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A Study of the Safety and Tolerability of MEDI-570 (Experimental Drug) in Systemic Lupus Erythematosus - NCT01127321-92037(Clinical Trial 635221)



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City:  LaJolla
State:  
CA
Zip Code: 92037
Conditions: Systemic Lupus Erythematosus
Purpose: The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).
Study summary: To evaluate the safety and tolerability of escalating, single, subcutaneous (SC) doses of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).
Criteria: Inclusion Criteria: - Meet or have met at least 4 of the 11 revised American College of Rheumatology (ACR) classification criteria for SLE - Score ≥ 6 points on the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at screening - Ability to complete the study period, including follow-up period through Day 169 - Willingness to forego other forms of experimental treatment during the study. Exclusion Criteria: - History of cancer except basal cell carcinoma treated with apparent success with curative therapy ≥ 1 year before randomization into the study - Evidence of active or latent tuberculosis (TB) - History of primary immunodeficiency - Evidence of infection at any time with hepatitis B or C virus or human immunodeficiency virus HIV-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at screening - History of sepsis or serious, recurrent, chronic infection, current signs and symptoms of clinically significant chronic infection, or recent (within 6 months before baseline visit) serious infection - Any history or evidence of opportunistic infection within 6 months of screening including severe cytomegalovirus (CMV) or herpetic infections (such as disseminated herpes, herpes encephalitis, ophthalmic herpes) - Receipt of cyclophosphamide (IV or oral) within 6 months of screening - Have any absolute contraindications to skin punch biopsies, for example, a history of coagulation disorders
Study is available at: Research Site
LaJolla, CA 92037
United States

Primary Contact:
Gerard Barron
Email: barrong@medimmune.com
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: March 23, 2011
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