A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis

TerminadoFase 2ClinicalTrials.gov

ID: NCT05516758Tipo: INTERVENTIONALInicio: 31 de ago de 2022Fin estimado: 17 de ene de 2025

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have a diagnosis of adult onset rheumatoid arthritis (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 an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD ( bDMARD), or targeted synthetic DMARD (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 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

Peresolimab

Administered SC

drug

Placebo

Administered SC

Ubicaciones

Organizacion Medica de Investigacion

CABA, Buenos Aires, Argentina

Centro Privado de Medicina Familiar / Mindout Research

Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina

CIPREC

Buenos Aires, Buenos Aires F.D., Argentina

APRILLUS Asistencia E Investigacion

CABA, Buenos Aires F.D., Argentina

Clinica Adventista Belgrano

CABA, Ciudad Autónoma de Buenos Aire, Argentina

Centro de Investigaciones Reumatológicas

San Miguel de Tucumán, Tucumán Province, Argentina

Centro de Investigaciones Médicas Tucuman

San Miguel de Tucumán, Tucumán Province, Argentina

Fundación Respirar

Buenos Aires, Argentina

Hospital Córdoba

Córdoba, Argentina

Instituto Medico Strusberg

Córdoba, Argentina

Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan

San Juan, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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