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Clinical Trials/JPRN-UMIN000000763
JPRN-UMIN000000763
Completed
未知

Phase II study of rituximab in patients with severe systemic lupus erythematosus - Rituximab clinical investigation in severe systemic lupus erythematosus

Zenyaku Kogyo Co., Ltd.0 sites30 target enrollmentJuly 5, 2007

Overview

Phase
未知
Intervention
Not specified
Conditions
Systemic lupus erythematosus
Sponsor
Zenyaku Kogyo Co., Ltd.
Enrollment
30
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 5, 2007
End Date
July 1, 2010
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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