Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab With Adalimumab Reference Arm, in Children With Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT04527380Tipo: INTERVENTIONALInicio: 13 de abr de 2021Fin estimado: 1 de abr de 2028

Traducción no disponible, mostrando original

Resumen

The reason for this study is to see if the study drug ixekizumab is safe and effective in children with juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) (including juvenile onset ankylosing spondylitis \[JoAS\]) and juvenile psoriatic arthritis (JPsA).

Elegibilidad

Edad mínima: 2 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Participants must have active juvenile idiopathic arthritis (categories of enthesitis related arthritis or juvenile psoriatic arthritis)
Participants must have weight of at least 10 kilograms (Kg), age starting at 2 years for participants with juvenile psoriatic arthritis and starting at 6 years for participants with enthesitis related arthritis
Participants must have all immunizations up-to-date in agreement with current immunization guidelines, in the opinion of the investigator

Criterios de exclusión

Participants must not have active or history of inflammatory bowel disease
Participants must not have active uveitis
Participants must not have active or latent tuberculosis
Participants must not have an active infection
Participants must not have concurrent use of biologic agents for the treatment of the juvenile idiopathic arthritis

Intervenciones

drug

Ixekizumab

Administered SC

drug

Adalimumab

Administered SC

Ubicaciones

Instituto CAICI SRL Loc. 15

Rosario, Santa Fe Province, Argentina

Centro Medico Privado de Reumatologia Loc. 20

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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