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Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus - NCT00624338-02115(Clinical Trial 204814)



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City:  Boston
State:  
MA
Zip Code: 02115
Conditions: Systemic Lupus Erythematosus, SLE
Purpose: This study is intended to evaluate the use of atacicept compared to placebo in reducing the number of flares for people with SLE. The study is randomized and is designed to find the most effective dose of atacicept. Study medication is administered via subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by weekly doses for one year. Follow-up will continue for an additional 24 weeks.
Study summary:
Criteria: Inclusion Criteria: - 16 years of age or older - Disease history of at least six months meeting at least 4 ACR criteria for SLE - BILAG flare A or B at screening requiring a change in corticosteroids - a positive ANA or anti-dsDNA at screening - Female subjects must be willing to avoid pregnancy Exclusion Criteria: - Active moderate to severe glomerulonephritis (kidney impairment) - Active central nervous system SLE deemed to be severe/progressive - Previous treatment with rituximab, abatacept, or belimumab - History of demyelinating disease or optic neuritis
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: January 5, 2011
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