Estudio Multicéntrico, Aleatorizado, Abierto, de Grupos Paralelos, de 52 Semanas para Evaluar la Eficacia y Seguridad de Ixekizumab Versus Adalimumab en Pacientes con Artritis Psoriásica que No Han Recibido Previamente Fármacos Modificadores de la Enfermedad Biológicos

CompletadoFase 4ClinicalTrials.gov

ID: NCT03151551Tipo: INTERVENTIONALInicio: 24 de ago de 2017Fin estimado: 4 de sept de 2019

Resumen

El objetivo principal de este estudio es evaluar la efectividad y seguridad de ixekizumab versus adalimumab en participantes con artritis psoriásica (APs) que no han recibido previamente fármacos modificadores de la enfermedad biológicos (FAME biológicos).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Presence of established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
Active PsA defined as the presence of at least 3 (out of 68) tender and at least 3 (out of 66) swollen joints
Presence of active plaque psoriasis with a BSA ≥3%
Men must agree to use a reliable method of birth control or remain abstinent during the study
Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Have had an inadequate response when treated with 1 or more conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)

Criterios de exclusión

Current or prior use of biologic agents for treatment of Ps or PsA
Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
Serious disorder or illness other than psoriatic arthritis
Serious infection within the last 3 months
Active Crohn's disease or active ulcerative colitis
Active vasculitis or uveitis
Diagnosis of or history of malignant disease \<5 years prior to randomization
Women who are breastfeeding

Intervenciones

drug

Ixekizumab

Administered SC

drug

Adalimumab

Administered SC

Ubicaciones

Atencion Integral en Reumatología

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Clinica Adventista de Belgrano

Ciudad de Buenos Aires, Buenos Aires, Argentina

CER Instituto Medico

Quilmes, Buenos Aires, Argentina

Instituto de Asist Reumatologica Integral

San Fernando, Buenos Aires, Argentina