A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose Corticosteroids

CompletadoFase 4ClinicalTrials.gov

ID: NCT02953821Tipo: INTERVENTIONALInicio: 16 de dic de 2016Fin estimado: 25 de oct de 2019

Traducción no disponible, mostrando original

Resumen

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

Descripción detallada

This trial was initiated (started recruiting) in October 2016, but first patient was not enrolled (randomized) until December, 2016.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Acthar Gel

1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)

drug

Placebo Gel

1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)

Ubicaciones

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

Patrocinadores

PrincipalMallinckrodt

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