Estudio Multicéntrico, Aleatorizado, Doble Ciego, Controlado Activo y con Placebo de 16 Semanas Seguido de Evaluación a Largo Plazo de la Eficacia y Seguridad de Ixekizumab (LY2439821) en Pacientes con Espondilitis Anquilosante Activa

RetiradoFase 3ClinicalTrials.gov

ID: NCT01870284Tipo: INTERVENTIONALInicio: 1 de jul de 2014Fin estimado: 1 de abr de 2018

Resumen

Este estudio evaluará la seguridad y eficacia de ixekizumab (LY2439821) comparado con placebo en participantes con espondilitis anquilosante (EA) activa.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984)
Have active AS defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 and the spinal pain (back pain) score ≥4 on a numeric rating scale (NRS)
Participants should have been on nonsteroidal anti-inflammatory drugs (NSAIDs) with an inadequate response
Participants who are regularly taking NSAIDs or cyclooxygenase-2 (COX-2) inhibitors as part of their AS therapy are required to be on a stable dose
Participants who have been on a tumor necrosis factor alpha (TNF) inhibitor (not more than one) must have experienced an inadequate response
Total duration of prior therapy (NSAIDs and/or adequate physical therapy) should be at least 12 weeks
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

Criterios de exclusión

Participants with a total ankylosis of the spine
Prior or current treatment with adalimumab
Participants previously treated with any biological or other immunomodulating agents except for those targeting TNF
Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than ankylosing spondylitis
Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
Serious disorder or illness other than ankylosing spondylitis
Serious infection within the last 3 months
Breastfeeding or nursing (lactating) women

Intervenciones

drug

Ixekizumab

Administered SC

drug

Placebo

Administered SC

drug

Adalimumab

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.

Buenos Aires, 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.

Caba, 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.

Córdoba, 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

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