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UMIN ID: UMIN000000639

Registered date:16/03/2007

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedSystemic lupus erythematosus
Date of first enrollment2007/03/01
Target sample size150
Countries of recruitmentJapan
Study typeInterventional
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).


Primary OutcomeComparison of overall response rate between IDEC-C2B8 and placebo.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum16years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1.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


public contact
Address Japan
Telephone 03-3946-1113
Affiliation Zenyaku Kogyo Co., Ltd. License-in Product Development Section
scientific contact
Name Yoshiya Tanaka
Address 1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan Japan
Affiliation School of Medicine, University of Occupational and Environmental Health, Japan First Department of Internal Medicine