Last updated on May 2018

A Study to Assess the Efficacy and Safety of H.P. Acthar Gel in Subjects With Active Systemic Lupus Erythematosus (SLE)

Brief description of study

Subjects with active systemic lupus erythematosus (SLE) will be randomized to receive Acthar or placebo. Active treatment will continue for 24 weeks. Efficacy will be assessed at multiple timepoints using the SLE Responder Index (SRI), SLEDAI-2K, BILAG, PGA, CLASI and 28 Joint Count

Detailed Study Description

This is a randomized, placebo controlled, double blind study. Following a screening period of up to 28 days, subjects with active systemic lupus erythematosus (SLE) including moderate to severe rash and/or arthritis despite corticosteroid therapy will be randomized in a 1:1 ratio to receive 1 mL (80 Units [U]) of Acthar or matching placebo. During Weeks 1 to 4, 1 mL (80 U) of Acthar or volume matched placebo will be administered subcutaneously (SC) every other day. For the remainder of the study (Weeks 5 to 24), Acthar 1 mL (80 U) or volume matched placebo will be administered SC 2x/week.

Clinical Study Identifier: NCT02953821

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Advanced Pharma - Miami

2950 NW 83rd St Miami, FL USA
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Precision Research Organization

Miami Lakes, FL United States
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Millennium Research

Ormond Beach, FL United States
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Omega Research Dalton

Dalton, GA United States
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iResearch Atlanta

Decatur, GA United States
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June DO, PC

Lansing, MI United States
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Albuquerque Clinical Trials

Albuquerque, NM United States
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DJL Clinical Research

Charlotte, NC United States
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Paramount Medical Research & Consulting

Middleburg Heights, OH United States
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ACME Research, LLC

Orangeburg, SC United States
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Ramesh C. Gupta, MD

Memphis, TN United States
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Sun Research Institute

San Antonio, TX United States
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Primary Care Research

Atlanta, GA United States
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Accurate Clinical Research

Houston, TX United States
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Recruitment Status: Open

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