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

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000000639
• Date of registration: 16/03/2007
• Prospective Registration: No
• Primary sponsor: Zenyaku Kogyo Co., Ltd.
• Public title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus Erythematosus
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus Erythematosus - Rituximab clinical Investigation in Systemic lupus Erythematosus (RISE study)
• Date of first enrolment: 2007/03/01
• Target sample size: 150
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000775
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Yoshiya Tanaka
• Affiliation: School of Medicine, University of Occupational and Environmental Health, Japan First Department of Internal Medicine

• Affiliation: Zenyaku Kogyo Co., Ltd. License-in Product Development Section

Key inclusion & exclusion criteria

Inclusion 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

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

Health Condition(s) or Problem(s) studied

Systemic lupus erythematosus

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 Outcome(s)

Comparison of overall response rate between IDEC-C2B8 and placebo.

Source(s) of Monetary Support

Zenyaku Kogyo Co., Ltd.

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 01/03/2011