NIPH Clinical Trials Search

UMIN ID: UMIN000000763

Registered date:05/07/2007

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedSystemic lupus erythematosus
Date of first enrollment2007/05/01
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)1000 mg of rituximab on days 1, 15, 169 and 183


Primary OutcomeEfficacy evaluation
Secondary Outcome

Key inclusion & exclusion criteria

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


public contact
Address Japan
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