A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients With Axial Spondyloarthritis

CompletadoFase 3ClinicalTrials.gov

ID: NCT03129100Tipo: INTERVENTIONALInicio: 9 de may de 2017Fin estimado: 27 de may de 2021

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have completed the final study visit in Study RHBV (NCT02696785), RHBW (NCT02696798), or RHBX (NCT02757352).
(Note: Participants from Study RHBX are not eligible if they permanently discontinued ixekizumab and were receiving a tumor necrosis factor \[TNF\] inhibitor).
Must agree to use a reliable method of birth control.

Criterios de exclusión

Have significant uncontrolled disorders or abnormal laboratory values that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered.
Have a known hypersensitivity to ixekizumab or any component of this investigational product.
Had investigational product permanently discontinued during a previous ixekizumab study.
Had temporary investigational product interruption at any time during or at the final study visit of a previous ixekizumab study and, in the opinion of the investigator, restarting ixekizumab poses an unacceptable risk for the participant's participation in the study.
Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol.
Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

Intervenciones

drug

Ixekizumab

Administered SC

drug

Placebo

Administered SC

Ubicaciones

Clinica Adventista de Belgrano

Ciudad de Buenos Aires, Buenos Aires, Argentina

CER Instituto Medico

Quilmes, Buenos Aires, Argentina

Centro de Enfermedades del Higado y Aparato Digestivo

Rosario, Santa Fe Province, Argentina

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Tucumán Province, Argentina

Consultorios Reumatologicos Pampa

Ciudad Autonoma de Buenos Aire, Argentina

CIR Centro de Investigacions Reumatologicas

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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