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

Not Applicable

• Conditions: Systemic lupus erythematosus

• Registration Number: JPRN-UMIN000000763
• Lead Sponsor: Zenyaku Kogyo Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-05
• Study Completion: 2010-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy evaluation