Estudio observacional prospectivo en participantes con lupus eritematoso sistémico (LES) activo (incluida la nefritis lúpica) con respuesta inadecuada a glucocorticoides y al menos 2 inmunosupresores

ReclutandoClinicalTrials.gov

ID: NCT07175285Tipo: OBSERVATIONALInicio: 8 de oct de 2025Fin estimado: 1 de nov de 2032

Resumen

El propósito de este estudio es caracterizar la eficacia y seguridad de las opciones terapéuticas actuales del estándar de atención en participantes con lupus eritematoso sistémico (LES) activo (incluida la nefritis lúpica) con respuesta inadecuada a glucocorticoides y al menos dos inmunosupresores.

Elegibilidad

Edad mínima: 16 YearsSexo: ALL

Criterios de inclusión

Participants must have signed and dated an Institutional Review Board/ Independent Ethics Committee (IRB/IEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines
Participants must be ≥16 years of age at the time of signing the ICF
Meet the European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) 2019 classification criteria for systemic lupus erythematosus (SLE)
Have an inadequate response to glucocorticoids and ≥ 2 immunosuppressant therapies such as cyclophosphamide, mycophenolic acid and its derivatives, belimumab, anifrolumab, rituximab, methotrexate, azathioprine, obinutuzumab, cyclosporine, tacrolimus, or voclosporin, used for at least 3 months each. Eligibility is regardless of prior hydroxychloroquine or any anti-malarial treatment. Inadequate response is defined as a lack of response, insufficient response, or lack of sustained response after at least 3-month treatment with appropriate doses of a standard of care agent. Intolerance or contraindication may be considered as inadequate response provided it is documented and confirmed acceptable by the Adjudication Committee
Have active disease at study entry when signing ICF, defined as:
≥ 1 British Isles Lupus Assessment Group Index (BILAG) A OR ≥ 1 BILAG B with history of SLE manifestations that would qualify for a BILAG A within the last 24 months, AND
Positive autoantibodies (at least one) to confirm diagnosis of SLE: Antinuclear antibody ≥1:160, anti-dsDNA, anti-Sm, anti-Ro (SSA), anti-La (SSB), or low complement (C3 or C4)
Participants with lupus nephritis meeting the study eligibility criteria must have had a renal biopsy per standard of care within the last 6 months indicating the presence of active Class III or IV lupus glomerulonephritis (alone or in combination with Class V) according to the 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS), with \< 60% interstitial fibrosis and tubular atrophy \< 60% global glomerulosclerosis

Criterios de exclusión

Pregnant women
Participants enrolled in concurrent interventional clinical trials involving investigational therapies or any other clinical trial
Participant is unwilling and unable to adhere to the study visit schedule and other protocol requirements

Intervenciones

drug

Current standard of care treatment options

According to the product label

Ubicaciones

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Tucumán Province, Argentina

Walter Spindler, Site 0029 · +54-9-381-5537820

RECRUITING

Organización Médica de Investigación (OMI)

Buenos Aires, Argentina

Joaquin Martinez Serventi, Site 0050

RECRUITING

Instituto De Reumatologia - IR Medical Center - Hospital de Dia

Mendoza, Argentina

Marcos Alfredo Borgia, Site 0008 · +54155440980

RECRUITING

Patrocinadores

PrincipalBristol-Myers Squibb

Contactos

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

Clinical.Trials@bms.com 855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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