) of Monetary Support: Zenyaku Kogyo Co., Ltd.