Phase II study of rituximab in patients with severe systemic lupus erythematosus

UMIN ID: UMIN000000763

Registered date:05/07/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Systemic lupus erythematosus
• Date of first enrollment: 2007/05/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 1000 mg of rituximab on days 1, 15, 169 and 183

Outcome(s)

• Primary Outcome: Efficacy evaluation

Key inclusion & exclusion criteria

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

Related Information

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