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A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus - NCT00962832-36207(Clinical Trial 422435)



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City:  Anniston
State:  
AL
Zip Code: 36207
Conditions: Systemic Lupus Erythematosus
Purpose: 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.
Study summary:
Criteria: 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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Data Source: ClinicalTrials.gov
Date Processed: August 16, 2010
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