A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus - NCT00962832-77004 (Clinical Trial 422459)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy422459.aspx
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| City: |
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Houston |
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State:
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TX |
| Zip Code: |
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77004 |
| Conditions: |
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Systemic Lupus Erythematosus |
| Purpose: |
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This is a Phase II, randomized, double-blind, placebo-controlled multicenter study to
evaluate the efficacy and safety of rontalizumab compared with placebo in patients with
moderately to severely active systemic lupus erythematosus (SLE). The study will enroll
approximately 210 patients at up to 100 sites in North America, Latin America, and Europe.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria
- Diagnosis of SLE
- Active disease at the time of screening
- Agreement to use an effective form of contraception for the duration of the study
Exclusion Criteria
- Acutely life- or organ-threatening manifestations of SLE (e.g., proliferative
nephritis, unstable neuropsychiatric disease)
- Pregnancy or breastfeeding
- History of severe allergic or anaphylactic reactions to monoclonal antibodies or
intravenous (IV) immunoglobulin
- Significant, uncontrolled medical disease in any organ system not related to SLE that
in the investigator's opinion would preclude patient participation
- Concomitant conditions that required systemic corticosteroid use within 1 year prior
to screening. Use of topical, intraarticular, or inhaled corticosteroids is not
exclusionary.
- History of cancer within 5 years of screening
- Any current or recent (within 4 weeks of screening) signs or symptoms of infection,
except for minor infections, fungal infections of the nail beds, or oral or vaginal
candidiasis
- History of severe systemic bacterial, fungal, viral, or parasitic infections (two or
more hospitalizations or two or more courses of IV antibiotics) within 6 months prior
to screening |
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| Study is available at: |
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Rheumatic Disease Clinic
Houston, TX 77004
United States
Primary Contact:
Shree Cooper
Email: scooper@rdch.org
Phone: 713-521-7865
Secondary Contact:
Natalie Rossignol
Email: rossignol.natalie@gene.com |
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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 16, 2010 |
Modifications to
this listing: |
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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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