Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus - NCT00624338-02115 (Clinical Trial 204814)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy204814.aspx
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Boston |
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State:
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MA |
| Zip Code: |
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02115 |
| Conditions: |
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Systemic Lupus Erythematosus, SLE |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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 |
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| Study is available at: |
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Brigham and Women's Hospital
Boston, MA 02115
United States
Primary Contact:
Jade Cumberbatch
Phone: 617-732-5354
Secondary Contact:
Ellen Rotty, BSN
Email: ellen.rotty@emdserono.com
Phone: +1-781-681-2889 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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