The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization.
Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening.
Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 during screening.
Have a clinical SLEDAI-2K score ≥4 at randomization.
Have at least 1 British Isles Lupus Assessment Group (BILAG) A score or 2 BILAG B scores during screening.
Are receiving at least one of the following standard of care medications for SLE:
A single antimalarial at a stable dose for at least 8 weeks prior to screening
A single immunosuppressant at a stable dose for at least 8 weeks prior to screening
An oral corticosteroid, initiated at least 4 weeks prior to screening, at a stable dose ≤40 milligrams/day prednisone (or equivalent) for at least 2 weeks prior to screening. If the participant is not receiving an antimalarial or immunosuppressant, the dose of corticosteroid must be ≥7.5 milligrams/day prednisone (or equivalent)

Criterios de exclusión

Have severe active lupus nephritis.
Have active central nervous system (CNS) lupus.
Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.

Ubicaciones

Aprillus Asistencia e Investigacion - Servicio de neurologia

CABA, Buenos Aires, Argentina

DOM Centro de Reumatologia

Ciudad de Buenos Aires, Buenos Aires, Argentina

Framingham Centro Medico

La Plata, Buenos Aires, Argentina

CER Instituto Medico

Quilmes, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Quilmes

Quilmes, Buenos Aires, Argentina

Comite de Etica en Investigacion - CEMIC

Buenos Aires, Ciudad Autonoma de Buenos Aire, Argentina

Clinica Adventista Belgrano

CABA, Ciudad Autónoma de Buenos Aire, Argentina

Sanatorio Británico

Rosario, Santa Fe Province, Argentina

Centro Medico Privado de Reumatologia

SAN M. de Tucuman, Tucumán Province, Argentina

Sanatorio Guemes Cardiocirugia

Ciudad Autonoma Buenos Aires, Argentina

IR Medical Center S.A. Instituto de Reumatologia

Mendoza, Argentina

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus

Resumen