Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

Completed · Phase 4 · Has a placebo group

Conditions studied: Lupus Erythematosus, Systemic

In brief

This trial is to study Acthar Gel in participants with active systemic lupus erythematosus (SLE). The doctor will assign eligible patients to one of two groups (like flipping a coin). Participants will receive the treatment assigned to their group for 24 weeks: * Acthar Gel * Placebo Gel, which looks like Acthar Gel, but has no medicine in it. The doctor or his staff will take measurements and ask questions to: * see how well the gel is working * see how safe it is for patients with SLE

Key facts

Study ID

NCT02953821

Run by

Mallinckrodt

People needed

172

Starts

2016-12-16

Expected to finish

2019-10-25

Last updated by the study team

2020-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be eligible to participate in this trial, a patient must:
• Have a diagnosis of SLE according to 4 of the American College of Rheumatology revised criteria
• Have active SLE
• Have moderate to severe rash and/or arthritis as demonstrated by BILAG-2004 score A or B in the mucocutaneous and/or musculoskeletal body systems at both Screening and Randomization Visits
• Have a documented history or screening result of
• positive antinuclear antibody (ANA), OR
• elevated anti-dsDNA or extractable nuclear antigen (ENA) antibodies
• Have been on prednisone (or prednisone equivalent) before the screening visit:
• at least 8 weeks, and
• at a stable dose of 7.5 mg to 30 mg for at least 4 weeks

You may not qualify if…

• A patient is not eligible to participate if he/she:
• Has a history of sensitivity to adrenocorticotropic hormone (ACTH) preparations or porcine products
• Has active lupus nephritis
• Has active central nervous system (CNS) manifestations of SLE

Where it is running

• C.V. Mehta MD Medical Corporation — Hemet, California, United States
• Inland Rheumatology Clinical Trials — Upland, California, United States
• Center for Rheumatology Immunology and Arthritis — Fort Lauderdale, Florida, United States
• San Marcus Research Clinic — Miami, Florida, United States
• Advanced Pharma CR — Miami, Florida, United States
• Millennium Research — Ormond Beach, Florida, United States
• Office of George Timothy Kelly MD — Las Vegas, Nevada, United States
• NewYork-Presbyterian Columbia University Medical Center — New York, New York, United States
• DJL Clinical Research — Charlotte, North Carolina, United States
• Paramount Medical Research & Consulting — Middleburg Heights, Ohio, United States
• Arthritis & Rheumatology Center of Oklahoma — Oklahoma City, Oklahoma, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• West Tennessee Physicians' Alliance — Jackson, Tennessee, United States
• Office of Ramesh C. Gupta, MD — Memphis, Tennessee, United States
• Accurate Clinical Research — Houston, Texas, United States
• Sun Research Institute — San Antonio, Texas, United States
• Aprillus Asistencia e Investigación — Buenos Aires, Argentina
• Consultorios Médicos Dr. Catalán Pellet — Buenos Aires, Argentina
• Centro Medico Privado de Reumatología — San Miguel de Tucumán, Argentina
• Biomedica Research Group — Santiago, Chile
• Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara, Jalisco, Mexico
• IBIOMED Research Unit Aguascalientes — Aguascalientes, Mexico
• Centro Especializado en Investigación Clínica — Boca del Río, Mexico
• Phylasis Clinicas Research S de RL de CV — Cuautitlán Izcalli, Mexico
• Instituto de Investigaciones Aplicadas a la Neurociencia A.C. — Durango, Mexico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.