Estudio multicéntrico, aleatorizado, doble ciego, control... | EligiMed

Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo de 16 semanas seguido de evaluación a largo plazo de la eficacia y seguridad de ixekizumab (LY2439821) en pacientes con experiencia previa en inhibidores de TNF con espondiloartritis axial radiográfica

CompletadoFase 3ClinicalTrials.gov

ID: NCT02696798Tipo: INTERVENTIONALInicio: 12 de abr de 2016Fin estimado: 3 de may de 2019

Resumen

El propósito principal de este estudio es evaluar la eficacia y seguridad de ixekizumab en participantes con experiencia previa en inhibidores del factor de necrosis tumoral (TNF) con espondiloartritis axial radiográfica (EspAx-r).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Are ambulatory.
Have an established diagnosis of radiographic axial spondyloarthritis (rad-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.
Participants have a history of back pain ≥3 months with age at onset \<45 years.
Have had prior treatment with at least 1 and not more than 2 TNF inhibitors.
Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.
Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.

Criterios de exclusión

Have total ankylosis of the spine.
Have never taken a TNF inhibitor medication or have taken more than 2.
Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.
Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis.
Have a compromised immune system.
Have any other serious and/or uncontrolled diseases.
Have either a current diagnosis or a recent history of malignant disease.
Have had major surgery within 8 weeks of baseline, or will require surgery during the study.
Are pregnant or breastfeeding.

Intervenciones

drug

Ixekizumab

Administered SC

drug

Placebo

Administered SC

Ubicaciones

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Rosario, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Rosario, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

San Miguel de Tucumán, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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.