Estudio adaptativo de fase 2a/2b, aleatorizado, doble cie... | EligiMed

Estudio adaptativo de fase 2a/2b, aleatorizado, doble ciego, controlado con placebo de LY3871801 en participantes adultos con artritis reumatoide moderada a gravemente activa

ReclutandoFase 2ClinicalTrials.gov

ID: NCT05848258Tipo: INTERVENTIONALInicio: 23 de may de 2023Fin estimado: 1 de jul de 2026

Resumen

El objetivo principal de este estudio es evaluar la eficacia y seguridad de LY3871801 en participantes adultos con artritis reumatoide (AR) activa de moderada a grave.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have a diagnosis of adult-onset RA for at least 3 months prior to screening as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria.
Have moderately-to-severely active RA at screening and baseline, defined by the presence of
≥6 swollen joints based on 66 joint count, and
≥6 tender joints based on 68 joint count.
Have had a history of failure (an inadequate response, intolerance, or loss of response) to at least 1 conventional synthetic disease modifying anti rheumatic drug (csDMARD) and either 1 biologic (bDMARD), or targeted synthetic (tsDMARD) treatment.

Criterios de exclusión

Have Class IV RA according to ACR revised criteria
Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to
poorly controlled diabetes or hypertension
chronic kidney disease stage IIIa or IIIb, IV, or V
symptomatic heart failure according to New York Heart Association class II, III, or IV
myocardial infarction,unstable angina pectoris, stroke, or transient ischemic attack within the past 12 months before randomization
severe chronic pulmonary disease, for example, requiring oxygen therapy
major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to
systemic lupus erythematosus
psoriatic arthritis
axial spondyloarthritis,including ankylosing spondylitis and non-radiographic axial spondyloarthritis
reactive arthritis
gout
scleroderma
polymyositis
dermatomyositis
active fibromyalgia, or
multiple sclerosis

Intervenciones

drug

LY3871801

Administered orally

drug

Placebo

Administered orally

Ubicaciones

CIPREC

Buenos Aires, Argentina

COMPLETED

Mautalen Salud e Investigación

Buenos Aires, Argentina

COMPLETED

CENUDIAB

Buenos Aires, Argentina

COMPLETED

Medicina Reumatológica

San Fernando, Argentina

COMPLETED

Instituto de Alta Complejidad San Isidro

San Isidro, Argentina

COMPLETED

Patrocinadores

PrincipalEli Lilly and Company

ColaboradorRigel Pharmaceuticals

Contactos

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

LillyTrials@Lilly.com 1-317-615-4559

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.