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

Contact Investigators or Research Sites near you

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Lizelyn Foley

Clinica Vesalio
San Borja, Peru
1.78miles
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Lizelyn Foley

Cl nica M dica Cayetano Heredia
San Martin De Porres, Peru
4.15miles
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Lizelyn Foley

Hospital Nacional Cayetano Heredia
San Martin De Porres, Peru
4.15miles
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Lizelyn Foley

Hospital de Apoyo Maria Auxiliadora
San Juan De Miraflores, Peru
6.59miles
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Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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