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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Arais Quinones

Advanced Pharma - Miami
Miami, FL USA
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Lizelyn Foley

Arizona Arthritis and Rheumatology Research
Mesa, AZ United States
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Lizelyn Foley

C.V. Mehta MD Medical Corporation
Hemet, CA United States
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Lizelyn Foley

Inland Rheumatology Clinical Trials
Upland, CA United States
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Lizelyn Foley

Center for Rheumatology Immunology and Arthritis
Fort Lauderdale, FL United States
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Lizelyn Foley

Precision Research Organization
Miami Lakes, FL United States
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Lizelyn Foley

San Marcus Research Clinic
Miami, FL United States
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Lizelyn Foley

Millennium Research
Ormond Beach, FL United States
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Lizelyn Foley

Clinical Research of West Florida - Tampa
Tampa, FL United States
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Lizelyn Foley

Omega Research Dalton
Dalton, GA United States
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Lizelyn Foley

iResearch Atlanta
Decatur, GA United States
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Lizelyn Foley

June DO, PC
Lansing, MI United States
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Lizelyn Foley

Albuquerque Clinical Trials
Albuquerque, NM United States
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Lizelyn Foley

NewYork-Presbyterian Columbia University Medical Center
New York, NY United States
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Lizelyn Foley

DJL Clinical Research
Charlotte, NC United States
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Lizelyn Foley

Paramount Medical Research & Consulting
Middleburg Heights, OH United States
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Lizelyn Foley

Arthritis & Rheumatology Center of Oklahoma
Oklahoma City, OK United States
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Lizelyn Foley

Altoona Center for Clinical Research
Duncansville, PA United States
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Lizelyn Foley

ACME Research, LLC
Orangeburg, SC United States
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Lizelyn Foley

West Tennessee Physicians' Alliance
Jackson, TN United States
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Lizelyn Foley

New Phase Research and Development
Knoxville, TN United States
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Lizelyn Foley

Ramesh C. Gupta, MD
Memphis, TN United States
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Lizelyn Foley

Sun Research Institute
San Antonio, TX United States
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Lizelyn Foley

Quantum Research - Santiago
Providencia, Chile
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Lizelyn Foley

Servicios Profesionales SMOLAM
Providencia, Chile
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Lizelyn Foley

Centro de Estudios Cl nicos y Especialidades M dicas
Monterrey, Mexico
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Lizelyn Foley

C.V. Mehta MD Medical Corporation
Riverside, CA United States
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Lizelyn Foley

Omega Research Consultants-DeBary
Orlando, FL United States
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Lizelyn Foley

Primary Care Research
Atlanta, GA United States
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Lizelyn Foley

Office of George Timothy Kelly MD
Las Vegas, NV United States
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Lizelyn Foley

Accurate Clinical Research
Houston, TX United States
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Lizelyn Foley

Aprillus Asistencia e Investigaci n
Buenos Aires, Argentina
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Lizelyn Foley

Consultorios M dicos Dr. Catal n Pellet
Buenos Aires, Argentina
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Lizelyn Foley

Centro Polivalente de Asistencia e Investigaci n Cl nica CER San Juan
San Juan, Argentina
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Lizelyn Foley

Centro Medico Privado de Reumatolog a
Tucumán, Argentina
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Lizelyn Foley

Biomedica Research Group
Santiago, Chile
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Lizelyn Foley

Centro de Reumatologia y Ortopedia
Barranquilla, Colombia
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Lizelyn Foley

Centro Integral de Reumatologia Circaribe
Barranquilla, Colombia
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Lizelyn Foley

Centro Integral de Reumatologia Reumalab
Cali, Colombia
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Lizelyn Foley

Centro Medico Julian Coronel
Cali, Colombia
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Lizelyn Foley

Unidad de Investigaci n de las Enfermedades Reum ticas
Ciudad de mexico, Mexico
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Lizelyn Foley

Centro Peninsular de Investigacion Clinica S.C.P.
Mérida, Mexico
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Lizelyn Foley

Consultorio de Reumatolog a
México, Mexico
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Lizelyn Foley

Centro de Alta Especialidad en Reumatologia e Investigaci n del Potos , SC
San Luis Potosí, Mexico
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Lizelyn Foley

Clinica Vesalio
San Borja, Peru
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Lizelyn Foley

Hospital de Apoyo Maria Auxiliadora
San Juan De Miraflores, Peru
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Lizelyn Foley

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

Hospital Nacional Cayetano Heredia
San Martin De Porres, Peru
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Recruitment Status: Open


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