Estudio Abierto y Aleatorizado con un Brazo de Referencia... | EligiMed

Estudio Abierto y Aleatorizado con un Brazo de Referencia de Tocilizumab para Evaluar la Seguridad, Eficacia y Farmacocinética de Baricitinib en Niños de 1 a Menos de 18 Años de Edad con Artritis Idiopática Juvenil Sistémica

ReclutandoFase 3ClinicalTrials.gov

ID: NCT04088396Tipo: INTERVENTIONALInicio: 12 de feb de 2020Fin estimado: 1 de sept de 2026

Resumen

El motivo de este estudio es evaluar si el fármaco en investigación baricitinib es seguro y eficaz en participantes de 1 año a menos de 18 años de edad con artritis idiopática juvenil sistémica (AIJsist). Los participantes son asignados a 1 de 2 cohortes. En la cohorte 1, los participantes recibirán baricitinib o referencia con tocilizumab. En la cohorte 2, los participantes recibirán baricitinib.

Elegibilidad

Edad mínima: 1 YearEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) as defined by International League of Associations for Rheumatology (ILAR) criteria with onset before the age of 16 years
Participants must have at least 2 active joints at screening and baseline
Cohort 1 (IL-6 inhibitor therapy naive): Participants who are at least 1 year and less than 18 years of age, except in countries that restrict use of tocilizumab in participants less than 2 years of age
Cohort 2 (open-label baricitinib): Participants who are at least 1 year and less than 18 years of age

Criterios de exclusión

Participants must not have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis
Participants must not have persistent oligoarticular arthritis as defined by the ILAR criteria
Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA
Participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis
Participants must not have active fibromyalgia or other chronic pain conditions that, in the investigator's opinion, would make it difficult to appropriately assess disease activity for the purposes of this study
Participants must not have biologic features of Macrophage Activation Syndrome (MAS) over the past 12 weeks
Participants must not have a current or recent (\<4 weeks prior to baseline) clinically serious infection
Participants must not have a positive test for hepatitis B virus
Participants must not have evidence of active tuberculosis (TB) or untreated latent TB

Intervenciones

drug

Baricitinib

Administered orally

drug

Tocilizumab

Administered SC

Ubicaciones

Instituto CAICI SRL

Rosario, Argentina

RECRUITING

Centro Medico Privado de Reumatologia

SAN M. de Tucuman, Argentina

RECRUITING

Patrocinadores

PrincipalEli Lilly and Company

Contactos

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

LillyTrials@Lilly.com 1-317-615-4559

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

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.